EN 724

BRITISH STANDARD BS EN 724:1995 Guidance on the Application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices The European Standard EN 724:1994 has the status of a British Standard BS EN 724:1995 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 April 1995 © BSI 11-1998 The following BSI references relate to the work on this standard: Committee reference HCC/66 Draft for comment 92/52898 DC ISBN 0 580 23762 1 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee HCC/66, Quality systems for the manufacture of medical devices, upon which the following bodies were represented: Association of British Certification Bodies Association of British Health-care Industries Association of Contact Lens Manufacturers Association of X-ray Equipment Manufacturers (BEAMA Ltd.) British Anaesthetic and Respiratory Equipment Manufacturers’ Association British In Vitro Diagnostics Association British Orthopaedic Association British Surgical Trades Association Dental Laboratories Association Limited Department of Health Electro Medical Trade Association Limited GAMBICA (BEAMA Ltd.) Guild of Hospital Pharmacists Institute of Physical Sciences in Medicine (ISPM) Institute of Quality Assurance Medical Sterile Products Association Surgical Dressings Manufacturers’ Association Amendments issued since publication Amd. No. Date Comments BS EN 724:1995 © BSI 11-1998 i Contents Page Committees responsible Inside front cover National foreword ii Foreword 2 Text of EN 724 3 BS EN 724:1995 ii © BSI 11-1998 National foreword This British Standard has been prepared by Technical Committee HCC/66 and is the English language version of EN 724:1994 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices, published by the European Committee for Standardization (CEN). BS EN 724 provides guidance on the operation of quality management systems used in the manufacture of non-active medical devices. A similar standard, BS EN 501031), covers guidance for the manufacture of active medical devices including active implantable medical devices. In addition another standard, BS EN 928, which will provide guidance on quality management systems used in the manufacture of in vitro diagnostic devices, is in preparation. Cross-references Publication referred to Corresponding British Standard BS 5750 Quality systems EN 29001:19872) Part 1:1987 Specification for design/development, production, installation and servicing EN 29002:19872) Part 2:1987 Specification for production and installation EN 29004:19872) Part 0: Principal concepts and applications Section 0.2:1987 Guide to quality management and quality system elements EN 46001:1993 BS EN 46001:1994 Specification for application of EN 29001 (BS 5750-1) to the manufacture of medical devices EN 46002:1993 BS EN 46002:1994 Specification for application of EN 29002 (BS 5750-2) to the manufacture of medical devices A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2 to 21 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. 1) In preparation. 2) For information, since the ratification of this European Standard, EN 29001:1987, EN 29002:1987 and EN 29004:1987 have been superseded by EN ISO 9001:1994, EN ISO 9002:1994 and EN ISO 9004-1:1994. The corresponding British Standards are BS EN ISO 9001:1994, BS EN ISO 9002:1994 and BS EN ISO 9004-1:1994. EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN 724 October 1994 ICS 11.020; 11.040.30 Descriptors: Medical equipment, design, manufacturing, quality, quality assurance, quality control, specifications, maintenance English version Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices Guide d’application des EN 29001 et EN 46001 et des EN 29002 et EN 46002 pour les dispositifs médicaux non actifs Anleitung zur Anwendung von EN 29001 und EN 46001 und von EN 29002 und EN 46002 für nicht-aktive Medizinprodukte This European Standard was approved by CEN on 1994-10-27. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comité Européen de Normalisation Europäisches Komitee für Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels © 1994 Copyright reserved to CEN members Ref. No. EN 724:1994 E EN 724:1994 2 © BSI 11-1998 Foreword This European Standard was prepared by the Technical Committee CEN TC 205, Non-active medical devices, the Secretariat of which is held by BSI. This European Standard has been prepared under a Mandate given to CEN by the European Commission and the Secretariat of the European Free Trade Association, and supports essential requirements of EC Directive(s). This European Standard shall be given the status of a National Standard, either by publication of an identical text or by endorsement, at the latest by April 1995, and conflicting national standards shall be withdrawn at the latest by April 1995. Annexes designated informative are given only for information. In this standard annexes A, B and C are informative. According to the CEN/CENELEC Internal Regulations, the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom. Contents Page Foreword 2 Introduction 3 1 Scope 3 2 Normative references 3 3 Definitions 3 4 Guidance on quality system requirements 4 4.1 Management responsibility 4 4.2 Quality system 5 4.3 Contract review 5 4.4 Design control 5 4.5 Document control 7 4.6 Purchasing 8 4.7 Purchaser supplied product 8 4.8 Product identification and traceability 9 4.9 Process control 9 4.10 Inspection and testing 11 4.11 Inspection, measuring and test equipment 12 4.12 Inspection and test status 12 4.13 Control of nonconforming product 12 4.14 Corrective action 12 4.15 Handling, storage, packaging and delivery 13 4.16 Quality records 15 4.17 Internal quality audits 15 4.18 Training 16 4.19 Servicing 16 4.20 Statistical techniques 16 Annex A (informative) Guidance on elements of quality systems relevant to sterile product manufacture 17 Annex B (informative) Features of job descriptions of key individuals 20 Annex C (informative) Bibliography 21 EN 724:1994 © BSI 11-1998 3 Introduction This European Standard has been written to give guidance to organizations providing a non-active medical device who wish to ensure that they will comply with EN 29001/EN 29002 and the particular requirements given in EN 46001/EN 46002. It is also intended to provide guidance for certifying and regulatory bodies. The guidance in this standard for the fulfilment of requirements should always be in relation to the products being manufactured and interpreted accordingly. This standard needs to be read in conjunction with the EN 29000 series of standards with which compliance is sought. This standard is not intended as a replacement for EN 29004 which has its own very distinct relationship with the EN 29000 series of standards. The combination of EN 29001/EN 46001 and EN 29002/EN 46002 embraces the principles of Good Manufacturing Practices (GMP) which have been in operation in the manufacture of non-active medical devices for a number of years. This document seeks to assist in the transition from GMP to quality systems by presenting familiar concepts under the relevant paragraphs of EN 29001/EN 46001 and EN 29002/EN 46002. The references which have been made to EN 29004 are not necessarily exhaustive but seek to identify sections of EN 29004 with particular relevance to the guidance in this document. Consideration of this document alone is not an alternative to understanding EN 29004 and it is therefore recommended that EN 29004 is first read and understood in its entirety. For ease in the use of this standard, references to clauses in EN 29004 have been cited within the framework of EN 29001 and EN 29002. Annex A to this European Standard provides additional guidance on those elements of quality systems to which particular emphasis should be placed for medical devices which are supplied either sterile or to a defined standard of microbial or particulate cleanliness. The guidance in annex A is intended to be considered in addition to that provided in the body of the standard. 1 Scope This European Standard provides guidance on the establishment and maintenance of the quality systems specified in EN 29001/EN 46001 or EN 29002/EN 46002 for the manufacture of non-active medical devices. It does not add to, or otherwise change, the requirements of those standards and is not intended to be used for the assessment of a manufacturer’s quality system. This European Standard provides examples of how to meet the requirements, recognizing that other methods which achieve the same ends are equally acceptable; gives general advice on how to meet the requirements; and draws attention to aspects of requirements that may not be readily apparent to those unfamiliar with quality systems for non-active medical devices. Annex A to this European Standard provides guidance on the elements of quality systems which are relevant to the manufacture of medical devices which are to be supplied either sterile or at a defined level of microbiological or particulate cleanliness. The adoption of systems other than those described in this European Standard is not to be regarded as a non-compliance with EN 29001 and EN 29002 and/or the specific requirements in EN 46001 and EN 46002. 2 Normative references This European Standard incorporates, by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 29001:1987, Quality systems — Model for quality assurance in design/development, production, installation and servicing. EN 29002:1987, Quality systems — Model for quality assurance in production and installation. EN 29004:1987, Quality management and quality system elements — Guidelines. EN 46001:1993, Quality systems — Medical devices — Particular requirements for the application of EN 29001. EN 46002:1993, Quality systems — Medical devices — Particular requirements for the application of EN 29002. 3 Definitions For the purpose of this standard the definitions given in EN 46001 and EN 46002 apply, together with the following: 3.1 contract any agreement between the supplier and the purchaser concerning the supply of product NOTE A contract may be in writing, verbal, or a combination of both. EN 724:1994 4 © BSI 11-1998 3.2 design process of developing a product from concept to manufacture 3.3 purchaser recipient of product and/or service delivered by the supplier 3.4 specified requirements any of the following apply: a) requirements prescribed by the purchaser and agreed by the supplier in a contract for product; b) requirements prescribed by the supplier which are perceived as satisfying a market need; or c) regulatory requirements. 3.5 validation exercise of carrying out a programme designed and documented to demonstrate that a process, operating within specified limits, will consistently produce product or services complying with predetermined requirements NOTE Validation is considered as a total process which consists of: a) obtaining and documenting evidence that the installation of equipment follows design intentions and that the equipment as installed will perform consistently within predetermined limits (commissioning); and b) obtaining and documenting evidence that the equipment as installed and operated in accordance with process specifications will function reliably, produce acceptable product or services, and that key process variables are known (performance qualification). 4 Guidance on quality system requirements 4.1 Management responsibility 4.1.1 Quality policy Guidance for clauses 4.1.1 of EN 29001 and EN 46001 and for clauses 4.1.1 of EN 29002 and EN 46002. When defining and documenting the supplier’s quality policy, commitment and objectives, the management should express the policy in language that the staff can understand. The policy should be specific to the product supplied and to the staff employed. Management should be seen to demonstrate commitment to their quality policy both actively and on a continuing basis. For general guidance see 4.1, 4.2, 4.3 and 4.4.4 of EN 29004. 4.1.2 Organization 4.1.2.1 Responsibility and authority Guidance for clauses 4.1.2.1 of EN 29001 and EN 46001 and for clauses 4.1.2.1 of EN 29002 and EN 46002. It is important that conformance with specified requirements is not compromised by considerations of increased production, economy or market pressure. Therefore, within an organization, levels of responsibility, authority and inter-relationships are established and typically illustrated in an organization chart. In particular, responsibilities for key elements of the quality system should be identified and be included in written job descriptions. Responsibility for the effective operation of the quality system rests with the management representative (see 4.1.2.3) who should establish systems to ensure: a) product meets specified requirements; b) documented quality systems, standards and specifications are maintained; and c) regular internal quality audits are performed. The responsibility for quality assurance and production should be assigned to separate individuals. Annex B to this European Standard provides an example of the features of a job description for these individuals. Particular guidance on responsibility and authority for the manufacture of sterile products, or other products for which the microbiological cleanliness is of significance, is provided in annex A. Deputies for the key individuals identified above should be nominated and be capable of assuming the responsibilities when necessary. For general guidance, see also 5.2.1, 5.2.2 and 5.2.3 of EN 29004. 4.1.2.2 Verification resources and personnel Guidance for clauses 4.1.2.2 of EN 29001 and EN 46001 and for clauses 4.1.2.2 of EN 29002 and EN 46002. The resources which need to be provided may include personnel trained in specific disciplines, for example materials science, microbiology or statistics. For general guidance, see also 5.2.4 and 18.3 of EN 29004. EN 724:1994 © BSI 11-1998 5 4.1.2.3 Management representative Guidance for clauses 4.1.2.3 of EN 29001 and EN 46001 and for clauses 4.1.2.3 of EN 29002 and EN 46002. If the management representative (see also 4.1.2.1) who has the responsibility for the quality system has other functions to perform, there should be no conflict of interest. 4.1.3 Management review Guidance for clauses 4.1.3 of EN 29001 and EN 46001 and for clauses 4.1.3 of EN 29002 and EN 46002. For general guidance, see 5.5 of EN 29004. 4.2 Quality system Guidance for clauses 4.2 of EN 29001 and EN 46001 and for clauses 4.2 of EN 29002 and EN 46002. The main document in the quality system is usually a quality manual. This documents quality policy and describes the quality system. The quality manual is usually supported by detailed procedures, work instructions and specifications for product and processes. Such supporting documents themselves are generally not within the quality manual because of the frequency at which they may be subject to change. EN 46001 and EN 46002 require that documentation supporting the quality manual is organized in a file for each product type. Such files may be referred to as “Device Master File” or “Device Master Record”. This can contain, or give reference to the location of, documentation relevant to the manufacture of that product. Examples of such documentation may include: — specifications for raw materials, labelling, packaging materials, intermediate and finished products; — drawings; — work instructions, including equipment operation; — sterilization process details, if applicable; — inspection procedures and acceptance criteria. Such files may also contain quality records (see 4.16) such as: — design verification records; — process validation records. All this documentation forms part of the quality system and should be subject to document control procedures (see 4.5). For general guidance, see also 5.1.1, 5.1.2, 5.2.5, 5.3.2 and 5.3.3 of EN 29004. 4.3 Contract review Guidance for clauses 4.3 of EN 29001 and EN 46001 and for clauses 4.3 of EN 29002 and EN 46002. It is important that the supplier obtains a thorough understanding of the purchaser’s needs. This is established during contract review. Contract review should cover factors such as: — product description, quantity and price; — delivery details; — any special packaging, storage and transport requirements; — service; — spare parts. NOTE The relationship between the supplier and the sub-contractor is covered by 4.6 of EN 29001 and this standard. 4.4 Design control 4.4.1 General Guidance for clauses 4.4.1 of EN 29001 and EN 46001; not applicable to EN 29002 and EN 46002. The design phase takes a product from concept to production and is an important phase in the life cycle of a medical device. The essential quality aspects of safety, performance and reliability of a device are established during this phase. Therefore, adequate design controls should be established and implemented to ensure these aspects are met prior to production. One of the major causes of quality problems leading to device recalls and failures is deficient design. For general guidance see also 8.1 and clause 19 of EN 29004. 4.4.2 Design and development planning Guidance for clauses 4.4.2.1 of EN 29001 and EN 46001; not applicable to EN 29002 and EN 46002. The planning, operation and management of the design phase may be documented in a design manual. For general guidance, see also 8.2.1, 8.2.2 and