02/560598 DC : DRAFT FEB 2002

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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ISO/DIS 13485 - QUALITY SYSTEMS - MEDICAL DEVICES - SYSTEM REQUIREMENTS FOR REGULATORY PURPOSES

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Superseded date: 24-07-2003

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Published date: 23-11-2012

Publisher: British Standards Institution

Table of Contents - (Show below) - (Hide below)

0 Introduction
  0.1 General
  0.2 Process approach
  0.3 Relationship with other standards
  0.4 Compatibility with other management systems
1 Scope
  1.1 General
  1.2 Application
2 Normative reference
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
6 Resource management
  6.1 Provision of resources
  6.2 Human resources
  6.3 Infrastructure
  6.4 Work environment
7 Product realization
  7.1 Planning of product realizations
  7.2 Customer focus
  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
Annex B
Bibliography

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Comment Closes On
Committee	CH/66
Document Type	Draft
ISBN
Pages
Published
Publisher	British Standards Institution
Status	Superseded
Superseded By	BS EN ISO 13485:2016

Standards Referencing This Book - (Show below) - (Hide below)

ISO 10011-3:1991	Guidelines for auditing quality systems Part 3: Management of audit programmes
ISO 14160:2011	Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 10011-1:1990	Guidelines for auditing quality systems Part 1: Auditing
ISO 10012-2:1997	Quality assurance for measuring equipment Part 2: Guidelines for control of measurement processes
ISO 14937:2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 9001:2015	Quality management systems — Requirements
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
ISO 11134:1994	Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 11137:1995	Sterilization of health care products Requirements for validation and routine control Radiation sterilization
ISO 10012-1:1992	Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment
ISO 13683:1997	Sterilization of health care products Requirements for validation and routine control of moist heat sterilization in health care facilities
ISO 10011-2:1991	Guidelines for auditing quality systems — Part 2: Qualification criteria for quality systems auditors

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