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QUALITY SYSTEM

PROCEDURE
QP1
DOCUMENT CONTROL

[Your Company]

Signature Position Date

Prepared By

Reviewed By

Approved By

COMPANY PROPRIETARY INFORMATION

This document is an uncontrolled copy of a controlled document held by the Quality Management System. Prior to
use, ensure this document is the most recent revision by checking the Master Document List. To request changes,
submit a Document Change Request to the Document Control Representative.

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Quality System Procedure QP1

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Table of Contents

1. INTRODUCTION & PURPOSE ................................................................................................ 3


2. TERMS & DEFINITIONS ....................................................................................................... 3
3. APPLICATION & SCOPE....................................................................................................... 3
4. REQUIREMENTS ................................................................................................................. 3
4.1 Controlled Documents ............................................................................................ 3
4.2 Documentation Hierarachy ..................................................................................... 4
4.3 Responsibility.......................................................................................................... 4
4.4 Signature Authority ................................................................................................. 4
5. PROCESS .......................................................................................................................... 4
5.1 Receiving and Issuing a Controlled Document....................................................... 4
5.2 Revising a Controlled Document ............................................................................ 5
5.3 Recalling a Controlled Document ........................................................................... 5
5.4 External Documents................................................................................................ 5
5.5 Uncontrolled Documents......................................................................................... 6
5.6 Forms & Records .................................................................................................... 6
5.7 Document Change Requests.................................................................................. 6
6. REFERENCES..................................................................................................................... 6
7. REVISION HISTORY ............................................................................................................ 6

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1. Introduction & Purpose


This document defines the process for the creation, verification, control, issue and
amendment of all documentation in support of [Your Company’s] Quality Management
System.

2. Terms & Definitions


The following terms and definitions are taken from ISO 9000:2005:

Term Clause Definition


Document 3.7.2 Information and its supporting medium
Procedure 3.4.5 Specified way to carry out an activity or a process
Quality Manual 3.7.4 Document specifying the QMS of an organization
Record 3.7.6 Document stating results or evidence of activities performed
Specification 3.7.3 Document stating requirements

3. Application & Scope


The scope of this process encompasses all documentation utilised by [Your Company]
including documents of an external origin such as customer specifications, standards,
etc., that affect the quality of our products and/or services. This procedure works in
conjunction with the Control of Records Procedure QP2.

4. Requirements
4.1 Controlled Documents

Controlled documents define the requirements for performance of a process and must
be followed to ensure the quality of the process, product and/or service. Documents
typically controlled by this procedure include but are not limited to the following:

ƒ Quality manual, policy and related procedures


ƒ Specifications and drawings
ƒ External documents

Controlled documents are identified with a document name and document number

ƒ Procedures are referenced according to the ISO 9001:2008 element number


ƒ Quality procedures are prefixed QP
ƒ Forms are prefixed F
ƒ Work instructions are prefixed W

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4.2 Documentation Hierarchy

ƒ Level 1: Policies – key system objectives


ƒ Level 2: Quality Manual – approach & responsibility
ƒ Level 3: Procedures – methods (Who, What, Where & When)
ƒ Level 4: Work Instructions – description of processes (How)
ƒ Level 5: Forms, Data & Records – evidence of conformance

4.3 Responsibility

This procedure applies to all quality management system documentation and is to be


followed by all personnel where appropriate.

4.4 Signature Authority

While the company Director(s) are responsible for signing all policies and procedures,
[Your Company] may have other team members such as the Quality Management
Representative or other managers to approve work instructions, etc., which implement
the quality procedures.

5. Process
5.1 Receiving and Issuing a Controlled Document

The initiating person/department shall identify to Document Control the required


distribution of controlled documents to ensure the document is available and is
appropriate for the intended purpose. Document Control shall perform the following
steps when issuing a new or revised controlled document:

ƒ The master document shall be stamped with the word ‘Original’ in red, scanned
and stored electronically on the network

ƒ Documents shall be identified in the master document index indicating the


document title and number, the revision of the document, date of receipt and
document owner or location. (F101.1)

ƒ Issue a controlled copy to each person or location listed in the master document
index. Controlled documents may be issued to parties out the organization; in this
case, the initiating person/department shall identify its distribution to Document
Control who will generate a document issue sheet. (F101.2)

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ƒ Each controlled copy shall be a photocopy and/or scan of the master or a printed
master from the network with ‘Copy’ stamped in red

ƒ Only copies of documents issued as per the above are ‘Controlled Copies’. The
latest revisions of documents are maintained on the network and are available to
the applicable employees

ƒ Any documents printed from the network are ‘Uncontrolled Copies’ to be used for
reviews, examples or training purposes. If an employee has access to the network,
it is their responsibility to ensure they are working with the latest revision of a
document

5.2 Revising a Controlled Document

Controlled documents may be temporarily amended by authorised personnel through a


red-lining process. This includes hand-written amendments which are initialled and
dated by the authorised person. The document will be revised and issued in
accordance with Section 5.1.

5.3 Recalling a Controlled Document

When a controlled document is revised and reissued, it shall be done in accordance


with Section 5.1, above.

ƒ Document Control will not issue the new document until recall of the prior revision
ƒ Obsolete documents shall be immediately discarded
ƒ One copy of the obsolete document shall be maintained as a historical record

All historical hard copies shall be marked ‘Obsolete’ along with the name (or initials)
and date of the person who identified the document as obsolete. Obsolete copies may
also be retained on the network.

Historical copies are retained for purposes of configuration control and quality records
as per QP2.

5.4 External Documents

Hard copies of external documents such as international standards, customer


documents are verified periodically as current revision from the issuer.

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5.5 Uncontrolled Documents

‘Uncontrolled’ and ‘Reference Only’ are terms used which are deemed to have the
same meaning. Uncontrolled documents must be verified as current prior to use and
are for informational purposes only. They do not include documents required to ensure
the quality of a product or process.

5.6 Forms & Records

Master forms are be signed by the initiator and date indicated to evidence their
authority. Forms are controlled via their F number and revision status. Standard forms,
e.g. pre-printed material are listed in the appropriate procedure or work instruction.

5.7 Document Change Requests

Changes to a document may be requested using the document change request form
(F101.3) if a document is found to be deficient. Change requests must be submitted to
Document Control and the process owner for review and approval.

6. References

Quality Management Systems Manual Section 4.2.3


Master Document Index F101.1
Document Issue Sheet F101.2
Document Change Request F101.3

7. Revision History

Revision Date Name Change Ref.

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