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Quality Management Systems Guidelines
Appendix A - Quality Management System documentation requirements guide
AS/NZS ISO 9001 reference Quality Management SystemQuality Management PlanInspection and Test Plan
4 Quality Management System
4.2 Documentation requirements
Contract specific ITPs Contract specific Quality Management Plan
Documented Quality Management System
4.2.3 Control of documents Controlled documents Controlled documents Documented procedures
4.2.4 Control of records Inspection & test records controlled
Method of control and maintenance of contract records identified
Documented procedures
5 Management responsibility
5.1 Management commitment
Documentation not required
Documentation not required
Top management commitment documented
5.2 Customer focus Customer specified requirements included
Customer contract requirements identified
Process documentation for incorporating customer requirements for contracts
5.3 Quality policy Documentation not required
Documentation not required
Service provider's policy documented
5.4.1 Quality objectives Activity objectives documented
Contract objectives documented
Service provider's objectives documented
5.4.2 Quality Management System planning
Not applicable to ITPs Not applicable to a Plan
Planning documented
5.5 Responsibility, authority and communication
Documented for ITPs to suit activity
Documented for contract
Process documentation
5.6 Management review Documentation not required
Planned contract specific reviews documented
Planned system reviews documented
1
Quality Management Systems Guidelines
AS/NZS ISO 9001 reference Quality Management SystemQuality Management PlanInspection and Test Plan
6 Resource management6.1 Provision of resources Resources to carry
out inspections and tests identified
Contract work resources identified
Process documentation for identifying and providing resources for contract work
6.2 Human resources Competent people identified to carry out inspections and tests
Competent people identified for contract work
Process documentation for assigning competent people to contract work
6.3 Infrastructure Equipment, facilities and supporting services identified for inspections and tests
Equipment, facilities and supporting services identified for contract work
Process documentation to ensure equipment, facilities and supporting services provided for contract work
6.4 Work environment Critical working environments for inspections and tests identified and conditions of work documented (to suit risk levels)
Critical working environments for contract identified and conditions of work documented (to suit risk levels)
Critical environments that affect product/ service conformity documented and linked to applicable standards/work methods
7 Product realisation7.1 Planning of product
realisationInspection and Test Plans
Quality Management Plan
Documented procedures
7.2 Customer related processes
Identification of inspections and tests required to verify customer, statutory, regulatory and company requirements are met
Customer, statutory, regulatory and service provider requirements identified for contract work
Process documentation
7.3 Design and development Inspections and tests to verify and validate design identified
Design plan with competent personnel and their tasks identified for design and development, reviews, verification and validation
Process documentation
2
Quality Management Systems Guidelines
AS/NZS ISO 9001 reference Quality Management SystemQuality Management PlanInspection and Test Plan
7.4 Purchasing Inspections and tests identified to ensure purchased product meets requirements
Purchased product identified, with process for specifying and verifying, including control of subcontracted work
Process documentation
7.5 Production and service provision
Inspections and tests necessary to verify controlled conditions and work methods are identified
Controlled conditions and work methods identified
Process documentation
7.6 Control of monitoring and measuring equipment
Monitoring and measuring equipment used in Inspections and tests identified
Monitoring and measuring equipment identified for contract work and controls referenced
Process documentation
8 Measurement, analysis and improvement
8.2 Monitoring and measurement
Inspection and tests identified
Methods identified Process documentation
8.2.1 Customer satisfaction Documentation not required
Methods identified Process documentation
8.2.2 Internal audit Documentation not required
Methods identified Documented procedures
8.3 Control of non conforming products
Conformity sign-off identified
Methods identified Documented procedures
8.4 Analysis of data Documentation not required
Documentation not required
Process documentation
8.5 Improvement Documentation not required
Methods identified Documented procedures
8.5.2 Corrective action Documentation not required
Methods identified Documented procedures
8.5.3 Preventive action Documentation not required
Methods identified Documented procedures
3
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