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About This Item

 

Full Description

1 Scope

1.1 General

This International Standard specifies requirements 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 International 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 9001:2000 that are not appropriate as regulatory requirements.

Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001:2000 unless their quality management systems conform to all the requirements of ISO 9001:2000 (see Annex B).

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 controls (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 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 organization 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 are accounted for in the organization's quality management system [see 4.1 a)]. In this International Standard the terms "if appropriate" and "where appropriate" are used several times. When a requirement is qualified by either of these phrases, it is deemed to be "appropriate" unless the organization can document a justification otherwise. A requirement is considered "appropriate" if it is necessary in order for the product to meet specified requirements, and/or the organization to carry out corrective action.

In 2011 the European Commission raised a concern around the legal text supporting presumption of conformity to the Medical Device Directives (Annexes ZA, ZB, ZC) in EN ISO 13485:2003. The outcome was that CEN decided to publish a new edition of the standard (EN ISO 13485:2012). This standard has a revised Foreword and Annexes ZA, ZB and ZC, but the core text remains unchanged.

Contents:

0 Introduction
0.1 General
0.2 Process approach
0.3 Relationships with other standards
0.4 Compatibility with other management systems

1 Scope
1.1 General
1.2 Application

2 Normative references

3 Terms and definitions

4 Quality management system
4.1 General requirements
4.2 Documentation requirements

5 Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management review

6 Resource management
6.1 Provision of resources
6.2 Human Resources
6.3 Infrastructure
6.4 Work environment

7 Production realization
7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
7.6 Control of monitoring and measuring devices

8 Measurement analysis and improvement
8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of Data
8.5 Improvement

Annex A (informative) Correspondence between ISO 13485:2003 and ISO 13485:1996

Annex B (informative) Explanation of differences between ISO 13485:2003 and ISO 9001:2000

Bibliography
 

Document History

  1. BS EN ISO 13485:2016


    Medical devices. Quality management systems. Requirements for regulatory purposes

    • Most Recent
  2. BS EN ISO 13485:2012

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    viewing


    Medical devices. Quality management systems. Requirements for regulatory purposes

    • Historical Version
  3. BS EN ISO 13485:2003


    Medical devices. Quality management systems. Requirements for regulatory purposes

    • Historical Version
  4. BS EN ISO 13488:2001


    Quality systems. Medical devices. Particular requirements for the application of EN ISO 9002

    • Historical Version
  5. BS EN ISO 13485:2001


    Quality systems. Medical devices. Particular requirements for the application of EN ISO 9001

    • Historical Version
  6. BS EN 46003:1999


    Quality systems. Medical devices. Particular requirements for the application of EN ISO 9003

    • Historical Version
  7. BS EN 46001:1997


    Specification for application of EN ISO 9001 to the manufacture of medical devices

    • Historical Version
  8. BS EN 46002:1997


    Specification for application of EN ISO 9002 to the manufacture of medical devices

    • Historical Version