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Standard Checklist for ISO 9001

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

Procedure / Work Instruction

NOTES

Record form #

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 Product


Where 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 Traceability


Identification, at all stages of the process
Traceability (as appropriate)
batches
items
records

Process Control
Controlled 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 Testing


Incoming 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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