Appendix C: Checklist for ISO 9001:2000 Element 4.2.3: Control of Documents Quality Manual Requirements


Ref #: Date(s):

Supplier Name/Location:

Type: ISO 9001:2000

Item

Mandatory Activities To Be Covered in the Quality Manual

First Draft

First Edit

Final Edit

Release Date Plan/Actual

1.0

Define the tier II process documents (SOP procedure)

1.1

Controlled document attributes

Quality manual

Tier II processes or procedures

Tier III work instructions

Tier IV forms

1.2

Hard-copy versus electronic media

Access limits

Backup protocols

Read/write protocols

1.3

How documents are created

1.4

Review and approval protocols

QA documents

Engineering documents

Documents of external origin

Reapproval protocols

1.5

Mix (manuals versus individual documentation)

Tier II master list

Tier III master list

Tier IV master list

1.6

Method of distribution/removal

1.7

Control method (central versus local area manager)

QA documents

Engineering documents

Documents of external origin

1.8

Obsolete document protocols

1.8.1

Normal obsolete removal

1.8.2

Retained for info/legal purposes

1.9

Revision protocols

1.9.1

Review and approval

1.9.2

Nature of change control

1.9.3

Pertinent background protocol

2.0

Method of records control




ISO 9001(c) 2000 Quality Management System Design
ISO 9001: 2000 Quality Management System Design
ISBN: 1580535267
EAN: 2147483647
Year: 2003
Pages: 155

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