YY/T 0595-2020: Medical devices - Quality management systems - Guidance on the application of YY/T 0287-2017

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Scope

1.1 General
This standard provides guidelines for the application of medical device quality
management system requirements in YY/T 0287-2017.
This standard applies to organizations of various sizes and types, as well as
suppliers or other external parties that provide products and services for them,
which involves one or more stages of the life cycle of medical devices (including
the design and development, production, storage and circulation, installation,
service and final decommissioning and disposal of medical devices, as well as
the design and development or provision of related activities).
This standard does not apply to inspections by regulatory agencies or
assessment by certification agencies.
1.2 Application
1.2.1 General
The relevant requirements in Chapter 6, Chapter 7, Chapter 8 of YY/T 0287-
2017 can be reasonably omitted through one of the two methods of deletion or
inapplicability. For any deletion or inapplicability, the organization should
describe and justify it in its quality manual.
1.2.2 Deletion
The deletion of design and development must comply with regulatory
requirements. If applicable regulations allow the deletion of design and
development, this can be used as a reason for the organization to delete it from
the quality management system. The organization should provide methods to
verify that the design of products and services is sufficiently safe and effective;
this shall be described in the quality management system. When an
organization declares compliance with YY/T 0287-2017, it should clarify any
deletions in the design and development of its quality management system.
Some regulatory requirements allow organizations to place certain medical
devices on the market without having to prove that they meet the design and
development control requirements.
1.2.3 Inapplicability
The organization can review all the requirements in Chapters 6, 7, 8 of YY/T
0287-2017 according to its own roles and activities at different stages of the
medical device��s life cycle and the types of medical device products; identify
those activities do not need to be completed by the organization or
requirements that are not applicable to the organization��s products. Those
inapplicable requirements may not be considered in the quality management
system.

Basic Data

Standard ID	YY/T 0595-2020 (YY/T0595-2020)
Description (Translated English)	Medical devices - Quality management systems - Guidance on the application of YY/T 0287-2017
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01; 03.120.10
Word Count Estimation	102,158
Date of Issue	2020
Date of Implementation	2020-04-01
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the application guidelines for the medical device quality management system requirements in YY/T 0287-2017. This standard applies to one or more stages involved in the life cycle of a medical device (including the design and development, production, storage and distribution, installation, service and final decommissioning and disposal of medical devices, and the design and development or provision of related activities) organizations of all sizes and types, and suppliers or other external parties that provide products and services. This standard does not apply to regulatory body inspections or certification body assessments.