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ISO 9001 Documentation

Everything You Need To Know About ISO 9001 Documentation

What is a document?
Let’s begin with some definitions. A document is information that is written or recorded on some medium such as paper or computer. A document may specify requirements (e.g. a drawing or technical specification); provide direction (e.g. quality plan); or show results or evidence of activities performed (e.g. records).

What is a procedure?
A procedure is a specific way to perform an activity or process (methods or practice used by an organization) and it may or may not be written. If it is written, it is called a documented procedure. The same reasoning applies to work instructions (which are ways to perform a discrete task) which may or not be documented.

What purpose do quality management system documentation serve?
QMS documentation provide the following benefits and objectives:

1. Communication of Information - needed by the organization to plan, operate and control its processes. The type and extent of the documentation will depend on the criteria listed above, as well as the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture.

2. Evidence of conformity - provides evidence that what was planned and what has actually been done.

3. Knowledge reservoir and sharing - to preserve and disseminate the organization’s experiences; business and technical know-how. A typical example would be a technical specification, which can be used as a base for design and development of a new product.

4. Training tool - to train personnel in performing their responsibilities

5. Consistency of performance - by having all personnel perform to the same method, practice or procedure

6. Promote best practice - document the best way of performing activity using internal and external knowledge

What are the ISO 9001 requirements for quality management system documentation?
Clause 4.2.1 specifies all the different types of documentation needed for your QMS. You must have documented statements of your quality policy and objectives. Specific requirements for these documents are stated elsewhere in clause 5 of the standard.

You must have a documented Quality Manual. There are many ways to document your Quality Manual; and this would be determined by the size, structure and complexity of your organization. Clause 4.2.2 specifies more requirements for the contents of the quality manual.

This standard is not heavy on documented (written) procedures as was the case with previous standards. Clause 4.2.1d requires you to have documents needed to ensure the effective planning, operation and control for QMS processes. The nature and extent of such documentation will vary from organization to organization, based on factors listed below.

What criteria should an organization use to determine how much quality management system documentation it should have?
The need to have additional documentation beyond those specified in this standard may depend upon - customer, regulatory and your own organizational requirements. Other factors to consider may include - complexity of products and processes; effect on quality; risk of customer dissatisfaction; economic risk; effectiveness and efficiency; competence of personnel; workforce stability and past quality problems and non-conformances.

For example, the more complex your products or processes are, the greater the risk of problems occurring. The use of documentation and other controls serve to prevent or reduce these risks.

If you have a highly educated and stable workforce, then the amount of documentation needed may be significantly less than an organization that has a high workforce turnover and lower educational requirements.

Regardless of how and to what extent you document your QMS, you must demonstrate the effective implementation of your QMS in terms of conformity to ISO 9001, customer, regulatory and your own organizational requirements.

In what medium should QMS documents be communicated?
Any combination of media is acceptable for documents and records provided they conform to requirements specified in clause 4.2.3 control of documents and clause 4.2.4 control of records. These may include, but not limited to: paper, magnetic. electronic or optical computer disc, photograph, audio-visual, etc.

What are the mandatory documented procedures required by ISO 9001:2000?
Under ISO 9001, you must have documented procedures for - clause 4.2.3 - Control of documents; clause 4.2.4 - Control of records; clause 8.2.2 - Internal audit; clause 8.3 - control of nonconforming product; clause 8.5.2 - Corrective action and clause 8.5.3 - Preventive action.

These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3

You may choose to include your procedures and lower level documentation in your quality manual or organize them in some other fashion. The practicality of this would depend 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; maintainability; etc.

Depending on these same criteria, you may decide to have additional procedures (beyond the mandatory six) or carry over some or all the procedures you had under previous QMS systems.

Some of the mandatory procedures can be combined, e.g., correction and preventive action may be combined as long as you address the specific requirements of each clause 8.5.2 and 8.5.3. You could also have more than one procedure for any of the mandatory clauses listed above.

Note there are several ways to write procedures, other than the conventional narrative form. In fact, narrative documentation has been found to be the least effective way to promote user comprehension and ease of use. Procedures may be documented graphically (e.g. flowchart; video; series of pictures or photographs, etc.).