YY/T 0595-2006 English PDF (YY/T0595-2006)

YY/T 0595-2006: Medical devices. Quality management systems. Guidance on the application of YY/T0287-2003
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YY/T 0595-2006
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.01
C 37
YY/T 0595-2006 / ISO/TR 14969:2004
Medical Devices - Quality Management Systems -
Guidance on the Application of YY/T 0287-2003
(ISO/TR 14969:2004,IDT)
ISSUED ON: JUNE 19, 2006
IMPLEMENTED ON: MAY 1, 2007
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 4 
Introduction ... 5 
0.1 General ... 5 
0.2 Process Approach ... 6 
0.3 Relationship with Other Standards, Guidance Documents and Regulatory Requirements ... 7 
0.4 Compatibility with Other Management Systems ... 8 
1 Scope ... 9 
1.1 General ... 9 
1.2 Application ... 9 
2 Normative References ... 11 
3 Terms and Definitions ... 11 
4 Quality Management System ... 12 
4.1 General Requirements ... 12 
4.2 Documentation Requirements ... 14 
5 Management Responsibility ... 22 
5.1 Management Commitment ... 22 
5.2 Customer Focus ... 23 
5.3 Quality Policy ... 23 
5.4 Planning ... 24 
5.5 Responsibility, Authority and Communication ... 27 
5.6 Management Review ... 29 
6 Resource Management ... 33 
6.1 Provision of Resources ... 33 
6.2 Human Resources ... 33 
6.3 Infrastructure ... 35 
6.4 Work Environment ... 36 
7 Product Realization ... 40 
7.1 Planning of Product Realization ... 40 
7.2 Customer-related Processes ... 45 
7.3 Design and Development ... 49 
7.4 Purchasing ... 62 
7.5 Production and Service Provision ... 66 
7.6 Control of Monitoring and Measuring Devices ... 82 
8 Measurement, Analysis and Improvement ... 85 
8.1 General ... 85 
8.2 Monitoring and Measurement ... 87 
8.3 Control of Nonconforming Product ... 92 
8.4 Analysis of Data ... 95 
8.5 Improvement ... 96 
Annex A (informative) Terms Used in Certain Regulatory Administrations to
Describe Documents Referenced in this Technical Report ... 105 
Annex B (informative) Analysis of Significant Changes from YY/T 0287-1996 to
YY/T 0287-2003 ... 106 
Bibliography ... 114 
Foreword
This Standard equivalently adopts ISO/TR 14969:2004 Medical Devices - Quality
Management Systems - Guidance on the Application of ISO 13485:2003. ISO
13485:2003 has been equivalently converted to YY/T 0287-2003 Medical Devices -
Quality Management Systems - Requirements for Regulatory Purposes.
In this Standard, “应当” is translated to “should”, where merely serves as guidance, so
as to distinguish from YY/T 0287-2003 idt ISO 13485:2003, in which, “应” is translated
into “shall”.
This Standard may be jointly adopted with YY/T 0287 Medical Devices - Quality
Management Systems - Requirements for Regulatory Purposes.
In this Standard, Annex A and Annex B are informative.
In this Standard, the content in the box directly quotes the clauses in YY/T 0287-2003;
before the text, it clearly indicates “YY/T 0287-2003 Medical Devices - Quality
Management Systems - Requirements for Regulatory Purposes”.
In the INTRODUCTION part of this Standard, the regular script in 0.3 is the italics part
in the previous text.
This Standard was proposed by the Medical Devices Division of China Food and Drug
Administration.
This Standard shall be under the jurisdiction of National Technical Committee 221 on
Quality Management and General Requirements for Medical Device of Standardization
Administration of China (SAC/TC 221).
The drafting organizations of this Standard: National Technical Committee 221 on
Quality Management and General Requirements for Medical Device of Standardization
Administration of China; Beijing Hua Guang Certification of Medical Devices Co., Ltd.
The main drafters of this Standard: Zhang Mingzhu, Chen Zhigang, Zheng Yihan, Wu
Junhua, Qin Shuhua, Li Huimin.
Introduction
0.1 General
0.1.1 This Technical Report provides guidance to assist in the development,
implementation and maintenance of quality management systems that aim to meet the
requirements of YY/T 0287 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. Such medical devices include active, non-active,
implantable and non-implantable medical devices and in vitro diagnostic medical
devices.
YY/T 0287 specifies the quality management system requirements for medical devices
for regulatory purposes (see Annex A). YY/T 0287-2003 accommodates the previous
YY/T 0288 by permissible exclusion as specified in YY/T 0287-2003, 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 requirements.
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 an organization can use to
implement and maintain a quality management system which conforms with YY/T 0287.
Alternative approaches can be used if they also satisfy the requirements of YY/T 0287.
0.1.2 The guidance given in this Technical Report is applicable to the design,
development, production, installation and servicing of medical devices of all kinds. It
describes concepts and methods that can be considered by organizations which are
establishing and maintaining quality management systems.
An organization can voluntarily incorporate guidance from this Technical Report, wholly
or in part, into its quality management system.
0.1.3 Guidance contained in this Technical Report can be useful as background
information for those representing quality management system assessors, Conformity
Assessment Bodies and regulatory enforcement bodies.
The guidance contained in this Technical Report is not 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 organization’s quality management system, or unless such guidance is
Medical Devices - Quality Management Systems -
Guidance on the Application of YY/T 0287-2003
1 Scope
1.1 General
This Technical Report provides guidance for the application of the requirements for
quality management systems contained in YY/T 0287. It does not add to, or otherwise
change, the requirements of YY/T 0287. This Technical Report does not include
requirements to be used as the basis of regulatory inspection or certification
assessment activities.
NOTE: the terms “should”, “can” and “might” within this Technical Report are used as
follows. “Should” is used to indicate that, amongst several possibilities to meet a
requirement in YY/T 0287, 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
possibilities or options. These terms do not indicate requirements.
This guidance can be used to better understand the requirements of YY/T 0287 and to
illustrate some of the variety of methods and approaches available for meeting the
requirements of YY/T 0287.
1.2 Application
YY/T 0287-2003 Medical Devices - Quality Management Systems - Requirements
for Regulatory Purposes
1.2 Application
All requirements of this 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 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 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
YY/T 0595-2006
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.01
C 37
YY/T 0595-2006 / ISO/TR 14969:2004
Medical Devices - Quality Management Systems -
Guidance on the Application of YY/T 0287-2003
(ISO/TR 14969:2004,IDT)
ISSUED ON: JUNE 19, 2006
IMPLEMENTED ON: MAY 1, 2007
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 4 
Introduction ... 5 
0.1 General ... 5 
0.2 Process Approach ... 6 
0.3 Relationship with Other Standards, Guidance Documents and Regulatory Requirements ... 7 
0.4 Compatibility with Other Management Systems ... 8 
1 Scope ... 9 
1.1 General ... 9 
1.2 Application ... 9 
2 Normative References ... 11 
3 Terms and Definitions ... 11 
4 Quality Management System ... 12 
4.1 General Requirements ... 12 
4.2 Documentation Requirements ... 14 
5 Management Responsibility ... 22 
5.1 Management Commitment ... 22 
5.2 Customer Focus ... 23 
5.3 Quality Policy ... 23 
5.4 Planning ... 24 
5.5 Responsibility, Authority and Communication ... 27 
5.6 Management Review ... 29 
6 Resource Management ... 33 
6.1 Provision of Resources ... 33 
6.2 Human Resources ... 33 
6.3 Infrastructure ... 35 
6.4 Work Environment ... 36 
7 Product Realization ... 40 
7.1 Planning of Product Realization ... 40 
7.2 Customer-related Processes ... 45 
7.3 Design and Development ... 49 
7.4 Purchasing ... 62 
7.5 Production and Service Provision ... 66 
7.6 Control of Monitoring and Measuring Devices ... 82 
8 Measurement, Analysis and Improvement ... 85 
8.1 General ... 85 
8.2 Monitoring and Measurement ... 87 
8.3 Control of Nonconforming Product ... 92 
8.4 Analysis of Data ... 95 
8.5 Improvement ... 96 
Annex A (informative) Terms Used in Certain Regulatory Administrations to
Describe Documents Referenced in this Technical Report ... 105 
Annex B (informative) Analysis of Significant Changes from YY/T 0287-1996 to
YY/T 0287-2003 ... 106 
Bibliography ... 114 
Foreword
This Standard equivalently adopts ISO/TR 14969:2004 Medical Devices - Quality
Management Systems - Guidance on the Application of ISO 13485:2003. ISO
13485:2003 has been equivalently converted to YY/T 0287-2003 Medical Devices -
Quality Management Systems - Requirements for Regulatory Purposes.
In this Standard, “应当” is translated to “should”, where merely serves as guidance, so
as to distinguish from YY/T 0287-2003 idt ISO 13485:2003, in which, “应” is translated
into “shall”.
This Standard may be jointly adopted with YY/T 0287 Medical Devices - Quality
Management Systems - Requirements for Regulatory Purposes.
In this Standard, Annex A and Annex B are informative.
In this Standard, the content in the box directly quotes the clauses in YY/T 0287-2003;
before the text, it clearly indicates “YY/T 0287-2003 Medical Devices - Quality
Management Systems - Requirements for Regulatory Purposes”.
In the INTRODUCTION part of this Standard, the regular script in 0.3 is the italics part
in the previous text.
This Standard was proposed by the Medical Devices Division of China Food and Drug
Administration.
This Standard shall be under the jurisdiction of National Technical Committee 221 on
Quality Management and General Requirements for Medical Device of Standardization
Administration of China (SAC/TC 221).
The drafting organizations of this Standard: National Technical Committee 221 on
Quality Management and General Requirements for Medical Device of Standardization
Administration of China; Beijing Hua Guang Certification of Medical Devices Co., Ltd.
The main drafters of this Standard: Zhang Mingzhu, Chen Zhigang, Zheng Yihan, Wu
Junhua, Qin Shuhua, Li Huimin.
Introduction
0.1 General
0.1.1 This Technical Report provides guidance to assist in the development,
implementation and maintenance of quality management systems that aim to meet the
requirements of YY/T 0287 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. Such medical devices include active, non-active,
implantable and non-implantable medical devices and in vitro diagnostic medical
devices.
YY/T 0287 specifies the quality management system requirements for medical devices
for regulatory purposes (see Annex A). YY/T 0287-2003 accommodates the previous
YY/T 0288 by permissible exclusion as specified in YY/T 0287-2003, 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 requirements.
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 an organization can use to
implement and maintain a quality management system which conforms with YY/T 0287.
Alternative approaches can be used if they also satisfy the requirements of YY/T 0287.
0.1.2 The guidance given in this Technical Report is applicable to the design,
development, production, installation and servicing of medical devices of all kinds. It
descri...