ISO 9001- Understanding ISO 9001 Requirements

(4.2 Documentation Requirements)
4.2.1 General
QMS documentation must include:

a)Statements of a quality policy and quality objectives

b)A quality manual
c)Documented procedures required by the Standard

d)Documents needed by the organization (to ensure effective planning, operation, and control of QMS processes)

e)Records required by the Standard

(Notes)
Note 1 - Documented procedures must be established, documented, implemented, and maintained.

Note 2 - The extent of QMS documentation may differ from one organization to another due to:
a)size of organization and type of activities
b)complexity of processes and their interaction
c)competence of personnel

Note 3 - Documentation may be in any form or type of medium.

Key Explanation Points and Tips:

ÞLet’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).

Þ 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 may or not be documented.

ÞThis standard is not heavy on documented (written) procedures as was the case with previous standards. Clause 4.2.1 specifies all the different types of documentation needed for your QMS. 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.

ÞClause 4.2.1d requires you to have documents needed to ensure the effective planning, operation and control for QMS processes. Each organization must determine what documentation is needed to achieve this based upon the factors listed above.

ÞYou must have documented statements of your quality policy and objectives. These will be discussed later in clause 5. There are many ways to document your Quality Manual and would be determined by the size, structure and complexity of your organization (se note 2). Clause 4.2.2 specifies more requirements for the contents of the quality manual.



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