QMS General requirements (4.1)determine needed processes and their application

process sequence and interaction

effective control criteria and methods

resource and information availability

monitor / analyse processes

continual improvement action implementation

outsourced process control

QMS Documentation requirements (4.2)quality policy and objectives

quality manual

documented procedures and records

necessary documents to support planning, operation, and control of

control of documents

control of records

Management Responsibility (section 5)Quality Policy

Understood, implemented, maintained at all levels

Relevant to the organizational goals and the expectations and needs of

Responsibility and Authority

Quality related responsibilities and inter-relationships clearly defined

Specific references to organizational freedom and authority on quality related

Verification Resources and Personnel

Adequate, trained, resources

Includes independent audit resources

Management Representative

Custodian of the Quality Management System

Management appointment of one of its own personnel

Defined authority

Report Quality Management System performance to Management Review

Management Review

Does our Quality Management system still meet our needs and stated quality

Defined intervals

Records of the reviews

Review of previous activities

Contract Review (7.2.1, 7.2.2, 7.2.3)Customer requirements clear and documented

Verbal orders confirmed with the customer

Communication and interface with customer

Exceptions from standard requirements identified

Capability and capacity to meet requirements

Amendments to contract - controlled transfer of information

Records of review

Design Control (7.3.1 -- 7.3.7 inclusive)Procedures to control design process

Design and development plans

Technical interfaces identified and documented

Customer requirements fully documented

Identification of Regulatory requirements

Design reviews

Documentation available to show design output meets specification

Design Verification

Design Validation

Control of design changes

Document Control (4.2.3, 4.2.4, 7.1, 7.3)Documents and data

Approval and issue

Changes and modifications

Invalid and or obsolete document control

Retained invalid and or obsolete documents identified

Issue control

Distribution control

Master lists of documents

Record form #NOTESProcedure / Work InstructionStandard Checklist for ISO 9001

Record Control (4.2.4)identification

storage

protection

retrieval

retention

disposition

Purchasing (Purchase to specified requirements

Assessment and approval of suppliers including subcontractors

Fully specific purchase orders

Review of purchase orders

Verification arrangements in purchase documents

Customer verification of suppliers (if contractual)

Control of Customer Supplied ProductWhere you use customer supplied items

Procedures for receipt, storage and protection

Procedure where damage and or deterioration are concerned

Acceptable customer supplies

Records

Product Identification and TraceabilityIdentification, at all stages of the process

Traceability (as appropriate)

batches

items

records

Process ControlControlled process conditions

Documented procedures and or work instructions

Reference standards/samples

Monitoring of process characteristics

Approval of process capability

Workmanship standards

Maintenance of equipment

Special processes

where product characteristics not subsequently measurable

proof of final product characteristics by process monitoring

records

Inspection and TestingIncoming material inspection and testing

conformance to specifications

release control

positive recall for urgent release

In-process inspection and testing

process monitoring and control for conformance

defined in quality plan

hold procedures

identify non-conforming product

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