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
1
Management reviews
Management review minutes
2
Education, training, skills and experience
Training plan, training matrix, training records and CVs
3
Evidence that the realization processes and resulting product fulfill requirements
Project quality plan
4
Results of the review of requirements related to the product and actions arising from the review
Change review
5
Design and development inputs relating to product requirements
Customer specifications, design approval logs
6
Results of design and development reviews and any necessary actions
Design development minutes
7
Results of design and development verification and any necessary actions
Design plan, test plan document outputs
8
Results of design and development validation and any necessary actions
Test plans, test reports and acceptance records
9
Results of the review of design and development changes and any necessary actions
Design review minutes
10
Results of supplier evaluations and any necessary actions arising from the evaluations
Supplier evaluations, subcontractor assessments, approved supplier list
11
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
12
The unique identification of the product, where traceability is a requirement
Serial number logs

13
Customer property that is lost, damaged or otherwise found to be unsuitable for use
Delivery notes, incoming material schedules, defective material reports or NCRs
14
Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist
Customer specifications, corporate standards
15
Validity of the previous measuring results when the measuring equipment is found not to conform to requirements
Test plan document outputs
16
Results of calibration and verification of measuring equipment
Calibration certificates. records and calibration logs
17
Internal audit results and follow-up action
Internal audit report
18
Indication of the person(s) authorizing release of product.
Release acceptance record
19
Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
Non conformance report, concession report
20
Results of corrective action
Corrective action reports and logs
21
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

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