Mandatory Records which are required by ISO 9001:2008

Pranay Kumar

May 7, 16

In ISO 9000, QMS audits we need to follow the mandatory records in the time of implementation and audit both. It is mandatory to follow for each audit.

Mandatory Records which are required by ISO 9001:2008

Every ISO standard will always have some mandatory requirements to meet. Mentioned below are the Mandatory Records which are required by ISO 9001:2008
1.1           Records required by ISO 9001:2008

Clause
Record required
5.6.1     Management reviews
6.2.2 e)     Education, training, skills and experience
7.1 d)     Evidence that the realization processes and resulting product fulfill requirements
7.2.2     Results of the review of requirements related to the product and actions arising from the review
7.3.2     Design and development inputs relating to product requirements
7.3.4     Results of design and development reviews and any necessary actions
7.3.5     Results of design and development verification and any necessary actions
7.3.6     Results of design and development validation and any necessary actions
7.3.7     Results of the review of design and development changes and any necessary actions
7.4.1     Results of supplier evaluations and any necessary actions arising from the evaluations
7.5.2 d)     As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement
7.5.3     The unique identification of the product, where traceability is a requirement
7.5.4     Customer property that is lost, damaged or otherwise found to be unsuitable for use
7.6 a)     Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist
7.6     Validity of the previous measuring results when the measuring equipment is found not to conform to requirements
7.6     Results of calibration and verification of measuring equipment
8.2.2     Internal audit results and follow-up actions
8.2.4     Indication of the person(s) authorizing release of product.
8.3     Nature of the product non conformities and any subsequent actions taken, including concessions obtained
8.5.2 e)     Results of corrective action
8.5.3 d)     Results of preventive action

Please refer these Mandatory Records which are required by ISO 9001:2008 when you would want to prove the conformity to this international standard.

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