8/4/2019 Records Required by ISO 9001

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Records Required by ISO 9001

Ref. ISO 9001:2008 Quality Management System Requirements Stephen Nicholson, 2011

The ISO9001 Quality Management System requires that you demonstrate conformance to thestandard through the maintenance of records.

Records differ from other documents in that they exist after the fact. For example, a document iswritten as an instruction, policy or procedure, whereas a record contains data as a result of some taskor activity.

The requirement to maintain records is defined in Clause 4.2.4, Control of Records, which notes thatrecords shall be established and controlled to “provide evidence of conformity to requirements and theeffective operation of the quality management system”.

The following lists the records that ISO 9001:2008 require to be kept and maintained.

Clause Heading Record

5.6.1 General Management Reviews

6.2.2 Competence, Training &Awareness

Appropriate records of education, training, skills &experience

7.1 Planning of product realisation Demonstrate that realisation processes and resultingproducts meet requirements

7.2.2 Requirements Review Records and results of reviews and actions taken7.3.2 Design and Development Inputs Inputs relating to product requirements

7.3.4 Design and Development Review Records and results of reviews and actions taken

7.3.5 Design and DevelopmentVerification

Records and results of verification and actions taken

7.3.6 Design and DevelopmentValidation

Records and results of validation and actions taken

7.3.7 Control of Design andDevelopment Changes Records and results of design and developmentchanges and actions taken

7.4.1 Purchasing Process Supplier evaluations (based on defined selection criteria)and actions taken

7.5.2 Validation of Processes As required to monitor deficiencies in product or servicefollowing delivery

7.5.3 Identification and Traceability Unique product IDs where traceability is required7.5.4 Customer Property Customer property recorded as lost, damaged or

unsuitable for use

7.6 Control of Monitoring andMeasuring Equipment

Records of reference to traceable standard or basis forcalibration or verification

8.2.2 Internal Audits Records of internal audits results and actions taken

8.2.4 Monitoring and Measurement ofProduct

Records of person(s) authorising release of product fordelivery

8.3 Control of Non-ConformingProduct

Records of non-conformities and actions taken, includingany concessions obtained

8.5.2 Corrective Action Records of corrective actions taken to eliminate causesof non-conformities

8.5.3 Preventive Action Records of preventive actions taken to eliminate thecauses of potential non-conformities