According to ISO 9000:2005, Record is defined as a document stating results achieved or providing evidence of activities performed.
Records shall remain legible, readily identifiable, and retrievable according clause 4.2.4 of ISO 9001:2008.
The Records maintained by the organization are to be controlled.
Clause 4.2.4 deals with control of records
ISO 9001:2008 requires some records to be maintained mandatory. A statement saying “records shall be maintained” (See 4.2.4) against various clauses for identifying them.
The Mandatory records to be in complaint with ISO 9001:2008 are
- Records from Management Reviews (5.6.1)
- Appropriate records of Education, Training, Skill and Experience for personnel performing work (6.2.2)
- Records which can provide evidence that the realization process and the resultant product meets the requirements (7.2)
- Results and actions arising out of review of requirements related to the product (7.2.2) (For eg Sales Records)
- Design and development inputs relating to the product (7.3.2)
- Results and actions arising out of the review of design and development m(7.3.4)
- Results and actions arising out of verification of design and development (7.3.5)
- Results and actions arising out of validation of design and development (7.3.6)
- Results and actions arising out of review of design and development changes (7.3.7)
- Results and actions arising out of evaluation of suppliers (7.4.1)
- Records to demonstrate validation of special processes (7.5.1)
- Records of unique identification of the product (where traceability is a requirement) (7.5.3)
- Records of information to the customer in case the customer property is lost, damaged or otherwise found to be unsuitable for use (7.5.4)
- Validity of the previous measuring results when measuring equipment is found to be out of calibration
- Results of calibration and verification of the monitoring and measuring equipment (7.6)
- Records of basis used for calibration or verification of monitoring and measuring equipment in case of absence of specified standards (7.6)
- Records of audits and their results including follow up actions (8.2.2)
- Records of person(s) authorizing release of product for delivery (8.2.4)
- Records of product non-conformities and the subsequent actions (8.3)
- Results of corrective action (8.5.2)
- Results of preventive action (8.5.3)
Originally posted 2011-06-12 08:47:00.