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.
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