Appendix A

Quality Management
System (QMS) Control
of Documents Procedure

Purpose
This procedure defines the process for controlling the origination, approval,
release, revision, distribution, storage, and disposition of project and organi-
zational QMS documents.

Responsibility/Authority (Perform all steps unless indicated otherwise

in a specific step)
[Select: ISO Management Representative or designee
–OR-
Configuration Manager (CM) or designee]

Special Considerations
QMS documents are defined in the Quality System Manual (QSM). All QMS
documentation, except QMS records, is covered by this procedure. QMS
records are controlled in accordance with the QMS Control of Records
Procedure.
This procedure deviates from the standard procedure format, and steps are
independent rather than sequential.

Total Quality Process Control for Injection Molding, by M. Joseph Gordon

Copyright © 2010 John Wiley & Sons, Inc.

576
 10.1002/9780470584491.app1, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/9780470584491.app1 by INASP (Tanzania), Wiley Online Library on [19/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
APPENDIX A 577

Inputs Entry Criteria

• Potential QMS documents • Potential QMS documents are
• Suggestions for new QMS generated
documents
• Requests for change

Outputs Exit Criteria

• Approved QMS documents
• Obsolete QMS documents properly
marked (if retained)
• QMS documents are under CM
• QMS documents are available at
appropriate work areas
• Current versions of the internal
QMS documents are identified

Activities
Step 1. Ensure organizational and project QMS documents are reviewed and
approved prior to release. Review documents for adequacy and
compliance with contractual requirements.
NOTE:
— Each organization should identify functional responsibilities that
will review and approve various types of documents. [Direction:
Provide the list of functional responsibilities and who will perform
them as an appendix to this procedure or include a reference in this
step to the document where this information is contained.]
— Each organization should establish a document numbering scheme
and a method of identifying drafts. [Direction: Provide the docu-
ment numbering scheme as an appendix to this procedure or include
a reference in this step to the document where this information is
contained.]

Step 2. Ensure that the current version of organizational and project QMS
documents is identified and readily available for staff members.
NOTE: This can be a list of documents and current version with hard
copy access to documents, an electronic database, or a link to the latest
documents with appropriate access or another method as determined
by CM.

Step 3. Ensure that organizational and project QMS documents are updated
as needed. Documentation updates are reviewed and approved prior
to release.
NOTE: Each organization should identify functional leads that will
review and approve changes to released documents. [Direction:
Provide the list of functional leads and their responsibilities as an
 10.1002/9780470584491.app1, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/9780470584491.app1 by INASP (Tanzania), Wiley Online Library on [19/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
578 APPENDIX A

appendix to this procedure or include a reference in this step to the

document where this information is contained.]

Step 4. Ensure documents are legible and easily identifiable.

Step 5. Ensure that external QMS documents are identified. Control distribu-
tion of external documents and coordinate with the PM.
NOTE:
— This can be an electronic list of documents with appropriate access
or another method.
— The distribution of external project documents is usually con-
trolled as the Quality Manager (QM) designates. [Direction:
Describe how external documents will be controlled in an appendix
to this procedure or include a reference in this step to the document
where this information is contained.]
— The revision of project external documents to be used is as speci-
fied in the project contract or as agreed with the customer.
— The distribution of external non-project documents is usually con-
trolled by the QM or CM.

Step 6. If obsolete (superseded or cancelled) QMS documents are retained,

ensure that they are properly marked to prevent unintended use.

Step 7. Ensure QMS documents that are company proprietary are disposed
of in accordance with applicable security and/or company directives
as well as local instructions and/or customer requirements.

Step 8. When required by a contract or considered appropriate by senior

management, make QMS documents available to customers or to
customer representatives.

Revisions
Version Number Date Description
[Direction: Begin revision history [Sub: date in the format
after first, non-draft release.] month day, year]