Ten Tips for Moving to ISO 9001:2000 – 4. Revise Quality Manual and Procedures

The documentation for a compliant quality management system must include the quality policy, quality objectives, quality manual, required procedures, and other documents deemed necessary for its effective planning, operation, and control. These requirements are covered in clause 4.2.1 of ISO 9001:2000.

You may already have the necessary documentation in place for the new standard. However, check your current documents to ensure they adequately address the new and changed ISO 9001:2000 requirements.

For organizations registered to ISO 9001:1994 along with a specific industry scheme (QS-9000 for automotive, TL 9000 for telecommunications, or AS9100 for aerospace), you may find that many of the new ISO 9001:2000 requirements are already being practiced within your current system.

What the standard does not tell you is how all this information should be documented. Avoid creating overly complex or burdensome documentation. Use the transition period as an opportunity to examine your current documents for the right level of detail, usable formats, and business value.

You might even decide to define some processes (and not document them) due to their simplicity, and rely instead on the skills, training, and experience of the people doing the work. This approach may cause auditors to adjust their auditing techniques and focus more on interviewing individuals and observing operations. However, you need to do what is best for your business, which may be to reduce the amount of documentation compared to your current system.

Although not required, some organizations may choose to revise their quality manual to reflect the new clause structure of ISO 9001:2000. The quality manual must address the scope of your system and provide the details of any excluded requirements. In addition, it must describe the interaction between processes and include or reference the procedures.

Only six procedures are specifically required by the new standard: Control of Documents (4.2.3), Control of Records (4.2.4), Internal Audit (8.2.2), Control of Nonconforming Product (8.3), Corrective Action (8.5.2), and Preventive Action (8.5.3). Although these procedures are part of current systems, they will need to be revised to incorporate the new and changed requirements of ISO 9001:2000.

The other procedures required by ISO 9001:1994, e.g., contract review, design control, purchasing, and training, are no longer required by ISO 9001:2000. However, defined processes for these areas are still necessary and must comply with the requirements.

Many organizations will see the business value in retaining and revising their existing procedures. It is also unlikely that lower-level work instructions will be affected by the new requirements.

As you examine your current documentation, consider using electronic media for easier access and better document control. Process mapping will help you identify your product realization processes and will enable your organization to more clearly determine what documentation is critical for the application of its quality management system.

The extent of the documentation, and the use of electronic media, will vary due to organization size, activity type, process complexity, and personnel competence. While the documents can be in any form or media, they must be maintained and controlled.

For more documentation guidance, see: http://www.iso.ch/iso/en/iso9000-14000/iso9000/2000rev7.html