Many times during implementation of ISO system, people are confused between record and documents. A record is a document that states results achieved or provides objective evidence of activities performed. Records establish evidence of conformance to requirements. Where as document is guideline to follow. Organizations must retain records, which are legible, readily identifiable and retrievable to meet the ISO 9001 requirements for records.

During an ISO audit, the auditor will ask for records or evidence the quality system being audited has effectively maintained the records required or not. For example, when an auditor is reviewing the corrective and preventive action system, he or she will be looking for a CAPA Report to provide evidence that the CAPA system has met the requirements for section 8.5.2 Corrective Action and 8.5.3 Preventive Action. In this report auditor is more interested to see results after implementation of CAPA

The ISO 9001:2008 Quality Management System Standard has many references to 4.2.4 Control of Records. Everywhere for ISO 9001 references 4.2.4, there must be a record. Although the ISO 9001:2008 only requires six procedures, the standard has twenty one (21) references to Control of Records (4.2.4). Note: Section 7.6 of the standard contains two references.

The following table identifies the specific records required by ISO 9001:2000. The list does not include records that your business might choose to retain voluntarily or those required by legislative requirements for your product or service.

These references occur in the following sections of the standard:

5.6.1 Minutes from your Quality Management Review meetings, including any actions taken place.

6.2.2 Education, training, skills and experience. (Sub clause-e)

7.1 Evidence that the realization processes and resulting product fulfill requirements. (Sub clause-d)

7.2.2 Results of the review of the requirements relating to the product and actions arising from the review.

7.3.2 Design and development inputs.

7.3.4 Results of design and development reviews and any necessary action.

7.3.5 Results of design and development verification and any necessary action.

7.3.6 Results of design and development validation and any necessary action.

7.3.7 Results of the review of design and development changes and any necessary action.

7.4.1 Results of supplier evaluations and actions arising from evaluations.

7.5.2 As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring and measurement. (Sub clause-d)

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 Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist. (Sub clause-a)

7.6 Validity of previous results when measuring equipment is found not to conform with its requirements.

7.6 Results of calibration or verification of measuring equipment.

8.2.2 Internal audit results.

8.2.4 Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product.

8.3 Nature of the product non-conformities and any subsequent actions taken, including concessions obtained.

8.5.2 Results of corrective actions.

8.5.3 Results of preventive actions.

Global Managers Group provides ISO 9001 2008 consultancy, auditing, software, and training services. They also supply an ISO 9001 2008 compliant Quality Management System or improving upon an existing one. Contact Global Manager Group Consultancy Services at: http://www.globalmanagergroups.com


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