Company Name Division or Address Division or Address
Document and Data Control Doc. No. Date: 7/2/94 Rev. No. Page 1 of x
ISO Procedure
Document and Data Control
Approved:
title
__________________________________________________
Name
Approved:
___________________________________________________
title Name
Approved:
title
__________________________________________________
Name
Approved:
title
__________________________________________________
Name
Approved:
title
__________________________________________________
Name
Change Record Rev A Date Responsible Person Name Description of Change Initial Release
Distribution List (list the departments that receive controlled copies)
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name Division or Address Division or Address
Document and Data Control Doc. No. Date: 7/2/94 Rev. No. Page 2 of x
1.
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.
2.
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 Division or Address Division or Address
Document and Data Control Doc. No. Date: 7/2/94 Rev. No. 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 Division or Address Division or Address
Document and Data Control Doc. No. Date: 7/2/94 Rev. No. Page 4 of x
4.
Procedure 4.1 Types of Documents The following documents are in the Document Control system.
Type of Document
Description
4.2
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 Division or Address Division or Address
Document and Data Control Doc. No. Date: 7/2/94 Rev. No. 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 Division or Address Division or Address
Document and Data Control Doc. No. Date: 7/2/94 Rev. No. 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
