Quality Management Systems Guidelines

1
Appendix A - Quality Management System documentation
requirements guide

AS/NZS ISO 9001 reference Quality Management System
Quality Management Plan
Inspection 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




Quality Management Systems Guidelines
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AS/NZS ISO 9001 reference Quality Management System
Quality Management Plan
Inspection and Test
Plan

6 Resource management
6.1 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 realisation
7.1 Planning of product
realisation
Inspection 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




Quality Management Systems Guidelines
3
AS/NZS ISO 9001 reference Quality Management System
Quality Management Plan
Inspection 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