YY/T 0595-2020 PDF English
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Medical devices - Quality management systems - Guidance on the application of YY/T 0287-2017
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Medical devices. Quality management systems. Guidance on the application of YY/T0287-2003
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YY/T 0595-2020: Medical devices - Quality management systems - Guidance on the application of YY/T 0287-2017
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0595-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.01; 03.120.10
C 30
Replacing YY/T 0595-2006
Medical devices- Quality management systems-
Guidance on the application of YY/T 0287-2017
Issued on. FEBRUARY 21, 2020
Implemented on. APRIL 01, 2020
Issued by. National Medical Products Administration
Table of Contents
Foreword... 4
Introduction... 5
1 Scope... 7
2 Normative references... 8
3 Terms and definitions... 8
4 Quality management system... 9
5 Management responsibilities... 28
6 Resource management... 42
7 Product realization... 53
8 Measurement, analysis and improvement... 122
Appendix A (Informative) Examples of the process of integrating applicable
regulatory requirements into the quality management system... 160
Appendix B (Informative) Example of corresponding relationship between YY/T
0287-2017 and "Medical device manufacturing quality management
specification" (released on December 29, 2014) and Appendix... 167
References... 173
1 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.
2 Normative references
The following documents are essential to the application of this document. For
the dated documents, only the versions with the dates indicated are applicable
to this document; for the undated documents, only the latest version (including
all the amendments) are applicable to this standard.
GB/T 19000-2016 Quality management systems - Fundamentals and
vocabulary (ISO 9000.2015, IDT)
YY/T 0287-2017 Medical devices - Quality management systems -
Requirements for regulatory purposes (ISO 13485.2016, IDT)
3 Terms and definitions
The terms and definitions defined in GB/T 19000-2016 and YY/T 0287-2017
are applicable to this document.
4 Quality management system
4.1 General requirements
4.1 General requirements
4.1.1 The organization shall document the quality management system and
maintain its effectiveness in accordance with the requirements of this standard
and applicable regulatory requirements.
4.2 Document requirements
4.2.1 General
4.2 Document requirements
4.2.1 General
The quality management system documents (see 4.2.4) shall include.
4.2.1.1 The organization's quality management system document structure and
the level of detail shall be suitable for the organization's needs and depend on.
4.2.1.2 The organization's quality management system documents should
include.
4.2.2 Quality manual
4.2.2 Quality Manual
The organization shall prepare a quality manual, which includes.
4.2.3 Medical device documentation
4.2.3 Medical device documentation
The organization shall establish and maintain one or more documents for each
medical device type or medical device family. The documents contain or
reference the documents to prove compliance with the requirements of this
standard and applicable regulatory requirements.
4.2.4.2 The record is a special document; its particularity is that it is a document
when it is not filled in. It should be controlled according to YY/T 0287-2017,
4.2.4.Once filled in, it serves to provide evidence of the completed activity. It
should be controlled according to YY/T 0287-2017, 4.2.5.
4.2.4.3 The review of the document can be carried out at different times during
the validity period of the document. The suitability of the document shall be
reviewed if the following situations occur.
4.2.4.4 The uniform structure of quality management system documents
facilitates the implementation of document control procedures. These
procedures should clearly indicate what kind of document control information
should be included in each document; the document control information should
include the following elements.
5 Management responsibilities
5.1 Management commitment
The top management shall provide evidence of its commitment to establish and
implement the quality management system and maintain its effectiveness
through the following activities.
5.1.1 The top management has the right to authorize and provide resources
within the organization. If the scope of the quality management system only
covers a part of the organization, the top management is the person or group
of people who direct and control this part of the organization.
5.2 Focus on customers
5.2 Focus on customers
The top management shall ensure that customer requirements and applicable
regulatory requirements are determined and met.
5.2.1 The input to the quality management system comes from customer
requirements and applicable regulatory requirements. This shows that no
matter who actually communicates with customers and regulatory agencies, top
management has the responsibility to ensure that these requirements are
understood and allocate the necessary resources. To solve this problem, the
following inputs shall be considered.
5.3 Quality policy
5.3 Quality policy
The top management shall ensure that the quality policy.
5.3.1 When formulating overall policies related to business operations (such as
marketing, sales, finance), the organization should consider the quality policy
to ensure that the policies are consistent and mutually supportive.
5.3.2 The quality policy should convey the top management's commitment to
quality and the significance of quality to the organization's business and
customers. To confirm the organization's commitment to implement its quality
policy, it should determine the quality objectives directly related to the
organization and its customers.
5.4 Planning
5.4.1 Quality objectives
The top management shall ensure that quality objectives are established in the
relevant functions and levels of the organization. The quality objectives include
the content required to meet applicable regulatory requirements and product
requirements. The quality objectives shall be measurable and consistent with
the quality policy.
5.4.2 Quality management system planning
Top management shall ensure.
5.5 Responsibility, authority and communication
5.5.1 Responsibilities and authority
Top management shall ensure that responsibilities and authorities are defined,
documented and communicated within the organization.
6 Resource management
6.1 Provision of resources
The organization shall determine and provide the required resources, in order to.
6.1.1 Providing and maintaining sufficient resources is a prerequisite for the
organization to effectively establish, implement, maintain and manage the
quality management system and its processes. The nature and quantity of such
resources shall be based on the type and complexity of the organization's
products and processes, as well as the risks associated with these products
and processes.
6.1.2 The management of the organization should identify and provide sufficient
resources required to implement the quality policy, achieve the quality
objectives, meet applicable regulatory requirements and customer
requirements.
6.2 Human resources
Based on appropriate education, training, skills and experience, personnel
engaged in work affecting product quality shall be competent.
The organization shall document one or more processes of establishing
competence, providing required training, ensuring personnel awareness.
The organization shall.
6.3 Infrastructure
In order to meet product requirements, prevent product confusion, ensure
orderly disposal of products, the organization shall document the required
infrastructure requirements. Where appropriate, the infrastructure includes.
6.3.5 The infrastructure should be designed, constructed, correctly installed and
positioned so that it can be properly operated, maintained, debugged and
cleaned. For infrastructure.
6.4 Working environment and pollution control
6.4.1 Working environment
The organization shall document the requirements for the working environment
required to meet product requirements.
6.4.2 Pollution control
When appropriate, in order to prevent contamination of the working
environment, personnel or products, the organization shall plan and document
the control of contaminated or susceptible products.
7 Product realization
7.1 Planning of product realization
The organization shall plan and develop the processes required for product
realization. The planning of product realization shall be consistent with the
requirements of other processes of the quality management system.
The organization shall document one or more processes of risk management
during the product realization process. Records of risk management activities
shall be kept (see 4.2.5).
7.1.2 Risk management
According to the requirements of YY/T 0287-2017, 7.1, the organization should
document one or more processes of risk management during product
realization and keep records of risk management activities.
7.2 Customer-related processes
7.2.1 Determination of product requirements
The organization shall determine.
7.2.1.1 The customer-related process involves the following aspects.
7.2.1.2 The requirements for products (including services) can cover more
elements, such as.
7.2.3 Communication
The organization shall plan and document the arrangements for communication
with customers in the following areas.
7.2.3.1 For complaints, corrective measures, preventive measures, product
changes or quality management system changes, the terms, definitions, and
reporting requirements, etc., there are subtle differences in the regulatory
requirements of different countries or regions, meanwhile the responsibility
requirements for organizations, regulatory agencies, customers and third
parties are also different. In order to understand and comply with the applicable
regulatory requirements of the country or region where the product is intended
to be marketed, the organization should make corresponding provisions.
7.3 Design and development
7.3.1 General
The organization shall document the design and development procedures.
7.3.5 Design and development review
According to the planned and documented arrangements, the design and
development shall be systematically reviewed at an appropriate stage to.
8 Measurement, analysis and improvement
8.1 General
The organization shall plan and implement the required monitoring,
measurement, analysis and improvement processes to.
8.1.1 For the monitoring, measurement, analysis and improvement processes
planned and implemented by the organization, Figure 3 illustrates the four
typical stages that can be used to plan, implement and keep the process
effective.
8.1.1.1 Stage I. Planning
Planning includes identifying and determining the appropriate methods and
resources required, to meet the specific objectives of effective monitoring and
measurement of the various processes of the organization's quality
management system. This planning stage should be consistent with the
organization's overall business planning process, include consideration of the
Stage I.
8.2 Monitoring and measurement
8.2.1 Feedback
As a measure of the effectiveness of the quality management system, the
organization shall collect and monitor relevant information on whether the
organization meets customer requirements; document the methods for
obtaining and using this information.
8.3 Control of nonconforming product
8.3.1 General
The organization shall ensure that products that do not meet product
requirements are identified and controlled, to prevent unintended use or
delivery. The organization shall establish procedures and document the control
of nonconforming products and the responsibilities and authorities related to
the identification, recording, isolation, evaluation, disposal of nonconforming
products.
8.3.1 of YY/T 0287-2017, to specify nonconforming product control
requirements and related responsibilities and authorities. Procedure
documents should be used to.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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