ISO 9001-2008 Frequently Asked Questions (FAQ)

What Is The ISO 9001: 2008 Standard?

The latest edition of the ISO 9001 standard ISO 9001: 2008, Quality Management Systems Requirements, was officially published by (ISO) the International Organization for Standardization on November 14, 2008. It is the fourth edition of the ISO 9001 standard since it was first published in 1987.

ISO 9001:2008 is a standard that provides a generic set of requirements for organizations wishing to develop a quality management system (QMS). The ISO 9001:2008 standard focuses on improving an organizations business processes. It does not specify any requirements for product or service quality.  Customers typically set product and service quality requirements. However, the expectation is that an organization with an effective ISO 9001 based QMS will indeed improve its ability to meet customer, statutory and regulatory requirements.

This is the only QMS standard to which an organization may obtain formal third party certification. Because requirements are generic and not specific, organizations have flexibility in tailoring their QMS to fit their business, culture and risks.

ISO 9001 requirements complement contractual and applicable statutory and regulatory requirements. Those implementing a QMS conforming to ISO 9001 must ensure that the specific requirements of their customers and relevant statutory and regulatory agencies are met.

Who Is Responsible For Revising QMS Standards?

The ISO Technical Committee no.176, Sub-committee no.2 (ISO/TC 176/SC 2) is responsible for the revision process in collaboration with consensus among quality and industry experts nominated by ISO Member bodies, and representing all interested parties.

Does ISO 9001:2008 Have Additional Requirements Beyond ISO 9001:2000?

This latest (4th) edition of ISO 9001 contains no new requirements compared to the (3rd) year 2000 edition, which it replaces. What it does is provide clarification to the existing requirements of ISO 9001:2000 based on eight years experience of worldwide implementing of the standard and introduces changes intended to improve consistency with the environmental management system standard, ISO 14001:2004.

The clarifications and changes in ISO 9001:2008 represent fine-tuning, rather than a thorough overhaul. It focuses on changes that organizations might make to better comply with the spirit of the standard without adding, deleting, or altering its requirements. The changes are minor in nature and address such issues as the need to clarify, provide greater consistency, resolve perceived ambiguities, and improve compatibility with ISO 14001. The numbering system and the structure of the standard remain unchanged. As a result, the new standard looks much like the old standard.

ISO has organized the changes incorporated in this ISO 9001:2008 edition into the following categories:

- No changes or minimum changes on user documents, including records

- No changes or minimum changes to existing QMS processes

- No additional training required or minimal training required

- No effects on current certifications

In contrast, the 3rd edition, ISO 9001:2000 published in 2000, represented a major overhaul of the standard, including new requirements and a sharpened customer focus, reflecting developments in quality management and experience gained since the publication of the initial version.

Then Why Was It Necessary To Introduce This Revision?

All ISO standards, currently more than 17 400, are periodically reviewed. To ensure that ISO standards are maintained at the state of the art, ISO has a rule requiring them to be periodically reviewed and a decision taken to confirm, withdraw or revise the documents. The review process must be initiated within 3 years of publication of a standard. The review considers several factors such as technological evolution, new methods and materials, new quality and safety requirements, or questions of interpretation and application.

The review of ISO 9001 resulting in the 2008 edition was carried out by subcommittee SC 2 of ISO/TC 176. This subcommittee, which is responsible for the ISO 9000 family, unites expertise from 80 participating countries and 19 international or regional organizations, plus other technical committees.

This review has a number of inputs that help it:

o A global user questionnaire/survey 

o A market Justification Study 

o Suggestions arising from the ISO/TC 176 interpretation process 

o Opportunities for increased compatibility with ISO 14001 

o The need for greater clarity, ease of use, and improved translation

o Current trends - keeping up with recent developments in management system practices.

How Does The New ISO 9001 Standard Affect Existing ISO 9001 Quality Management Systems?

As currently certified organizations start looking at ISO 9001:2008, they will wonder to what extent the changes will affect them. To a large extent, the new standard will not result in significant change to existing quality management systems (QMS).

ISO/TC 176 was careful in not making change for change sake. The changes that have been incorporated into this edition of the ISO 9001 standard include changes that should lead to a better understanding across a broader range of product types, including service organizations; use of deliberate wording to minimize the potential for incorrect user interpretation; and reflect nuances of similar word concepts. Lastly, some of the changes to specific clauses were made based on the 2004 International User Feedback Survey. This survey was conducted after the publication of ISO 9001:2000 and had invited respondents to identify areas they most wanted to see improved.

What Is The Transition Time Frame To Comply With This Revision And Does My Organization Require Full Re-Assessment For Certification?

Certification to ISO 9001:2008 is not considered an upgrade.  The rules for transition are as follows:

1. The new edition will not require any specific reassessment for certification. Certification Bodies will evaluate conformity to the new ISO 9001:2008 standard during regular surveillance visits and full reassessment will only take place once your current certificate expires.

2. ISO and the IAF have agreed that all certificates to ISO 9001 should be transitioned to ISO 9001:2008 within 2 years of publication date, (i.e., by November 14, 2010). Your organization can request your Certification Body (Registrar) to asses your QMS to ISO 9001:2008 at your next Surveillance audit.

3. One year after publication of ISO 9001:2008 (i.e., by November 14, 2009), all certifications issued (new certifications and re-certifications) must be to ISO 9001:2008.

4. Two years after publication of ISO 9001:2008 (i.e., by November 14, 2010), existing ISO 9001:2000 certifications will not be valid.

5. Organizations in the process of certification to ISO 9001:2000 are recommended to apply for certification to ISO 9001:2008.

This transition plan is deemed realistic, because ISO 9001:2008 introduces no new requirements. So basically, you have a two year transition window starting from November 14, 2008, so don't leave it to the last moment to make the transition.

What Will Happen To The Other Standards And Documents In The Current (2000) ISO 9000 Family?

The four primary standards of the current ISO 9000 family are the following:

o ISO 9000:2005 already published  - no major changes expected for 2009 

o ISO 9001:2000 to be superseded by ISO 9001:2008 

o Significant changes are planned for ISO 9004 with a planned publication date of late 2009. 

o ISO 19011:2002 is currently in the initial stages of the revision process, with a new version expected in 2011.

The other standards and documents will be reviewed and updated as necessary.

How Much Is The Implementation Of The New Standard Going To Cost?

One of the goals of ISO/TC 176/SC 2 is to produce standards that will minimize any potential costs in implementation or transition.  Any additional costs may be considered as a value-adding investment. A key factor in the development of ISO 9001:2008 was to limit the impact of changes and costs on users. So don't flinch at negotiating with your certification / registration body, if they try to increase costs of certification.

What Do Auditors Need To Know About ISO 9001:2008 Standard? 

Auditors, whether external or internal, should be able to demonstrate their competence on the structure, content and terminology of the standards listed below, and also on the underlying Quality Management Principles.

The standards require that auditors are able to understand the organization's activities and processes and appropriately audit against the requirements of the ISO 9001 in relation to the organization's objectives. Auditors should be able to demonstrate competency in:

o The requirements of the ISO 9001:2008. 

o The concepts and terminology of the ISO 9000:2005. 

o The eight Quality Management Principles 

o A general understanding of  ISO 9004 

o Familiarity with the auditing guidance standard ISO 19011. 

How Will ISO 9001:2008 Relate To The Needs Of Specific Business Sectors? 

ISO 9001:2008 remains compatible with existing management systems standards for specific business sectors like ISO/TS 16949, AS 9000/EN 9100 and TL 9000. 

Users of a specific sector scheme should refer to the organization that is responsible for that sector scheme, e.g. for:

o           ISO/TS 16 949 refer to the IATF, 

o           TL 9000 refer to the QuEST Forum 

o           For AS 9000/EN 9100 refer to the IAQG

If you enjoyed reading this article and want to learn more about the specific changes in ISO 9001:2008, then you may  visit the web site Askartsolutions/ for tons of free information and tools on quality and other business management systems.

 

Q.Base quality management system

A problem has emerged since the rapid development of quality standards - ISO 9000, as companies had many difficulties in applying these standards, especially in a matter of costs.

Telare - the leading quality certification agency in New Zealand, after researching the market, has presented a quality management system (QMS) but simpler and easier way apply basic standards of ISO9000, in a still used. This system contains all the essential requirements, a company, a good relationship with the customer to maintain and their faith in the product or to keep service. This system is referred to as Q.Base.

For some issues Q.Base not clarify how in ISO9000, but requires companies to build some basic standards. A company can start from Q.Base system and develop its standards according to ISO9000. Q.Base is very flexible and any company can apply this system in accordance with the real business condition. This system is a very necessary tool to manage small and medium-sized enterprises, not only in the management of the quality of work.

Q.Base system is a collection of quality management experience in New Zealand and some other countries such as Denmark, Canada, Australia Sweden. Q.Base focuses on the key aspects of the management of the quality of work and policies; the review of contract with customers and suppliers of the chain; in the management of resources, process and complete products; manage audit, documents and training and improvement of the quality.

Q.Base is not such an international standard as ISO9000, but it is more and more generally used as standard in the certification a system for the quality requirements or not. Q.Base used the principles used ISO9000 but in lighter and more applicable way, especially on small and medium-sized enterprises have just developed your QMS.

Q.Base, consists entirely of the fundamental factors of a quality assurance system that help a company to the main business activities in its operation to control. It focuses on the sharing of responsibilities and delegation which makes responsible employees for their actions.

To meet all requirements of the Q.Base can the company of apply new quality standards and gradually to meet all requirements of the ISO9000 (including ISO 9001).

Q.Base is very flexible and not contradictory to ISO9000 or TQM and it is also useful for suppliers for larger companies that have ISO9000 certification.

Finally the Q.Base in the following conditions applies:

o in the company to improve its competitiveness status and the product quality management in the most economical way follow introduction to quality management.
o Treaty between company and customers (party A and B), if customers have a requirement, should the company to insure Q.Base in quality management, quality products for the care applied.
o of third-party certification: the quality management system of the company is examined and certified officially by the CA.

I am a writer by the quality assurance management at http://qualitymanagement.hrvinet.com. Find all the templates, process quality management, ISO... at: ISO 9001 procedures.

Importance of leadership, customer satisfaction and benchmarking in total quality management (TQM)

Implementation of TQM:
* The management's contribution is essential in any successful TQM implementation, especially of CEO.

* Next step is to form a quality circle, providing a vision, mission and quality statement. Middle managers are needed to be actively involved in the implementation.

* If there is any union present in the organization, representatives from it should be involved in the process.
Role of senior management:
Senior management must practice the philosophy of Management provided by Wandering Around or MBWA. They must let the employees think themselves. They must be informed of the topics of quality improvement by generating good reading habits. They must celebrate success in the organization. They must organize seminars, coaching etc. Customer listening is another parameter. Good and regular communication with feedback is again required with employees and consumers.
Characteristics of Quality Leaders
* The quality leaders take the matters with respect to customers and work on the changing requirements of the customers.

* Quality leaders are such that they have total control over the work of their sub-ordinates.

* Quality leaders believe in improvement more than in maintaining the current position.

* These leaders are more likely to prevent any mishap rather than waiting for them to happen.

* Quality leaders develop the skill of mutual co-operation rather than mutual competition.

* Quality leaders believe in working with the team, helping them from time to time.

* They believe in the concept of quality after learning from problems. They strive to improve the ability of dissemination of information.
Leadership Concepts
* A leader is well acquainted with the fact that all employees need independence along with security.

* Even though rewards and punishments matter to a large extent, self-motivation is highly followed.

* It is a common tendency that people like to hear well about themselves. They should be appreciated for their achievements.

* A leader is also required to make things easily understandable.

* Self-confidence is more trustworthy than the statistical data.

* People don't obey a leader if his words contradict.
The 7 Habits of highly Effective People
* The first of these habits is to be proactive which means to look at alternatives and take decisions rather than wait for things to happen.

* Secondly, one must begin keeping the end in mind. One should be true to himself in taking any step in life.

* Thirdly, one must put first things first which is an inclusion of self-management.

* Fourthly, one must think win-win. This suggests that one should always be optimistic.

* Next, one must think such that he can understand what others say rather than seek to be understood by all.

* Sixth, one should believe in synergy such that he can achieve a goal with a feeling of togetherness rather than an individualistic approach.

* Finally, one must look forward to sharpen the saw. This means that one must enhance the four dimensions of nature namely-physical, spiritual, mental and social or emotional.
Quality Council:
Quality council comprises of CEO, senior managers of functional areas like finance, production etc. A regular meeting should be organized to discuss and plan issues like:
* Developing a vision, mission and quality statement,

* Developing a long term goal strategy

* Education and training plan

* Determining performance plan

* Determining processes that improves the present ones

* Establishing multifunctional project and group based work culture, developing a reward system etc.
Core Values and concept:
Some core values in TQM include customer driven quality which considers:
* It is end user who determines the quality of the product not any manager

* Second is leadership which states that

o Leaders need to set directions

o Continuous improvement and learning process in the organization and employees

o Valuing employees

o A more dynamic market response mechanism

o Emphasizing design quality and preventing waste through developing quality in the products

o Long term orientation rather than seeking short term opportunities

o Management by facts

o Developing partnership

o Understanding corporate and citizen responsibility and focusing on end result.
Shared Values:
Shared values process is composed of eight principles. They are:
* Treating others with truth

* plentiful trust on co-workers and associates

* Creating learning atmosphere with unselfish mentoring (employee to management and vice versa)

* Invites new ideas

* Take personal risks for the sake of organizational benefits

* Appreciate people wherever possible

* Honesty

* Put other's interest before your own
Ethics:
Organization must leave cause of unethical behaviour and should manage ethical management program.

Quality Statement:
It includes vision statement: It is what an organization will seek to achieve in near future, mission statement: mission statement states that what is the organization is all about, who are the consumer, how it work etc. and the important one that is Quality policy statement: it is a type of guide for everyone in the organization to know how to provide service and service to the consumers.

Strategic planning:
Strategic planning is for about three to 10 years. It comprises of
* Goal and objectives: Goals are ultimate aim and objectives are intermediate checkpoints.

* Seven steps of strategic planning including consumer need, positioning, predicting future, gap analysis, alignment, closing the gap and implementation.

* Yearly quality improvement process
Communication:
Interactive form is best when communication is between workforce and immediate supervisor, formal communication includes printed and electronic communication which includes graph, posters etc. Feedback adds to the soundness of effective communication.

Decision making:
Here seven habits are highly efficient:
* Being proactive

* Keep the result in the mind

* Prioritizing

* Think "win/win"

* Try to understand first than to be understood

* To be in race (sharpen the saw) and

* Synergy.
Leadership survey:
This is a tool to evaluate the leader's performance.
Customer Satisfaction
Who are customers?
A person who employs the service or buys the product is often termed as consumer or customer. Two types of customers are identified by the customers: External and Internal.
* Internal customers are those lying within the organization like engineering, order processing etc and

* The external customers are those who are outside the organization and buy products and services of the organization.
Consumer perception of quality:
As the customer's need, expectation and values keep on changing, there is no such picture of customer's quality need. As according to ASQ, survey, important factors for purchase for the customer are:
* Features

* Performance

* Price

* Service

* Reputation and

* Warranty
Feedback:
TQM requires customer feedback to be continuously monitored. It is required to identify costumer dissatisfaction, needs, opportunities for enhancement and comparison with substitute in the market.
Methodology for feedback involves comment card, survey, focus group, toll free numbers, report card, internet, customer visits, employee feedback and using standard indexes like ACSI of "American Customer Satisfaction Index". ASCI allow contrast in between company and industry averages.
Using customer Complaints:
Studies suggest that the customer who did not complain is most prone to switch to another product. Every individual complaint is needed to be entertained. Results also suggest that half of the dissatisfied-customers will buy again if they feel that their complaint had been addressed.
Service Quality:
Research suggests that elements of customer service are:
* Customer care: A firm must revolve around the customers.

* Communication: Communication with customers is essential.

* Organization: Such that same level of quality can be delivered to everyone.

* Front-line people: Only the best employees should be allowed to communicate with the customers.

* Leadership: Involvement of management is essential in any quality management process.
Translating needs into requirements:
Kano model is the most basic conceptualization of customer requirement. There are three lines-red, blue and green to explain its ideology. The red line shows innovation, blue shows spoken and expected requirement and green line shows unspoken and expected requirements.
Kano model is based on an assumption that a customer buys when he needs something, however is it not completely true, an organization must overflow the customer needs. This can be understood by "Voice of the customer" concept.
Customer Retention:
It is more powerful and efficient in company's point of view as with customer satisfaction. It is involved with the activities which basically are related to customer satisfaction in order to increase the loyalty of the customers towards the company.
It moves customer satisfaction to next level by determining what is actually important for the customer.
Quality Management Systems
Quality Management Systems like the ISO are required to facilitate the exchange of goods between customers and sellers across different nations worldwide.
Benefits of ISO Registration
* After the inclusion of ISO in the products, it was observed that most of the attributes of internal quality like scrap were measured to be better.

* The reliability of the production also increases as a matter of fact.

* Even the external qualities that were measured by customers were highly improved after the inclusion of ISO standards.

* The time performance of the system also increased vastly as a result of this.

* The cost of producing poor quality also decreased after including ISO standards.
ISO 9001 Requirements
* Scope: ISO 9001 is essential to meet the customer's requirements such that customer satisfaction is attainable.

* Normative Reference: The fundamentals and vocabulary provide the normative references.

* Terms and Definitions: In addition to the standard terms and definition, the chain starting from supply to organization to customer is required in the terms and conditions.

* Quality Management Systems (QMS): The organizations should look to establish, document, implement, and maintain a QMS for effectiveness.

* Management Responsibility: ISO 9001 guarantees management control, customer focus, quality policy, planning, responsibility, and a review by the management at the general level.

* Resource Management: This includes provision of resources, human resources, infrastructure, and a proper work environment in order to achieve the goals.

* Product Realization: This section of ISO 9001 secures planning of product realization according to the requirements of the QMS, customer related process, design and development, purchasing, production and service provision, control and monitoring and measuring devices.

* Measurement, Analysis and Improvement: In general, the statistical technique and the extent of use should also be reasonable by the concept of ISO 9001. Under the monitoring and control there should be customer satisfaction, an internal audit, monitoring and measurement of processes and also products and services. This also includes control of nonconforming products, analysis of data, and improvement continuously by taking corrective and preventive action.
Implementation
The next important factor to understand in this context is the implementation of the quality management system. This can be done in the following steps:
* Top Management Commitment: It is highly essential that there is total support of the higher level authority of the organization.

* Appoint the Management Representative: After the top management is contented with the procedure, it is important that the correct representative is appointed so as to follow the quality system with care.

* Awareness: It is also required at this point of time that the organization spreads awareness of the quality systems as it effects all who are attached with the organization.

* Appoint an Implementation Team: Once the levels are all made aware of the quality systems, the organization should form an implementation team such that it is kept visible to all the employees in the future.

* Training: All the above mentioned teams should be trained in order to produce the best results.

* Time Schedule: There should be a time schedule such that the activity is followed in the correct time sequence and the results expected of the implementation of the quality systems are achieved as desired.
The other processes to follow are selecting of the element owners, reviewing the present system, writing the document, installing the new system, internal auditing, and management review, pre-assessment and registration.

Documentation
One must appreciate the fact that the quality systems are meant to be recognized by all. This implies that it is very important to have simplicity rather than complexity in understanding. It should follow the following four principles:
* Policy: This defines as to what would be done and why would that be so. This should be done extremely carefully as it is the root of the documentation on which the entire quality system depends.

* Procedure: Next, one must decide the methods that would be required in order to achieve the task. It includes making decisions related to when the tasks are to be done etc.

* Work instructions: This gives the detail of the documentation. Based on the readings of the work instructions, the readers would come to know of the idea behind the quality systems.

* Records: In order to keep an account of the actions on a specific product, it is required to keep the record.

* Document Development: In order to provide a proper document, it is required to gather all the policies, procedures, work instructions and forms that are being used presently. This will form the basis of the new work.
Internal Audits
The purpose of internal audits can be seen as follows:
* It will compare the actual performance of the quality system with the one that had been documented.

* It would take the corrective measures for the same.

* All those items that were non compliant previously, would be followed

* It would provide continuous improvement through the feedback to the manager.

* It would also create a further chance of improvement by generating a cause to think.
This internal audit would be done by the auditor by using the techniques of examining the documents and following the procedure of the audit plan.

Registration
If Quality systems are assessed by a third party called as a registrar, it is referred to as registration.
A registrar is chosen based on the qualifications and experience, certificate recognition like approval from RAB, the registration process according to the organization's needs under the time and cost constraints and the auditor's qualifications.
It is essential to mention at this point that registration is not a compulsion. It is rather a provision such that the nonconformities are solved.
Benchmarking
Finally Benchmarking is done to measure performance as a comparison with those adopted by the best organization in the industry.
Reason for benchmarking:
It is a tool to achieve competition and corporate goals. It is a tool for organizations to reduce its weakness and to enhance its strengths. Benchmarking requires external orientation as it greatly reduces the uncertainty offered by global and external competition.
It is time and cost efficient and provides working model of a better process.
The primary weakness of benchmarking is attaining the best practices is just like catching a moving target. Key threat is continuously improving technology.

Process:
Organization that adopts benchmarking, take the process to adjust with the present culture and needs. Six steps that are crucial are as follows:
* Estimate present performance

* Decide what the organization can benchmark

* Apply a study on others

* Try to understand form the data collected

* Plan

* And utilize the findings
Two famous industrial standards are those of Xerox and AT&T's 12 step process. Let's have a close discussion on the above headings.

Deciding what to benchmark:
Most organization has a strategy to decide that which benchmarking strategy to adopt. This is mainly highlighted in terms of vision and mission statement. These statements determine the "critical success factors". Thus when deciding what to benchmark, it is best to start with analyzing vision statement and critical factors.

Understanding present performance:
To apply benchmarking that requires applying outside policies in organization, it is essential to analyze own policies and performance first. Current performance can be understood by various methods such as cause and effect diagram and flow diagram.
Exceptions should be identified. Units of measure must be determined and proper documentation is required here.

Planning:
After identification of process and documentation, next step is to plan the way to conduct the study. A team known as benchmarking team is needed to be selected. It is the responsibility of the team to decide what kind of benchmarking is to be carried out. The team also prepares time-line for the process to decide the desired result from the study carried out.

Studying others:
Studies related to benchmarking concept seek two types of data. They are details of best practices and results that can be measured from these practices. Information needed form others in benchmarking may be present publicly and may not need to research down. But there remain few things that are tough to investigate form open sources. For these kinds of information, team can conduct site visits; questionnaire and can apply the focus group etc to determine the desired information.

Learning form data:
Benchmarking studies can reveal 3 basic kinds of outcomes like
* The result of external process's supremacy over the internal process

* They may be equal

* Internal process can be better than the founded and explored external process
In this analysis, important thing is parameters of judgement of the process.

Using the findings:
If the study of benchmarking standards reveal the gap between the internal process and the observed process in negative, the next task to bridge the task by appropriate steps.

Pitfall and criticisms:
Most important pitfall is benchmarking is like copying others. Question here is how can an organization become the best if it copies from the best? Innovation is lagging in benchmarking.
Thus benchmarking is not a substitute of innovation but is just a source of successful ideas.
Overall, we can see that if the ultimate motive is customer satisfaction; leadership and benchmarking should be deployed in conformity with Quality Management Systems to manage the system well.

Important principles of total quality management systems

A total quality management system organisations can match all your quality systems in a single, unified strategy, to integrate what advantages, which can result in both profitability and regulatory compliance. To make the best of it, the entire company must accept, however, completely the basic guidelines of quality and the way that apply to each and every person.

If a company able to explain how important are its workers of quality standards, and help recognize you as you have any responsibility for a certain level of quality, the company can work much more effective than before. High quality is not subjective judgment, it is something that is easily quantifiable and a TQM system can help to achieve a company its goals.

A total quality management system must integrate many tools, the companies that virtually every industry keep their standards of quality in addition to regulatory compliance can help. If all these tools in a solution, it can easily for an organization to improve the efficiency and the relationship between productivity and quality to harmonise.

A few of the familiar tools for maintaining the quality include things such as strategies for document control, CAPA activities, internal audits, training management, customer treatment of complaints and more. Some of these solutions may be different on the surface, but you are, in fact, directly linked and the most efficient, in conjunction with each other.

Combination techniques such as customer treatment of complaints and CAPA processes is a popular tactic for the increase of the quality measures in a company. A total quality management system is closely bind activities like this so that you will immediately lead others to one. This process deletes some on complications associated with manual solutions that are open to human error.

A TQM system can increase the degree of quality to ensure that when a customer complaint with a company is logged on it quickly will trigger the answer CAPA. The system will tell the company, if the problem is something that should be treated as soon as possible or if it is a frivolous complaint. It will then maintain a record of the resolution process until it is closed, and everyone with the results is satisfied.

Usually the principles declare one quality management system total, quality is something that can and must be maintained effectively. Every customer has to make an impression, of course, if you all seriously take your responsibility for the quality, the company will begin to deliver the products, which include on their customers.

A total quality management system should help companies set measurable objectives that which depend on the customer requirements. In this way, how the company works to meet these needs can regularly improvements of the quality assurance system and ensure that the products are delivered by quality and services to the consumer. Quality principles as this will ensure that company before the opposition and in accordance with sectoral rules remains.

With a total Quality Management System, you can start a program on a single platform and dramatically optimize to increase a company's processes and profitability. Getting to information about the use of Quality management software, and change the way you do business.

Providing total quality management

Quality management is vital with brick and mortar or even online companies. A company's ultimate goal is to meet the needs and expectations of the customer by you quality products or services. Quality must be maintained with a shop in every aspect of operations. The three factors that make up quality management include control, quality assurance and improvement. All three of these factors are within the process of a successful enterprise quality management achieve total interwoven with each other.
Quality control is a part of quality management which is focused on the needs of customers. These include the fault testing during design and production of products or services. Quality control is found normally in design and manufacture a branch. If a company produces each kind of product or service for another, this is important to ensure that products or services specifically meet or exceed client expectations are designed. Quality control methods wraps such as test failures, quality assurance, statistical control and even quality.
Quality assurance is another aspect of quality management, an enterprise, requires your product or service to achieve the confidence. Quality assurance is also known as QA. QA is branch that typically maintains customer requirements and guarantee the products or services that produced by the company meet or exceed the requirements. All errors are eliminated at this level. QA is used to improve the quality of raw materials, regulate services in production, products and components, management, and process even to the entire organization. Quality assurance includes thorough examination of the processes, products and services.
Quality management should also improve quality. Each company should be consistent products or services offered on a regular basis to improve. Consistency is also important. Process improvement, who include improvements and enhancements based on improvement in a company is broken in many factors. These factors can successfully containing certainly drive quality improvement and a company functions.
A target company must work continuously in direction on a daily basis is achieving quality management. This is not a process that can be achieved and be finalized but a constant approach. Control, secure, and improvement are three factors that must be used in order for a business successfully achieve quality management.

Tony Jacowski is a quality analyst for the MBA journal. Aveta solutions - Six Sigma online (http://www.sixsigmaonline.org/) offers online Six Sigma training and certification classes for six sigma, black belts, green belts and yellow belt lean.

How total is your quality management?

Notre Dame football coach Lou Holtz, once said "When all is said and done, more is said than done". Despite of all Reden--passionate talk glossy brochures, clever show high-tech videos, convincing sales pitches, snappy slogan, strategic plans, and solemn Jahresberichte--the service and quality action is provided by most organizations, at best mediocre.

Many well-intentioned "total quality management" improvement efforts are not working. Their international study total quality management practices found in the Conference Board of Canada is a study which showed that "seven out of ten North American companies in their attempt to run a total quality strategy fail". But before we conclude that TQM was just another fad-a "taste of the month"-take a closer look. Only a tiny number of organizations in the United States really tried total quality management. Most spoke about TQM during implementation Pqm-part quality.

Move some quality management to true total quality management is exceptionally hard. Here are a few of the key:

Senior management involvement - Permission, Lippenbekenntnisse--even passionate Lippenbekenntnisse--is not enough. Managers and supervisors adopt, the visible priorities of your boss. All too often service and quality is improving what above delegates in the middle to do below. Vancouver based shark finning Ltd (the world's largest Caterpillar dealer) CEO Jim Shepard and its leaders are not just mainly for all service and quality of training to everyone else are given, the teacher providing sessions for their people.

Aligned and support teams-work during Department, group, branch, project or process of improvement teams are clearly at the heart of today's high performing organizations, managers will find too many teams who go ahead of time. Many medium to large organizations are not prepared more than a few pilot team a year or two of their implementation to support. In an organization with poorly prepared improvement teams smack in "old guard" supervisors and a trainer in a hockey rink is one manager who think or means "if I want any your bright ideas I will give foster innovation to you". Team suggestions inhibiting systems and cross-functional processes reorient a lukewarm and sometimes hostile welcome are given by this very managers and specialists installed and now "Snoopervise" you.

Planning and reporting-service and quality with the same discipline and strict as good business planning needs to be addressed. Manager, employee, $ or training activities aimed at enhancing the stick whimsical convinced some of which it is bound, raises deserves the whimsical service and quality that he or she receives. Effective organizations spend often months management, trade unions, working groups, members of the Board and may be important suppliers and customers in strategic quality planning. Their service and quality are measurement and reporting systems every bit as tightly as their accounts.

Width and balanced recognition-a sure sign of partial quality management is a tools and techniques avoid some improvement. Effective implementations pull together the best techniques from the areas of customer service-understanding and perceived value, improve improve quality - improvement processes at all levels by collecting, analyzing, and monitoring critical performance data (Xerox calls this "fact-based management") and organizational development-building leadership skills and changing the corporate culture.

Capacity as also knowledge building-three can slide of trays, a series of videos and five pounds of books and manuals all delivered through a dynamic Presenter Guide about group dynamics or process management or team members teach. But often not this "spray and pray" approach participants calculate how to keep meetings focused or help resolve conflicts. Improve physical fitness, we all know that the understanding of the healthy common sense ideas is one thing, put something else sense in practice. Technology used in the most training programs does not work. It can be enlightened attendees excited and aware, but leaves is rarely more competent.

True total quality management produces dramatic results. But moving PQM is required so much discipline, consistency in TQM and endless diets or new resolutions on long-term and sustainable lifestyle change new habit-forming as moving year's fitness.

Jim Clemmer is a best-selling author and internationally acclaimed keynote speaker, workshop retreat leader and change management team developer on leadership, customer orientation, culture, teams and personal growth. In the last 25 years, he has delivered over two thousand customized keynote presentations, workshops and retreats. Jim's five international best-seller books include the VIP strategy that on all cylinders, pathways to performance, increasing the distance and the leader's Digest firing. His site is http://www.clemmer.net/articles

Quality management - from the bottom up

One advantage of having a small business is that you don't bother with the management theories that living from selling to larger businesses need to make the consultants. But is this really an advantage? Total quality management is maybe making the correct option for money.

For many companies always quality management the only way to follow. There are huge companies who insist on quality certifications from their suppliers such as e.g. BS5750. Obtaining that could be a costly and laborious process and while you do not require a drive for total quality management, if all these problems then why not take are starting a TQM policy?

Total quality management made sense, the now former Chairman of John McGavigan & co, Jack McGavigan. The family business was founded in 1860 by Jack's grandfather, as a traditional printing business but in the 1960s, it became a specialist in graphics related plastics technology. The Group won a market share of 12% world in the car parts market with innovation and expansion into new technologies.

However, this may not have reached McGavigan had not responded to a growing crisis already in 1987. Competition was hotting and the company was equally pressed from suppliers and customers is how costs increased. The company was already towards quality, with employees, to group together to answer questions in an effort to address set up from bottom to top.

Managing Director John McGavigan automotive products, Edward Smith, believed that further action was required, if disaster was averted. He believed that ' employees are experts, and he was interested in human potential. This meant teams, training and communication.

The will to win was something else, the Smith advocates with high expectations, which form the basis for the company's drive. The company 1.5 would at the same time accept until 2% declines. However, this maximum has been 0.005% - 500 parts per million.

Total quality management has absolutely everyone in society to - therefore the term total', engage, is otherwise useless. The idea is to produce and supply perfect products by perfect processes perfectly satisfied with customers.

That sound like impossible and indeed it is. But the search for "continuous improvement" is the key. Total quality management is not "flavor of the month". It takes years and years. It is a challenge to change the culture of the business, but it is important that everyone is involved. These were the main topics delivered to employees at the McGavigan if your TQM drive began in April 1988.

It has certainly paid off. The company looked Smith to the involvement of employees, an increase in productivity by 80% - improving below provided. And as for the long-term consequences? The company was sold for £ 9.75 million holdings to Pressac.

Robert is a renowned economist and co-author of thinking managers covering a management website quality management and all aspects of managing the modern business world.

Integrated CGMP and ISO 13485 quality management system

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The ISO 13485 Standard is widely used in the medical device manufacturing industry as a means of establishing compliance with Canadian Medical Device Regulation, European Medical Device Directive and other regulations. Since the majority of medical device manufacturers comply with both 21 CFR 820 QSR and ISO 13485 standards, it is practical to consider establishing an integrated 21 CFR 820 and ISO 13485 Quality Management System (QMS).

Documentation Structure

To establish an integrated QSR and ISO 13485 QMS, an organization may use approaches outlined in the ISO 10013 Standard, Guidelines for Developing Quality Manuals. Among other suggestions, this standard gives an example of a documentation structure that can be used for QSR and ISO 13485 quality management systems. While the standard suggests using a three-level documentation structure, most organizations implement four-level structures to include quality records, as required by both QSR Subpart M - Records and ISO 13485, element 4.2.4. A typical four-level documentation structure includes: Quality Manual, Procedures, Instructions, and Records.

Actually, the documentation structure for an organization should most likely start from the quality policy, as the policy, among other commitments, defines the regulations and standards that a company intends to comply with. If you choose to use this approach, your QMS will have five levels, as shown below:

Quality Policy - level 1
Quality Manual - level 2
Procedures - level 3
Instructions - level 4, and
Records - level 5

Quality Policy

QSR, section 820.20 (a) and ISO 13485, element 5.3 require the establishment of a quality policy. To satisfy these requirements an organization may develop a quality policy that meets requirements of both QSR and ISO 13485 standards. While QSR requires a quality policy to include a commitment to quality and be "...understood, implemented, and maintained at all levels of the organization", ISO 13485 requirements are somewhat broader. Therefore, an organization can adhere to the requirements of ISO 13485 which requires that a quality policy include:

A commitment to comply with requirements,
A commitment to maintain the effectiveness of the QMS,
A framework for establishing and reviewing quality objectives

The organization shall also ensure that the quality policy is:

Appropriate for the organization,
Communicated and understood within the organization, and
Reviewed for continuing suitability

Despite the fact that these requirements appear to be rather simple, many consultants and auditors find that most companies have difficulties with documenting their quality policies by not addressing all the requirements above. It is important to establish a quality policy that, at a minimum, addresses all the requirements above because that quality policy will document a company's commitment to establish a QMS that complies with the given regulations and standards. To demonstrate this point, let's assume that one's quality policy does not require its review "for continuing suitability" or does not include "a framework for establishing and reviewing quality objectives". If there are no "triggers", there is a good chance that these activities will not be performed. Let's take a look at a few examples of quality policies that did not address specified requirements.

"We Practice Continual Improvement to achieve Customer Delight by providing Customer-Centric, Qualitative ... Solutions and Services on time"

Assuming that this quality policy is appropriate to the purpose of the organization and is communicated, it does not appear to contain "a commitment to comply with requirements", a "framework for establishing and reviewing quality objectives", and a commitment to quality. Based on these deficiencies, this policy does not meet our requirements.

The second example of a quality policy states:

"[Company] will earn customer loyalty by providing products, services, and interaction experiences of the highest quality and greatest value. To achieve this result, we will:

Ensure that all of our products comply with relevant safety and regulatory requirements;
Ensure our products meet and/or exceed their published specifications;
Maintain and continually improve the effectiveness of our product and service business management systems;
Continually monitor the quality of our customer interactions, with the intent to improve our customer's total experience;
Establish quality requirements for suppliers, partners, and contractors and hold them accountable to comply


Treat customers in accordance with [Company]'s Standards of Business Conduct and Privacy policies."

This quality policy, while apparently very much customer-focused, still does not cover a framework for establishing and reviewing quality objectives and committing to review it for continuing suitability. One of our clients came up with a quality policy that won our "The Worst Quality Policy" Grand Prize. Their quality policy simply stated:

"I improve the Quality of Patient Care and all things [Company name]"

This sorry example of a quality policy has been restated verbatim! (The company name has been omitted). Obviously, this quality policy has met only one requirement: that it has in fact been "established."

Integrated 21 CFR 820- ISO 13485 Quality Manual

While QSR does not specifically require the establishment of a quality manual, Section 820.186 requires a manufacturer to establish a quality system record that: "...shall include or refer to the location of procedures and the documentation of activities required by [the QSR]." This definition very closely resembles requirements for a quality manual for an ISO 13485 compliant QMS. A quality manual is the top-level document of a QMS. There are at least two definitions of what a quality manual for a QMS should be.

ISO 10013, Guidelines for Developing Quality Manuals, element 4.2, gives detailed suggestions for creating a quality manual. It defines a quality manual, among other requirements, as a document that should "consist of, or refer to, the documented quality system procedures intended for [the] planning and administration of activities which [have an] impact on quality". ISO 13485 2003, element 4.2.2 requires a quality manual to include:

The scope of the QMS,
Details of and justification for any exclusion or non-application,
The documented QMS procedures or references to them,
A description or interaction between the processes of the QMS; and
An outline of the structure of the documentation used in the QMS.

The scope of the QMS is usually located in the corresponding section of the quality manual. It simply states which activities an organization performs within the scope of its certification. For example: "My Company, Inc. designs, manufactures and distributes laser generators for cosmetic surgery applications". If an organization does not perform some of the processes required by ISO 13485, clause 7, such as design or manufacture, this fact, with justification, is documented in the exclusions section of the manual.

After we defined the scope and exclusions, let's describe used processes and references to the corresponding procedures. The easiest way to start this is to transform 21 CFR 820 cGMP and ISO 13485 standards from a set of requirements into your company's commitments to satisfy those requirements. For example: If section 820.5, Quality System, requires that:

"Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part." our manual will state:

"QW Medical, LLC. Has established and maintains a quality management system that is appropriate for the specific medical device(s) designed and manufactured, and that meets the requirements of 21 CFR 820 QSR."

Following this approach by addressing all applicable sections of the QSR and the ISO 13485 standard and referencing supporting procedures, we will establish a manual that can be used to meet requirements of 21 CFR 820 and ISO 13485.

Interaction between the processes may be documented in a number of ways. Some companies choose to define interaction of the top-level processes by using variations of Figure 1 in the ISO 9001 2008 Standard. Combining such a diagram with references to procedures within the manual will, to a particular degree, define interactions between your processes.

The last requirement of the element 4.2.2 of ISO 13485 is to outline the structure of the documentation. Very often companies define their structures as four- or five-level documentation structures in the documentation management section of the manual.

Another important function of a quality manual, very often overlooked, is to be a marketing tool. Well written and professionally published, a quality manual may become a powerful promotional instrument. It can communicate to your potential customers, suppliers and subcontractors that your company is not only a quality-conscious organization, but that it also knows how to document and communicate its commitment to quality and compliance with regulatory requirements.

I always wonder what companies achieve by stamping their quality manuals in bold red capitol letters "CONFIDENTIAL". As far as I am concerned, a quality manual is a company's resume for quality, and if you hide your resume, there is a very good chance that you will never get a job! All Quality Works customers are encouraged to make their quality manuals public!

Naming Your Documents

As you may have noticed, the titles of the documents above are quite short. It is a very typical convention in the medical device manufacturing and other regulated industries to call the second-level documentation "Standard Operating Procedures", known as SOPs. Unless one has a level called "Non-standard Operating Procedures," I really do not see a practical or economical reason for long titles. As long as a short title conveys the idea and leads a user to the right place within the system, let's use it. Quality Works relentlessly promotes this optimization and reduction of waste approach throughout all our publications and consulting work. Let's not make things more complicated than they need to be. For example, one of our customers titled their quality manual as "Quality Management System Quality Manual." I bet, just "Quality Manual" will mean the same for users.

Numbering Your Documents

It is not a specific requirement of 21 CFR 820 QSR or any other regulation or standard to uniquely number a part or a document. It is a worldwide practice in most documentation systems to give a document or a component a number and a title, and to identify its revision level. As long documentation titles that we discussed earlier, use of document numbering formats very often present opportunities for improvement.

Once I worked with a cGMP compliant business of less than 100 people, manufacturing fairly simple surgical instruments. Their documentation system included a few numeration formats depending on the type of a document. One of the procedures had a number 000023-001, which they simply called "twenty three." Drawings were numbered in a format like 987-323-11-02.

Is it acceptable to have long and difficult to read and remember) document numbers? Yes, of course! Is it practical? I do not believe so! In the example above, the procedure number, without the tab, contained six digits. This meant that the system was prepared to handle almost one million documents or part numbers. The company had approximately 150 documents and about the same number of parts and probably would never go beyond doubling those numbers. If nothing else, just reading these numbers with sequential zeros in the front may give one a headache. Surprisingly, this is not the worst case. The business that won our "The Worst Part Number" Grand Prize assigned twelve (!) characters to their part numbers in the alphanumeric format.

If you are designing or manufacturing a sophisticated X-ray, CAT scan or other complex piece of equipment, you will need thousands or even millions of parts and documents. In this case, a long part number format would be needed and will make business sense. Otherwise, save yourself the trouble of writing all those zeros and make your numbering system practical. One of my customers, who won my "The Best Part Number" Grand Prize, numbered their QMS documents as 101, 102, 103, and so on. Short and sweet! Most small- and medium-size companies will benefit from this optimization approach. After all, isn't the part title the best designator? Throughout my entire professional career, I worked only with a couple of companies that did not use document numbers. Their documents were simply identified by unique titles and a two-digit revision level, like Quality Manual 01.

Another debatable issue with part-numbering formats is part number designation. Some management systems associate a part number with a particular part type. For example, 20-xxx indicates a procedure, 30-xxx indicates a drawing, P-xxx indicates a policy-level document, and so on. My experience with a number of medical device manufacturers has convinced me in the benefits of a "no designation" system. Three of our clients' systems that used designation failed. Just recently, one of our clients reported that he ran out of range in his company's part-numbering format. The documentation system allowed for assigning materials through a two-digit designator within the part number. When the system was designed a few years ago, needing more than 99 materials was not considered possible. Unfortunately, company's needs change over time, and just a few years later, the QMS needed more than 99 materials causing the existing part number format to fail.

An alternative approach to numbering parts and documents within your management system is a "no designation" approach. In such a system, documents or parts are given sequential unique numbers within a specified format, regardless of their level, type, material, application or other attributes.  

Mark Kaganov was born and raised in Moscow, Russia. He graduated from Moscow University of Radio-electronics and Automation, where he earned his Bachelor's and Master's degrees in design and technology of electronic equipment. While attending the university, he worked for the Institute of Plastics, the former USSR's leading organization in the research and development of plastic materials.

In 1981, Mr. Kaganov immigrated to the United States and continued his professional career in Quality Assurance and Research & Development in the plastics, electronics, and medical device manufacturing industries. He has worked for major US corporations such as Capitol Records, RCA, COBE Laboratories and Medtronic.

Since 1990, Mark Kaganov is the Director of Operations and Lead Consultant at Quality Works. The company specializes in providing businesses with consulting, documentation, training, implementation and auditing in the areas of ISO 9001, ISO 13485, 21 CFR 820, ISO 14001 and other management systems. Among other products, Quality Works offers Integrated cGMP / ISO 13485 Quality Manual.

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ISO9001: 2000 QMS - how to interpret the eight quality management principles

During my early days of employment in the late 80's, the company I worked with engaged a consultant to get the company certified in ISO9002 QMS. I was one of the working committee then. Training was provided, followed by documentation of all our processes. A simple guideline was given to us to "document what we do" and "do what we documented". During that time, this guideline was quite straight forward. So we did and the company obtained its ISO 9002 certification.
In late 90's there was a rush into converting our ISO9002 QMS to meet the new ISO9001:2000 revision. I was told that this new revision is more align to business needs as well as less emphasis on documentation. On the business needs aspect, there is the "Eight Quality Management Principles" in the new revision. They are as follows:-
1) Customer Focus
2) Leadership
3) Involvement of People
4) Process Approach
5) System approach to management
6) Continual improvement
7) Factual approach to decision making
8) Mutually beneficial supplier relationship
Here is the interesting part of this article. The author like to share with readers how some of the companies he worked with interpret these principles and applied them. By no means these companies are wrongly applied the Eight Quality Management Principles. As a matter of fact, these companies has their valid reasons for doing so. This articulation of the principles is written in 3 parts, namely; principles supposed to meant; how it is applied as a case; and author's view to expand its application
Principle 1) Customer Focus

"Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations".
Case 1) Many companies viewed customer needs are obtained from a survey. And as ISO auditor come around to conduct surveillance audit once or twice a year, they get the survey done right before the auditor come around.
Author's view 1) Conducting a survey is a form of documentation. In fact, customer needs can be obtained in many forms (most company knows that). Other than a formal survey, customer needs obtained in other forms such as during customer visits, customers complaints, customer feedback etc. These data should be taken officially as an input into the ISO system
Principle 2) Leadership

"Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives".
Case 2) Most leaders set direction in the Quality Policy and Quality Objectives. Management reviews were conducted to ensure its fulfillment. However, most leaders are not involved in creating an internal environment in achieving the organization's objectives. Most often than not, they delicate to the Quality manager.
Author's view 2) Delegating to the Quality manager seems to be the most logical role to a Quality Manager. However, in some smaller company, Quality manager does not have enough influencing power to his/her peers hence cannot command radical improvement to the Quality System.
Principle 3) Involvement of People :

"People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit".
Case 3) While most company involve their employee in the ISO compliance effort, some involves them in other aspect of the business especially in production and process improvements as well.
Author's view 3) This is the principle which is well implemented by most companies I came across. While it is perfect to involve employee in ISO compliance aspect. Some involve too much with the employee in selecting improvement projects. It is only logical that employee select projects that they are familiar and easy to do. But this selection often miss the key alignment to the company critical issues.
Principle 4) Process Approach

"A desired result is achieved more efficiently when activities and related resources are managed as a process".
Case 4) All if not most ISO certified companies are very good in production processes. Their ISO documentation for these process are well kept. However, their process approach seem to limit within the production and related supporting departments.
Author's view 4) In the aspect of business process such as decision making, there is lack usage of a process approach in decision making. Often than not, quick decision are expected hence attention is not given to go through a logical steps.
Principle 5) System Approach to Management

"Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives".
Case 5) This area seem to show a loose link between production and the rest of the departments especially the supporting group. In some case, Key Performance Indicators (KPI) are established for each department but they are not interdependent.
Principle 6) Continual Improvement

"Continual improvement of the organization's overall performance should be a permanent objective of the organization".
Case 6) In general, most companies work on continuous improvement as oppose to continual Improvement. some of the companies take "fire-fighting" as a way to continual improvement. VEry few realize the objective of this principle.
Author's view 6) it is my opinion companies need to understand that source of information to trigger a continual improvement effort. And to establish it in order to clearly identify whether it is a "fire Fighting" or continual improvement.
Principle 7) Factual approach to decision making

"Effective decisions are based on the analysis of data and information".
Case 7) This is probably the weakness principle in terms of its application. To a large extent, Management make decision based on past experience, statement past around and so on. Often minimum data are sough after when a decision is made. Perhaps it is due to time factor. However, this phenomenon is so in the Quality Department.
Author's View 7) This is an important principle management staffs need to develop. Past right decision made may not be repeated due to changes in the business environment.
Principle 8) Mutually beneficial supplier relationship

"An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value"
Case 8) Most smaller company practice to some extent this principle quite well. perhaps it is due to smaller outfit that cannot command better service from the supplier, person in charge seems to have close relationship with supplier. On the other hand, bigger companies are bound by internal policies that requires 2-3 quotes from different supplier for the same items. Relation ship with supplier does not help to some extent.
Author's View 8) This principle is difficult to master due to the fact that integrity is involved. Unless the company has big volume of purchase and strong vendor development program, it is understandable company pay less attention to this principle.
In summary, while ISO certified companies tried to comply to ISO requirements, they should extent the objectives of these Eight Quality Management Principles to enhance their business such that it become part of their business system.
As a side note, these quality management principles has many similarity to the TQM principles. So, it is of the interest of leaders in ISO certified companies understand it and put an effort to extent the objective of ISO certification beyond certification purpose.
Disclaimer

The "Author's View" section provided are merely the author's personal point of view and has no binding to any implication thereof. The author take no responsibility to the use of this article by anyone in any way.
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Resource Box: About the Author, LM Foong
The author holds a MBA major in TQM. He is an expert in Malcolm Baldrige Business Framework and Baldrige Assessment and TQM Implementations in manufacturing and service sector. He facilitates workshops and Cost Reduction and Productivity Improvement projects. He publishes TQM articles, ebooks, case studies, trainer manual and presentation slides available at More to View or Please Visit my Web Site.

Top 5 quality management software myths - busted!

Technology is constantly evolving and people are more technologically demanding, must keep company with technology the rapid pace of sourcing cutting edge tools, to manage both customers and internal processes. Managing quality and processes manually is a daunting task without the proper tools and can lead to a variety of problems, including delays in project schedules, poor customers, a lack of team motivation and poor resource allocation. To solve these and other problems, the use of an electronic quality management system (QMS) is strongly recommended to save time and costs of process documentation, non-conformance management and risk reduction. This article sheds light on the top five myths relating to quality management software, especially useful, if you use a paper-based system and are not sure, such as electronic QMS will help you.

Myth 1: Electronic quality systems are only for large companies

This widespread myth claims that an electronic QMS is designed and intended only for large companies with multiple sites. The fact is that in such a competitive environment, it is mandatory for every organization to track and tax documents non deviations to manage regulatory compliance - what the size of the company, the sites, or number of employees. All companies have to demonstrate the highest standards and quality auditor if you are certified to a standard that meets industry standards and customer demands. These objectives can be simple with an electronic QMS which ensures continuous improvement, critical information security, visibility, fast problem resolution and fast regulatory approvals

to effectively and efficiently new products market.

Myth 2: Provision of an electronic quality system costs can companies huge amounts of money

The demand for quality management software has competition between suppliers. Companies choose electronic QMS at an affordable price. Many vendors offer less expensive, low-cost quality management software through services such as on-demand / SaaS, where is the software that

the manufacturer's server. Furthermore, this reduces total cost of ownership by over 60% and allows you to implement in days rather than weeks, all for a low monthly fee.

Myth 3: Only technical staff can use quality management software.

It is a common misconception that is about the software relating to the technical team of a company. There is this myth that only IT departments / technical staff of enterprises can handle and use electronic quality systems. The fact is, is it quality management programs that, are software that designed for everyday users who are familiar with the use of the Internet - are intended that user friendly and intuitive. Essentially who can surf the Internet can easily use a well-designed electronic QMS system. Quality management software is more far easier to use than a paper-based system as the QMS software typically help will include manuals and technical support. Additionally, deploying software through an on demand service requires even an IT Department, not how the provider has a support team installed and implemented the software.

Myth 4: Poor at no return on investment on quality management software

If you consider the use of a QMS senior is potential return on investment management usually the QMS's question. Various studies show that quality management can with software for the administrative time, save printing costs reduce production cycles, accelerating change control processes improve and speed of response - all of which adds up to a significant return on investment. One of the largest costs relates to risk; a good QMS will mitigate substantially incorrect documentation using specifications or inspections and offer a thus difficult to quantify, yet significant savings. Depending on the scope of implementation a QMS can offer return on investment in less than 12 months.

Myth 5: Risk of data loss with an electronic quality management system

One of the more persistent myths related to QMS systems includes the perception that the electronic data is somehow risky than paper versions of the data retained. Electronic documents are in fact far safer than all other methods of documentation. Ask a question: you know you back up the files in your cabinet every day? Probably not, but with an electronic QMS a backup of all your data sure every night so that your data is always safe and secure. Do you have a copy of your paper systems off site? With an electronic QMS thats normal - or at least it should be.

If you are looking for ways to save administrative costs, increase productivity, business performance improve and accelerate the process of customer response, is a must have an electronic QMS. Deploying a QMS by on-demand / SaaS solution is an easy and affordable for small and medium-sized enterprises.

Kanupriya is a copywriters for Proquis. PROQUIS offers Web-based compliance management, process mapping and analysis-software. PROQUIS software provides enterprise-wide process automation, complete audit trail and an efficient document change management with the affordable Proquis-on-demand software solution. Visit http://www.proquis.com to request a live demonstration of the Proquis software.

The role of the quality Manager

A quality assurance Manager, also commonly known as the quality manager or quality control manager, is responsible for the development and implementation of quality management systems and practices. You work in a variety of sectors such as manufacturing, engineering, manufacture of food, transport, petrochemical industry and the public sector.

General skills of A quality Manager

Quality Manager have the following skills:

o excellent analytical skills so that you can filter points from complex details and develop plans accordingly.

o effective editors and excellent motivators.

o good negotiating skills.

o good report writing skills.

o you should be familiar with the methods, tools and concepts of quality management.

o you should be able to interpret statistical data using software packages.

o excellent planning skills; able to conduct projects to completion.

o be customer-oriented.

Major area of work

More than often, the role of a quality assurance Manager defines the type of the participating companies. However, the basic needs of all businesses are quite similar. The main task of ensuring the proper production and marketing of products. Integrate to your knowledge and expertise to the objectives and always by first understanding and establishing their role and relationship begin staff line. This gives you the inner knowledge of various processes and the way you work. To gain insight into the amount of work that can be done during a shift, compliance with the highest standards of work.

A quality manager sets standards for policies and often works to assure that are the standards of production up to the mark with the production manager. Check to verify that current standards are capable enough to maintain good customer relations also past records of quality production. There are several teams of quality inspectors are allowed to make products as soon as you come from the production line. This ensures that the were the quality standards.

You are most in demand in the area of production and production, and especially in support functions. Many times, head of Division in both the production and the quality standard maintenance are responsible. You play an important role in a company's success.

The following are the basic tasks of a quality Manager:

o, explain customer needs to the sales and marketing department and identify ways in which the organization can meet.

o various business statistics to analyze.

o identify areas of improvement and document.

o check, test and test the entire production process to verify the quality of products.

o review existing policies and develop new plans for improving the existing quality system.

o procedures which comply with legislation such as equal opportunities, health and safety, and financial regulations ensure.

o check you and evaluate the effectiveness of the changes.

A career as a quality manager can be immensely satisfying for candidates who have an eye for detail and taste for continuous improvement.

Tony Jacowski is a quality analyst for the MBA journal. Aveta solutions - Six Sigma online, http://www.sixsigmaonline.org offers online Six Sigma training and certification classes for six sigma, black belts, green belts and yellow belt lean.

Enterprise quality management systems

Before discussing enterprise quality management it is necessary to define the definition of quality management (QM) systems. Many organizations and other groups of individuals have tried to define QM. There are several different operational definitions of quality, commonly used in many industries. The most common definition of quality is that it meet an integrated approach to achieve and to maintain high-quality output, focusing on the maintenance and the continuous improvement of processes and error prevention at all levels of the organization or exceed customer expectations. Quality management can be classified into two main categories, industry-specific quality and not industry specific QM. For example, some QM programs, such as ISO 14000, AS9100, QS 9000 and TL 9000 industry and others including lean management, six sigma, TQM and ISO 9000: 2000, company-wide quality management programs are. Our goal in this article is the enterprise-wide quality management systems, to compare the comparison of the systems, let me the high level to illustrate view enterprise QM systems.
The lean QM program focuses mainly on removing not value-added activities processes and services in an organization. Japanese engineers mainly Taiichi Ohno and Shingo, developed a concept called the Toyota production system, lean management calls the Western world. The main components of the lean quality management system called the 5S-System: sort, set in the order, lamps, to standardize and maintain. Similar to the principles of lean management, Six Sigma has been intense interest from the business. It was developed by Motorola in the 1980s and was popularized by General Electric Chief Executive Officer (CEO) Jack Welch and others in the 1990s. It is a data-driven approach to process improvement. Statistical tools and mathematical modelling in six sigma, you can reduce the error rate between 3.4 per million and 2 per billion. Framework, called DMAIC (define: define the scope of the problem, measure: collect data, analyze the problem, analyze: determine the cause, implement: implementation of the solution to the problem, and control: monitor and make it free of charge defective), is the heart of six sigma.
Similar to how lean management and six sigma, a considerable number of companies TQM, have applied, is a different quality management system and is the subject of many books and research. It is not a new concept, but it is an extension of a company-wide quality concept from Japan. Researchers have identified several definitions for TQM. The well-known definition of TQM is an ongoing process at the top management be necessary arrangements takes, standards everyone in the organization in the course of all duties to establish and achieve or exceed the needs and expectations of their customers to enable both internal and external. TQM is a never-ending process to meet internal and external customers and customer orientation in all activities in an organization. It uses statistical instruments to make defect-free processes. The core ideas presented by Deming, Juran, Crosby and Ishikawa are the key elements of the TQM. ISO 9000 is another powerful QM system similar to lean management, Six Sigma and TQM which is worldwide across all industries to support continuous improvement. A number of international standards and guidelines is designed to promote by a technical Committee consisting of experts from industry and other organizations around the world QM in organizations. There are five ISO standards: ISO 9000, ISO 9001, ISO 9002, ISO 9003 and ISO 9004. ISO 9000: 2000 is the most comprehensive and it provides a model for quality assurance in design, development, production, installation and services.
I am sure you can understand overview wide QM systems of enterprises. Let us now compare the systems.
Lean management is focused on process flow. It is assumed that the disposal of waste can improve performance. Well known benefits of lean are improving productivity; Quality and flexibility. But the importance of using statistical analysis was appreciated in lean.
Six Sigma assumes that focusing on process performance can improve operational efficiency, can improve customer satisfaction. The adoption of this approach is that variation in all present and analyze this derogation can improve performance. There are two types of variation in each process. Is a normal variation and other abnormal variation. Six Sigma talk about normal variation but abnormal variation. This is a frequent criticism of the use of six sigma.
In contrast to lean and six sigma, TQM focuses on all activities. This approach would assume quality is everyone's responsibility. All employees in an organization should put your best efforts to improve the quality of their products. It focuses on long-term results that require lot of coordination.
Finally ISO. It is a detailed document oriented approach to quality. It is a kind of looking inward approach. Factors are the business environment analysis, market requirements and business needs not taken into account.
Numerous surveys of the above-mentioned QM programs around the world have conducted since 1990. Each QM system begins his journey quality from a different perspective and drives on the shared goal of customer satisfaction. Some organizations integrate a quality management system in other maximum benefits of the quality management programs to. The important lesson for every organization to learn is that by just pick up a company-wide quality system and start you implemented not fruitful results will bring. Organizations should use Deming's plan-do-check-Act approach to implement all QM system. When considering organisational requirements; Customizing QM program to meet the requirements; Conduct some type of pilots which fine tuning test the approach before full implementation would bring maximum benefits. But don't forget, the fine tuning of the approach further certain your business companies large QM program by evaluating the results before the standardization.

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What you should know before implementing an ISO 9001 quality management system

Successfully implementing an ISO 9001 Quality Management System depends on developing a clear understanding of seven aspects of the program, including:
1. The purpose of a quality management system
The principles of quality management are:
Quality is achieved through conformance to defined specifications in terms of performance, price, and delivery and is not just limited to how a product or service looks or performs.
Customer satisfaction is achieved by understanding the customer requirements and using methods to ensure that these requirements are consistently met.
Controlling and improving processes are achieved through the use of documented policies, procedures, and continual improvement activities.
The ISO 9001 Quality Management System is a business system designed to make it easier for companies to comply with these principles.
The system establishes both the rules for identifying the customer requirements and the policies and procedures for providing organizations with the means for delivering products and services that comply with these requirements. It also creates a means for ensuring consistency, stability, and the continual improvement of the processes used in running a business. It's based on documentation and demands effective information management, operational discipline, and accountability.
The ISO 9001 Quality Management System was developed and is managed by an internationally recognized organization. The system was originally implemented in 1987, subsequently revised in 2000, and is currently used in over 130 different countries by over 350,000 companies.
2. The benefits of a system
An ISO9001 Quality Management System has the potential of providing several significant benefits, including:
Improved Profitability - Profit improvement results from more productive employees, better organization, better suppliers, better infrastructure, and systematic continual improvement programs.
Employees are more productive because the system establishes standards for hiring and training, requires employee involvement, and demands accountability.
Documented procedures create better organization, which promotes consistency and reduces the number of mistakes.
Qualification criteria, auditing procedures, and the use of performance measurements improves supplier performance.
Controls and policies placed on the management of the infrastructure including the buildings, machinery, tooling, software and hardware, and the general working conditions result in more reliable and better working conditions.
Corrective and preventive action programs and other continual improvement processes provide a mechanism for preventing problems from reoccurring, finding and fixing problems before they occur, and developing new and better ways of doing things.
If effectively implemented a quality management system can eliminate duplication and process variability, lower cycle times and inventories, and reduce both in-house and field failures.
Improved Customer Satisfaction - Customers benefit because:
Policies and procedures for managing process information, measuring instruments, and the verification and validation requirements result in better products.
Procedural changes and improvements in supplier performance result in better deliveries.
Changes in the way customer communication and product development are managed result in better customer relations.
Increased Sales - ISO 9001 certification is an internationally recognized accomplishment. It's a bragging right but more importantly it's a promotional opportunity. It opens doors to prospects that treat certification as a tipping point or a supplier requirement, and it's a means of letting your customers know that you comply with a set of internationally recognized management standards.
Improved Job Satisfaction - Job satisfaction improves because:
The system includes change processes that provide all employees with an opportunity to make a difference in how a company is managed.
There's comfort in knowing what you're responsible for doing, and
There's security in knowing that the system creates a more competitive position.
The instructions bridge interrelated responsibilities, which eliminates confusion and reduces conflict.
The key word to remember is "potential." The benefits don't come automatically and won't happen without a genuine commitment starting at the top, a system that is well composed and managed, and a long-term commitment.
3. The components of the implementation process
The three components of the implementation process are: 1) documentation, 2) information management, and 3) operational changes.
Documentation - On the surface it may seem that developing the ISO 9000 documentation shouldn't be that difficult. You must have a manual that includes a policy, objectives, scope, and the interaction of the processes; and you must have written instructions for:
1. Managing the quality system documents
2. Managing the quality system records
3. Conducting internal audits
4. Controlling nonconforming product
5. Implementing corrective action
6. Implementing preventive action
The standard also hints at the need for additional instructions, e. g. referring to the work instructions, section 7.1 states "shall determine the following, as appropriate," but technically, aside from the manual and these six instructions, anything more is optional.
The reality, however, is that in order to get the most out of a quality management system a great deal of additional documentation is required. A primary function of the system is to establish consistency and eliminate misunderstandings, which is best facilitated with clear and unambiguous written instructions. Policies, which are a pervasive part of any system, have absolutely no value if they're not in writing, and enforcing accountability is extremely difficult if the responsibilities are not spelled out.
Information Management - Extensive information management is another integral part of the implementation process. Just keeping track of all of the records associated with the quality system is in itself a daunting challenge. Then there are training records, records of all of the customer complaints, warranty claims, and past due shipments. There's also sales and purchasing records, traceability documentation, product development records, verification and validation records, incoming inspection records, and internal and external non-conformance records.
All of this involves gathering, managing, and analyzing information, which is an unavoidable requirement of the ISO 9001 standard.
Operational Changes - The final component of the implementation process is the operational changes, which are the changes needed in order to meet the procedural requirements of your system. These include such things as training, instrument calibration, housekeeping, product traceability, product preservation, managing nonconforming materials, auditing, and the implementation of the corrective and preventive action activities. It's not good enough to say what you're going to do, you actually have to do it.
System documentation and information management are the paperwork part of the system. The operational changes are the action part and represent the part of the implementation process that makes the system work.
4. The system content
An ISO 9001 quality management system is not limited to just the processes and procedures required by the ISO 9001 Standard.
Section 0.3 in the Introduction of the International Standard states:

ISO 9004 is recommended as a guide for organizations whose top management wish to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance.
Section 0.4 states:
This International Standard does not include guidance specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management, or risk management. However, this International Standard enables an organization to align or integrate its own quality management system(s) in order to establish a quality management system that follows the guidelines of this International Standard.
The implications are: 1) you're encouraged to use the ideas in the 9004 standard and therefore not limited to building your quality management system exclusively around the requirements in the ISO 9001 standard, and 2) you're free to combine processes and instructions from other systems.
What makes this significant is the fact that the ISO 9001 requirements are far from inclusive. There's nothing, for instance, in the standard to address inventory control, yet this is a major concern for most companies and a logical addition to a quality management system. The same can be said for product costing. It's difficult to develop the cost of quality if you're not costing your products. Nor is there anything in the standard to regulate environmental, safety, business planning, or financial concerns, all of which have a significant impact on the way most people run their business.
The objective is to create a system that effectively manages the important activities of your business, which means that if something is not included in the standard but nevertheless important to your operation, not only can it be included it should be included.
5. The system structure
The authors of the standard have also made it clear that the outline of the standard is not meant as an outline for the quality system documentation.
Section 0.1 of the Introduction states:
It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.
It is also noted that every system is:
[i]nfluenced by varying needs, particular objectives, the products provided, the processes employed, and the size and structure of the organization.
The message is that you're responsible for structuring your own system. There is no process list and no procedure list anywhere to be found in the standard, and nowhere in the standard is it suggested that you should use the outline of the standard as a basis for identifying your processes or developing your procedures.
To the contrary, a persuasive argument can be made that to do so is a mistake. It limits the scope of the system because it removes the need for thinking about the processes that are unique to your operation, and it bogs down the implementation process because it causes you to design procedures around requirements rather than developing procedures to meet your needs, which can be like pushing a square peg into a round hole.
6. The "process approach"
While the "process approach" is one of the eight quality management principles listed in section 4.3 of the ISO 9004 standards, and the use of the "process approach" is recommended as a means for structuring your ISO 9001 system (refer to section 0.2 of the standard), neither standard provides a clear explanation of what a process approach is.
The ISO 9004 standard defines the process approach principle as:
A desired result is achieved more efficiently when activities and related resources are managed as a process.
The ISO 9001 standard defines a process as:
An activity using resources, and managed in order to enable the transformation of inputs into outputs.
Our way of interpreting the meaning of a "process" is to group related activities based on defining inputs and outputs. For example, the inputs and outputs of the human resource process may be defined as:
Input = Rules for making sure employees are informed and capable of performing the assigned responsibilities
Output = Capable, competent, trusted, and motivated employees
A process that defines the management of the infrastructure of an organization may be described by:
Input = Rules and policies for managing the tangible assets used to support the business
Output =Fewer disruptions, a better working environment resulting in fewer mistakes, better efficiency, better throughput, and more satisfied customers
Policies and procedures that affect such things as hiring, training, and performance management would be part of the human resource process. Housekeeping, machinery maintenance, network maintenance, and the maintenance of measuring devices would be part of the infrastructure process.
The authors of the 9001 standard explain the "process approach" as:

The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management.
Our way of interpreting the meaning of "process approach" is to think in terms of a common objective for a set of different processes. An objective might be the continual improvement of the management system, which is what is used in the illustration shown in the standard; or an objective might be the growth and profitability of the organization, which is what we use in our 9000 Advisers system model. It's the objective that binds the processes together and determines how the processes interact. It is also an explanation that fits the model illustrated in the ISO 9001 Standard.
Structuring systems based on this interpretation of the "process approach" result in systems that are more personal, flexible, and easier to develop. You're not handcuffed by the outline of the ISO
Standard, and you're not limited by the requirements of the standard. You establish processes that represent the particular needs of your operation and develop the policies and procedures that bring about the desired output of these processes. Then you make sure these policies and procedures accommodate all of the requirements of the ISO 9001 Standard.
7. The basic compliance requirements
Under certain circumstances it is possible to request an "exclusion" if for some reason you find it impossible to comply with certain requirements within the standard. The requirement must be part of clause 7 of the standard, you must provide an explanation and the justification for the request in the Quality System Manual, and your alternative solution must not affect the ability "to provide product that meets customer and applicable regulatory requirements." (Refer to sections 1.2 and 4.2.2 of the standard.)
Procedures that are added to your system as a result of ideas taken from the ISO 9004 Standard, or from other systems, or simply because they are an important part of the way you run your business are not subject to the compliance audit for ISO 9001 certification. Only the requirements specified in the ISO 9001 standard are audited, but unless you have been granted an exclusion you must comply with all of these requirements.

Mr. John Orthaber, BS Metallurgical Engineering, MBA
For the last ten years John has worked as independent consultant specializing in quality systems and product costing. He owns Success Resources and the subsidiary The 9000 Advisers, which specializes in assisting companies implement ISO 9001 Quality Management Systems.