YY/T 0595-2006: Medical devices. Quality management systems. Guidance on the application of YY/T0287-2003

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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

Basic Data

Standard ID	YY/T 0595-2006 (YY/T0595-2006)
Description (Translated English)	Medical devices. Quality management systems. Guidance on the application of YY/T0287-2003
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C37
Classification of International Standard	11.040.01
Word Count Estimation	67,627
Date of Issue	2006-06-19
Date of Implementation	2007-05-01
Quoted Standard	GB/T 19000-2000; YY/T 0287-2003
Adopted Standard	ISO/TR 14969-2004, IDT
Regulation (derived from)	State Food and Drug Administration [2006] No. 271
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard applies to YY/T 0287 standard contains medical device quality management system requirements of the application to provide guidance. This standard does not add or change YY/T 0287 requirements. This standard does not contain as a regulatory agency inspection or certification body activity requirements. The guide can be used to better understand the YY/T 0287 requirements, and describes some of the meet YY/T 0287 requirements of the various available methods and means.