ISO 9001 - Understanding ISO 9001 Requirements

4.2.3 Control of Documents
Control all documents required by your QMS

Have a documented procedure that defines controls needed to:

a)Approve the adequacy of documents prior to issue

b)Review, update as necessary, and re-approve documents

c)Identify changes to documents as well as identify their current revision status

d)Make relevant versions of applicable documents available at points of use

e)Maintain documents so that they are legible and readily identifiable

f)Identify documents of external origin and control their distribution

g)Prevent the unintended use of obsolete documents, and apply suitable identification to these documents if they are kept for any purpose.

Records are a special type of document (controlled by requirements in clause 4.2.4)

Key Explanation Points and Tips:

ÞAs mentioned in clause 4.2.1 notes, 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).

ÞClause 4.2.1 tells you what documents you must include in your QMS. All documents that you determine under clause 4.2.1 to be needed for your QMS processes must be controlled. This clause 4.2.3 provides requirements on how these documents must be controlled. Documents outside the QMS need not be subject to these controls.

ÞThis clause requires you to have a documented procedure. Your procedure must - define responsibility for and description of the controls required by 4.2.3 a - 4.2.3g; methods to measure process document control performance; and continual improvement of the document control process.

ÞEnsure that your procedure specifically addresses each of the control requirements, in terms of who, what when, where and how as applicable. Your procedure must address new and old as well as internal and external documents used by the QMS.

ÞYou must approve all new QMS documentation prior to issue. Some degree of checking, examination or assessment is inherent in ‘approval for adequacy’. You must periodically determine if any updating or revisions of any QMS documentation is needed, and if they are changed, they must be re-approved for adequacy.

ÞThe frequency of this review, responsibility and method must be defined in your procedure. This will be determined by events within your organization and how mature or recent your QMS is. Auditors will explore this if they find that your documents have not changed in years, while the nature of your business has changed significantly.

ÞIdentify changes made to documents so users know exactly what has changed. There are many ways of doing this on printed as well as computerized documents. Your procedure must cover how this is done.

ÞHave a method for revision control such as a revision log and master-list of documents which identifies the current revision status. Again, there are other ways of doing this as well. Your procedure must cover how this is done.



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