This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0287-2003 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes in whole, and the following technical deviations have been made with respect to YY/T 0287-2003:
— the importance of regulatory requirements is highlighted;
— the scope of application is expanded;
— the requirements of risk management are strengthened;
— the requirements for communicating with and reporting to regulators are added;
— the requirements for post-listing supervision and management are added;
— the requirements for documentation and record-keeping are added.
This standard is identical with International Standard ISO 13485:2016 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the China Food and Drug Administration.
This standard is under the jurisdiction of the National Technical Committee 221 on Quality Management of and General Requirements for Medical Devices of Standardization Administration of China (SAC/TC 221).
The previous editions of this standard are as follows:
— YY/T 0287-1996, YY/T 0287-2003.
Introduction
0.1 General
This standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support). The requirements in this standard can also be used by suppliers or other external parties providing product (e.g. raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations. The supplier or external party can voluntarily choose to conform to the requirements of this standard or can be required by contract to conform.
Several jurisdictions have regulatory requirements for the application of quality management systems by organizations with a variety of roles in the supply chain for medical devices. Consequently, this standard expects that the organization:
— identifies its role(s) under applicable regulatory requirements;
— identifies the regulatory requirements that apply to its activities under these roles;
— incorporates these applicable regulatory requirements within its quality management system.
The definitions in applicable regulatory requirements differ from nation to nation and region to region. The organization needs to understand how the definitions in this standard will be interpreted in light of regulatory definitions in the jurisdictions in which the medical devices are made available.
This standard can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements applicable to the quality management system and the organization’s own requirements. It is emphasized that the quality management system requirements specified in this standard are complementary to the technical requirements for product that are necessary to meet customer and applicable regulatory requirements for safety and performance.
The adoption of a quality management system is a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by the:
a) organizational environment, changes in that environment, and the influence that the organizational environment has on the conformity of the medical devices;
b) organization’s varying needs;
c) organization’s particular objectives;
d) product the organization provides;
e) processes the organization employs;
f) organization’s size and organizational structure;
g) regulatory requirements applicable to the organization’s activities.
It is not the intent of this standard to imply the need for uniformity in the structure of different quality management systems, uniformity of documentation or alignment of documentation to the clause structure of this standard.
There is a wide variety of medical devices and some of the particular requirements of this standard only apply to named groups of medical devices. These groups are defined in Clause 3.
0.2 Clarification of concepts
In this standard, the following terms or phrases are used in the context described below.
— When a requirement is qualified by the phrase “as appropriate”, it is deemed to be appropriate unless the organization can justify otherwise. A requirement is considered appropriate if it is necessary for:
— product to meet requirements;
— compliance with applicable regulatory requirements;
— the organization to carry out corrective action;
— the organization to manage risks.
— When the term “risk” is used, the application of the term within the scope of this standard pertains to safety or performance requirements of the medical device or meeting applicable regulatory requirements.
— When a requirement is required to be “documented”, it is also required to be established, implemented and maintained.
— When the term “product” is used, it can also mean “service”. Product applies to output that is intended for, or required by, a customer, or any intended output resulting from a product realization process.
— When the term “regulatory requirements” is used, it encompasses requirements contained in any law applicable to the user of this standard (e.g. statutes, regulations, ordinances or directives). The application of the term “regulatory requirements” is limited to requirements for the quality management system and the safety or performance of the medical device.
The following auxiliary verbs are used in this standard:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— "may" indicates permission;
— "can" indicates a possibility or a capability.
"Note" is for guidance in understanding or clarifying the associated requirement.
0.3 Process approach
This standard is based on a process approach to quality management. Any activity that receives input and converts it to output can be considered as a process. Often the output from one process directly forms the input to the next process.
For an organization to function effectively, it needs to identify and manage numerous linked processes. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach.”
When used within a quality management system, such an approach emphasizes the importance of:
a) understanding and meeting requirements;
b) considering processes in terms of added value;
c) obtaining results of process performance and effectiveness;
d) improving processes based on objective measurement.
0.4 Relationship with ISO 9001
While this is a stand-alone standard, it is based on GB/T 19001-2008, which has been replaced by GB/T 19001-2016. For the convenience of users, Annex B shows the correspondence between this standard and GB/T 19001-2016.
ISO13485:2016 is intended to facilitate global alignment of appropriate regulatory requirements for quality management systems applicable to organizations involved in one or more stages of the life-cycle of a medical device. This standard includes some particular requirements for organizations involved in the life-cycle of medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this standard cannot claim conformity to ISO 9001 unless their quality management system meets all the requirements of ISO 9001.
0.5 Compatibility with other management systems
This standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, or financial management. However, this standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this standard.
Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes
1 Scope
This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). This standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of this standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
The processes required by this standard that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.
If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to this standard reflect any exclusion of design and development controls.
If any requirement in Clauses 6, 7 or 8 of this standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 19000-2016 Quality Management Systems — Fundamentals and Vocabulary (ISO 9000: 2015, IDT)
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in GB/T 19000-2016 and the following apply.
3.1
advisory notice
notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information or to advise on action to be taken in the:
— use of a medical device;
— modification of a medical device;
— return of the medical device to the organization that supplied it; or
— destruction of a medical device.
Note: Issuance of an advisory notice can be required to comply with applicable regulatory requirements.
3.2
authorized representative
natural or legal person established within a country or jurisdiction who has received a written mandate from the manufacturer to act on his behalf for specified tasks with regard to the latter’s obligations under that country or jurisdiction’s legislation
[Source: GHTF/SG1/N055:2009, 5.2]
3.3
clinical evaluation
assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer
[Source: GHTF/SG5/N4:2010, Clause 4]
3.4
complaint
written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization’s control or related to a service that affects the performance of such medical devices
Note: This definition of “complaint” differs from the definition given in GB/T 19000-2016.
3.5
distributor
natural or legal person in the supply chain who, on his own behalf, furthers the availability of a medical device to the end user
Note 1: More than one distributor may be involved in the supply chain.
Note 2: Persons in the supply chain involved in activities such as storage and transport on behalf of the manufacturer, importer or distributor, are not distributors under this definition.
[Source: GHTF/SG1/N055, 5.3]
3.6
implantable medical device
medical device which can only be removed by medical or surgical intervention and which is intended to:
— be totally or partially introduced into the human body or a natural orifice; or replace an epithelial surface or the surface of the eye;
— remain after the procedure for at least 30 days.
Note: This definition of implantable medical device includes active implantable medical device.
3.7
importer
natural or legal person in the supply chain who is the first in a supply chain to make a medical device, manufactured in another country or jurisdiction, available in the country or jurisdiction where it is to be marketed
[Source: GHTF/SG1/N055:2009, 5.4]
3.8
labelling
label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents
[Source: GHTF/SG1/N70:2011, Clause 4]
3.9
life-cycle
all phases in the life of a medical device, from the initial conception to final decommissioning and disposal
[Source: YY/T 0316-2016, 2.7]
3.10
manufacturer
natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s)
Note 1: This “natural or legal person” has ultimate legal responsibility for ensuring compliance with all applicable regulatory requirements for the medical devices in the countries or jurisdictions where it is intended to be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory Authority (RA) within that jurisdiction.
Note 2: The manufacturer’s responsibilities are described in other GHTF guidance documents. These responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse event reporting and notification of corrective actions.
Note 3: “Design and/or manufacture”, as referred to in the above definition, may include specification development, production, fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for a medical purpose.
Note 4: Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation does not change the intended use of the medical device.
Note 5: Any person who changes the intended use of, or modifies, a medical device without acting on behalf of the original manufacturer and who makes it available for use under his own name, should be considered the manufacturer of the modified medical device.
Note 6: An authorized representative, distributor or importer who only adds its own address and contact details to the medical device or the packaging, without covering or changing the existing labelling, is not considered a manufacturer.
Note 7: To the extent that an accessory is subject to the regulatory requirements of a medical device, the person responsible for the design and/or manufacture of that accessory is considered to be a manufacturer.
[Source: GHTF/SG1/N055:2009, 5.1]
3.11
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— investigation, replacement, modification, or support of the anatomy or of a physiological process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means
Note: Products which may be considered to be medical devices in some jurisdictions but not in others include:
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[Source: GHTF/SG1/N071:2012, 5.1]
3.12
medical device family
group of medical devices manufactured by or for the same organization and having the same basic design and performance characteristics related to safety, intended use and function
3.13
performance evaluation
assessment and analysis of data to establish or verify the ability of an in vitro diagnostic medical device to achieve its intended use
3.14
post-market surveillance
systematic process to collect and analyse experience gained from medical devices that have been placed on the market
3.15
product
result of a process
Note 1: There are four generic product categories, as follows:
— services (e.g. transport);
— software (e.g. computer program, dictionary);
— hardware (e.g. engine mechanical part);
— processed materials (e.g. lubricant).
Many products comprise elements belonging to different generic product categories. Whether the product is then called service, software, hardware or processed material depends on the dominant element. For example, the offered product “automobile” consists of hardware (e.g. tyres), processed materials (e.g. fuel, cooling liquid), software (e.g. engine control software, driver’s manual), and service (e.g. operating explanations given by the salesman).
Note 2: Service is the result of at least one activity necessarily performed at the interface between the supplier and customer and is generally intangible. Provision of a service can involve, for example, the following:
— an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired);
— an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return);
— the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission);
— the creation of ambience for the customer (e.g. in hotels and restaurants).
Software consists of information and is generally intangible and can be in the form of approaches, transactions or procedures.
Hardware is generally tangible and its amount is a countable characteristic. Processed materials are generally tangible and their amount is a continuous characteristic. Hardware and processed materials often are referred to as goods.
Note 3: This definition of “product” differs from the definition given in GB/T 19000-2016.
[Source: GB/T 19000-2008 , 3.4.2, modified]
3.16
purchased product
product provided by a party outside the organization’s quality management system
Note: The provision of product does not necessarily infer a commercial or financial arrangement.
Foreword IV Introduction V 1 Scope 2 Normative References 3 Terms and Definitions 4 Quality Management System 4.1 General requirements 4.2 Documentation requirements 4.2.1 General 4.2.2 Quality manual 4.2.3 Medical device documents 4.2.4 Control of documents 4.2.5 Control of records 5 Management Responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.4.1 Quality objectives 5.4.2 Quality management system planning 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority 5.5.2 Management representative 5.5.3 Internal communication 5.6 Management review 5.6.1 General 5.6.2 Review input 5.6.3 Review output 6 Resource Management 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment and contamination control 6.4.1 Work environment 6.4.2 Contamination control 7 Product Realization 7.1 Planning of product realization 7.2 Customer-related processes 7.2.1 Determination of requirements related to products 7.2.2 Review of requirements related to products 7.2.3 Communication 7.3 Design and development 7.3.1 General 7.3.2 Design and development planning 7.3.3 Design and development inputs 7.3.4 Design and development outputs 7.3.5 Design and development review 7.3.6 Design and development verification 7.3.7 Design and development validation 7.3.8 Design and development transfer 7.3.9 Control of design and development changes 7.3.10 Design and development files 7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased product 7.5 Production and service provision 7.5.1 Control of production and service provision 7.5.2 Cleanliness of product 7.5.3 Installation activities 7.5.4 Service activities 7.5.5 Particular requirements for sterile medical devices 7.5.6 Validation of processes for production and service provision 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier system 7.5.8 Identification 7.5.9 Traceability 7.5.10 Customer property 7.5.11 Preservation of product 7.6 Control of monitoring and measuring equipment 8 Measurement, Analysis and Improvement 8.1 General 8.2 Monitoring and measurement 8.2.1 Feedback 8.2.2 Complaint handling 8.2.3 Reporting to regulatory authorities 8.2.4 Internal audit 8.2.5 Monitoring and measurement of processes 8.2.6 Monitoring and measurement of product 8.3 Control of nonconforming product 8.3.1 General 8.3.2 Actions in response to nonconforming product detected before delivery 8.3.3 Actions in response to nonconforming product detected after delivery 8.3.4 Rework 8.4 Analysis of data 8.5 Improvement 8.5.1 General 8.5.2 Corrective action 8.5.3 Preventive action Annex A (Informative) Comparison of content between YY/T 0287-2017 and YY/T 0287- Annex B (Informative) Correspondence between YY/T 0287-2017 and GB/T 19001- Bibliography
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0287-2003 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes in whole, and the following technical deviations have been made with respect to YY/T 0287-2003:
— the importance of regulatory requirements is highlighted;
— the scope of application is expanded;
— the requirements of risk management are strengthened;
— the requirements for communicating with and reporting to regulators are added;
— the requirements for post-listing supervision and management are added;
— the requirements for documentation and record-keeping are added.
This standard is identical with International Standard ISO 13485:2016 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the China Food and Drug Administration.
This standard is under the jurisdiction of the National Technical Committee 221 on Quality Management of and General Requirements for Medical Devices of Standardization Administration of China (SAC/TC 221).
The previous editions of this standard are as follows:
— YY/T 0287-1996, YY/T 0287-2003.
Introduction
0.1 General
This standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support). The requirements in this standard can also be used by suppliers or other external parties providing product (e.g. raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations. The supplier or external party can voluntarily choose to conform to the requirements of this standard or can be required by contract to conform.
Several jurisdictions have regulatory requirements for the application of quality management systems by organizations with a variety of roles in the supply chain for medical devices. Consequently, this standard expects that the organization:
— identifies its role(s) under applicable regulatory requirements;
— identifies the regulatory requirements that apply to its activities under these roles;
— incorporates these applicable regulatory requirements within its quality management system.
The definitions in applicable regulatory requirements differ from nation to nation and region to region. The organization needs to understand how the definitions in this standard will be interpreted in light of regulatory definitions in the jurisdictions in which the medical devices are made available.
This standard can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements applicable to the quality management system and the organization’s own requirements. It is emphasized that the quality management system requirements specified in this standard are complementary to the technical requirements for product that are necessary to meet customer and applicable regulatory requirements for safety and performance.
The adoption of a quality management system is a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by the:
a) organizational environment, changes in that environment, and the influence that the organizational environment has on the conformity of the medical devices;
b) organization’s varying needs;
c) organization’s particular objectives;
d) product the organization provides;
e) processes the organization employs;
f) organization’s size and organizational structure;
g) regulatory requirements applicable to the organization’s activities.
It is not the intent of this standard to imply the need for uniformity in the structure of different quality management systems, uniformity of documentation or alignment of documentation to the clause structure of this standard.
There is a wide variety of medical devices and some of the particular requirements of this standard only apply to named groups of medical devices. These groups are defined in Clause 3.
0.2 Clarification of concepts
In this standard, the following terms or phrases are used in the context described below.
— When a requirement is qualified by the phrase “as appropriate”, it is deemed to be appropriate unless the organization can justify otherwise. A requirement is considered appropriate if it is necessary for:
— product to meet requirements;
— compliance with applicable regulatory requirements;
— the organization to carry out corrective action;
— the organization to manage risks.
— When the term “risk” is used, the application of the term within the scope of this standard pertains to safety or performance requirements of the medical device or meeting applicable regulatory requirements.
— When a requirement is required to be “documented”, it is also required to be established, implemented and maintained.
— When the term “product” is used, it can also mean “service”. Product applies to output that is intended for, or required by, a customer, or any intended output resulting from a product realization process.
— When the term “regulatory requirements” is used, it encompasses requirements contained in any law applicable to the user of this standard (e.g. statutes, regulations, ordinances or directives). The application of the term “regulatory requirements” is limited to requirements for the quality management system and the safety or performance of the medical device.
The following auxiliary verbs are used in this standard:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— "may" indicates permission;
— "can" indicates a possibility or a capability.
"Note" is for guidance in understanding or clarifying the associated requirement.
0.3 Process approach
This standard is based on a process approach to quality management. Any activity that receives input and converts it to output can be considered as a process. Often the output from one process directly forms the input to the next process.
For an organization to function effectively, it needs to identify and manage numerous linked processes. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach.”
When used within a quality management system, such an approach emphasizes the importance of:
a) understanding and meeting requirements;
b) considering processes in terms of added value;
c) obtaining results of process performance and effectiveness;
d) improving processes based on objective measurement.
0.4 Relationship with ISO 9001
While this is a stand-alone standard, it is based on GB/T 19001-2008, which has been replaced by GB/T 19001-2016. For the convenience of users, Annex B shows the correspondence between this standard and GB/T 19001-2016.
ISO13485:2016 is intended to facilitate global alignment of appropriate regulatory requirements for quality management systems applicable to organizations involved in one or more stages of the life-cycle of a medical device. This standard includes some particular requirements for organizations involved in the life-cycle of medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this standard cannot claim conformity to ISO 9001 unless their quality management system meets all the requirements of ISO 9001.
0.5 Compatibility with other management systems
This standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, or financial management. However, this standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this standard.
Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes
1 Scope
This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). This standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of this standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
The processes required by this standard that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.
If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to this standard reflect any exclusion of design and development controls.
If any requirement in Clauses 6, 7 or 8 of this standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 19000-2016 Quality Management Systems — Fundamentals and Vocabulary (ISO 9000: 2015, IDT)
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in GB/T 19000-2016 and the following apply.
3.1
advisory notice
notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information or to advise on action to be taken in the:
— use of a medical device;
— modification of a medical device;
— return of the medical device to the organization that supplied it; or
— destruction of a medical device.
Note: Issuance of an advisory notice can be required to comply with applicable regulatory requirements.
3.2
authorized representative
natural or legal person established within a country or jurisdiction who has received a written mandate from the manufacturer to act on his behalf for specified tasks with regard to the latter’s obligations under that country or jurisdiction’s legislation
[Source: GHTF/SG1/N055:2009, 5.2]
3.3
clinical evaluation
assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer
[Source: GHTF/SG5/N4:2010, Clause 4]
3.4
complaint
written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization’s control or related to a service that affects the performance of such medical devices
Note: This definition of “complaint” differs from the definition given in GB/T 19000-2016.
3.5
distributor
natural or legal person in the supply chain who, on his own behalf, furthers the availability of a medical device to the end user
Note 1: More than one distributor may be involved in the supply chain.
Note 2: Persons in the supply chain involved in activities such as storage and transport on behalf of the manufacturer, importer or distributor, are not distributors under this definition.
[Source: GHTF/SG1/N055, 5.3]
3.6
implantable medical device
medical device which can only be removed by medical or surgical intervention and which is intended to:
— be totally or partially introduced into the human body or a natural orifice; or replace an epithelial surface or the surface of the eye;
— remain after the procedure for at least 30 days.
Note: This definition of implantable medical device includes active implantable medical device.
3.7
importer
natural or legal person in the supply chain who is the first in a supply chain to make a medical device, manufactured in another country or jurisdiction, available in the country or jurisdiction where it is to be marketed
[Source: GHTF/SG1/N055:2009, 5.4]
3.8
labelling
label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents
[Source: GHTF/SG1/N70:2011, Clause 4]
3.9
life-cycle
all phases in the life of a medical device, from the initial conception to final decommissioning and disposal
[Source: YY/T 0316-2016, 2.7]
3.10
manufacturer
natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s)
Note 1: This “natural or legal person” has ultimate legal responsibility for ensuring compliance with all applicable regulatory requirements for the medical devices in the countries or jurisdictions where it is intended to be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory Authority (RA) within that jurisdiction.
Note 2: The manufacturer’s responsibilities are described in other GHTF guidance documents. These responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse event reporting and notification of corrective actions.
Note 3: “Design and/or manufacture”, as referred to in the above definition, may include specification development, production, fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for a medical purpose.
Note 4: Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation does not change the intended use of the medical device.
Note 5: Any person who changes the intended use of, or modifies, a medical device without acting on behalf of the original manufacturer and who makes it available for use under his own name, should be considered the manufacturer of the modified medical device.
Note 6: An authorized representative, distributor or importer who only adds its own address and contact details to the medical device or the packaging, without covering or changing the existing labelling, is not considered a manufacturer.
Note 7: To the extent that an accessory is subject to the regulatory requirements of a medical device, the person responsible for the design and/or manufacture of that accessory is considered to be a manufacturer.
[Source: GHTF/SG1/N055:2009, 5.1]
3.11
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— investigation, replacement, modification, or support of the anatomy or of a physiological process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means
Note: Products which may be considered to be medical devices in some jurisdictions but not in others include:
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[Source: GHTF/SG1/N071:2012, 5.1]
3.12
medical device family
group of medical devices manufactured by or for the same organization and having the same basic design and performance characteristics related to safety, intended use and function
3.13
performance evaluation
assessment and analysis of data to establish or verify the ability of an in vitro diagnostic medical device to achieve its intended use
3.14
post-market surveillance
systematic process to collect and analyse experience gained from medical devices that have been placed on the market
3.15
product
result of a process
Note 1: There are four generic product categories, as follows:
— services (e.g. transport);
— software (e.g. computer program, dictionary);
— hardware (e.g. engine mechanical part);
— processed materials (e.g. lubricant).
Many products comprise elements belonging to different generic product categories. Whether the product is then called service, software, hardware or processed material depends on the dominant element. For example, the offered product “automobile” consists of hardware (e.g. tyres), processed materials (e.g. fuel, cooling liquid), software (e.g. engine control software, driver’s manual), and service (e.g. operating explanations given by the salesman).
Note 2: Service is the result of at least one activity necessarily performed at the interface between the supplier and customer and is generally intangible. Provision of a service can involve, for example, the following:
— an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired);
— an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return);
— the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission);
— the creation of ambience for the customer (e.g. in hotels and restaurants).
Software consists of information and is generally intangible and can be in the form of approaches, transactions or procedures.
Hardware is generally tangible and its amount is a countable characteristic. Processed materials are generally tangible and their amount is a continuous characteristic. Hardware and processed materials often are referred to as goods.
Note 3: This definition of “product” differs from the definition given in GB/T 19000-2016.
[Source: GB/T 19000-2008 , 3.4.2, modified]
3.16
purchased product
product provided by a party outside the organization’s quality management system
Note: The provision of product does not necessarily infer a commercial or financial arrangement.
Contents of YY/T 0287-2017
Foreword IV
Introduction V
1 Scope
2 Normative References
3 Terms and Definitions
4 Quality Management System
4.1 General requirements
4.2 Documentation requirements
4.2.1 General
4.2.2 Quality manual
4.2.3 Medical device documents
4.2.4 Control of documents
4.2.5 Control of records
5 Management Responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.4.1 Quality objectives
5.4.2 Quality management system planning
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal communication
5.6 Management review
5.6.1 General
5.6.2 Review input
5.6.3 Review output
6 Resource Management
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment and contamination control
6.4.1 Work environment
6.4.2 Contamination control
7 Product Realization
7.1 Planning of product realization
7.2 Customer-related processes
7.2.1 Determination of requirements related to products
7.2.2 Review of requirements related to products
7.2.3 Communication
7.3 Design and development
7.3.1 General
7.3.2 Design and development planning
7.3.3 Design and development inputs
7.3.4 Design and development outputs
7.3.5 Design and development review
7.3.6 Design and development verification
7.3.7 Design and development validation
7.3.8 Design and development transfer
7.3.9 Control of design and development changes
7.3.10 Design and development files
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.2 Cleanliness of product
7.5.3 Installation activities
7.5.4 Service activities
7.5.5 Particular requirements for sterile medical devices
7.5.6 Validation of processes for production and service provision
7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier system
7.5.8 Identification
7.5.9 Traceability
7.5.10 Customer property
7.5.11 Preservation of product
7.6 Control of monitoring and measuring equipment
8 Measurement, Analysis and Improvement
8.1 General
8.2 Monitoring and measurement
8.2.1 Feedback
8.2.2 Complaint handling
8.2.3 Reporting to regulatory authorities
8.2.4 Internal audit
8.2.5 Monitoring and measurement of processes
8.2.6 Monitoring and measurement of product
8.3 Control of nonconforming product
8.3.1 General
8.3.2 Actions in response to nonconforming product detected before delivery
8.3.3 Actions in response to nonconforming product detected after delivery
8.3.4 Rework
8.4 Analysis of data
8.5 Improvement
8.5.1 General
8.5.2 Corrective action
8.5.3 Preventive action
Annex A (Informative) Comparison of content between YY/T 0287-2017 and YY/T 0287-
Annex B (Informative) Correspondence between YY/T 0287-2017 and GB/T 19001-
Bibliography
