Document Review In ISO 9001 Standards

Document Review In ISO 9001 Standards

The ISO 9001 Standard requires that documents be reviewed.
Previously the implication was that the review was a check by potential users that the document was fit for purpose before it was offered for approval. It
could be construed that for a document to receive approval it must be checked and therefore review and approval in this context are one and the same and the requirement is in this instance enhanced rather than relaxed.
A review is another look at something. Therefore document review is a task that is carried out at any time following the issue of a document.
This requirement responds to the Continual Improvement principle.
Reviews may be necessary when:
- Taking remedial action (i.e. Correcting an error)
- Taking corrective action (i.e. Preventing an error recurring)
- Taking preventive action (i.e. Preventing the occurrence of an error)
- Taking maintenance action (i.e. Keeping information current)
- Validating a document for use (i.e. When selecting documents for use in
connection with a project, product, contract or other application)
- Taking improvement action (i.e. Making beneficial change to the
information)
Reviews may be random or periodic. Random reviews are reactive and arise
from an error or a change that is either planned or unplanned. Periodic reviews
are proactive and could be scheduled once each year to review the policies,
processes, products, procedures, specification etc. for continued suitability. In
this way obsolete documents are culled from the system. However, if the
system is being properly maintained there should be no outdated information
available in the user domain. Whenever a new process or a modified process
in installed the redundant elements including documentation and equipment
should be disposed of.

Assessment to ISO 9000 Standards

Assessment to ISO 9001 Standards
Once all the requirements of ISO 9001 have been met, it is time for an external audit. This should be carried out by a third party, accredited certification body. In the UK, the body should be accredited by UKAS. The chosen certification body will review the quality manuals and procedures. This process involves looking at the companys evaluation of quality and ascertains if targets set for the management program are measurable and achievable. This is followed at a later date by a full on-site audit to ensure that working practices observe the procedures and stated objectives and that appropriate records are kept.
After a successful audit, a certificate of registration to ISO 9001 will be issued. There will then be surveillance visits (usually once or twice a year) to ensure that the system continues to work.