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Minimum Documentation Requirements for ISO9001:2008
I agree with Ahmad Khreasat....6 procedures are mandatory and it is organizations need for any other procedures.
Six6 mandatory procedure to obtain ISO9001
1. Control of Documentations
2.Control of records.
3.Internal Audits.
4.Control of Non Conformance Product.
5.Corrective Action.
6. Prventive Action
Moreover Quality Policy mandetory and Quality Manual + MR and Customer Satsfaction too in my opinion.
A written procedure to control the approval and re-approval of procedures prior to issue as well as ensuring that the current revision status is displayed. To ensure that documents are legible and that the current versions are available at point of use. To also ensure that obsolete documents are controlled and documents from external parties such as your customers.
4.2.4 Control of RecordsA procedure to control the identification, storage, protection, retrieval, retention and disposal of records.
8.2.2 Internal AuditsA procedure to define a planned program of audits to ensure that your processes meet both ISO9001 requirements and your own requirements. Also for the reporting, follow up and records of these audits.
8.3 Control of Non-conforming ProductA procedure to ensure that non-conforming product is not used and action is taken.
8.5.2 Corrective ActionA written procedure to ensure that root causes of problems are identified and actions taken to correct them, actions must be verified to ensure effectiveness
8.5.3 Preventive ActionA written procedure similar to that for corrective action but the organization should take steps to identify POTENTIAL problems and eliminate them before a problem occurs.
It is not How Many but What are:
The required procedures are:
1. Document Control
2. Record Control
3. Corrective Actions
4. Preventive Actions
5. Internal Audit
6. Control of Non-Conforming Works.
beside, you need Quality Manual, Policy and Objectives and any other procedure the organisation may see fit.
I said what not How, because you may cover two of the requirements in a single procedure (for example: you may have one procedure for Corrective and Preventive Action) or you may have more than one procedure to cover the same topic (for example: two procedure for document contrls: one for document coding and one for issuing and distribution).
This is clearly identifed in Note1, Caluse4.2.1 ISO9001:2008
so, how many is up to you.
It is6 procedures (Document control - Record control - Corrective action - Preventive action - Internal Audit - Control of nonconforming product)
In my factory, we issued4 procedures as follow:
1- Document / record control -2 procedures in (ONE) procedure
2- Corrective / preventive action -2 procedures in (ONE) procedure
3- Internal Audit
4- Control of nonconforming product
It is not the number of procedures but how the standard's requirements are addressed matters.
Unfortunately many consultants interpret standards in their own way which end up in pile of documentation. The shift in approach by the standardization body from procedural approach to process approach should be clearly understood to obtain benefits from ISO standard based systems.