ISO 9001 Record Requirements

A record is a document stating results achieved or providing objective evidence of activities performed. Records establish evidence of conformance to requirements. 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 be asking for records or evidence the quality system being audited has effectively maintained the records required. 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 8.52 Corrective Action and 8.5.3 Preventive Action.

The ISO 9001:2008 Quality Management System Standard has many references to 4.2.4 Control of Records. Everywhere 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.

These references occur in the following sections of the standard:

* 4.2.3 - Control of Documents
* 5.6.1 - Management Review, General
* 6.2.2 - Competence, Training and Awareness
* 7.1 - Planning of Product Realization
* 7.2.2 - Review of Requirements related to the product
* 7.3.2 - Design and Development Inputs
* 7.3.4 - Design and Development Review
* 7.3.5 - Design and Development Verification
* 7.3.6 - Design and Development Validation
* 7.3.7 - Control of Design and Development Changes
* 7.4.1 - Purchasing Process
* 7.5.2 - Validation of processes for production and service provision
* 7.5.3 - Identification and Traceability
* 7.5.4 - Customer Property
* 7.6 - Control of Monitoring and Measuring (2 References)
* 8.2.2 - Internal Audit
* 8.2.4 - Monitoring and Measurement of Product
* 8.3 - Control of Non-Conforming Product
* 8.5.2 - Corrective Action
* 8.5.3 - Preventive Action

Do the exercise and find the 4.2.4 references.


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