Guidelines for writing documents of the quality system ISO9001-2008

If you're reading this, chances are that you have about writing documentation of the quality system of the company. This would include the manuals, procedures, perhaps some of the forms, and possibly some of the work instructions.

ISO9001-2008 supported by a quality manual and documented procedures are required. There are 6 of the quality of the procedures that are in accordance with the ISO9001 2008, but all will end up with more than 6. 6 the necessary procedures are as follows: procedure inadequate materials, internal audit, inspection of documents, checking records, corrective action and preventive measures. You might want to write to some of the additional procedures for your organization. Procedures, such as issue a purchase order, sales order, receive the control, inspection, etc., all very commonly used.

Now you don't want to go to overthinking. However, this does not mean that you have to have a guide of 50 pages. Each of these procedures cannot be written to in paragraph 2, or if you need to adequately describe how to do this. In General, I would like to keep the individual procedures for 1 or 2 pages maximum. If you are not particularly complicated, the majority of the documented procedures can be written to the page.

The manuals can be also very simple. It would be a thing of the 3 or 4 parties. Each paragraph should say something like "We conduct regular internal audits. The procedure for internal audit is the responsbility of the quality Manager. See how to number 8 in the course of the implementation of internal audits.

You don't Necessarily have a documented procedure for everything you can do. For example, in ISO9001 2008 is the requirement that the evaluation and approval of suppliers. Can be very useful to have a documented procedure for how shall be carried out, but it is not a requirement. The organization is very small and the process of evaluating a vendor may be included in the training is not necessary to document this process. Of course, the better you are ready to defend yourself during the audit of your party. But you can describe the process auditor intelligently and you have the records show that you are in accordance with the ISO9001 standard, then you don't necessarily have a documented procedure. View the original article here

How you can get people to adhere to the quality system ISO9001-2008?

Is working with the company, which was registered to ISO9001 2008 for one year. Are large groups of people to work and I very much look forward to visit is. Do you have about 100 employees. This company is very concerning quality standards and are put out an excellent products. In General, are very enthusiastic about the certification of ISO9001 2008. Most of these Management.

There is only one guy who suspect for their quality management system ISO9001-2008 is a nuisance. But he knows how much that means top management have the certification, so he grudgingly goes together with the program. Requests for corrective measures to allocate this man take a little longer to get back. But this is not my main concern curmudgeon.

My biggest concern is 30 or 40 people in a device that is not actually seem to be just very much depends. They sit quietly in training, nodding the head up and down. You ask if they understand what is talking about and say Yes. You will still be governed by the program for a week or two after you told them what should I do.

A week or 2, obviously, to forget the importance such as the identification of products and signature are beyond the control of paperwork. Internal audits are almost always capture a significant number of the unknown parts of shelves or pallets. Often I catch control documents are missing some of the stamps and signatures, must demonstrate that the product has gone in each production process and has been approved to go the next steps.

The company has attempted to address these issues by asking politely line employee on the meeting of the society. This Usually leads to compliance with the above mentioned a week or 2, and the cycle is repeated.

It is the old argument to here carrot versus stick. We reward employees for compliance? And their punishment for violations. I guess each situation is different and unique, and cannot actually make this call, if you know the people involved.

But I'm looking for more ideas here. How will you deal with employees who matter really pay attention to the details? View the original article here

How you can get your people to comply with your quality system ISO9001-2008?

There is no company with a registered ISO9001-2008 for around one year. They're a great bunch of people to use and very much look forward to you visit them. They've got about 100 employees. This company exclusively with quality as they offered excellent products. In General, they are very enthusiastic about the ISO9001: 2008 certification. Most of them anyways.

There is only one person that I doubt it, the quality management system ISO9001-their 2008 to be a nuisance. But he knows what it means for senior management to have a certification, so he went with lukewarm. Requests for corrective measures assigned to this man take somewhat longer to return. A Curmudgeon but this is not my main concern here.

My biggest concern is 30 or 40 people in enterprise really does not seem to care that much. They sit quietly in training sessions, nodding their heads up and down. Ask if they understand what you are talking about and say Yes. Even if they will follow the program for a week or 2 after you've told them what should be done.

After that week or 2 though, they forget the importance of things like the identification of products and signing off inspection paperwork. Internal audits catch almost always a significant number of unidentified parts sitting on shelves or pallets. I often catch paperwork inspection, are some of the stamps and signatures necessary to furnish proof that the product has gone through each production process and has been approved to move to the next process.

The company is trying to deal with these problems by asking politely on the conformity of the employee at the meetings of the company. Typically, this is in accordance to the week or 2 and then the cycle is repeated.

Of course, is an old carrot versus stick argument here. We Reward employees for performance? Or to impose penalties for non-compliance. I guess that every situation is different and unique, and you can't really call this unless you know that people who were involved.

But I'm looking for more ideas here. How to deal with employees who do not really care to be given to the details? This entry was posted on Saturday, October 2nd, 2010 at 2: 46 pm and is filed under Uncategorized. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

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Tips for saving your documents of the quality system ISO9001-2008

If you read this, it is likely that you have thought of writing system documentation on the quality of your company. This will include your quality manual, procedures, perhaps some, and perhaps some work instructions.

In ISO9001-2008 require documented quality manual and documented procedures. There are 6 procedures of the quality required under ISO9001-2008 but all ends up with more than 6. 6 the procedures are as follows: control of non-conforming material, internal audit, document management, records management, corrective action and preventive action. Most likely you want to write some more of the procedures for your organization. Procedures, such as how to issue a purchase order, processing a sales order, receiving inspection, checking of maritime transport, etc, all very often used.

Overthinking it Now does not go. This does not mean that you have a 50 page manually. Each of these procedures can be written in paragraph or, if this is all you need to adequately describe how you can do so. In general I don't like to maintain each procedure to 1 or 2 pages maximum. Unless they are particularly complex, the most documented procedures can be written on page 1.

Your guide to quality can be very simple. It may be a matter for 3 or 4 pages. Each paragraph you can say something like "we conduct periodic internal audits. Procedure for internal audit is the responsbility of the Manager of quality. See the procedure number 8 for how we carry out internal audits. "

You don't necessarily have a documented procedure for everything you do. For example, in ISO9001-2008 is the requirement that evaluate and approve suppliers. You can find very useful to have a documented procedure on how this is done, but this is not a requirement. If your organization is very small and the evaluation process of the supplier may be covered by the training may not be necessary to document the process. Of course you will have better prepared to protect themselves during the audit your third party. But if intelligently you can describe the process of the auditor and you have the records to prove that you are in compliance with the standard ISO9001, then it is not necessarily need a documented procedure. This entry was posted on Tuesday, 10th August 2010 at 2: 47 PM and is filed under From cuttings, overall quality system ISO9001: 2000 blog. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

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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.

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.

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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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.

Benefits of ISO 9001 quality management system

These days, ISO 9001 certification almost helps an organization improve business reputation. The ISO 9001: 2008 to facilitate standard requires the implementation of a documented quality management system, improved performance and efficiency.

ISO 9001 certification is for any organization, regardless of size, type or product including service. A number of requirements that must meet an organization in order meet ISO 9001 standard meet customers, regulatory and legal requirements.

Make sure that customer satisfaction with the quality management system is a key objective of the standard. The ISO 9001 standard includes elements that require monitoring and measurement of processes and continuous improvement.

To achieve certification, an organization should have a documented quality management system and a system of documents. The three main objectives of the documentation should be for the transmission of information, evidence of compliance and knowledge sharing. Quality management system documentation can be in any form or type of media such as paper, electronic or image.

Key elements of the standard must be a compliant quality management system. There are five sections that outline the requirements of a compatible system, section 4 quality management system, section 5 management responsibility, section 6 resource management, section 7 product realization and section 8 measurement analysis.

ISO 9001 section 4 requires that an organization has a documented system of procedures for the control documents and records. Section 5 requires that include quality management system to a quality policy and for the senior assign management, management, commitment, responsibility and authority and perform management reviews

Section 6 of the standard requires your system to address and requirements for resources, human resources and training to verify infrastructure and work environment.

Section 7 of the standard specifies requirements for planning, design and development, purchasing, production, control of customer data property and monitoring and measurement.

Section 8 defines the quality management system requirements for measurement, monitoring and improvement and includes internal audit, control of non-conforming product, corrective and preventive measures of which all mandatory procedures are defined by the standard subclause subclause.

ISO 9001: 2008 refers specifically to only 6 documented procedures, but other documentation of an organization may be necessary to manage the processes that are required for the effective operation of the QMS. In addition to the minimum document requirements, the standard defines twenty-one specific requirements for records.

There are several requirements of ISO 9001: 2008, where a quality management system to add value by preparing other documents approved compliance such as process to demonstrate flow charts, organization charts, process descriptions, specifications, instructions, supplier lists and test plans.

The documentation in a system ISO 9001 certification requires less than incriminating to the year 2000 and the value has never been higher ISO 9001 certification for an organization. Certification sends a clear message to all interested parties that an organization is committed to high standards and continuous improvement.

Learn how you can implement your own Quality management system both cost effective and easily by purchasing one of our quality manual packages. You can also in this ISO 9001 manual be interested to develop of a HACCP system.

Total quality management system

TQM is a total quality management system.
According to Histoshi Kume "TQM is a management method to succeed." "It creates appropriate conditions for the sustainable development of the Organization (or companies) to create Director everyone seeking economic quality according to customer request".
ISO 9000 - "total quality management (TQM) ,a management approach that aims for the long-term success of aims, by focusing on customer satisfaction." "TQM is based on the participation of all members of the organization or society in improving processes, products, services and culture where you work."
The goal of TQM is to help produce a quality product, lowing the costs, improve productivity, shorten lead times and make a proper delivery. This means also that TQM for the 3 P aims: (1) performance or perfection, (2) price and (3) timeliness of the quality of the product through the hassle of all Member States of the organization.
TQM is a set of principles for improving through promotion of direct and indirect employees, officers and managers (employees short) in improving processes, products, services and culture.
These principles are generally:
o is it customers, set quality standards for the product and your needs are absolute.
o the highest level manager of the company must be the person who follows the quality standards.
o quality is a strategic issue and must consider the priority in the plan making.
o quality is the problem of all people in all levels and departments in the Organization and all must work together to solve this problem.
o the functions of the company must focus on the continuous improvement to achieve the strategic objectives of the organization.
The problem-solving and continuous quality improvement based on the statistics quality control (SQC) method and the use of the Deming cycle.
Education and training are the basis for continuous improvement.
The basic modules of TQM include:
o quality control circle
o 7 technical tools to control and improve the quality
o Kaizen (quality management theory of a Japanese)
o 5s (house keeping)
o QC (quality control story) history
o PREMA - GHK (profitable environmental management - good housekeeping Guide)
I am a writer by the quality assurance management at http://qualitymanagement.hrvinet.com. Find all the templates, process quality management, ISO... at: quality management.

Implementing an ISO 9001 quality management system

Implementing a quality management such as ISO 9001:2008 requires transforming the culture. It will affect the entire company, not just the quality department. More people in the organization are affected by it than just the management representative, or the person spearheading the effort. Implementing a quality system to the point of certification and registration is a daunting task but is achievable with your current resources. Implementation times can vary but it can be accomplished.

When considering implementation of a quality system such as ISO 9001:2008 you should consider "why are you doing it?" Companies pursue quality system implementation for various reasons, to become better, their customer's are requesting it, they are having quality problems or they would like the recognition of being certified. In either scenario, the circumstances are different as will be the driving force to implement the quality management system. An organization should consider the benefits of having an ISO 9001:2008 quality system and are not concerned about flying the flag. The following steps best describe the implementation process:

1. Why do you want to implement an ISO quality system?

2. Educate Top Management

3. Commitment from Top Management

4. Select a Management Representative

5. Select Implementation Team

6. Understand the current system and processes

7. Understand the Standard

8. Gap Analysis

9. Create an Implementation Plan

10. Employee Training

11. Monitor

12. Internal Auditor Training

13. Internal Audits

14. Select Registrar

15. Management Reviews

16. Continual Improvement

17. Pre-Assessment Audit

18. Registration Audit

Why implement a quality management system such as ISO 9001:2008 To understand why you would consider implementing a quality management system, let us understand the various quality management systems. There is the ISO 9001:2008 standard along with the industry specific standards such as ISO/TS 16949 (Automotive), TL 9000 (Telecommunications) and AS9100 (Aerospace). In addition to these standards is the Malcolm Baldrige Award.

The ISO 9000 standards cover all areas of control which has a potential to impact the degree of compliance of a product or service. The standard is not a cookie cutter quality system that means you will have the same quality system as your competitor, or customer. It means you will have quality systems that meet the minimum requirements but the details of how the requirements are met can vary dramatically.

There are several misconceptions surrounding the standard, one is it creates a great deal of non value added paperwork, another misconception is it does not provide any value because all I have to do is "say what I do and do what I say" and they third misconception is it restricts creativity by burdening employees with structured approaches.

Addressing the first concern of generating non value added paperwork. The belief is you must document, document, document everything you do. Actually, the standard requires one quality manual, six procedures, instructions where?necessary and 26 records. This may sound like a lot but it really is not. The need for extensive documentation can be mitigated with a thorough training program that reinforces what is to be done and how it should occur. It is common for companies to utilize more documentation than the standard requires, simply because they find it valuable. When you are in an environment of continuous change and improvement, processes, duties and tasks are continually changing to keep pace with improvement. It could be extremely hard to know what the agreed upon method was without a formal documentation and change process. The end process would drift because the tasks within the process drift. It would be analogous to not having maximum speeds posted; they would be verbally communicated from area to area.

The second misconception is that the standard does not really benefit a company because it simply means you documented what you do (even if it is wrong) and you can show you do it. I recall an example when I was touring a manufacturer and I could see they were lacking in quality systems. I asked the Vice President of Quality if they considered adopting an ISO quality system. He replied, "ISO is nothing more than doing what you say you'll do. We could make cement life jackets and we could get certified. Our customers wouldn't buy cement life jackets". I listened to what he said (laughing inside) and suggested he get some training on the standard, because that is not the intent. The current standard focuses on ensuring you provide a product or service that continually meets the requirements of the customer with the aim of improving customer satisfaction. To make a long story short you could have a system that is extremely well documented and everyone follows the procedures and instructions. If this system is not producing an output that is meeting the requirements of your customer you will not get certified, end of story. Understand, the documentation portion of the standard is a tool or method, the end game is customer satisfaction and meeting you business goals.

The third misconception perceives the standard as restrictive in that it binds employees into a specific, structured way to do their job. It removes creativity and replaces it with a mundane repetitive approach. This is to some degree true and dependent upon the organization. The level of control is at the discretion of the company. My experience supports having a level of structure that is consistent with achieving the desired output of the process. For example, if the process is purchasing, the desired output is to have quality product delivered on time in the correct quantities.

The ISO 9001:2008 quality system standard provides an organization with a solid quality management system to build upon and improve. The objective of the ISO 9001:2008 standard is to provide a guideline which enables an organization to deliver a consistent product or service that meets the customer's requirements and strive to enhance customer satisfaction. The requirements within the standard are developed for a company to maintain a predictable output from their key business processes and continually improve those processes.

ISO 9000 is a combination of three quality system standards, ISO 9000, ISO 9001 and ISO 9004. The ISO 9000 standard covers the concepts and vocabulary. The ISO 9004 standard is guideline for improvement. The ISO 9001 standard is for quality system requirements and is the only?standard with requirements. ISO 9001:2008 means the ISO 9001 standard with the revision year of 2008. From this point forward when I reference the standard I am referring to the ISO 9001:2008 requirements standard.

Is an ISO 9001 quality system right for you? To answer that you must first answer why are you going to implement and possibly get certified to the standard? Let me give you a few scenarios that may help.

Scenario 1 Your company is doing well. Your sales are increasing, you have little or no competitive pressure to reduce costs and upper management is happy with the current state of the company and the business climate. Your customers are not requesting you to become certified and do not perceive a competitive advantage with having an ISO 9001:2008 certification. Implementing and becoming certified to the standard is probably not right for you at this time. Chances are you will not get the support you need or convince anyone in upper management there is a need. Could implementing an ISO 9001 quality system improve your current situation? Absolutely, you could see cost savings and improvements in all types of areas. Implementation is more of timing thing and right now sounds like the wrong timing.

Scenario 2 Your company is doing well. Your sales are increasing, you have competitive pressure but your current business practices are able to keep you competitive. Upper management is happy with the current state of the company, but your customers are requesting it of you. You are pursuing ISO 9001:2008 certification because your customers require it. I have experienced this difficult situation many times. The major obstacle is that nobody in the organization wants it or realizes a need for it. The driving force is external. An ISO 9001 quality system will probably be implemented and certified. The big question lies in the long term effectiveness and sustainability of the system or is it only needed to "fly the flag". You can approach this by learning as much as you can about the standard so you can speak intelligently about it. You will continually "sell" this program to upper management to obtain their buy in. Once the benefits of the program begin to surface, your selling efforts will diminish.

Scenario 3 Your company is doing marginal to bad. Sales are level to decreasing; you have quality problems that are adding a lot of cost. You are experiencing pressures from global competitors. Upper management is not content with the current state of the business, but they are unsure what to do. The climate is good for implementing an ISO 9001 quality system. If you can convince top management of the benefits and expected results of having a quality system this can be very good environment for implementation. You can choose to not become certified, you will gain benefits by simply having a quality system modeled after ISO 9001:2008. The benefits of having a structured quality system will provide the incentive and reward. Having implemented ISO 9001 quality systems in all three scenarios, experience has proven scenario 3 is the best. It is much easier to achieve buy in and commitment from the top.

The overwhelming question for top management to answer is "why are we doing this and what do we want from it?" Understand why you are doing it and be fair regarding what you want from it. Don't go in with expectations of an elite quality system generating a great deal of benefits if you're going to seek the path of less resistance toward implementation and registration.

Educate Top Management The education process for top management is a two-part approach. One part is to educate them on what ISO 9001:2000 is, the benefits, how it fits into your current business and what it will take to implement the system and be certified. The second part is to educate them and ensure they understand why they are doing it and what the challenges are.

What are the ISO 9000 standards? We discussed this previously; ISO 9000 is a combination of three quality system standards, ISO 9000, ISO 9001 and ISO 9004. The ISO 9000 standard covers the concepts and vocabulary. The ISO 9004 standard is guideline for improvement. The ISO 9001 standard is for quality system requirements and is the only auditable standard.

The ISO 9000 standards are internationally recognized. They are developed, maintained and revised by the International Organization for Standardization or ISO. ISO maintains thousands of standards. The ISO 9000 standards deal with quality management. You may have heard of ISO 14000 which deals with environmental management.

The ISO 9001:2000 standard is adopted as a national quality system in more than 100 countries throughout the world. There are over 700,000 ISO 9001:2000 certificates issues in more than 140 countries worldwide. The number of certificates in Europe exceeds 200,000; the number in the US is over 60,000 with an estimated 30,000 organizations currently pursuing ISO 9001:2000 certification.

The benefits of an ISO 9001:2008 quality system The soft benefits of an ISO 9001:2008 quality system are improved quality and customer satisfaction. The hard savings come in the form of a tangible reduction in the cost of quality. Appraisal costs will decrease significantly as will failure costs. A slight increase in prevention costs should be observed, which is desired, but the savings in the other two areas will overshadow the slight increase you see in prevention costs. For a quick review, appraisal costs are those costs associated with inspecting, evaluating and testing. Failure costs are costs associated with scrap, both internal and external along with warranty. Prevention costs are associated with quality planning, fmea's, control plan development and quality engineering. Depending upon your company's current situation including market, size, business practices and culture, it should be safe to estimate a savings in the area of 1% of sales. There is no reason why you can't realize savings of up 2 - 5% of sales. This amounts to approximately $1,250,000 annually for a $50,000,000 company. On average for a $10,000,000 company you could expect savings in the $250,000 range. Where do the savings come from? They are in the form of reduced inspection, rework, scrap, warranty and handling customer complaints. How does the implementation of an ISO 9001:2008 quality system realize cost savings? It is estimated that approximately 75% of the total quality costs are the result of internal and external failures. For a manufacturing company, failure costs are associated with sorting or reworking product. For a service company, examples of failure costs would be working with a customer to resolve a problem or revising documents because they were not done correctly. Having a quality system in place will reduce significantly the amount of failure costs incurred. You will also be able to reduce the amount of appraisal costs or how much you test, inspect or validate the product or process. Below is an example of the savings realized by a company after implementing an ISO 9001:2008 quality system.

A study was completed that showed a company reduced it's total cost of quality from $1,323,302 to $748,567.? These are staggering improvements. Keep in mind that sales remained level but direct labor hours did not. A reduction in direct labor hours was observed due to process improvements. The cost of quality breakdown does not include financial gains in productivity, inventory reduction and reduction in changeover time. An important feature to recognize in the chart above is the shift in costs from appraisal and failure category to prevention.

The important thing to remember is the savings are only visible if the accounting systems are in place to accurately report them. The process to capture, report and analyze the cost of quality is very detailed and beyond the scope of this article. There is a financial reward for implementing an ISO 9001:2008 quality system.

How ISO 9001:2008 fits into your current business model The thought of a quality management system similar to ISO 9001:2008 brings fear to people because they believe they have to adopt someone else's program, or force a system or method to work for them. The intent of the standard is to adopt a system that works for you. You could benchmark a company and observe how they determine customer satisfaction and your first thought is, "that would never work at our place". That is alright, there is more than one way to "skin a cat".

Here is the best piece of advice I can offer, there is no best way to implement a process or create a system. There is no single best method or the right way to do it. That is where continual improvement becomes important. Don't become overwhelmed with trying to find the one correct method, get something implemented and continually improve it. The power and value with the standard is that you start somewhere and improve. Not everyone starts at the same place or ends at the same place. This endeavor to implement an ISO 9001:2008 quality system does not end with certification. Not all ISO 9001:2000 registered companies quality systems are the same. Just like not all doctors, lawyers, teachers or car mechanics are the same. They all have certifications and credentials but differentiation lies in their approaches to the job.

The implementation and maintenance of a quality management system can be tailored to a specific company. Don't confuse this with allowance to not meet the requirements. It means there are many ways to meet the requirements. You can choose to meet the requirements or you can choose to exceed the requirements. It is dependent upon the organization. My hope is that should you adopt the ISO 9001:2008 standard and implement it, your decision is to do more than just simply meet the requirements of the standard. This is where so many companies fall short in realizing gains from a quality management system. They do just enough to meet the requirements but never push themselves to exceed. The implementation of a quality management system is like anything else in life, you get out of it what you put in.

What it will take to implement ISO 9001:2000 This is dependent upon how fast you want to go, status of your current business practices and what type of resources you have. A typical timeline would be a year. I see no reason why you can't go from where you are now to certification in one year. Can you do it quicker, say six months, three months, yes. It just takes time and money. Time and money can cure just about anything. I wish it could cure everything, but unfortunately it can't.?? From a human resources standpoint, for a single location company of about 500 people it will take about 4500 man-hours to implement on your own. Keep in mind a portion of that time will be consumed because it's new to you. It wouldn't take a consultant or someone with experience that long because they've done it before. If you hire a consultant you can reduce the amount of time it takes, but you will spend it in consulting fees. A good estimate would be about 8 man-hours per employee to complete it in a year by yourself. At an estimated cost of $25 per man-hour, you may look at it as $20,000 for a 100 person operation (8 x 100 x 25) = 20,000. One thing to keep in mind is the people working on the project are there anyway, you are not hiring extra people. You are going to temporarily reassign resources to accomplish the goal.

Now let's look at the cost to get certified. Depending on the registrar you select and we'll talk about that later, the costs can vary slightly. A good baseline for costs to become certified and maintain certification, are as follows:

Document Review $750 onetime cost, pre Assessment Audit $4,500 Registration Audit $7,500 one time cost Surveillance Audits $4,500 ongoing annual cost

Training costs should be in the $1,400 - $10,000 range for internal auditor training. You can cut some costs of training by having one person in your facility trained and then have them train your internal auditors ($1,400) or you can have all of your internal auditors trained by an outside source ($10,000).

Commitment from top management I can't teach you how to get commitment from top management, I'm not that good, and nobody is. What I can teach you is how important it is, what it means and how to tell if top management is really supporting the implementation of a quality system. Can you implement an ISO 9001:2008 quality system without top management support and commitment? Yes, but the resultant quality system will not be as effective as it could be and you will probably find yourself asking where the benefits are. You will question the validity of the standard and the quality system because you won't see a dramatic change in your complaints, quality levels, quality costs and warranty. You can implement a system, pass a registration audit and get your company ISO 9001:2008 certified. I have seen a large number of companies that are certified but are not reaping the benefits of the standard or the quality system. The root cause of this is most often top management support.

In an attempt to avoid this scenario, it is important to educate top management of the commitment requirement and the ramifications of falling short. Educating top management does not guarantee the commitment. When the results are not there and people begin to question the initiative, you can point to this as a possible way to right the ship.

Top management commitment does not mean they verbalize it. When it comes to an endeavor such as implementing an ISO 9001:2008 quality management system, people will not care what you say; they want to see what you do. It will be extremely difficult to get momentum when top management talks the talk but will not walk the walk. Employees at all levels of the organization will be watching to see if this is real, or is it another "flavor of the month". They won't look at the management representative singularly; they will be watching the members of top management and particularly the highest ranking individual at that site.

That individual must provide continual support for the implementation process. They achieve that with actions that are consistent with what is spoken. For example, a situation exists where an area is having problems with a specific supplier. This has been occurring for six months and no activity is taking place. People will not believe top management is serious or supports the implementation of a quality system if this occurs. Take the same scenario but now the top ranking individual communicates to the employees what is being done and when. This is a big step. The biggest step is doing something to correct the problem.

The key for top management is to be visible and active in the effort and have their actions consistent. If this hasn't been a characteristic of top management at your facility then they need to change. Can it be implemented without this, yes but as we stated above it will be much more difficult and the results you get will be significantly reduced. This effort can't be viewed as something the quality manager, improvement manager or any other anointed person does. This must be an effort spearheaded, guided and monitored by top management. If it is not, everyone associated will know and the progress will be slow, the results will be substandard and your frustration level will be high.

Select Management Representative and Implementation Team The management representative is the person who has the responsibility to report on the status of the quality system and is most often the person who will spearhead the efforts. This person oversees the implementation process and is responsible to ensure management is aware of the condition of the quality system in order to facilitate continual improvement. It is not imperative this person is part of top management, but it does help. If the management representative is not a member of top management make certain they have direct report to someone in top management. The management representative is to the ISO 9001:2008 implementation what a black belt is to a six sigma project. They are the catalyst that makes the reaction move. Important characteristics of a management representative are forward thinking, change agent, and embody continual improvement, positive thinking and not content with just getting by.

The next step is to identify the implementation team. This can vary depending upon the size of the organization. A 500 person facility could have an implementation team of perhaps 10 - 15 people. A 50 person facility could manage with an implementation team of 1 to 2 people. For the implementation team you're looking for some resources that could carve 1 - 2 hours per day out of their schedule and work on the ISO implementation. You are also looking for change agents within the company. You do not want to fill your implementation team with individuals who are antagonistic, negative thinking and happy with simply doing what it takes to meet the requirements.

Robert Badner is a freelance writer for Innovations for Quality, LLC. Innovations for Quality, LLC specializes in online training within the quality profession. You can visit their website at http://www.certifiedquality.net.