Company Name
Document and Data Control
Division or Address
Doc. No.
Rev. No.
Division or Address
Date: 7/2/94
Page 1 of x
ISO Procedure
Document and Data Control
Approved:
__________________________________________________
Name
title
Approved:
___________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Change Record
Rev
Date
A
Responsible
Person
Description of Change
Name
Initial Release
Distribution List
(list the departments that receive controlled copies)
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name
Document and Data Control
Division or Address
Doc. No.
Rev. No.
Division or Address
Date: 7/2/94
Page 2 of x
1.
2.
Purpose
•
To ensure that only the most recent revision of documents for
manufacturing and assemblies are available to appropriate personnel.
•
To control that documents requiring changes are revised in a timely
fashion and receive the required approvals.
•
To ensure that the Quality Manual and ISO 9000 procedures are of
current issue.
•
To define the method for establishing, approving, changing, maintaining,
replacing, and distributing product documents pertaining to agency
approvals.
Scope
All internal component specification sheets, assembly drawings, blueprints,
rework procedures, printed circuit board (PCB) artwork, Manufacturing
Engineering instructions (MEI), regulatory documentation, work instructions,
Original Equipment Manufacturing (OEM) distribution Bill of Materials (BOM),
qualification reports, Engineering Change Orders (ECO), service and installation
documents, handling procedures, subcontractor procedures, and routings are
controlled by Documentation Control.
This procedure covers control of the ISO 9000 Quality Manual and the
procedures that are controlled by the <department>.
The marketing literature pertaining to all products and services offered by
<COMPANY>.
This procedure applies to reference documents. Reference documents cover
certification records that include U/L, CSA, TUV, FCC, and FDA.
3.
Responsibilities
<Job title> oversees the control of all documents, keeps a master list of the
location of all documents.
<Job title> is responsible for ensuring all ISO 9000 procedures and the Quality
Manual are revised and approved as required. <Job title> notifies employees of
revisions available.
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name
Document and Data Control
Division or Address
Doc. No.
Rev. No.
Division or Address
Date: 7/2/94
Page 3 of x
<Job title> distributes the work orders with the newly revised documents
according to a distribution list. When a work order is complete the <Job title>
destroys the work order and associated documents.
<Job titles> approve newly released documents and revised documents.
Any employee can request a change to a document.
<Job title> plans product literature based on the company needs and writes or
assigns a writer to develop the text.
<Job title> is responsible for operation and service manuals. <Job title> ensures
that the publication is technically correct and usable, and coordinates with the
printer to produce the publication.
<Job titles> review drafts of technical manuals and approve final copy to be sent
for production.
<Job title> assigns part numbers and revision levels to technical manuals to
control the changes to the documents.
<Job title> maintains the ISO 9000 Quality Manuals and procedures in a state
that reflects the needs of the company.
<Job title> has primary responsibility for control of engineering changes. This
includes ECR number assignment, coordination and approval, expediting,
reproduction, distribution and maintenance of the ECR approval and signature
list. <Job title> updates the database and Bill of Materials to reflect the approved
change.
<Job title> maintains agency standards and is the conduit for all agency
communications. <Job title> stores reference documents.
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name
Document and Data Control
Division or Address
Doc. No.
Rev. No.
Division or Address
Date: 7/2/94
Page 4 of x
4.
Procedure
4.1
Types of Documents
The following documents are in the Document Control system.
Type of Document
4.2
Description
Distribution
<Job title> ensures that only the latest revisions of documents are
available at the required locations.
<Job title> maintains the distribution list. <Job title> disposes obsolete
documents. <Marking> identifies obsolete documents.
Where necessary, obsolete documents may be retained for legal reasons
or for knowledge preservation. <Job title> identifies obsolete drawings
with <marking>. <Job title> stores retained obsolete documents
<location>.
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name
Document and Data Control
Division or Address
Doc. No.
Rev. No.
Division or Address
Date: 7/2/94
Page 5 of x
A <name of distribution coversheet> accompanies the distribution and is
signed by the recipient. <Job title> maintains completed sign-off sheets.
The following documents are distributed electronically: <documents>.
Only the latest version of the controlled document is available. Recipients
are notified of revised documents in the following manner: <activity>.
<Job title> maintains the distribution list. The distribution list is available
<location>.
4.3
Identification of Controlled Copy
Controlled copies are indicated by <marking>. Uncontrolled copies are
indicated by <marking>. <Job title> can request an uncontrolled copy.
4.4
Master List
<Job title> maintains a Master List of the most recently approved
documents with the current revision number and stores the Master List
<location>.
The Master List is stored <location>.
4.5
Revisions
<Job title> can initiate a change to a document by completing a <name of
form>. <Job title> reviews the change request. Change requests are
logged in <name of log>.
<Frequency> meetings to review change requests are attended by <job
titles>. If the change is approved, <job title> is responsible for updating
affected documents. If necessary, due to safety considerations <job title>
contacts the regulatory agency.
<Name of form> indicates the change.
<Job title> is responsible for making the change. <Job title> approves the
changes to procedures. <Job title> increments the revision level of
affected documents. <Job title> logs revised documents in the <name of
log>.
4.6
Change Record
A record of changes is found <location>. <Job title> is responsible for
maintaining the change record. <Job title> records the status of the
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name
Document and Data Control
Division or Address
Doc. No.
Rev. No.
Division or Address
Date: 7/2/94
Page 6 of x
change in the <name of log>. <Frequency>, <job title> reviews the status
of change requests opened beyond their implementation date.
5.
Related Documentation
<logbook>
<distribution sheet>
<Master List>
<Engineering Change Request/Order>
<ECR Logbook>
<Engineering Change Notice>
Design Control
Process Control
Inspection and Testing
Handling, Storage, Packaging, Preservation, and Delivery
<list of work instructions>
Controlled Copy, Do Not Duplicate
For Internal Use Only