ISO 9001 - 2008 QMS

 ISO 9001 QUALITY SYSTEM DOCUMENTATION REQUIREMENTS

• Quality policy
• Quality objectives
• A quality manual
• Other documents required for effective planning, operation and control
• The following  21 records specified by ISO 9001  

	ISO CLAUSE	DESCRIPTION	EXAMPLE DOCUMENTS
	5.6.1	Management reviews	Management review minutes
	6.2.2e	Education, training, skills and experience	Training plan, training matrix, training records and CVs
	7.1d	Evidence that the realization processes and resulting product fulfill requirements	Project quality plan
	7.2.2	Results of the review of requirements related to the product and actions arising from the review	Change review
	7.3.2	Design and development inputs relating to product requirements	Customer specifications, design approval logs
	7.3.4	Results of design and development reviews and any necessary actions	Design development minutes
	7.3.5	Results of design and development verification and any necessary actions	Design plan, test plan document outputs
	7.3.6	Results of design and development validation and any necessary actions	Test plans, test reports and acceptance records
	7.3.7	Results of the review of design and development changes and any necessary actions	Design review minutes
	7.4.1	Results of supplier evaluations and any necessary actions arising from the evaluations	Supplier evaluations, subcontractor assessments, approved supplier list
	7.5.2d	As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement	Schedules of achieved results
	7.5.3	The unique identification of the product, where traceability is a requirement	Serial number logs
	7.5.4	Customer property that is lost, damaged or otherwise found to be unsuitable for use	Delivery notes, incoming material schedules, defective material reports or NCRs
	7.6a	Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist	Customer specifications, corporate standards
	7.6	Validity of the previous measuring results when the measuring equipment is found not to conform to requirements	Test plan document outputs
	7.6	Results of calibration and verification of measuring equipment	Calibration certificates. records and calibration logs
	8.2.2	Internal audit results and follow-up action	Internal audit report
	8.2.4	Indication of the person(s) authorizing release of product.	Release acceptance record
	8.3	Nature of the product nonconformities and any subsequent actions taken, including concessions obtained	Non conformance report, concession report
	8.5.2	Results of corrective action	Corrective action reports and logs
	8.5.3	Results of preventive action	Preventive action reports and logs

 

ISO 9001 SIX  MANDATORY PROCEDURES

• Document control procedure 4.2.3
• Control of Records procedure 4.2.4 
• Internal audit procedure 8.2.2
• Control of non-conformance procedure 8.3
• Corrective action procedure 8.5.2
• Preventive action procedure 8.5.3