GB/T 42061-2022 Medical devices - Quality management systems - Requirements for regulatory purposes
1 Scope
This document 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 document can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of this document 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 document 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 document reflect any exclusion of design and development controls.
If any requirement in Clauses 6, 7 or 8 of this document 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 documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. 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 : 2009, 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, and
——remain after the procedure for at least 30 days
Note 1: 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: GB/T 42062-2022, 3.8]
Foreword I
Introduction II
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 file
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 product
7.2.2 Review of requirements related to product
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 Servicing 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 systems
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 GB/T 42061-2022 and YY/T 0287-2003
Annex B (Informative) Correspondence between GB/T 42061-2022 and GB/T 19001-2016
Bibliography
GB/T 42061-2022 Medical devices - Quality management systems - Requirements for regulatory purposes
1 Scope
This document 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 document can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of this document 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 document 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 document reflect any exclusion of design and development controls.
If any requirement in Clauses 6, 7 or 8 of this document 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 documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. 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 : 2009, 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, and
——remain after the procedure for at least 30 days
Note 1: 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: GB/T 42062-2022, 3.8]
Contents of GB/T 42061-2022
Foreword I
Introduction II
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 file
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 product
7.2.2 Review of requirements related to product
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 Servicing 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 systems
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 GB/T 42061-2022 and YY/T 0287-2003
Annex B (Informative) Correspondence between GB/T 42061-2022 and GB/T 19001-2016
Bibliography
