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YY/T 0595-2020: Medical devices--Quality management systems--Guidance on the application of YY/T 0287-2017
YY/T 0595-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
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 
4.1 General requirements... 9 
4.2 Document requirements ... 17 
5 Management responsibilities ... 28 
5.1 Management commitment ... 28 
5.2 Focus on customers ... 30 
5.3 Quality policy ... 31 
5.4 Planning ... 32 
5.5 Responsibility, authority and communication ... 34 
5.6 Management review ... 37 
6 Resource management ... 42 
6.1 Provision of resources ... 42 
6.2 Human resources ... 43 
6.3 Infrastructure ... 46 
6.4 Working environment and pollution control ... 48 
7 Product realization ... 53 
7.1 Planning of product realization ... 53 
7.2 Customer-related processes ... 57 
7.3 Design and development... 61 
7.4 Procurement ... 86 
7.5 Production and service provision ... 96 
7.6 Control of monitoring and measuring equipment ... 119 
8 Measurement, analysis and improvement ... 122 
8.1 General ... 122 
8.2 Monitoring and measurement ... 127 
8.3 Control of nonconforming product ... 139 
8.4 Data analysis ... 145 
8.5 Improvement ... 150 
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 
development control requirements. The organization should determine whether
the design and development can be deleted according to different products and
the applicable regulatory requirements of the country or region to be marketed.
For example, if the applicable regulations of the country or region to be
marketed provide for medical device categories (such as low-risk medical
devices) or the medical device has passed a specific conformity assessment
procedure (such as type test), the design and development may not meet the
requirements of 7.3 of YY/T 0287-2017. Even if the regulations allow the
organization to delete the requirements of clause 7.3 of this standard, the
organization is still responsible for meeting the product realization requirements
of 7.1, 7.2, 7.4, 7.5, 7.6 of this standard. In addition, outsourcing the design and
development process cannot be used as a reason to delete clause 7.3 from the
organization's quality management system.
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.
information system resources, etc.;
- Guide the necessary changes to the quality management system;
- Respond to feedback;
- Initiate corrective and preventive measures;
- Accept and respond to independent external assessments;
- Use appropriate evaluation methods, such as internal audits and
management reviews.
The organization should identify one or more roles of itself in the medical
device’s life cycle or supply chain in accordance with the applicable regulatory
requirements in different jurisdictions; document them. Organizations play
different roles in different jurisdictions, and the applicable regulatory
requirements are also different. Organizations can assume the following
different roles under applicable regulatory requirements:
- Manufacturer;
- Suppliers of raw materials, parts or components;
- Contract manufacturer;
- Packaging, sterilization or logistics service provider;
- Metrology and calibration service agencies;
- Importer;
- Dealer;
- Authorized representative.
4.1.2 The organization's quality management system is composed of
interrelated processes. The organization's establishment of a quality
management system should identify and determine the required processes and
their application in the entire organization based on one or more roles it
assumes. The determination and application of these processes are related to
the organization's activities, operation methods, management requirements,
applicable regulatory requirements.
The quality management system requires the application of a risk-based
approach to the appropriate processes of the organization. The organization
can apply a risk-based approach to determine the degree of control required for
each process of the quality management system. Identify and deal with risks
that affect the compliance and effectiveness of the quality management system.
The following clauses of YY/T 0287-2017 do not clearly state the relevant risks,
but risk-based methods have been applied:
- Time interval for management review (see YY/T 0287-2017, 5.6);
- Control of production and service provision (see YY/T 0287-2017, 7.5.1);
- The nature of the handling of nonconforming products and the necessary
corrections (see YY/T 0287-2017, 8.3);
- Determination of measures to prevent the occurrence and recurrence of
nonconformities (see YY/T 0287-2017, 8.5.2, 8.5.3).
Organizations can take a variety of measures to deal with risks; the
requirements of YY/T 0287-2017 have covered these measures, such as:
- Specify responsibilities and authorities;
- Identify training needs, implement training and assign competent personnel;
- Implement the design and development of products and processes;
- Prepare specific method documents and work instructions;
- Confirm the implementation process;
- Calibrate or verify the monitoring and measuring equipment;
- Implement inspection or other monitoring and measurement of products
and processes;
- Implement corrective measures and ensure that they are extended to other
relevant departments of the organization.
4.1.3 After determining the various processes required by the quality
management system and the related risks of each process, the organization
may focus on each process. Each process has some basic elements that need
to be addressed, which can be addressed by considering the following
questions:
- How does the organization know whether a process is effective?
- What needs to be done to ensure that the process runs effectively?
- Which controls are necessary for process monitoring?
- How does the organization know whether the process control is effective?
- What human resources and material resources are needed to operate and
b) Quality manual (see YY/T 0287-2017, 4.2.2);
c) All requirements, procedures, activities or arrangements and records that
need to be documented as specified in YY/T 0287-2017;
d) The documents required by the organization to ensure that the processes
related to the quality management system are effectively planned,
operated and controlled, including records, such as the quality plan
formed by the quality planning of a specific project, product, process or
contract; work instructions, operating procedures, etc. prepared for
carrying out a certain activity or process. Quality records refer to
documents that provide objective evidence of quality activities completed
or quality results achieved;
e) Other documents required by applicable regulatory requirements.
Regulatory requirements may specify processes that must be described
in documented procedures or use specific types of document carriers,
such as clinical evaluation activities (see YY/T 0287-2017, 7.3.7) or review
of experience in post-production activities (see YY/T 0287-2017, 8.2.1)
which are used as a part of the medical device documentation (see YY/T
0287-2017, 4.2.3).
Documents that meet applicable regulatory requirements, documents required
by YY/T 0287-2017, documents (including records) determined by the
organization to effectively control its activities, these three constitute quality
management system documents and meet document control and record control
(see YY/T 0287-2017, 4.2.4, 4.2.5) requirements.
4.2.1.3 The procedures or work instructions can be made into charts or
audiovisual materials.
4.2.1.4 The documented procedures (including work instructions and flow
charts) should be concise, clear and easy to understand; it should state the
methods to be used and the criteria to be met. These procedures mainly identify
activities and describe the following:
- What to do and who will do it;
- When, where and how to do it;
- What materials, equipment and documents are used;
- How to monitor and measure an activity;
- What records are required to be kept.
4.2.1.5 In terms of the effectiveness of the quality management system, the
documents should be evaluated against the following criteria, such as:
Medical device documentation is a road map that shows how the product
completes related activities in accordance with the requirements of the quality
management system. The medical device documents should be controlled in
the same way as other documents, kept updated and archived. Medical device
documentation may include complete files, copies of approved files, or maintain
an index of relevant files and records.
4.2.3.2 Regulators in different jurisdictions usually require specific parts of the
medical device documentation as part of the market license. The content of
medical device documents required by regulatory agencies in different
jurisdictions is different. Medical device documentation may include but is not
limited to the following:
- General description of the medical device, including device classification
and planned changes as appropriate;
- Product specifications, including drawings, composition, formulas, parts
specifications and medical device software specifications;
- Production process procedures, including equipment specifications,
production methods, all special processing and infrastructure requirements;
- Quality assurance procedures and specifications, including acceptance
criteria and measuring equipment used;
- Packaging specifications, including methods and processes;
- Description of Intended use/purpose;
- Design output that meets the applicable regulatory requirements for
medical devices;
- Risk management records, including the results of risk analysis, risk control
measures, resulting residual risks and risk/benefit analysis;
- Mark, including any instructions for use;
- Installation specifications;
- Product maintenance procedures or instructions;
- The unique identification of the applied device;
- Records of various languages available in the country or region where the
medical device is intended to be marketed;
- Clinical evaluation data;
- Information on the materials and components that make up the medical
data analysis. For these system records, YY/T 0287-2017 requires the
organization to determine the appropriate retention period. When determining
the retention period, the organization should consider the nature of the medical
device, the risks associated with its use, the records involved and the applicable
regulatory requirements.
4.2.5.5 Handwritten records should use non-erasable media. The person
authorized to fill in or check the record shall have clear handwriting and keep
the signature or seal and date. Where appropriate, good recording practices
should include:
- Enter data and observation results in time;
- Do not make records in advance or late;
- Do not use other people's signatures or seals;
- All items should be completed or checked when using the form to record;
- When transmitting data, it should be faithful to the original data and be
transcribed and verified by others;
- Check the completeness and correctness of all entries;
- Prepare page numbers to ensure completeness.
4.2.5.6 If an error is found in the record, the correction method should ensure
that the original input data cannot be lost and the correction content has a
signature and date. When appropriate, the reason for the correction should be
recorded. If an electronic record system is used instead of paper records, the
electronic record system should include as far as possible a time-stamped,
unmodifiable, system-formed inspection and tracking log, so that record
changes can be traced back. The log may include the identity of authorized
users, creation, deletion, modification/correction, date and time, links, and
embedded notes.
4.2.5.7 The organization may make additional provisions for the entry of key
data in electronic records, such as:
- The second authorized person with login name, identity, date and time who
can verify data entry through the keyboard;
- As part of the verification system function, a second inspection can be
performed on the el...