ISO 9001:2008 Documentation Requirements

ISO 9001:2008 Documentation Requirements
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Most of the executives face difficulty when it comes to documenting their quality management system because it does require some amount of expertise. The ISO 9001 standard requires you to document your quality management system. The following documentation must be present within the system :

Quality Documents:-

  • Quality Policy
  • Quality Objectives
  • Quality Manual

+ Records required by the ISO 9001 International Standard**

Documented Procedures: – that are required by the ISO 9001 Standard includes the following:

  • Control of documents
  • Control of records
  • Internal audit
  • Control of nonconforming product
  • Corrective action
  • Preventive action

Records that are required by the ISO 9001 Standard includes the following (only where applicable to your organization):-

* Management reviews
* Education, training, skills and experience
* Evidence that the realization processes and resulting product fulfill requirements
* Results of the review of requirements related to the product and actions arising from the review.
* Design and development inputs relating to product requirements
* Results of design and development reviews and any necessary actions
* Results of design and development verification and any necessary actions
* Results of design and development validation and any necessary actions
* Results of the review of design and development changes and any necessary actions
* Results of supplier evaluations and any necessary actions arising from the evaluations
* Validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement
* The unique identification of the product, where traceability is a requirement
* Customer property that is lost, damaged or otherwise found to be unsuitable for use
* Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist
* Validity of the previous measuring results when the measuring equipment is found not to conform to requirements
* Results of calibration and verification of measuring equipment
* Internal audit results and follow-up actions
* Indication of the person authorizing release of product
* Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
* Results of corrective action
* Results of preventive action

Other documents needed by your organization to ensure the effective planning, operation and control of its processes may be included within your quality management system, such as:

  • Process maps, process flow charts and/or process descriptions
  • Organization charts
  • Specifications
  • Work and/or test instructions
  • Documents containing internal communications
  • Production schedules
  • Approved supplier lists
  • Test and inspection plans
  • Quality plans

You ought to know that the extent of the QMS documentation may differ from one organization to another. Therefore, there is no reason to maintain piles of documentation unless it is really necessary. Essentially, the amount of your documentation depends on the following factors:

  • The size of your organization and type of activities;
  • The complexity of your processes and their interactions, and
  • The competence of your personnel.

The documentation strategy is to keep it simple but yet effective and efficient of its functions and purposes.After all implementing the ISO 9001 standard was never meant to be a system of documents!

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