ISO 9001 Consulting, Training
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Can you provide examples of documents, other than policies, quality manual and procedures, that an organization may need for its quality management system?
In addition to the documents specifically called out in ISO 9001, clause 4.2.1d calls for documents deemed necessary for effective management and control of your processes. These could include - process maps, process flow charts and/or process descriptions; organization charts; quality plan, material specifications; competence criteria, product specifications, packaging specifications, manufacturing specifications, work and test instructions; forms; schedules; set-up specifications, etc.

ISO 9001 calls for many records to provide evidence of effective planning, operation and control of processes. Examples include - management review records; calibration records, internal audit records; corrective action records, etc. Again, your processes may call for additional records beyond those expected by ISO 9001.

Many clauses do not specifically call for documents and records, but there is a strong implication in the wording of the need to have them. This is where you must be guided by clauses 4.2.1d and 7.1b for documents and 4.2.1e; 4.2.4 and 7.1d for records. Use these clauses to determine what documents and records are needed to provide evidence of effective planning, operation and control.

Remember to use the requirements of clause 4.2.3 to control all documents you choose to include in your QMS; and the requirements of clause 4.2.4 to control all QMS records.

What should be documented in my Quality Manual?
The quality manual (QM) is a special type of document that describes your QMS. Your QMS is comprised of a number of business processes needed to satisfy customer and other stakeholder requirements. For your QMS manual to be meaningful, provide a brief description of each of these processes and the key ISO 9001 control requirements that apply to them.

Do not follow the common practice of writing back the clauses of the standard. This serves no useful purpose to anyone.

Your quality manual must also include a description of the interaction of your QMS processes. This can be done in any number of ways including - process maps; flowcharts; process diagrams; spreadsheets; etc.

You QM must define the scope of your QMS. Your QMS scope should include - facilities (manufacturing and support locations), products, processes, your policies for Quality Management and other standards, etc. Customers will want to know the extent of your product, QMS and manufacturing capabilities and the Certification Body (Registrar) will want to determine the time and effort needed to audit your organization.

Provide details of any clause exclusions from your scope, e.g. 7.3 Product Design and Development, and your justification for it. You must justify all exclusions and remember, exclusions can only be made from clause 7.

Besides describing your QMS, your quality manual could provide information on organizational background and capabilities. It may be used by customers, regulatory bodies, suppliers and company personnel for a variety of purposes. There are many other acceptable ways to document your quality manual.

You have flexibility in whether or not to include your procedures and lower level documentation with your quality manual or organize them in some other fashion. You may include all or some of your procedures in your Quality Manual or reference them to your Quality Manual. Keep a listing or index at the front or back of your Manual showing the complete list of your procedures whether included or referenced.

The practicality of all this would depend, of course, on the size of your organization; complexity of products and processes; competency of personnel; media used for documentation (hard copy versus computerized); ease of use and understanding by personnel; etc. So go ahead and organize your documentation to facilitate ease of use; understandability, availability and maintainability.

As a part of your QMS (see 4.2.1) documentation, the quality manual is subject to all of the controls in clause 4.2.3.

How does an organization demonstrate conformance to ISO 9001, if it has minimal documentation?
In order to claim conformity with ISO 9001:2000, the organization must be able to provide objective evidence of the effectiveness of its processes and its quality management system.

Clause 3.8.1 of ISO 9000:2000 defines "objective evidence" as "data supporting the existence or verity of something" and notes that "objective evidence may be obtained through observation, measurement, test, or other means."

Note that organizations may be able to demonstrate conformity without the need for extensive documentation.

Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2000. In some cases, (for example, in clause 7.1(d) Planning of product realization, and clause 8.2.4 Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.

Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the requirements of clause 5.6 and it can also be used for both internal and external conformity audit purposes.

Where can I get further help?
This article is an excerpt from my eBook, “Understanding ISO 9001:2000”. This book provides a complete and in-depth coverage of all ISO clause requirements and well as key quality management principles and concepts. It is an excellent guide for QMS development, maintenance or improvement.

Need Training or Consultancy help?
Ask Art Solutions has significant expertise in all of the implementation steps and can help you fast track your way to an effective and profitable QMS.
If you need help in developing or implementing your ISO 9001:2000 QMS, please call us at 905-593-8867 for a no obligation review of your needs.

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