QSD111.39 Document Control Policy Rev.

109

1. Process Flow. This portion (section 1) of the document may be posted for reference.

File location: Intelex\Global Policies\ Page 1 of 9

QSD111.39 Document Control Policy Rev. 109

2. Purpose and Scope

This procedure defines the policy and requirements for Fluke’s Quality Management
Systems (QMS) documentation and provides guidelines for consistency of formats.
Following this procedure is important to ensure all ISO 9001 and Fluke QMS
requirements are met and to provide consistency between all Fluke facilities.

This procedure applies to all QMS documents under Fluke’s control.

3. Responsibility and Authority – defined throughout this document.

4. Definitions
QMS – Quality Management System is a series of processes and procedures required to
insure product and services achieve their planned result.

PDM System – Product Data Management System is a method of maintaining design and
manufacturing disclosure information.

Process Owner – the person who implements, maintains and approves the process and
its interactions.

Document Owner – the person who creates and maintains the document and ensures it is
correct, current and usable.

In some cases, the process owner and the document owner may be the same person.

For a list of available definitions, please go to

http://fww.tc.fluke.com/~engtools/mcad/acronyms/acronym_index.cgi?

5. Procedure Details
Intelex is the preferred document management system for all QMS documentation on the
Quality System Document (QSD) and Local Process Document (LPD) levels. Other web
based systems (SharePoint, intranet pages, etc.) can be used to present the information
in a user-friendly manner but should link back to the master document in Intelex.

Product Data Management (PDM) System is the preferred method for maintaining design
and manufacturing disclosure information.

All systems used to control documented information required by the QMS must ensure
that:
 Documents are approved by authorized personnel.
 Only current versions of documents and information are available for use.

File location: Intelex\Global Policies\ Page 2 of 9

QSD111.39 Document Control Policy Rev. 109

 Obsolete documents, if retention is required, need to be controlled so they cannot

be used unintentionally.
 Where necessary, access is restricted to authorized personnel only.

Training needs should be considered when documents are revised. Reference

QSD111.02 Corporate Training Policy for additional requirements.

QSD111.16 Quality Systems Documentation Naming and Numbering Guidelines should

be followed unless a logical and consistent convention is already in use.

5.1 Quality System Documents (QSDs)

 Contain global policies and requirements that define minimum requirements to
insure effectiveness and conformity to the QMS.
 The Corporate Quality Council is responsible for reviewing QSDs and providing
feedback and suggestions to ensure they apply to all facilities. This review is
performed on appropriate community sharing sites such as SharePoint. QSD
review in Intelex will be performed by the Quality Systems Manager on behalf of
the Corporate Quality Council
 QSDs require the approval of the Process Owner, Quality Systems Manager and
the Director of Global Quality.
 QSDs follow the format defined in QSD111.XX Template.
 At a minimum, QSDs must include:
o Unique document name
o Unique document number
o Reviewers by title/function (see above)
o Approvers by title/function (see above)
o Revision number or date
 Note 1: QSDs that do not have an inherent flow may use a table of contents in
section 1 and define the process details in section 5.
 Note 2: ISO/IEC 17025 minimum requirements documents, designated FCM
documents, are considered QSD level documents. These are approved by the
ISO/IEC 17025 Quality Manager and the Chief Corporate Metrologist. FCMs
follow the format defined in FCM Template.

5.2 Local Process Documents (LPDs)

 LPDs describes the overall or key processes containing what, when, where, who
and why. LPDs should describe the process flow and key milestones of the
process.
 LPDs require the approval of the Process Owner, Document Owner and
managers of other areas directly impacted by the procedure.
 LPDs follow the format defined in LPDXXX Template.

File location: Intelex\Global Policies\ Page 3 of 9

QSD111.39 Document Control Policy Rev. 109

 Note: LPDs that do not have an inherent flow may use a table of contents in
section 1 and define the process details in section 4.
 At a minimum, LPDs must include:
o Unique document name
o Unique document number
o Approvers (by title/function)
o Revision number or date
5.3 Local Work Instructions (LWIs)
 LWIs describe step-by-step instructions on how to perform a task or activity.
They are used to ensure consistent and a repeatable process to build quality
product or service. Typical format includes text and visual depiction through flow
charts or pictures.
 LWIs require the approval of the process owner and document owner.
 LWIs may follow the format defined in LWIXXX Template.docx, LWIXXX
Template.ppt or other appropriate formats.
 At a minimum, LWIs must include:
o Document name
o Document number
o Approvers (by title/function)
o Revision number or date
5.4 Forms
 Forms are tools used to document information or provide a record of occurrence.
 The use of forms is defined in procedures. When information has been entered
on a form, it becomes a record and must be retained in accordance with its
parent procedure or as stated in QSD111.50 Records Retention.
o Note: A parent procedure may require a retention period longer than
QSD111.50 but shall not require a retention period that is less than stated in
QSD11.50.
 Forms are updated and approved in conjunction with the parent procedure and
are approved using the same method as the document.
 At a minimum, forms must include:
o Unique document number
o Revision number or date
5.5 Reference only documents
 Documents such as troubleshooting aids, reference guides and visual aids that
provide additional information but are not required to meet product, service and
quality requirements

File location: Intelex\Global Policies\ Page 4 of 9

QSD111.39 Document Control Policy Rev. 109

 “Reference Only Documents” do not have minimum requirements other than to

indicate they are “for reference only”.

5.6 Design Disclosure Information

 Design disclosure documentation is information required to describe end product,
sub-assembly and component form, fit and function.
 Product design disclosure information includes but is not limited to assembly
drawing, engineering drawings, bills of materials, PCA/PCB drawings and
schematics, work instructions, product firmware and end user software
o Product Design Disclosure revisions are considered a design change and
shall be formally controlled using a Product Data Management System
(PDM)
o Revisions affecting end-product form, fit, or function require an end product
part number change to ensure compliance with customer notification
agreements.
o Documented information is created where the "lack of" such could impact
product or service quality.
o Documented information can be paper, electronic, flow charts, diagrams,
pictures or other suitable formats.
 Manufacturing design disclosure information provides instructions for equipment
and tools used to build product and includes but is not limited to tool drawings,
equipment drawings, test software code and schematics for test machines.
 Refer to the flow chart in Appendix A to determine where configuration control
should be maintained.

5.7 Configuration Control

 A typical configuration control process is defined in the flow chart (Appendix A).
The development ECO should be used before Pilot Readiness Review (PRR).
 All product design disclosure shall use the Production ECO process no later than
Pilot Readiness Review as described in QSD 111.37 Product Development.
Many items will use the Production ECO process before PRR.
 Product design disclosure requires:
o Revision tracking and retention of historical information.
o Document name and/or number as a unique identifier.
o Change request, review and approval process.
o PDM documentation is created or changed, approved and released via
the PDM system.
o Creators of items may add signatures as required.
o Signatories may reassign signatures as appropriate.
o The process owner or their designee may change or update the require
approvers as necessary.
o Process Owners are responsible for conformance to the Design
Disclosure Document Change approval process.

File location: Intelex\Global Policies\ Page 5 of 9

QSD111.39 Document Control Policy Rev. 109

o The system must be able to capture the information for RoHS requirements
as defined by QSD111.59 European RoHS Compliance.
o The system must be able to track components that are required for
regulatory compliance such as Safety Critical, etc.
o A process to ensure that all associates that use the system (example Team
Center, Intelex, etc.) are adequately trained on its use and application.
 Manufacturing disclosure requires:
o Revision tracking and retention of historical information
o Document name and/or number as a unique identifier
o Change review and approval process
o A process to ensure that all associates that use the system (example Team
Center, Intelex, etc.) are adequately trained on its use and application.
 Legacy Documentation
o The PDM system supports document records that have paper/Mylar
originals stored in Product Data Management (Legacy Document Control).
A scanned electronic image file associated with the records will be available
within the PDM system.
o Unless a document supported by paper/Mylar is to be re-entered into a CAD
tool, this process should be followed:
o Check out the document from PDM
o Make changes to the drawing manually
o Check in the document when changes are completed
 Retiring Data
o PDM/Legacy documents refer to QSD111.50 Records Retention
o Local documents
 The process owner must move the electronic master to an obsolete
directory or delete the file.
 If a hard copy is to be kept for history it must state or be stamped retired
/ obsolete, then signed and dated by the process owner.
 Invalid and/or obsolete documents must be removed from all points of
issue or use.
5.8 External Documents
 Documents that are created and maintained externally but used to insure
conformance to industrial, national and international standards. Examples
include but are not limited to ANSI standards, ISO standards and safety
standards.
 Areas or functions using external documents are responsible for insuring current
revisions are available and used as required. TechStreet and other standards
management systems may be used to insure current versions are available

File location: Intelex\Global Policies\ Page 6 of 9

QSD111.39 Document Control Policy Rev. 109

6. Records - None

7. References

Internal References
QSD111.00 Corporate Quality Manual

QSD111.39 Document Control Policy

QSD111.02 Corporate Training Policy

QSD111.16 Quality Systems Documentation Naming and Numbering Guidelines
QSD111.37 Product Development
QSD111.50 Records Retention
QSD111.59 European RoHS Requirements
QSD111.XX QSD Template
LPDXXX Local Process Document Template
LWIXXX Local Work Instruction Template.docx
LWIXXX Local Work Instruction Template.ppt
FCM5403.41 FCM Document Template

External References
ISO 9001:2015 Quality management system requirements

8. Approvals and Notifications

Approver: Director of Global Quality
Process Owner/Approver: Quality Systems Manager
Document Reviewer: Corporate Quality Council
Document/Process Owner: Quality Systems Manager
Date: October 09, 2018

All area managers working under the Fluke ISO 9001 Quality Management System at
both certified and uncertified locations need to be notified of changes to this policy.

9. Change History
The translated version of this document must be reviewed and revised each time this
document is revised to ensure changes area easily identified for translation purposes.

File location: Intelex\Global Policies\ Page 7 of 9

 QSD111.39 Document Control Policy Rev. 109

Revision Brief Description of Change(s) Training

No. required
(Y/N)
Rev 107 Major revision for compliance with the ISO 9001:2015 standard Yes
requirements; updated to the new QSD format; changed title from
Dec 2016 “Document Control Management Manual” to “Document Control Policy”;
moved revision history to section 7
Rev 108 Reformatted to the new style (moved the title and revision to the header, No
moved approvals and notifications to section 8; removed the quality policy
May 2018 from the cover page; moved the purpose and scope to section 2); section
2 added the “why” statement the scope; simplified the scope statement to
apply to all of Fluke; section 4 added the definition of process owner and
document owner and added a link to the Fluke acronyms; section 7
updated the reference section to include both the upward and downward
references; added the translation statement in section 9; updated all
hyperlinks to Intelex V6 Document Control;
Rev 109 Section 5.1 clarified the QSD review process. The reviewer will be added No
to QSDs in Intelex as QSDs are revised. Section 5.6 added “work
Oct 2018 instructions” to the list of design disclosure information.

File location: Intelex\Global Policies\ Page 8 of 9

 QSD111.39 Document Control Policy Rev. 109

Appendix A – Configuration Management Process

Development ECO Process

Local Yes
Product in Prep for leaving Transfer to Update design
configuration Complete?
design design PDM system and documents
control

Can CSS go back to No

any product and pull
Sketches, schematics, Leaving design groups correct rev doc.?
part lists, PRS, SRS, (for official quote or
HRS, test spec internal/ external build)

No

Keep building No Change? Production Yes Test and Release to

OK?
same rev ready evaluate PDM

Yes

Production ECO process

No Yes

Update and sign Yes

Release to Test and
Complete? OK?
document PDM evaluate

No

End of Doc
Specific Product in Design process flows are located through PDM HOME Page

File location: Intelex\Global Policies\ Page 9 of 9