There are 21 records required by ISO 9001 : 2008 to be in compliant. The detailed list along with definitions are explained in this article.
What is a Record?
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
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)
In addition to the records listed above, the organization may decide to maintain additional records but it is always advisable to maintain the record maintained are simple
Also Note that the records can be combined where appropriate and also maintain a record in one or more parts.
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