YY/T 0287-2003 (YYT0287-2003)

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YY/T 0287-2003
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.01
C 30
YY/T 0287-2003 / ISO 13485.2003
Replacing YY/T 0287-1996
Medical devices - Quality management systems
- Requirements for regulatory purposes
(ISO 13485.2003, IDT)
ISSUED ON. SEPTEMBER 17, 2003
IMPLEMENTED ON. APRIL 1, 2004
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 6
2 Normative references ... 7
3 Terms and definitions ... 7
4 Quality management system ... 10
5 Management responsibility ... 13
6 Resource management ... 16
7 Product realization ... 18
8 Measurement, analysis and improvement ... 28
Annex A (informative) Correspondence between YY/T 0287-1996 and YY/T 0287-
2003... 33
Annex B (informative) Explanation of differences between YY/T 0287-2003 and GB/T
19001-2000 ... 38
Bibliography ... 80
Foreword
This standard is identical to ISO 13485.2003 “Medical devices - Quality management
systems - Requirements for regulatory purposes” (English version).
This Standard is a stand-alone standard basing on GB/T 19001-2000, and follows the
structure of GB/T 19001-2000.
For the convenience of users in the medical device community, in the text of this
Standard, the contents differ from those in GB/T 19001-2000 are in black block letters
[Translator note. in italics in this Standard].
The “Notes” in this Standard are additional information provided to users of the
English-version International Standard, in order to be identical to the International
Standard, these contents are retained in this Standard.
Annexes A and B of this Standard are informative.
This Standard is proposed by Medical Devices Division of China Food and Drug
Administration.
This Standard is under the jurisdiction of SAC/TC 221 National Technical Committee
on Medical Device Quality Management and General Requirements of Standardization
Administration of China.
Drafting organization of this Standard. National Technical Committee on Medical
Device Quality Management and General Requirements of Standardization
Administration of China, Beijing Hua Guang Certification of Medical Devices Co., Ltd.
(formerly China Medical Device Quality Certification Center).
Main drafters of this Standard. Zhang Mingzhu, Chen Zhigang, Wu Junhua, Li Huimin,
Qin Shuhua, Zheng Yihan, Meng Qingzeng, Li Zhaohui, Zhou Yajun, Liu Baoxia, Wang
Huifang, Liu Jingzhuan.
0.3 Relationship with other standards
0.3.1 Relationship with GB/T 19001
While this is a stand-alone standard, it is based on GB/T 19001.
Those clauses or subclauses that are quoted directly and unchanged from GB/T 19001
are in normal font. The fact that these subclauses are presented unchanged is noted
in Annex B.
Where the text of this Standard is not identical to the text of GB/T 19001, the sentence
or indent containing that text as a whole is shown in block letters [Translator note. in
italics in this Standard]. The nature and reasons for the text changes are noted in
Annex B.
0.3.2 Relationship with ISO/TR 14969
ISO/TR 14969 is a Technical Report intended to provide guidance for the application
of ISO 13485/YY/T 0287.
0.4 Compatibility with other management systems
This Standard follows the format of GB/T 19001 for the convenience of users in the
medical device community.
This Standard does not include requirements specific to other management systems,
such as those particular to environmental management, occupational health and safety
management, or financial management.
However, this 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 management system that complies with the requirements of this Standard.
Medical devices - Quality management systems -
Requirements for regulatory purposes
1 Scope
1.1 General
This 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 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
GB/T 19001 that are not appropriate as regulatory requirements. Because of these
exclusions, organizations whose quality management systems conform to this
Standard cannot claim conformity to GB/T 19001 unless their quality management
systems conform to all the requirements of GB/T 19001 (see Annex B).
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
management system [see 4.2.2 a)].
The processes required by this 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)].
Bibliography
[1] GB/T 19001-2000 Quality management systems - Requirements
[2] GB/T 19022 Measurement management systems - Requirements for measurement
processes and measuring equipment (ISO 10012.2003, IDT)
[3] GB 18278-2000 Sterilization of health care products - Requirements for validation
and routine control - Industrial moist heat sterilization (idt ISO 11134.1994)
[4] GB 18279-2000 Medical devices - Validation and routine control of ethylene oxide
sterilization (idt ISO 11135.1994 and Corrigendum 1 published 1994)
[5] GB 18280-2000 Sterilization of health care products - Requirements for validation
and routine control - Radiation sterilization (ISO 11137.1995 and Corrigendum 1
published 1995)
[6] ISO 13641.2002 Elimination or reduction of risk of infection related to in vitro
diagnostic medical devices
[7] ISO 13683.1997 Sterilization of health care products - Requirement for validation
and routine control of moist heat sterilization in health care facilities
[8] ISO 14155-11) Clinical investigation of medical devices for human subjects - Part 1.
General requirements
[9] ISO 14155-21) Clinical investigation of medical devices for human subjects - Part 2.
Clinical investigation plans
[10] ISO 14160.1998 Sterilization of medical devices - Validation and routine control of
sterilization of single-use medical devices incorporating materials of animal origin
by liquid chemical sterilants
[11] ISO 14937.2000, Sterilization of health care products - General requirements for
characterization of a sterilizing agent and the development, validation and routine
control of a sterilizing agent
[12] ISO/TR 149691) Medical devices - Quality management systems - Guidance on
the application of ISO 13485.2003
[13] YY/T 0316-2003 Medical devices - Application of risk management to medical
devices (ISO 14971.2000, IDT)
[14] GB/T 19011-2003 Guidelines for quality and/or environmental management
1) To be published.
systems auditing (ISO 19011.2002, IDT)
[15] Global Harmonization Task Force (GHTF) - Study Group 1 (SG1), Document No.
N029R11, dated 2 Feb., 2002