Ministry of Defence

Defence Standard

05-91/Issue 2

1 April 1995

QUALITY SYSTEM REQUIREMENTS FOR DESIGN / DEVELOPMENT, PRODUCTION, INSTALLATION AND SERVICING

Reprinted on the 23rd March 2001 incorporating Amendment 1

(ADOPTION OF ISO 9001:1994 OR ISO 9001:2000 WITH SUPPLEMENTARY REQUIREMENTS)

DEF STAN 05-91/2 AMENDMENTS ISSUED SINCE PUBLICATION

AMD NO 1

DATE OF ISSUE 22/2/2000

TEXT AFFECTED Pages 1, 3 and 4

SIGNATURE & DATE

Revision Note This document has been reprinted incorporating Amendment 1, which broadens the scope of the standard to cover ISO 9001:1994 and ISO 9001:2000. Historical Record Def Stan 05-21/1 Quality Control System Requirements for Industry AQAP-1 Edition 3 NATO Requirements for an Industrial Quality Control System Def Stan 05-91/1 Quality System Requirements for Design/Development, Production, Installation and Servicing Arrangement of Quality Standards The series of Defence Standards that are used for external Quality Assurance purposes are listed below: 05-91 05-92 05-93 05-94 05-95 Quality System Requirements for Design/Development, Production, Installation and Servicing Quality System Requirements for Production, Installation and Servicing Quality System Requirements for Final Inspection and Test Guidance on Quality System Requirements for the Implementation of Def Stans 05-91, 05-92 and 05-93 Quality System Requirements for the Design, Development, Supply and Maintenance of Software

DEF STAN 05-91/2 QUALITY SYSTEM REQUIREMENTS FOR DESIGN/DEVELOPMENT, PRODUCTION, INSTALLATION AND SERVICING PREFACE This Defence Standard supersedes Def Stan 05-91/Issue 1 dated 1 September 1991 i This Standard specifies quality requirements for a Contractor's design/ development, production, installation and servicing system. It embodies all of the requirements of ISO 9001, with supplementary requirements from AQAP 110 included in order to retain compliance with the extant NATO Quality System. ii The requirements of this Standard are detailed in sections two and three. The clauses are only included where there are additional requirements. Either the requirements of ISO 9001:1994 Clause 4 shall apply in its entirety, or the requirements of ISO 9001:2000 Clauses 4, 5, 6, 7 and 8 shall apply in their entirety. iii This Standard when referenced in a contract or purchase order applies to all materiel or services identified therein. If any inconsistency exists between the contract requirement and this Standard, the contract requirements shall prevail. iv This Standard has been prepared and issued under the auspices of the Director of Quality Assurance (DQA). v This Standard has been agreed by the authorities concerned with its use and is intended to be used whenever relevant in all future designs, contracts, orders etc and whenever practicable by amendment to those already in existence. If any difficulty arises which prevents application of the Defence Standard, the Directorate of Standardization shall be informed so that a remedy may be sought. vi Any enquiries regarding this Standard in relation to an invitation to tender or a contract in which it is incorporated are to be addressed to the responsible technical or supervising authority named in the invitation to tender or contract. vii This Standard has been devised for the use of the Crown and its contractors in the execution of contracts for the Crown. The Crown hereby excludes all liability (other than liability for death or personal injury) whatsoever and howsoever arising (including, but without limitation, negligence on the part of the Crown its servants or agents) for any loss or damage however caused where the Standard is used for any other purpose.

DEF STAN 05-91/2 CONTENTS Preface Section One. 0 1 2 3 General 3 4 4 4 PAGE 1

Introduction Scope Related Documents Definitions Requirements

Section Two. 4 4.1 4.2 4.4 4.6 4.10 4.11 4.13 4.16 4.17

Quality System Requirements Management responsibility Quality system Design control Purchasing Inspection and testing Control of inspection, measuring and test equipment Control of non conforming product Control of quality records Internal quality audits

5 5 5 5 5 6 6 7 7 8

Section Three. Assurance 5

Requirements - Assistance for Government Quality 9 A-1

Accommodation and Assistance List of Clauses with Supplements

Annex A

DEF STAN 05-91/2 QUALITY SYSTEM REQUIREMENTS FOR DESIGN/DEVELOPMENT, PRODUCTION, INSTALLATION AND SERVICING Section One. 0 General

Introduction

0.1 It is essential that materiel and services be designed, manufactured and provided so as to conform to the requirements of the purchaser and that the activities involved be effected as economically as practicable. 0.2 One discipline that facilitates the achievement of these objectives is quality assurance, which is based on a few basic concepts: (a) The quality of materiel and services depends on the Contractor's control of the design, manufacture, inspection and other operations which affect quality. Accordingly, Contractors must be prepared to institute such control of quality as is necessary to ensure that materiel and services conform to the purchaser's contractual requirements. (b) Contractors should be prepared, not only to deliver materiel and services on schedule at an agreed price, but in addition, to substantiate by objective evidence, that they have maintained control over the design, development, production, installation and servicing and have performed inspection which demonstrates the acceptability of materiel and services. 0.3 The purchaser should ensure that the requirements in the contract are complete and clear. The purchaser should also stipulate the assurance required to ascertain that the Contractor has control over the operations to be carried out to ensure that materiel and services are properly produced and inspected: (a) The purchaser may achieve this by stipulating in the contract those functions which must be controlled. (b) For protection the purchaser should exercise such quality assurance as is necessary to be assured that the Contractor has achieved the required quality. Such quality assurance should extend to Subcontractors when appropriate. The extent of the quality assurance performed by the purchaser should be a function of the demonstrated effectiveness of the Contractor's quality control system to meet contract requirements and of the demonstrated quality of materiel and services. The purchaser, an authorized representative, or the Quality Assurance Representative (QAR), may have reason to discontinue the verification or acceptance of materiel or services, pending action by the Contractor to correct any deficiency in the quality management system that could result in delivery of nonconforming materiel or services. 0.4 This document should be read in conjunction with Def Stan 05-94 which is the guidance document. 0.5 The purchaser's authority designated in the contract or its authorised representative, is herein referred to as the Quality Assurance Representative (QAR). The MOD QAR is the representative designated and registered by the MOD Quality Assurance Authority (QAA) to perform Government Quality Assurance (GQA).
3

DEF STAN 05-91/2 1 Scope

This Standard specifies the requirement for quality system elements to be designed, established, documented and maintained for the purpose of demonstrating the Contractor's capability of ensuring the conformity of the product designed and supplied to contract requirements, and for the furnishing of objective evidence. 2 Related Documents The following documents are referred to in this Standard:

2.1

ISO 8402 ISO 9001

Quality Vocabulary Quality Systems: Model for Quality Assurance in Design/ Development, Production, Installation and Servicing AQAP-110 NATO Quality Assurance Requirements for Design, Development and Production Def Stan 05-94 Guidance on Quality System Requirements for the Implementation of Def Stans 05-91, 05-92 and 05-93 2.2 Reference in this Standard to any related documents means in any invitation to tender or contract the edition and all amendments current at the date of such tender or contract unless a specific edition is indicated. 2.3 The following documents may also be found useful:

ISO 10012-1

Quality Assurance Requirements for Measuring Equipment Part 1: Metrological Confirmation System for Measuring Equipment Def Stan 05-95 Quality System Requirements for the Design, Development, Supply and Maintenance of Software 2.4 Related documents can be obtained from: SOURCE British Standards Institution BSI Standards 389 Chiswick High Road LONDON W4 4AL Directorate of Standardization Kentigern House 65 Brown Street GLASGOW G2 8EX

DOCUMENT International Standards Organization (ISO)

Defence Standards (Def Stan), Allied Quality Assurance Publication (AQAP)

Definitions

3.1 For the purpose of this Standard the definitions given in ISO 8402 apply. 3.2 GQA is the process by which the appropriate National Authorities establish confidence that the contractual requirements relating to quality are met.

DEF STAN 05-91/2 Section Two. 4 Requirements

Quality System Requirements Management responsibility. Management representative.

4.1

4.1.2.3

This authority shall include organizational freedom to resolve matters pertaining to quality. 4.1.3 Management review.

This review shall also apply to the requirements contained within this Standard. 4.2 Quality system. General.

4.2.1

The quality system shall be economical, effective, planned and developed in conjunction with other Contractor functions necessary to satisfy the contract requirements. The quality system shall be acceptable to the authority designated in the contract or the QAR. Objective evidence that the quality system is effective shall be readily available to the QAR. 4.2.3 Quality planning.

A quality plan, when contractually required, shall be acceptable to the authority defined in the contract. The Contractor shall define and implement procedures for risk management. The Contractor shall identify, analyze, prioritize and monitor the areas of the project that involve potential technical, quality cost or programme risk. The aim of risk management shall be to eliminate or minimize risks. 4.4 Design control. General.

4.4.1

Consideration shall be given to the investigation of new techniques and evaluation of new materiel. 4.6 Purchasing. Purchasing data.

4.6.3

Purchasing documents shall include, as applicable, appropriate quality assurance requirements and/or other specific quality control requirements, change control instructions and provision for quality assurance at the

DEF STAN 05-91/2 4.6.3 (Contd)

Subcontractor's facilities. All subcontracts and referenced data shall be available for review by the QAR. 4.6.4 Verification of purchased product.

Government verification at a Subcontractor's plant may be requested only by the QAR. When the QAR determines that Government verification is required at a Subcontractor's plant, the Contractor shall include in subsequent subcontracts a statement which stipulates such a requirement and forward copies with relevant technical data to the QAR on request. 4.10 Inspection and testing. Receiving inspection and testing.

4.10.2

The Contractor shall notify the QAR of nonconforming materiel received from a Subcontractor that has been subject to Government Quality Assurance. 4.10.3 In-process inspection and testing.

The Contractor shall perform inspection and testing during production, installation and servicing on selected characteristics which cannot be inspected or tested at a later stage. 4.11 Control of inspection, measuring and test equipment.

The Contractor shall identify and report to the QAR any measurement requirement that exceeds the known state of the art, or any measurement capability needed but not available. Depending upon the results of preceding calibrations, intervals of calibration shall be shortened so as to ensure continued accuracy, or may be lengthened if the results of previous calibrations provide definite indications that such action shall not adversely affect confidence in the accuracy of the equipment. Provision shall be made for the immediate removal, or conspicuous identification to prevent the use, of equipment outside its scheduled calibration interval. Provision shall be made for the immediate removal, or conspicuous identification to prevent the use, of any standard or measuring equipment which is known or suspected to be outside its designated limits, or bears evidence of physical damage which might affect its accuracy. All suspected and actual equipment failures shall be investigated. The QAR shall be notified immediately of any failure affecting the acceptability of the product. Any corrective action resulting from invalidation of calibration shall be recorded in detail. The cumulative effect of errors in each successive component of a calibration chain shall be taken into account for each standard or measuring equipment. The basis for the calculation shall be recorded. Corrective action shall be taken when the total error is such as to

DEF STAN 05-91/2

4.11

(Contd)

compromise significantly the ability to make measurements within the designated limits. Design data for tools and gauges, and performance data for measuring and test equipment, shall be made available when required by the QAR, for verification that the devices are functionally adequate. 4.13 Control of nonconforming product. Review and disposition of nonconforming product.

4.13.2

Acceptance of nonconforming material is the prerogative of the purchaser. Holding areas or procedures, for the control of nonconforming materiel provided by the Contractor, shall be agreed by the QAR. Procedures for rejecting, processing and dispositioning of nonconforming materiel shall be documented, and are subject to disapproval by the QAR when it can be shown that they do not provide the necessary controls. All repair and use-as-is dispositions shall be acceptable to the QAR. 4.16 Control of quality records

Records shall as appropriate include: explicit identification of the materiel, part, sub-assembly, assembly, equipment, sub-system or system; the number and nature of observations made, the number and type of deficiencies found, the quantities approved or rejected and the nature of the corrective action taken. Records shall include, as appropriate, the identification of the item, lot or batch, the inspection performed, and the results obtained. The amount of data, relating to standards and measuring equipment, to be recorded is dependent on the nature of the measuring equipment and standards in use and their application under the contract. Records shall include as a minimum the following information: (a) (b) (c) (d) description of equipment and unique identification; date on which each calibration was performed; calibration interval; results obtained;

and when appropriate: (e) (f) designated calibration limits; reference to calibration procedure;

(g) source of calibration and data necessary to establish traceability;

DEF STAN 05-91/2

4.16

(Contd)

(h) the environmental conditions for calibration and the measurement data as measured and corrected; (i) a statement of the cumulative effect of errors on the data obtained in the calibration; (j) details of any maintenance (service adjustment, repairs) or modifications which could affect the calibration's status; (k) any limitations in use.

Records, individual or collective, for functionally simple and rugged measuring equipment shall be confined to an indication that they are within their calibration interval and designated limits. 4.17 Internal quality audits.

Such audits shall also apply to the requirements contained within this Standard. The Contractor shall correct, promptly, deficiencies detected during audits, and notify the QAR of any major deficiencies and the revisions required in the quality system to correct them. Audit results shall be available to the QAR.

DEF STAN 05-91/2 Section Three. Assurance 5 Requirements - Assistance for Government Quality

Accommodation and Assistance

The Contractor shall provide the QAR with accommodation and facilities required for the proper accomplishment of the work, and shall provide any assistance required by the QAR for verification, documentation or release of materiel. The QAR shall have the right of access to any area of the Contractor's or the Subcontractor's premises where any part of the contracted work is being performed. The QAR shall be afforded unrestricted opportunity to verify compliance with system procedures and to verify conformance of materiel and services with contract requirements. The Contractor shall make inspection equipment available for reasonable use by the QAR for verification purposes. Contractor personnel shall be made available for operation of such equipment as required.

DEF STAN 05-91/2 ANNEX A List of Subclauses with Supplements A.1 The following subclauses have supplements: Management representative.

4.1.2.3 4.1.3 4.2.1 4.2.3 4.4.1 4.6.3 4.6.4 4.10.2 4.10.3 4.11

Management review. General (Quality system). Quality planning. General (Design control). Purchasing data. Verification of purchased product. Receiving inspection and testing. In-process inspection and testing.

Control of inspection, measuring and test equipment. Review and disposition of nonconforming product.

4.13.2 4.16 4.17

Control of quality records. Internal quality audits.

A-1

DEF STAN 05-91/2

INSIDE REAR COVER

DEF STAN 05-91/2 Crown Copyright 1995 Published by and obtainable from: Ministry of Defence Directorate of Standardization Kentigern House 65 Brown Street GLASGOW G2 8EX Tel No: Fax No: 041 224 2531/2532 041 224 2503 This Standard may be fully reproduced Except for sale purposes. The following conditions must be observed: 1 The Royal Coat of Arms and the publishing imprint are to be omitted. 2 The following statement is to be inserted on the cover: 'Crown Copyright. Reprinted by (name of organization) with the permission of Her Majesty's Stationery Office.' Requests for commercial reproduction should be addressed to MOD Stan 1, Kentigern House, 65 Brown Street, Glasgow G2 8EX

The following Defence Standard file reference relates to the work on this Standard - D/D Stan/348/02/15. Contract Requirements When Defence Standards are incorporated into contracts users are responsible for their correct application and for complying with contract requirements. Revision of Defence Standards Defence Standards are revised when necessary by the issue either of amendments or of revised editions. It is important that users of Defence Standards should ascertain that they are in possession of the latest amendments or editions. Information on all Defence Standards is contained in Def Stan 00-00 (Part 3) Section 4, Index of Standards for Defence Procurement - Index of Defence Standards and Specifications published annually and supplemented periodically by Standards in Defence News. Any person who, when making use of a Defence Standard encounters an inaccuracy or ambiguity is requested to notify the Directorate of Standardization without delay in order that the matter may be investigated and appropriate action taken.

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