1、Published in February 2006 by Canadian Standards AssociationA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044Visit our online store at www.ShopCSA.caCSA Special PublicationPLUS 13485The ISO 13485 essentials A pra
2、ctical handbook forimplementing theISO 13485 Standard for manufacturers of medical devicesISBN 1-55397-912-5 Canadian Standards Association 2006All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher. Created byPierre D.
3、 Landry,Cantley, QubecContributors and principal editors:Denis Pronovost,General Manager, Accademia Qualitas,Montral, QubecBetty Anne Butcher,President, Alta Quality b) definitions excerpted from ISO 9000, ISO 13485, and ISO 19011. The notes contained in these definitions are not always included in
4、each section. Appendix 1 provides all definitions and accompanying notes in alphabetical order;c) guidance, provided by ISO/TR 14969 or by other sources;d) typical audit questions asked by auditors when registering the QMS to ISO 13485; ande) self-assessment questions to be considered by an organiza
5、tion while developing its QMS.Detailed guidance on the QMS registration process and implementation path, and other valuable information is found in PLUS 9001, The ISO 9000 Essentials, published by CSA. The information provided in The ISO 9000 Essentials is not reproduced here. (Contact CSA at 1-800-
6、463-6727 for more information.) Canadian Standards Association The ISO 13485 essentialsFebruary 2006 1The Layout of this HandbookThe format and layout used in this Handbook are as follows:Note 1: In ISO 13485 the clauses that are identical to those in ISO 9001:2000 are presented in normal font. Wher
7、e the text of ISO 13485 is not identical to ISO 9001:2000, it is shown in italics (in blue italics for the electronic version). This Handbook reproduces this format.Note 2: ISO 13485 contains extensive informative annexes. Only Annex A, Table A.1 (Correspondence between ISO 13485:1996 and ISO 13485:
8、2003 version), is reproduced here (Appendix 2 at the end of this Handbook). To consult Annex A, Table A.2 (Correspondence between ISO 13485:2003 and ISO 13485:1996 version), or Annex B (a 30-page table explaining the differences between ISO 13485:2003 and ISO 9001:2000), readers should refer to ISO
9、13485:2003, available at CSA.Sections preceded by boxes with this icon contain guidance excerpted from ISO/TR 14969 and other sources. ISO/TR 14969 explains its use of terminology as follows:NOTE The terms “should”, “can” and “might” within this Technical Report are used as follows. “Should” is used
10、 to indicate that, amongst several possibilities to meet a requirement in ISO 13485, one is recommended as being particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required. “Can” and “might” are used to indicate possibi
11、lities or options. These terms do not indicate requirements.Text boxes with this icon contain all the clauses of ISO 13485.DefinitionsText boxes with this icon provide definitions from ISO 9000, ISO 13485, and ISO 19011. The notes contained in these definitions are not always included in the text bo
12、x. Appendix 1 supplies all definitions and their notes in alphabetical order.GuidancePLUS 13485 Canadian Standards Association2 February 2006This guidance can be used to better understand the requirements of ISO 13485 and illustrate some of the varity of methods and approaches available for meeting
13、the requirements of ISO 13485. (ISO/TR 14969, 1.1)Sections preceded by this icon contain typical questions asked by auditors when registering the QMS to ISO 13485.Sections preceded by this icon contain self-assessment questions to be considered by an organization while developing its QMS. Canadian S
14、tandards Association The ISO 13485 essentialsFebruary 2006 3PLUS 13485 The ISO 13485 EssentialsISO/TR 14969 provides the following introduction to quality management systems and ISO 13485:0Introduction 0.1 General This International Standard specifies requirements for a quality management system tha
15、t can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.It can also be used by internal and external parties, including certification bodies, to assess the organizations
16、 ability to meet customer and regulatory requirements. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement. It is emphasized that the quality management system requirements specified in this International Standard are complementary to technical require
17、ments for products. The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organizations quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the
18、size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.There is a wide variety of medical devices and some of the particular requirements of this International Stand
19、ard only apply to named groups of medical devices. These groups are defined in Clause 3.GuidancePLUS 13485 Canadian Standards Association4 February 20060.1.1This Technical Report provides guidance to assist in the development, implementation and maintenance of quality management systems that aim to
20、meet the requirements of ISO 13485 for organizations that design and develop, produce, install and service medical devices, or that design, develop and provide related services. It provides guidance related to quality management systems for a wide variety of medical devices and related services. Suc
21、h medical devices include active, non-active, implantable and non-implantable medical devices and in vitro diagnostic medical devices.ISO 13485 specifies the quality management requirements for medical devices for regulatory purposes (see Annex A). ISO 13485 accommodates the previous ISO 13488 by pe
22、rmissible exclusion as specified in ISO 13485:2003, 1.2. When judging the applicability of the guidance in this Technical Report, one should consider the nature of the medical device(s) to which it will apply, the risk associated with the use of these medical devices, and the applicable regulatory r
23、equirements.As used in this Technical Report, the term “regulatory requirement” includes any part of a law, ordinance, decree or national and/or regional regulation applicable to quality management systems for medical devices and related services.This Technical Report provides some approaches that a
24、n organization can use to implement and maintain a quality management system which conforms with ISO 13485. Alternative approaches can be used if they also satisfy the requirements of ISO 13485. ISO/TR 14969ISO/TR 14969 also notes the following:The guidance contained in this Technical Report is not
25、to be used for identifying specific deficiencies of quality management systems, unless such guidance is voluntarily incorporated by the organization into the documentation describing and supporting the organizations quality management systems, or unless such guidance is specifically made part of the
26、 regulatory requirements relevant to the organizations operation. ISO/TR 14969, 0.1.3The relationships among regulatory requirements, technical standards (see Appendix 4), and requirements for the QMS are illustrated in the figure below. Conformity with these various requirements will lead to the ma
27、nufacture and delivery of safe and effective quality medical devices. Canadian Standards Association The ISO 13485 essentialsFebruary 2006 5Regulatory requirements Technical Standards QMS0.2 Process approach This International Standard is based on a process approach to quality management. Any activi
28、ty that receives inputs and converts them to outputs can be considered as a process.For an organization to function effectively, it has to identify and manage numerous linked processes. Often the output from one process directly forms the input to the next. The application of a system of processes w
29、ithin an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”.NeedsRegulatory requirementsProduct ConfidenceQuality management systemRealization processesQualitySafe International Organization for Stand
30、ardization (ISO); European Committees for Standardization (CEN and CENELEC); national regulatory bodies.Many of these documents are listed in the Bibliography. ISO/TR 14969, 0.3ISO/TR 14969 notes that the following should be taken into account:Conformance to ISO 13485 quality management system requi
31、rements does not automatically constitute conformity with national or regional regulatory requirements. It is the organizations responsibility to identify and establish compliance with relevant regulatory requirements. ISO/TR 14969, 0.40.4 Compatibility with other management systems This Internation
32、al Standard follows the format of ISO 9001 for the convenience of users in the medical device community. This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, or
33、 financial management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for an organization to adapt its existing management system(s) in order to establish a quality manag
34、ement system that complies with the requirements of this International Standard.GuidancePLUS 13485 Canadian Standards Association12 February 2006Clause 1.1 defines the scope of ISO 13485. This should not be confused with the scope of the QMS, which is a term commonly used within the context of QMS c
35、ertification/registration to describe the products and product realization processes to which the QMS applies. The scope of the QMS should be based on the nature of the organizations products and their realization processes, the result of risk assessment, commercial considerations, and contractual,
36、statutory, and regulatory requirements. An organization is not obliged to include all the products that it provides within the scope of its QMS or to address the realization processes for products that are not included within the QMS.1Scope1.1 GeneralThis International Standard specifies requirement
37、s for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.The primary objective of this Internati
38、onal Standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of
39、 these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 (see Annex B). Guidance Canadian Standards Association The ISO 13485 essent
40、ialsFebruary 2006 13However, when an organization chooses to implement a QMS with a limited scope, this should be clearly described in the organizations quality manual and any other publicly available documents (e.g., certification/registration documents and marketing material) to avoid confusing or
41、 misleading customers and end users.Note: Annex B of ISO 13485 is not reproduced in this Handbook. This 30-page Annex details the similarities and differences between the requirements of ISO 13485 and those of ISO 9001, and states, where applicable, the reasons for such differences. Readers are advi
42、sed to consult ISO 13485 for detailed information.1.2 Application All requirements of this International Standard are specific to organizations providing medical devices, regardless of the type or size of the organization.If regulatory requirements permit exclusions of design and development control
43、s (see 7.3), this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity
44、with this International Standard reflect exclusion of design and development controls see 4.2.2 a) and 7.3.If any requirement(s) in Clause 7 of this International Standard is (are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organ
45、ization does not need to include such a requirement(s) in its quality management system see 4.2.2 a).The processes required by this International Standard, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and a
46、re accounted for in the organizations quality management system see 4.1 a).PLUS 13485 Canadian Standards Association14 February 2006The ISO Technical Committee responsible for the 9000 family of Standards, TC 176, has written the support documents on the following subjects: application, documentatio
47、n requirements, terminology, the process approach to QMS, and outsourced processes. These documents are available free at www.bsi.org.uk/iso-tc176-sc2. Other guides available at this site include Selection and use of ISO 9000 and Quality Management Principles and Guidelines on their Application.ISO/
48、TR 14969 provides guidance on the application of ISO 13485 as follows:1.2.1 GeneralCertain product realization requirements of ISO 13485 can legitimately be omitted in one of two ways: they can be “excluded”, or they might be “not applicable”. It is important to note, however, that any exclusion or
49、non-applicability should be detailed and justified in the organizations quality manual.1.2.2 ExclusionsSome regulatory requirements permit organizations to place some medical devices on the market without having to demonstrate conformance with design and development controls (see ISO 13485:2003, 7.3). Organizations should determine the exclusion of 7.3 on a product-by-product, market-by-market basis.Even if the organization is permitted by regulations to exclude the requirements of 7.3, it still has obligations to meet product realization r
