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YY/T 0287-2017

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Standard ID YY/T 0287-2017 (YY/T0287-2017)
Description (Translated English) Medical devices -- Quality management systems -- Requirements for regulatory purposes
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.01; 03.120.10
Word Count Estimation 37,317
Date of Issue 2017-01-19
Date of Implementation 2017-05-01
Older Standard (superseded by this standard) YY/T 0287-2003
Quoted Standard GB/T 19000-2016
Adopted Standard ISO 13485-2016, IDT
Drafting Organization Beijing Guoya Huaguang Certification Co., Ltd
Administrative Organization National Medical Device Quality Management and General Requirements Standardization Technical Committee (SAC/TC 221)
Regulation (derived from) Medical Device Industry Standard Announcement No. 11 of 2017
Proposing organization State Administration of Food and Drug Administration
Issuing agency(ies) State Administration of Food and Drug Administration
Summary This standard applies to organizations of all sizes and types. The requirements applicable to medical devices in this standard apply equally to the services provided by the organization.

YY/T 0287-2017
Medical devices -- Quality management systems -- Requirements for regulatory purposes
ICS 11.040.01;03.120.10
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0287-2003
Medical Device Quality Management System
Used for regulatory requirements
(ISO 13485.2016, IDT)
Published on.2017-01-19
2017-05-01 Implementation
The State Food and Drug Administration issued
Foreword V
Introduction VI
1 Range 1
2 Normative references 1
3 Terms and Definitions 1
4 Quality Management System 4
4.1 General Requirements 4
4.2 Document Requirements 5
4.2.1 General 5
4.2.2 Quality Manual 5
4.2.3 Medical Device Documentation 6
4.2.4 File Control 6
4.2.5 Record Control 6
5 Management responsibilities 6
5.1 Management Commitment 6
5.2 Focus on Customers 7
5.3 Quality Policy 7
5.4 Planning 7
5.4.1 Quality Objective 7
5.4.2 Quality Management System Planning 7
5.5 Responsibility, Authorization and Communication 7
5.5.1 Responsibilities and Permissions 7
5.5.2 Management Representative 7
5.5.3 Internal Communication 7
5.6 Management Review 8
5.6.1 General 8
5.6.2 Review Input 8
5.6.3 Review Output 8
6 Resource Management 8
6.1 Resource Availability 8
6.2 Human Resources 8
6.3 Infrastructure 9
6.4 Work Environment and Pollution Control 9
6.4.1 Working Environment 9
6.4.2 Pollution Control 9
7 Product realization 9
7.1 Planning for product realization 9
7.2 Processes Related to Customers 10
7.2.1 Determination of product requirements 10
7.2.2 Review of Product Requirements 10
7.2.3 Communication 10
7.3 Design and Development 10
7.3.1 General 10
7.3.2 Design and Development Planning 10
7.3.3 Design and Development Input 11
7.3.4 Design and Development Output 11
7.3.5 Design and Development Review 11
7.3.6 Design and Development Verification 11
7.3.7 Design and Development Confirmation 12
7.3.8 Design and Development Conversion 12
7.3.9 Designing and Developing Changed Controls 12
7.3.10 Design and Development Documentation 12
7.4 Procurement 12
7.4.1 Procurement Process 12
7.4.2 Purchase Information 13
7.4.3 Verification of Procured Products 13
7.5 Production and Service Delivery 13
7.5.1 Control of Production and Service Delivery 13
7.5.2 Cleaning of products 14
7.5.3 Installation Activity 14
7.5.4 Service Activity 14
7.5.5 Special Requirements for Sterile Medical Devices 14
7.5.6 Confirmation of Production and Service Delivery Process 14
7.5.7 Special requirements for confirmation of sterilization process and sterile barrier system 15
7.5.8 Identification 15
7.5.9 Traceability 15
7.5.10 Customer Property 15
7.5.11 Product Protection 15
7.6 Monitoring and Measuring Equipment Control 16
8 Measurement, Analysis and Improvement 16
8.1 General 16
8.2 Surveillance and Measurement 16
8.2.1 Feedback 16
8.2.2 Disposal 17
8.2.3 Reporting to Regulators 17
8.2.4 Internal Audit 17
8.2.5 Monitoring and Measurement of Processes 17
8.2.6 Surveillance and Measurement of Products 17
8.3 Nonconforming Product Control 18
8.3.1 General 18
8.3.2 Responsive Measures for Unqualified Products before Delivery 18
8.3.3 Responsive Measures for Unqualified Products after Delivery 18
8.3.4 Rework 18
8.4 Data Analysis 18
8.5 Improvement 19
8.5.1 General 19
8.5.2 Corrective Action 19
8.5.3 Preventive measures 19
Reference 30
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0287-2003 “Requirements for the Use of Medical Device Quality Management Systems for Regulations”, and YY/T 0287-
Compared with the main technical changes in.2003 are as follows.
--- Highlight the importance of regulatory requirements;
--- Expand the scope of application;
---Enhanced risk management requirements;
--- Increased requirements for communicating with regulators and reporting to regulatory agencies;
---Strengthen the requirements for post-market supervision and management;
--- Increased requirements for the formation of documents and records.
This standard uses the translation method equivalent to the adoption of the international standard ISO 13485.2016 "Medical Device Quality Management System for Regulations
Please note that some of the contents of this document may involve patents. The issuing agency of this document does not assume responsibility for identifying these patents.
This standard is proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Medical Device Quality Management and General Requirements Standardization Technical Committee (SAC/TC221).
This standard was drafted by. Beijing National Medical Machinery Huaguang Certification Co., Ltd.
The main drafters of this standard. Milan Ying, Chang Jia, Zheng Yixi, Li Zhaohui, Li Xin, Wang Meiying, Chen Zhigang.
The previous versions of the standards replaced by this standard are.
---YY/T 0287-1996, YY/T 0287-2003.
0.1 General
This standard stipulates the requirements of the quality management system. Organizations involved in one or more stages of the life cycle of medical devices can follow this requirement.
Medical device design and development, production, storage and distribution, installation, service and eventual decommissioning and disposal, and related activities (eg, technical support
Design and development or supply. The requirements of this standard can also be used to provide products (such as raw materials, components, components, medical supplies) to such organizations.
Suppliers or other external parties of equipment, sterilization services, calibration services, distribution services, maintenance services. The supplier or external party can voluntarily choose the symbol
Meet the requirements of this standard or meet the requirements of this standard as required by the contract.
Some jurisdictions have regulatory requirements for the application of quality management systems to organizations serving various roles in the medical device supply chain. Therefore, this standard
Quasi-expected organization.
--- Identify one or more roles of the organization in accordance with applicable regulatory requirements;
--- Identify the regulatory requirements applicable to organizational activities based on these roles;
---Incorporate these applicable regulatory requirements into the organization's quality management system.
The definitions in the applicable regulatory requirements vary from country to country. The organization needs to comply with the law applicable to the jurisdiction of the medical device
The definition in the regulations interprets the definition of this standard.
This standard can also be used by internal and external parties (including certification bodies) to assess that the organization meets customer requirements and applies to quality management systems.
Regulatory requirements and the organization's own requirements. It is worth emphasizing that the requirements of the quality management system stipulated in this standard are
The addition of this requirement is necessary to meet customer requirements as well as applicable regulatory requirements in terms of safety and performance.
The adoption of a quality management system is a strategic decision of the organization. The design and implementation of an organization’s quality management system is subject to the following factors.
a) Impact of the organizational environment, environmental changes and organizational environment on the compliance of medical devices;
b) Organize changing needs;
c) the specific goals of the organization;
d) the products provided by the organization;
e) the process used by the organization;
f) the size and organization of the organization;
g) Regulatory requirements applicable to organizational activities.
The implementation of this standard does not mean that there is a need to unify the structure of different quality management systems, to harmonize documents, or to form a structure with the terms of this standard.
Consistent documents.
There are many types of medical devices. Some of the specific requirements specified in this standard apply only to the designated medical device category. This standard
Chapter 3 gives definitions of these categories.
0.2 clarify the concept
An explanation of the following terms or phrases in this standard.
--- When the phrase "appropriately" modifies a requirement, it is generally considered that the requirement is appropriate unless the organization can provide other reasonable reasons.
by. If a requirement is required for any of the following, the requirement is considered appropriate.
---Product meets requirements;
--- Meet applicable regulatory requirements;
--- Organize implementation of corrective measures;
---Organize management risk.
--- When the term "risk" is used, the application of this term within the scope of this standard relates to the safety or performance requirements or satisfaction of medical devices.
Applicable regulatory requirements.
---When a requirement requires "documentation," it also needs to be established, implemented, and maintained.
--- When the term "product" is used, it also means "service." The product is suitable for the customer's desired or required output or product implementation process
Any expected output formed.
--- When the term "regulatory requirements" is used, it covers any laws and regulations (such as laws, regulations, regulations) applicable to users of this standard
Or instruction) requirements. Application of the term "regulatory requirements" is limited to quality management system requirements and safety or performance of medical devices
Use the following auxiliary verbs in this standard.
--- "Shall" indicate requirements;
--- "Yi" means proposal;
--- "Can" indicates permission;
--- "Can" means possible or able;
"Note" is a guide to understand or explain the requirements.
0.3 Process Method
This standard is based on the quality management process method. Any activity that receives input and converts it into output can be treated as a process. through
Often, the output of one process directly forms the input to the next process.
For an organization to operate effectively, it needs to identify and manage many interconnected processes. In order to achieve the desired result, a system of processes is
The applications within the organization, together with the identification and interaction of these processes, and the management of these processes, are called "process methods."
The use of this process approach in quality management systems emphasizes the importance of.
a) understand and meet requirements;
b) consider the process from the perspective of value added;
c) Obtain results of process performance and effectiveness;
d) Improve the process based on objective measurements.
0.4 Relationship with ISO 9001
This standard is an independent standard based on GB/T 19001-2008. For the convenience of users, Appendix B gives the standard and
GB/T 19001-2016 (instead of GB/T 19001-2008) correspondence.
ISO 13485.2016 aims to promote the harmonization of appropriate regulatory requirements for quality management systems worldwide.
Used for organizations that involve one or more stages of the medical device life cycle. This standard covers organizations involved in the life cycle of medical devices
Some of the specific requirements have eliminated those requirements in ISO 9001 that are not suitable for regulatory requirements. Due to these deletions, the quality management system
Organizations that meet this standard cannot claim to conform to the ISO 9001 standard unless their quality management system meets all requirements of ISO 9001.
0.5 Compatibility with other management systems
This standard does not include requirements for other management systems, such as specific requirements for environmental management, occupational health and safety management, or financial management.
begging. However, this standard enables the organization to coordinate or integrate its own quality management system with related management system requirements. Organization for
The establishment of a quality management system that meets the requirements of this standard may change one or more of its current management systems.
Medical Device Quality Management System
Used for regulatory requirements
1 Scope
This standard is for medical devices and related services that need to prove their ability to provide continuous compliance with customer requirements and applicable regulatory requirements.
The organization specifies the quality management system requirements. Such organizations can cover one or more stages of the medical device life cycle, including medical devices.
The design and development, production, storage and distribution, installation or service, and the design and development or provision of related activities (eg technical support). this
Standards can also be used to provide suppliers or external parties with products (including those related to quality management systems) to such organizations.
Unless otherwise specified, the requirements of this standard apply to organizations of all sizes and types. This standard applies to medical devices with the same requirements
This applies to the related services provided by the organization.
For the process required by this standard that is applicable to the organization but not implemented by the organization, the organization organizes monitoring and maintenance in the quality management system.
And it is responsible for controlling these processes.
If the applicable regulatory requirements permit the deletion of design and development controls, it can serve as a deduction from the quality management system.
by. If these regulations require other methods, these methods should be described in the quality management system. The organization has the responsibility to ensure that
The deletion of any design and development controls is explicitly stated in the declaration of this standard.
Any of the requirements in Chapter 6, 7 or 8 of this standard, if any of the medical devices involved in the activities or quality management system
When characteristics do not apply, organizations do not need to include such requirements in their quality management system. For any articles that have been determined not to be applicable, the group
Weave records its reason according to the requirements of 4.2.2.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 19000-2016 Quality Management System Foundation and Terminology (ISO 9000.2015, IDT)
3 Terms and Definitions
The definitions of GB/T 19000-2016 and the following terms and definitions apply to this document.
Advisory notice advisorynotice
A notice issued by the organization after the delivery of the medical device to provide additional information or suggest actions to be taken.
--- Use of medical devices;
---Changes in medical devices;
--- Medical device returned to the organization; or
--- The destruction of medical devices.
Note. The publication of advisory notices may require compliance with applicable regulatory requirements.
Authorized representative authorized delegate
In countries or jurisdictions, authorized by the manufacturer in writing and in accordance with the laws of the country or jurisdiction, on behalf of the manufacturer
The natural or legal person assigned to the task related to his or her duties.
[Source. GHTF/SG1/N055.2009, Definition 5.2]
Clinical evaluation
Assess and analyze clinical data related to medical devices to verify the clinical safety and performance of the device as intended by the manufacturer.
[Source. GHTF/SG5/N4.2010, Chapter 4]
Medical devices that have been released from the organization’s control exist with presence, identity, quality, durability, reliability, availability, safety, or performance
There are inadequate written, electronic, or verbal communication of defects or services that claim to affect the performance of these medical devices.
Note. This definition of "complaint" is different from the definition defined by GB/T 19000-2016.
Distributor distributor
Natural or legal persons in the supply chain who represent themselves to sell medical devices to end users.
Note 1. Multiple dealers may be involved in the supply chain.
NOTE 2 Persons involved in such activities as storage and transport activities in the supply chain on behalf of manufacturers, importers or distributors are not distributors in this definition.
[Source. GHTF/SG1/N055, Definition 5.3]
Implantable medical devices implantablemedicaldevice
Medical devices that can only be removed by medical or surgical surgery are expected to.
--- Is inserted in whole or in part in the human body or in the natural cavity, or in place of the epidermis or the surface of the eye;
--- And stay at least 30 days.
Note. The definition of implantable medical devices includes active implantable medical devices.
Importer importer
The first nature in the supply chain that enables medical devices manufactured in other countries or jurisdictions to be sold in the countries or jurisdictions to be listed
Person or legal person.
[Source. GHTF/SG1/N055.2009, Definition 5.4]
Labels, instruction manuals, and any other information related to the identification, technical description, intended use, and proper use of the medical device, but not
Including shipping documents.
[Source. GHTF/SG1/N70.2011, Chapter 4]
Life cycle
In the life of medical devices, from the initial concept to all stages of final decommissioning and disposal.
[Source. YY/T 0316-2016, Definition 2.7]
Manufacturer manufacturer
Natural or legal persons who, in their name, manufacture the medical equipment that is expected to be used and bear the medical device design and/or manufacturing responsibilities, regardless of
The design and/or manufacture of the therapeutic device is performed by the natural or legal person or performed by another natural person or natural persons or legal persons on their behalf.
Note 1. This “natural person or legal person” has the final law to ensure compliance with all applicable regulatory requirements in the country or jurisdiction where the medical device is expected to be available or sold.
Liability, unless the regulatory agency (RA) in the jurisdiction explicitly imposes that responsibility on another natural or legal person.
Note 2. Manufacturer's responsibilities are described in other GHTF guidance documents. These responsibilities include meeting pre-listing requirements and post-listing requirements, such as bad things
Report and corrective action notice.
Note 3. The "design and/or manufacture" referred to in the above definition may include the specification, production, manufacture, assembly, processing, packaging, repackaging, and labeling of medical devices.
Record, re-label, sterilize, install, or remanufacture; or combine multiple instruments (which may include other products) for medical purposes.
Note 4. If the assembly or modification does not change the intended use of the medical device, the medical device has been provided by another natural or legal person in accordance with the instructions for use.
A physical patient, any natural or legal person who assembles or modifies a medical device is not a manufacturer.
Note 5. Any natural or legal person who does not change the intended use of the medical device or improve the medical device in the name of the original manufacturer, so that the device is provided on its behalf
Use should be considered as a manufacturer of improved medical devices.
Note 6. Authorized representatives, distributors or importers who do not overwrite or change the existing mark and add their own address and contact information to or on the medical device.
Not considered as a manufacturer.
Note 7. Annexes that incorporate regulatory requirements for medical devices, natural or legal persons responsible for the design and/or manufacture of such attachments are considered to be manufacturers.
[Source. GHTF/SG1/N055.2009, Definition 5.1]
Medical device medicaldevice
Instruments, equipment, tools, machinery, appliances, implants, in vitro reagents, software, materials, or other similar or related items used in humans.
The intended use is determined by the manufacturer, whether used alone or in combination, to achieve one or more of the following specific medical purposes.
--- diagnosis, prevention, surveillance, treatment or relief of disease;
--- Diagnosis, monitoring, treatment, mitigation or compensation of injuries;
--- Examination, substitution, adjustment or support of physiological structures or physiological processes;
--- Support or maintenance of life;
--- Pregnancy control;
---Disinfection of medical devices;
--- Information is provided through in vitro examination of samples taken from the human body.
It acts on the human body or on the body surface. The main expected function is not through pharmacology, immunology or metabolism, but these methods
Can help achieve the desired functionality.
Note. Products that may be considered as medical devices in some countries or regions but are not considered as medical devices in other countries or regions include, but are not limited to.
--- Disinfectant;
---Aids for persons with disabilities;
--- Instruments containing animals and/or human tissues;
--- Instruments for in vitro fertilization or assisted reproductive technology.
[Source. GHTF/SG1/N071.2012, Definition 5.1]
Medical device family medicaldevicefamily
The same basic design and performance characteristics that are made by the same organization or for the same organization with regard to safety, intended use, and functionality
Group medical devices.
Performance evaluation performance evaluation
Assess and analyze data to establish or validate the ability of in vitro diagnostic medical devices to achieve their intended use.
Post-market surveillance post-marketsurveilance
The systematic process of collecting and analyzing experience gained from marketed medical devices.
The result of the process.
Note 1. There are the following four generic product categories.
--- Services (such as transportation);
--- Software (such as computer programs, dictionaries);
--- Hardware (such as engine mechanical parts);
--- Process materials (such as lubricating oil).
Many products consist of components that belong to different product categories. Their attributes are services, software, hardware, or process-related materials, depending on the product's leading performance.
Minute. For example. The product "car" is made of hardware (such as tires), process material (such as. fuel, coolant), software (such as. engine control software, driver
Manual) and services (such as the sales staff's instructions).
Note 2. Services are generally intangible and are the result of the need to complete at least one activity at the supplier and customer interface. The provision of services can involve, for example.
--- Activities performed on customer-supplied tangible products (such as cars that need repair);
--- Activities completed on customer-supplied intangible products (such as the income statement needed to prepare tax returns);
--- Delivery of intangible products (such as providing information on knowledge transfer);
--- Create atmosphere for customers (such as hotels and restaurants).
Software consists of information, usually intangible products, and can exist in the form of methods, reports or procedures.
Hardware is usually a tangible product whose quantity has the characteristic of counting. Process material is usually a tangible product whose amount has continuous characteristics. Hardware and flow
Process materials are often referred to as goods.
Note 3. This definition of "product" is different from the definition defined in GB/T 19000-2016.
[Source. Rewrite GB/T 19000-20081], Definition 3.4.2]
1) Replaced by GB/T 19000-2016.
Products provided by a party other than the organization's quality management system.
Note. The provision of products cannot necessarily infer business or financial arrangements.
Risk risk
The probability of injury occurring and the severity of the damage.
Note. This definition of "risk" is different from the definition defined by GB/T 19000-2016.
[Source. YY/T 0316-2016, definition 2.16]
Risk Management riskmanagement
Systematic application of management guidelines, procedures and practices for risk analysis, evaluation, control and monitoring.
[Source. YY/T 0316-2016, definition 2.22]
Sterile barrier system sterilebarriersystem
The minimum package that prevents the entry of microorganisms and enables the product to be used sterilely at the point of use.
[Source. GB/T 19633.1-2015, definition 3.22]
Sterile medical device stereomedicaldevice
Medical devices that are expected to meet sterility requirements.
Note 1. The sterility requirements for medical devices may be implemented in accordance with applicable regulatory requirements or standards.
4 Quality Management System
4.1 General requirements
4.1.1 The organization shall document and maintain the effectiveness of the quality management system in accordance with the requirements of this standard and applicable regulatory requirements.
The organization shall establish, implement, and maintain all requirements, procedures, activities, or documents that need to be documented in accordance with this standard or applicable regulations.
The organization should document one or more of its roles under the applicable regulatory requirements.
Note. The roles undertaken by the organization may include manufacturers, authorized representatives, importers, or distributors.
4.1.2 The organization shall.
a) consider the roles assumed by the organization to determine the processes required for the quality management system and the application of these processes throughout the organization;
b) apply risk-based methods to control the appropriate processes required for the quality management system;
c) Determine the sequence and interaction of these processes.
4.1.3 For each quality management system process, the organization shall.
a) Determine the required criteria and methods to ensure the effective operation and control of these processes;
b) Ensure that the necessary resources and information are available to support the operation of these processes and the monitoring of these processes;
c) Implement necessary measures to achieve the results of these process planning and maintain the effectiveness of these processes;
d) monitor, measure (as appropriate) and analyze these processes;
e) Establish and maintain the required records to verify compliance with this standard and meet applicable regulatory requirements (see 4.2.5).
4.1.4 The organization shall manage these quality management system processes in accordance with the requirements of this standard and applicable regulations. Changes to these processes should.
a) the impact of changes in the evaluation process on the quality management system;
b) the impact of the evaluation process on the medical devices produced in the quality management system;
c) Control in accordance with the requirements of this standard and applicable regulatory requirements.
4.1.5 If the organization chooses to outsource any process that affects the compliance of the product, the organization should monitor such processes and ensure their control.
The organization shall retain the responsibility of the outsourcing process to meet the requirements of this standard, customer requirements, and applicable regulatory requirements. Control should be related to the risks involved and
The external party adapts to meet the requirements of 7.4. Controls should include written quality agreements.
4.1.6 The organization shall document the verification procedures for computer software applications used in the quality management system. Deal with the software before it is used for the first time
The software application confirms that, if appropriate, the software application should also be confirmed after the software or its application is changed.
Specific methods and activities related to software validation and revalidation should be adapted to the risks associated with the use of the software.
A record of these activities should be kept (see 4.2.5).
4.2 Document Requirements
4.2.1 General
The quality management system documentation (see 4.2.4) should include.
a) document the quality policy and quality objectives;
b) quality manual;
c) the documented procedures and records required by this standard;
d) documents required by the organization to ensure the effective planning, operation and control of its processes, including records;
e) other documents required by applicable regulatory requirements.
4.2.2 Quality Manual
Organizations should prepare quality manuals. Quality manuals include.
a) The scope of the quality management system, including any detailed explanations and justifications for deletion or non-applicability;
b) a documented procedure or reference to a quality management system;
c) Expression of the interaction between quality management system processes.
The quality manual should outline the file structure of the quality management system.
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.
To prove compliance with the requirements of this standard and applicable regulatory requirements.
The contents of the document should include but not be limited to.
a) Overview of the medical device, intended use/intended purpose and marking, including all instructions for use;
b) product specifications;
c) specifications or procedures for manufacturing, packaging, storage, disposal and distribution;
d) measurement and monitoring procedures;
e) installation requirements as appropriate;
f) Service procedures, as appropriate.
4.2.4 File Control
Documents required by the quality management system should be controlled. Records are a special type of document and should be based on the requirements of 4.2.5
The documented procedure should specify the controls required in the following areas.
a) In order to make the document adequate and appropriate, the document is reviewed and approved before it is issued;
b) review and update documents as necessary and approve again;
c) ensure that the current revision status and changes of the document are identified;
d) ensure that the relevant version of the applicable document is available at the place of use;
e) Ensure that documents are kept clear and easily identifiable;
f) Ensure that the organization’s identified external documents required for the planning and operation of the quality management system are identified and controlled for distribution;
g) to prevent damage or loss of documents;
h) Prevent unintended use of obsolete documents, and properly identify these documents.
The organization shall ensure that the changes to the document are reviewed and approved by the original approval department or other designated approval department, and the designated approval department
It should be able to obtain relevant background information for making decisions.
For at least one voided document, the organization should specify its shelf life. This period should ensure that at least the medical treatment prescribed by the organization
During the lifetime of the medical device, documents for the manufacture and testing of these medical devices are available, and they should be not less than the record (see 4.2.5) or applicable
Regulatory requirements require a shelf life.
4.2.5 Record Control
Records should be maintained to provide evidence of compliance with the requirements and the effective operation of the quality management system.
The organization shall establish procedures and documents to specify the identification, storage, security and completeness of the records, retrieval, retention time, and disposal requirements
In accordance with applicable statutory requirements, the organization shall address the confidential health information contained in the record and implement protection methods.
Records should be kept clear, easy to identify and retrieve. Changes to the record should remain identifiable.
The organization shall maintain records for at least the life of the medical device as specified by the organization or applicable regulatory requirements.
It should also be from the organization to release medical devices for at least two years.
5 Management responsibilities
5.1 Management commitment
The top management should provide evidence of its commitment to establish and implement a quality management system and maintain its effectiveness through the following activities.
a) communicate to the organization the importance of meeting customer requirements and applicable regulatory requirements;
b) Develop a quality policy;
c) Ensure the establishment of quality objectives;
d) Conduct management review;
e) Ensure availability of resources.
5.2 Focus on Customers
Top management should ensure that customer requirements and applicable regulatory requirements are determined and met.
5.3 Quality Policy
Top management should ensure the quality policy.
a) Adapt to the purpose of the organization;
b) Including commitment to meeting requirements and maintaining the effectiveness of the quality management system;
c) Provide a framework for the development and review of quality objectives;
d) get communication and understanding within the organization;
e) Reviewed for continued suitability.
5.4 Planning
5.4.1 Quality Objectives
Top management should ensure that quality objectives are established at the relevant functions and levels of the organization. Quality objectives include meeting applicable regulatory requirements.
And product requirements required. The quality goal should be measurable and consistent with the quality policy.
5.4.2 Quality Management System Planning
Top management should ensure that.
a) Plan the quality management system to meet the requirements of 4.1 and the quality objectives;
b) Maintain its integrity when planning and implementing changes to the quality management system.
5.5 Responsibilities, Permissions, and Communication
5.5.1 Responsibility and Authority
Top management should ensure that responsibilities and authorities are regulated, documented, and communicate within the organization.
The top management should document the interrelationships of all personnel involved in quality management, enforcement and verification and should
Ensure that they have the necessary independence and authority to complete these tasks.
5.5.2 Management Representative
The top management should designate one member of the management, regardless of the member’s responsibilities in other areas, so that it should have the following aspects.
Responsibility and authority.
a) Ensure that the process required for the quality management system is documented;
b) Report to top management the effectiveness of the quality management system and any requirements for improvement;
c) Ensure that awareness of applicable regulatory requirements and quality management system requirements is raised throughout the organization.
5.5.3 Internal Communication
Top management should ensure that appropriate communication processes are established within the organization and that the effectiveness of the quality management system is communicated.
5.6 Management Review
5.6.1 General
The organization should document the management review process. The top management should follow the documented planning intervals for the quality management of the organization.
Management systems are reviewed to ensure their continued suitability, adequacy and effectiveness. The review should include evaluation of opportunities for improvement and quality management
Departmental requirements for changes, including changes in quality policy and quality objectives.
Records of management reviews should be kept (see 4.2.5).
5.6.2 Review Input
Inputs for management reviews should include, but are not limited to, information generated by.
a) Feedback;
b) Disposal of complaints;
c) reports to regulatory agencies;
d) audit;
e) monitoring and measurement of the process;
f) product monitoring and measurement;
g) corrective measures;
h) preventive measures;
i) follow-up measures of past management reviews;
j) Changes that may affect the quality management system;
k) improved recommendations;
l) Applicable new or revised regulatory requirements.
5.6.3 Review Output
The output of the management review shall be recorded (see 4.2.5) and include the reviewed inputs and any decisions and measures related to.
a) the improvement required to maintain the suitability, adequacy and effectiveness of the quality management system and its processes;
b) improvement of products related to customer requirements;
c) changes required to respond to applicable new or revised regulatory requirements;
d) Resource requirements.
6 Resource Management
6.1 Resource Availability
The organization should identify and provide the necessary resources to.
a) implement a quality management system and maintain its effectiveness;
b) Meet applicable regulatory requirements and customer requirements.
6.2 Human Resources
Based on appropriate education, training, skills, and experience, personnel involved in product quality work should be competent.
The organization should document one or more processes such as establishing competency, providing required training, and ensuring staff awareness.
The organization should.
a) Identify the competencies required of those involved in the work affecting product quality;
b) Provide training or take other measures to obtain or maintain the required capabilities;
c) evaluate the effectiveness of the measures taken;
d) Ensure that the people in the organization are aware of the relevance and importance of the activities they are engaged in and how they contribute to achieving the quality objectives;
e) Maintain appropriate records of education, training, skills and experience (see 4.2.5).
Note. The inspection method for the effectiveness of providing training or taking other measures should be compatible with work-related risks.
6.3 Infrastructure
In order to meet product requirements, prevent product confusion, and ensure orderly disposal of products, organizations should document the requirements of the required infrastructure.
Pieces. Where appropriate, infrastructure includes.
a) buildings, workplaces and related facilities;
b) process equipment (hardware and software);
c) Support services (such as transportation, communications or information systems).
If maintenance activities or lack of maintenance activities may affect the quality of the product, the organization shall include the requirements for such maintenance activities including the implementation of maintenance activities.
The time interval forms the file. Where appropriate, requirements should apply to production equipment, work environment control equipment and monitoring and measurement equipment.
A record of such maintenance should be kept (see 4.2.5).
6.4 Work Environment and Pollution Control
6.4.1 Working Environment
The organization should document the requirements for a working environment that meets product requirements.
If the working environment conditions may have an adverse effect on the product quality, the organization shall set the working environment requirements and monitor and control the working environment.
The program forms a file.
The organization should.
a) Document the health, cleanliness and dress requirements of a particular person, and the exposure of such personnel to the product or work environment may affect
Safety or performance of medical devices;
b) Ensure that all personnel who need to work temporarily under special environmental conditions in the work environment are competent or under the supervision of qualified personnel
Note. See ISO 14644 and ISO 14698 for more information.
6.4.2 Pollution Control
When appropriate, in order to prevent contamination of the working environment, personnel or products, the organization shall implement measures for the control of contaminated or easily contaminated products.
Plan and arrange documents.
For sterile medical devices, the organization shall document the requirements for the control of microbiological or particulate contamination, and maintain the process during assembly or packaging.
The required cleanliness.
7 Product realization
7.1 Product Planning
The organization should plan and develop the required process for product realization. The planning of product realization should 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 product realization. Should keep records of risk management activities
(See 4.2.5).
In planning the implementation of the product, the organization shall determine the following in due course.
a) Quality objectives and requirements of the product;
b) Requirements for product creation process, documentation (see 4.2.4) and provision of resources, including infrastructure and work environment;
c) Verification, validation, monitoring, measurement, inspection and testing, disposal, storage, circulation and traceability activities required for the product and
Product acceptance criteria;
d) Records required to provide evidence that the process and its products meet the requirements (see 4.2.5).
The output of this plan should be documented in a form suitable for the way the organization operates.
Note. See ISO 14971 for more information.
7.2 Processes related to customers
7.2.1 Determination of product requirements
The organization should determine.
a) Customer defined requirements, including requirements for delivery and post-delivery activities;
b) the customer does not have an explicit, but required use of the intended use or known intended use;
c) applicable regulatory requirements related to the product;
d) Ensure that any user training required for the specific performance and safe use of medical devices;
e) any additional requirements determined by the organization.
7.2.2 Review of Product Requirements
The organization should review the requirements related to the product. The review shall make commitments to provide products to the customer in the organization (such as submission of bids, acceptance of
The same or order and acceptance of contract or order changes) before proceeding and should ensure that.
a) Product requirements have been defined and documented;
b) that the contract or order requirements inconsistent with the previous statements have been resolved;
c) meet applicable regulatory requirements;
d) that any user training identified in accordance with 7.2.1 is available or is available as planned;
e) The organization has the ability to meet the required requirements.
A record of the review results and the actions resulting from the review should be kept (see 4.2.5).
If the customer does not provide a documented requirement, the organization should confirm the customer's request before accepting the customer's request.
If the product requirements change, the organization should ensure that the relevant documents are modified and that the relevant personnel know the changed requirements.
7.2.3 Communication
The organization shall plan and communicate with customers in the following aspects and form a document.
a) Product information;
b) processing inquiries, contracts or orders, including changes;
c) customer feedback, including complaints;
d) Advice on advice.
The organization should communicate with regulatory agencies in accordance with applicable regulations.
7.3 Design and Development
7.3.1 General
The organization should document the design and development process.
7.3.2 Design and Development Planning
The organization shall plan and control the design and development of product......
Related standard: YY/T 0595-2020    YY/T 0611-2020
Related PDF sample: YY/T 0313-2014    YY/T 0149-2006