Guidance on ISO 9001:2000 Documentation

An important objective for ISO 9001:2000 was to have the amount and detail of the required documentation be more relevant to the desired results of the organization’s process activities. It significantly reduced the documentation requirements and is much less prescriptive than the 1994 standard.

An organization has more flexibility in the way it chooses to document its quality management system. Each organization should develop the minimum amount of documentation needed to demonstrate the effective planning, operation, and control of its processes (and continual improvement of its system).

Required Documentation

You must establish, document, implement, maintain, and continuously improve your quality system in accordance with ISO 9001 requirements. The standard identifies some mandatory procedures and requires any other documents needed for the effective operation and control of your processes.

Procedures are required for document control, record control, internal audit, nonconformity control, corrective action, and preventive action. Other documents are required as evidence of conformity with requirements, e.g., a quality policy and a quality manual.

ISO 9001 says that work instructions may be needed, but does not specifically require them. However, QS-9000 for the automotive industry requires set up, operator, and rework instructions.

Requirements for documentation may arise from customer contracts, industry standards, relevant regulations, and your own organizational needs. Ensure your planned documents serve a business need and will reflect actual operation. Be careful writing documents to satisfy future plans if those plans may not be implemented before the documents are issued.

Why Document?

There are a number of good reasons why documentation at the appropriate level of detail can be of benefit to your company and its employees. It is important for your organization to clearly understand the management policies that are meant to guide activities. Documenting these policies may help management reach agreement on them and also provide a method of communicating them for training and operational purposes.

Measurable quality objectives must be established. Documented objectives are easier to convey, plus it serves as proof of their existence for audits. Your responsibilities and authority must be defined and communicated to facilitate effective quality management.

The ISO 9001:2000 standard requires specific documented procedures, as well as, any procedures needed by your organization to ensure the effective operation and control of its processes.

Using documented procedures and instructions should result in more consistent and repeatable processes, and ultimately in improved quality. Documents preserve information and experience, plus share organizational knowledge.

Your documented quality system will be examined for audit purposes and may be reviewed by your customers as part of their supplier evaluation process. The documentation could even be used as a model by your suppliers.

Why Not Just Defined?

A degree of formality is necessary to clearly and consistently communicate policies and procedures. Informal or verbal directions may be misunderstood, not satisfy management policies, and be difficult to evaluate during audits.

If everyone sees the system through the same documentation, they are much more likely to have a uniform understanding of the quality system. Workers having access to documented instructions will perform their tasks more consistently.

Having a documented system provides a known platform for evaluating, approving, and making changes in a controlled manner.
If documentation exists, it can be used to train employees on the process and communicate their responsibilities.

Taking all this into consideration, there may still be some processes that do not warrant documentation due to the education, training, skills, and experience of the people performing the activities.

What is the Objective?

Keep in mind that the primary reason for documentation is to add value and serve the company. Each document should be of value to its users. If it is not required by ISO 9001, see if it is really needed, or if the training, skills, and experience of qualified workers will be sufficient.

Remember, documents should be created for the readers, not to satisfy the creativity of the author. Process users are your customer. Write for them.

Although not created especially for auditors, well written and organized documents will be easier for them to understand and use during assessments.

Documents capture the policies and practices in place during its development. As your business changes, the documentation must keep pace to maintain the benefits of your quality system. Anticipate process changes and keep the related documents current.

How Much is Needed?

The extent and nature of the documentation should be appropriate for the organization. The documents may be in any suitable form or media.

Process users have defined responsibilities. Write documents based on their required qualifications, such as, training, skill, and experience levels. Write documents that are simple, clear, and concise. However, be warned. It is more difficult to write a short, simple document than a long, rambling one.

Avoid generating too much documentation. It may reduce process flexibility and will certainly require more effort to maintain and keep current.

Rewrite All our Documents?

An organization with an existing quality management system should not need to rewrite all its documentation to meet the requirements of ISO 9001:2000. This is particularly true if their system was structured using a process approach. The current documentation might be adequate and could be simply referenced from the revised quality manual.

However, if the process approach was not used in the past, the organization will have to pay special attention to the definition of its processes, their sequence, and interaction.

Since many policy statements do not address management’s commitment to continually improve the effectiveness of its quality management system, these policy statements will have to be changed.

Quality manuals will need to be revised. The six required procedures must be examined to see if they need to be revised to address the new or clarified requirements. Other procedures that are retained (or created) must also comply with the new and changed requirements.

Work instructions are optional and so specific to a task that it is unlikely they will require modification (unless impacted by a change to a related procedure).

Evidence of conformity with requirements must be supplied. The expanded focus on system and product planning may require additional documentation.

Needed (But Not Required) Documents

Some organizations, particularly large ones or those with complex processes, may need additional documented procedures (especially those relating to product realization). Other organizations, due to their size or culture, may be able to effectively implement additional processes without them being documented.

There are several ISO 9001:2000 requirements where an organization could add value to its system and demonstrate conformity by the preparation of other documents (even though the standard does not specifically required them).

Many organizations will update and retain their current procedures, although they may no longer be required by ISO 9001:2000. These companies have decided the procedures are useful for the reasons covered earlier. All these documents, such as, requirements, design, purchasing, test, and training procedures, must be controlled in accordance with clause 4.2.3.

Documents versus Records

Documents are “revisable” and are under document control to indicate the current revision level. Records are not revisable and are under record control to indicate the retention time. When a document is superseded, it is archived as a record for a suitable retention period.

Records required by the quality management system must be controlled. They provide evidence of conformity to requirements and of effective operation. Most ISO 9001 clauses require records. Some are explicitly mentioned and others implied for proof of conformity.

Both documents and records are examples of evidence (or documentation) for audit purposes.