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