YY/T 0287-2003: Medical devices. Quality management systems. Requirements for regulatory purposes

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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

Basic Data

Standard ID	YY/T 0287-2003 (YY/T0287-2003)
Description (Translated English)	Medical devices. Quality management systems. Requirements for regulatory purposes
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01
Word Count Estimation	49,482
Date of Issue	2003-09-17
Date of Implementation	2004-04-01
Older Standard (superseded by this standard)	YY/T 0287-1996
Quoted Standard	GB/T 19000-2000
Adopted Standard	ISO 13485-2003, IDT
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the action of the quality management system requirements, organizations may so require a medical device design and development, production, installation and services, and related services to design, develop and deliver. This standard can also be used for internal and external (including certification bodies) to assess the organization to meet customer and regulatory requirements. This standard needs to demonstrate its ability to consistently meet customer requirements and to provide for medical devices and related services regulatory requirements for medical devices and related services organization defines the quality management system requirements. The main purpose of this standard is to facilitate the coordinated implementation of the quality management system regulations. Therefore, the standard specifies a number of requirements for medical devices, the deletion of GB/T 19001 suitable as regulatory requirements in certain requirements. Because of these deletion, the quality management system conforming to this standard organization can not claim to comply with GB/T 19001 standard, unless its quality management system also complies with GB/T 19001 All the requirements (see Appendix B).