YY/T 0595-2020Medical devices—Quality management systems—Guidance on the application of YY/T 0287-2017 (English PDF)

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.

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

4.2.4.2 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.

4.2.1 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

The organization shall prepare a quality manual, which includes.

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.

4.2.4.4 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.

5.1 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

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

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.

6.1 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.

7.1 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.

8.1 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.