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YY/T 0595-2020 (YY/T0595-2020)

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YY/T 0595-2020English1305 Add to Cart 0--3 minutes. Auto-delivery. Medical devices--Quality management systems--Guidance on the application of YY/T 0287-2017 Valid


YY/T 0595-2020: PDF in English (YYT 0595-2020)
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 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
policy;
- 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 system that provides supporting
services.
6.3.4 The organization should plan appropriate infrastructure and ensure that it
meets the needs of production capacity; meanwhile it is easy to clean, maintain
or take other required measures. The layout of the site should have sufficient
space for the orderly disposal of products; at the same time prevent material or
product confusion, such as incoming materials, different batches of product in
progressing, scrap materials, reworked products, any other unqualified
materials, medical device final products, production equipment, inspection tools,
documents and drawings, etc. Organizations should plan and document the
process of product transfer. The organization should specify the appropriate
storage and disposal conditions required for product protection (see YY/T 0287-
2017, 7.5.11), including available space, specific environmental conditions and
transportation methods.
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:
- In order to meet product requirements, the organization shall implement full
life cycle management of infrastructure, including the process of purchase,
installation, use, maintenance, overhaul and scrapping. The organization
should consider ways to respond to risks, such as preventing possible
problems (e.g., preventive maintenance of critical equipment) or planning
future needs;
- When applicable, the organization should ensure that the restricted ranges
or allowable tolerances of production, measurement, installation, service
and test equipment are documented and are available for inspection by the
operator at any time;
- The organization should document and make it easy to obtain the
maintenance, cleaning and inspection procedures for all equipment used
for production, measurement, testing, repair and work environment control.
The time interval of debugging and maintenance required should be
- People in the working environment;
- Storage conditions and conditions of circulation links.
For the work environment, the organization should consider the following
factors:
- Appropriate parameters, indicators and control requirements related to the
workplace;
- Appropriate visitor waiting areas and facilities;
- Maintenance of proper sanitary equipment (such as toilets) and
maintenance of personnel hygiene;
- Non-production activities that need to be isolated (such as catering
preparation);
- Use appropriate methods/mechanisms to reduce the risks caused by
potential hazards (sources) (such as electrostatic discharge of electronic
components, disposal of animal-derived materials, other contamination of
products or spillage of volatile chemicals).
These requirements apply to activities that directly affect the conformity of
products and services.
6.4.1.2 Environmental control in product realization
6.4.1.2.1 The need and degree of work environment control depends on the
type of products produced and external environmental factors. Work
environment control refers to the guidance, management, coordination and
monitoring of activities and variable factors that affect environmental conditions,
so that the state of the work environment can be controlled. The organization
should define qualitative and quantitative constraints on the characteristics of
the defined work environment, in order to describe the degree of control over
the environment. The types of facilities, equipment, resources and documents
required to determine, monitor and maintain the working environment will be
affected by the degree of environmental control. If the output of the
environmental control system cannot be verified (see YY/T 0287-2017, 7.5.6),
the organization should verify the environmental control system and conduct
regular monitoring to verify that the environmental system is operating normally.
The organization should document these systems and their inspections.
6.4.1.2.2 According to YY/T 0287-2017, 7.5.2, there are situations where the
working environment may affect product quality. Examples of situations where
the working environment may affect product quality involve the following
medical devices:
requirement of the work environment, to determine whether the lack of
corresponding control will increase the risk in product use, that is, the need and
degree of environmental control can be traced through the records of product
risk management activities. If environmental conditions are critical in the
product manufacturing process, the organization should establish requirements
for the working environment in which the product is located. When applicable,
ensure the traceability of the environment in which the product is located.
6.4.1.3 Personnel
6.4.1.3.1 For any personnel who may come into contact with the product or the
working environment (including those who enter the work area temporarily or
for a short time), if their clothing, cleanliness, health conditions have an adverse
effect on the product, the organization should clarify the requirements for the
dressing, cleanliness, health of these specific personnel and document them.
Examples of people who may enter the work environment are as follows:
- Production staff and their supervisors and managers;
- Material manager;
- Manufacturing engineer;
- Design and development engineer;
- Quality inspection personnel, quality assurance personnel, quality
engineering personnel;
- Any material or service (including cleaning service) supplier;
- Personnel responsible for the maintenance of production equipment;
- Customer;
- Auditor;
- Visitors.
6.4.1.3.2 The organization should pay attention to the health status of personnel
meeting the specified requirements. If the health of the personnel may have an
adverse effect on the product, they need to be restored to their health before
they can operate or enter a controlled working environment. For medical
devices that are essential for sterile provision, sterilization before use, or
microbiological cleaning, the health of the personnel during the production
process is particularly important.
6.4.1.3.3 The organization shall provide professional training and (or)
supervision for personnel working under special environmental conditions (such
that the medical devices produced in its quality management system are safe
and operate as expected. As part of the quality management system, product
realization activities have a direct impact on the safety and performance of
medical devices. These plans should be consistent with the requirements of
other processes in the quality management system, which may include:
- Specify the input required for each process;
- Determine the expected results of each process;
- Determine the sequence of each process and document it, including the
time limit necessary to achieve the expected results;
- Allocation of appropriate human resources and clear assignment of
responsibilities;
- Determine the necessary monitoring and measurement of each process
parameter.
The organization prepares planning documents to clearly understand the
process and requirements in order to achieve success in product realization
activities. The planned output should also clarify who is responsible for
establishing requirements for quality objectives, processes, documents
(including records) and resources in product realization.
7.1.1.4 The determination of the life span of a medical device is part of the
product realization plan. By determining the life span of the medical device, the
identified residual risk can be partially controlled. When the medical device is
used for an extended period of time, this residual risk may increase to an
unacceptable level.
The life span of medical devices should be determined based on regulations,
standards, technical, commercial or other considerations. The organization may
document the basis for determining the life of medical devices. To help
determine the life span of medical devices, the following factors should be
considered and the reasons for determining the life span recorded:
- Storage period of medical devices;
- Replacement of degradable components and consumable parts or the
expiry date of medical devices;
- Normal use, maintenance and maintenance of medical devices;
- The number of uses or the period of use of the device based on the life test
of the medical device;
- The expected material degradation;
......
 
(Above excerpt was released on 2021-03-20, modified on 2021-06-07, translated/reviewed by: Wayne Zheng et al.)
Source: https://www.chinesestandard.net/PDF.aspx/YYT0595-2020