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YY/T 0595-2020 English PDF (YYT0595-2020)

YY/T 0595-2020 English PDF (YYT0595-2020)

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

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.
YY/T 0595-2020
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 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
- 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. The procedures or work instructions can be made into charts or
audiovisual materials. 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. 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. 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. 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. 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. 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 electronic record system that directly obtains the data. The application of the above system can ensure the integrity of electronic records and prevent unauthorized entry. The subject of electronic records is complex and constantly evolving. Applicable regulatory requirements and management as an integral part of the quality management system must also meet the applicable system requirements.
Top management should implement the following activities:
- By formulating a quality policy, clarify its commitment to implement and maintain a quality management system that meets the requirements of
YY/T 0287-2017 and applicable laws and regulations;
- Establish measurable quality objectives to ensure that the operation of the quality management system complies with YY/T 0287-2017 and the quality
- Improve the quality management system and communicate the value of the organization's quality management system through the quality policy and quality objectives; ensure the normal operation of the quality management system (during management review); support the quality management
system training for employees; support quality personnel; allocate
resources for the quality management system;
- Through regular review of the elements of the quality management system, review the suitability, adequacy and effectiveness of the quality
management system; identify the problems of the quality management
system; solve these problems through decision-making, measures and the
provision of necessary resources (carried out during management review). Top management?€?s considerations should include, but are not limited to: - Ensure that the sequence and interaction of the various processes are designed to effectively achieve the planning results;
- Ensure that the inputs, activities and outputs of each process are clearly defined and controlled;
- Monitor inputs and outputs to verify that the processes are related to each other and operate effectively;
- Identify hazards (sources) and manage risks;
- Conduct data analysis to promote necessary process improvement;
- Determine the person in charge of each process and assign corresponding responsibilities and authorities;
- Manage each process to achieve process goals;
- Ensure that a written agreement has been signed with the supplier (see YY/T 0287-2017, 7.4).
out in stages according to needs and planning requirements, usually
including continuing education or further education training. For full-time, part-time or contract personnel that affect the quality of products, the organization usually provides appropriate training according to the work assigned by the personnel to ensure the competence of the personnel.
The training should cover:
???The nature of the work and the responsibilities of the employees;
???The organization's quality management system documents, including
quality policy, quality objectives and related program documents, work
instruction documents, etc.;
???Technical knowledge and job skills related to products.
d) Evaluate the effectiveness of training or other measures taken to ensure personnel capabilities. If training is provided or other measures are taken for a job, the organization should use the following methods to evaluate effectiveness based on the risks related to the job:
??? Investigate the trainees to assess whether they have the required
knowledge and information;
???Test or ask trainees to assess their ability to apply objective criteria; ???Evaluate the work performance of trainees;
???Review the trainer?€?s assessment of the effectiveness of the training.
Note: The organization shall consider the risk of insufficient completion of tasks or processes before determining the level of effectiveness of
training and declaring competence by demonstrating that personnel have
the ability to complete tasks or processes.
e) Strengthen quality awareness education. For example, by refining the quality objectives of each level, so that personnel know the relevance of the work they are engaged in and the importance of the quality
management system.
f) Keep records of personnel capabilities. The personnel competency records should include the records of the measures taken (such as transfer,
recruitment), or records of the personnel received training, the results of the measures taken, which constitute evidence that the personnel are
competent. Records show that the measures or training courses have
been successfully completed and the personnel have acquired the
required capabilities. The method of evaluating ability should be adapted to the risk of the job. The effectiveness of any further measures, education b) Process equipment (such as production equipment, various control
equipment containing computer software, test equipment, various tools,
auxiliary tools, etc.), that is, equipment directly used in the product realization process;
c) Supporting services (such as outlets that provide maintenance activities after product delivery, warehousing logistics, communication services, IT and network technology applications, etc.). If an information management system is applied, the organization should consider whether the business processes covered by the quality management system are coordinated
with the information management syst...

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