ISO 9001 control of Records 4.2.3

DOWNLOAD our FREE guides - no need to register!
 

Records are an important organizational asset; they provide the primary route for evidence based verification and traceability since they demonstrate compliance with customer requirements. Records also prove the efficacy of your quality management system. Implementing a compliant documentation management system could mean keeping certain records that your organization might not be already keeping.

A mandatory records procedure is required to specify

>    which records are kept

>    by whom

>    for how long

>    and how they are disposed of

The following clauses of ISO 9001 contain the instruction 'see 4.2.4' which means that you must retain these 21 records:
 

5.6.1 Management review minutes
6.2.2 Records of education, training, skills and experience
7.1 Evidence that the realization processes and product fulfil requirements
7.2.2 Records of sales activities

7.3.2 Design and development inputs
7.3.4 Design and development reviews and any related actions
7.3.5 Design and development verification and any related actions
7.3.6 Design and development validation and any related actions
7.3.7 Design and development changes and any related actions

7.4.1 Results of supplier evaluations and any actions arising
7.5.2 Records to demonstrate the validation of special processes
7.5.3 Where traceability is required, the unique identification of the product is recorded
7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable

7.6 Basis used for calibration of measuring equipment where no international or national standards exist
7.6 Validity of the previous measuring results when measuring equipment is found to be out of calibration
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 Records of the product nonconformities and any subsequent actions
8.5.2 Results of corrective action
8.5.3 Results of preventive action

Looking for help with your document control process?

We recommend the document management solution from ISO 9001 Checklist. It provides a great foundation for implementing a compliant document management system and includes everything you need to start controlling your documentation and records. It is simple, and easy to follow.

There are examples of the procedures and forms they provide here