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CSA - PLUS 9001MD-98

ISO 9000 and 13485 Essentials for Medical Device Manufacturers

inactive
Organization: CSA
Publication Date: 1 February 1998
Status: inactive
Page Count: 228
scope:

Preface

The primary objective of this handbook is to provide both novice and experienced quality practitioners with a concise, user-friendly guide for understanding and implementing the requirements of the two standards ISO 13485 and ISO 13488, which are based on ISO 9001 and ISO 9002 respectively.

The first section (1. Foreword) of the handbook outlines the background of the ISO 9000 family of standards as it now looks and gives an insight into the forecasted year 2000 version.

The second section (2. Conceptual Overview of the ISO 9000 and 13485 Standards) presents a conceptual overview of these and other standards, and helps explain the mandatory nature of quality assurance requirements as it applies to the medical device industry.

The third section (3. An Implementation Path) describes a quality system registration process for organizations that are pursuing the path of third-party certification.

The fourth section (4. Quaiity System Requirements) contains

the actual text of ISO 9001:94 and ISO 13485:96

guidance made up of excerpts from CAN/CSA-ISO 9000-1-94, CAN/CSA-Q10001-94, and ISO 9000-2:97; from the Global Harmonization Task Force guidance; from the ISO/FDIS 14969:97 draft guidance prepared by ISO Technical Committee 210; and from guidance developed by the Medical Devices Bureau of Canada.

definitions from the vocabulary CAN/CSA-ISO 8402-94, and from ISO 13485:96 (which are specific for medical devices)

typical self-diagnostic and audit questions

where applicable, interpretations provided by the CSA Technical Committee on Quality Management

The standard ISO 9000-2:97 issued on June 15, 1997, is an update of ISO 9000-2: 1993 and is based on the 1994 edition of ISO 9001 and 9002.

Finally, a series of Appendices further describes these and other standards which form quality assurance requirements for medical devices.

Document History

January 1, 2017
The ISO 9000 essentials - A practical handbook for implementing the ISO 9000 family of standards
General The ISO 9000 series of standards was developed to assist organizations of all types and sizes to implement and operate an effective quality management system (QMS). It consists of four core...
March 1, 2009
The ISO 9000 Essentials A practical handbook for implementing the ISO 9000 family of standards
General The ISO 9000 family of standards was developed to assist organizations, of all types and sizes, to implement and operate an effective quality management system (QMS). It is made up of four...
April 1, 2001
ISO 9000 Essentials a Practical Handbook for Implementing the ISO 9000 Standards
General The ISO 9000:2000 family of Standards was developed to assist organizations, of all types and sizes, to implement and operate an effective quality management system (QMS). It is made up of...
February 1, 1998
ISO 9000 and 13485 Essentials for Medical Device Manufacturers
Preface The primary objective of this handbook is to provide both novice and experienced quality practitioners with a concise, user-fiiendly guide for understanding and implementing the requirements...
February 1, 1998
ISO 9000 Essentials a Practical Handbook for Implementing the ISO 9000 Standards
The primary objective of this handbook is to provide both novice and experienced quality practitioners with a concise, user-hendly guide to understanding and implementing the requirements of ISO...
PLUS 9001MD-98
February 1, 1998
ISO 9000 and 13485 Essentials for Medical Device Manufacturers
Preface The primary objective of this handbook is to provide both novice and experienced quality practitioners with a concise, user-friendly guide for understanding and implementing the requirements...
January 1, 1995
ISO 9000 Essentials - Handbook for Medical Device Manufacturers
Foreword Successful organizations in today’s business environment focus on doing the right things the first time, on time, every' time, and always to the customer’s satisfaction. Achieving this...
January 1, 1994
ISO 9000 Essentials a Practical Handbook for Implementing the ISO 9000 Standards
Foreword Successful organizations in today’s business environment focus on doing the right things the first time, on time, every time, and always to the customer’s satisfaction. Achieving this...

References

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