2025-5-14 18.97.14.88
Code of China Chinese Classification Professional Classification ICS Classification Latest News Value-added Services

Position: Chinese Standard in English/YY/T 0287-2003
YY/T 0287-2003   Medical devices - Quality management systems - Requirements for regulatory purposes (English Version)
Standard No.: YY/T 0287-2003 Status:superseded remind me the status change

Email:

Language:English File Format:PDF
Word Count: 22000 words Price(USD):280.0 remind me the price change

Email:

Implemented on:2004-4-1 Delivery: via email in 1 business day
,,
Standard No.: YY/T 0287-2003
English Name: Medical devices - Quality management systems - Requirements for regulatory purposes
Chinese Name: 医疗器械 质量管理体系 用于法规的要求
Chinese Classification: C30    Medical apparatus and devices in general
Professional Classification: YY    Professional Standard - Pharmaceutics
ICS Classification: 11.040.01 11.040.01    Medical equipment in general 11.040.01
Issued by: SFDA
Issued on: 2003-9-17
Implemented on: 2004-4-1
Status: superseded
Superseded by:YY/T 0287-2017 Medical devices-Quality management systems- Requirements for regulatory purposes
Superseded on:2017-5-1
Superseding:YY/T 0287-1996 Quality system―Medical devices―Particular requirements for the application of GB/T 19001―ISO 9001
YY/T 0288-1996 Quality system. Medical devices. Particular requirements for the application of GB/T 19002. ISO 9002
Language: English
File Format: PDF
Word Count: 22000 words
Price(USD): 280.0
Delivery: via email in 1 business day
1 Scope 1.1 General 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 requirements and regulatory requirements applicable to medical devices and related services. The primary objective of this standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of GB/T 19001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this standard cannot claim conformity to GB/T 19001 unless their quality management systems conform to all the requirements of ISO 9001 (see Appendix B). 1.2 Application All requirements of this standard are specific to organizations providing medical devices, regardless of the type or size of the organization. If regulatory requirements permit exclusions of design and development controls (see 7.3), this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with this standard reflect exclusion of design and development controls [see 4.2.2 a) and 7.3]. If any requirement(s) in Chapter 7 of this standard is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system [see 4.2.2 a)]. The processes required by this standard, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system [see 4.1 a)]. In this standard the terms “if appropriate” and “where appropriate” are used several times. Where a requirement is qualified by either of these phrases, it is deemed to be “appropriate” unless the organization can document a justification otherwise. A requirement is considered “appropriate” if it is necessary in order for - the product to meet specified requirements, and/or - the organization to carry out corrective action. 2 Normative References The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments to (excluding amending errors in the text), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this standard are encouraged to study whether the latest edition of the normative document is applicable. For undated references, the latest edition of the normative document applies. GB/T 19000-2000 Quality Management Systems - Fundamentals and Vocabulary (idt ISO 9000:2000) 3 Terms and Definitions For the purposes of this standard, the terms and definitions given in GB/T 19000-2000 apply, together with the following. The following terms, used in this standard to describe the supply chain, have been changed to reflect the vocabulary currently used: suplier→orgnization→customer The term “organization” replaces the term “supplier” used in YY/T 0287-1996, and refers to the unit to which this standard applies. Also, the term “supplier” now replaces the term “subcontractor”. Throughout the text of this standard, wherever the term “product” occurs, it can also mean “service”. Wherever requirements are specified as applying to “medical devices”, the requirements apply equally to related services as supplied by the organization. The following definitions should be regarded as generic, as definitions provided in national regulations can differ slightly and take precedence.
Foreword I Introduction II 0.1 General II 0.2 Process Approach II 0.3 Relationship with Other Standards II 0.4 Compatibility with Other Management Systems III 1 Scope 1.1 General 1.2 Application 2 Normative References 3 Terms and Definitions 4 Quality Management System 4.1 General Requirements 4.2 Documentation Requirements 5 Management Responsibility 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, Authority and Communication 5.6 Management Review 6 Resource Management 6.1 Provision of Resources 6.2 Human Resources 6.3 Infrastructure 6.4 Work Environment 7 Product Realization 7.1 Planning of Product Realization 7.2 Customer-related Processes 7.3 Design and Development 7.4 Purchasing 7.5 Production and Service Provision 7.6 Control of Monitoring and Measuring Devices 8 Measurement, Analysis and Improvement 8.1 General 8.2 Monitoring and Measurement 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5 Improvement Appendix A (Informative) Correspondence between YY/T 0287-1996 and YY/T 0287- Appendix B (Informative) Explanation of Differences between YY/T 0287-2003 and GB/T 19001- Bibliography
Referred in YY/T 0287-2003:
*GB/T 9766.6-2021 Test method for tyre valve - Part 6: Test method for core
*GB/T 40904-2021 Methods for the determination of prohibited substances in furniture products and related materials—Azo dyes
*GB/T 40906-2021 Methods for the determination of prohibited substances in furniture products and related materials—Certain phthalate esters
*GB/T 40908-2021 Methods for the determination of prohibited substances in furniture products and related materials—Flame retardants
*GB/T 40971-2021 Methods for the determination of prohibited substance in furniture products and related materials—Polycyclic aromatic hydrocarbons
*GB/T 23799-2021 Methanol gasoline (M85) for motor vehicles
*GB/T 20096-2021 Roller skate
*GB/T 12678-2021 Reliability running test method for motor vehicles
*GB/T 12535-2021 Test method of starting performance for motor vehicle
*GB/T 5334-2021/XG1-2023 Passenger car―Wheels―Performance requirements and test methods for cornering and radial fatigue, includes Amendment 1
*GB/T 4985-2021 Standard test method for needle penetration of petroleum waxes
*GB/T 4942-2021 Degrees of protection provided by the integral design of rotating electrical machines (IP code)—Classification
*GB/T 3836.35-2021 Explosive atmospheres—Part 35:Classification of areas for explosive dust atmospheres
*GB/T 3836.31-2021 Explosive atmospheres—Part 31:Equipment dust ignition protection by enclosure “t”
*GB/T 3836.9-2021 Explosive atmospheres—Part 9:Equipment protection by encapsulation “m”
YY/T 0287-2003 is referred in:
* YY/T 0615.1-2007 Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices
*GB/T 19974-2018 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
*GB 18281.1-2015 Sterilization of health care products—Biological indicators—Part 1: General requirements
Code of China
Standard
YY/T 0287-2003   Medical devices - Quality management systems - Requirements for regulatory purposes (English Version)
Standard No.YY/T 0287-2003
Statussuperseded
LanguageEnglish
File FormatPDF
Word Count22000 words
Price(USD)280.0
Implemented on2004-4-1
Deliveryvia email in 1 business day
Detail of YY/T 0287-2003
Standard No.
YY/T 0287-2003
English Name
Medical devices - Quality management systems - Requirements for regulatory purposes
Chinese Name
医疗器械 质量管理体系 用于法规的要求
Chinese Classification
C30
Professional Classification
YY
ICS Classification
Issued by
SFDA
Issued on
2003-9-17
Implemented on
2004-4-1
Status
superseded
Superseded by
YY/T 0287-2017 Medical devices-Quality management systems- Requirements for regulatory purposes
Superseded on
2017-5-1
Abolished on
Superseding
YY/T 0287-1996 Quality system―Medical devices―Particular requirements for the application of GB/T 19001―ISO 9001
YY/T 0288-1996 Quality system. Medical devices. Particular requirements for the application of GB/T 19002. ISO 9002
Language
English
File Format
PDF
Word Count
22000 words
Price(USD)
280.0
Keywords
YY/T 0287-2003, YY 0287-2003, YYT 0287-2003, YY/T0287-2003, YY/T 0287, YY/T0287, YY0287-2003, YY 0287, YY0287, YYT0287-2003, YYT 0287, YYT0287
Introduction of YY/T 0287-2003
1 Scope 1.1 General 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 requirements and regulatory requirements applicable to medical devices and related services. The primary objective of this standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of GB/T 19001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this standard cannot claim conformity to GB/T 19001 unless their quality management systems conform to all the requirements of ISO 9001 (see Appendix B). 1.2 Application All requirements of this standard are specific to organizations providing medical devices, regardless of the type or size of the organization. If regulatory requirements permit exclusions of design and development controls (see 7.3), this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with this standard reflect exclusion of design and development controls [see 4.2.2 a) and 7.3]. If any requirement(s) in Chapter 7 of this standard is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system [see 4.2.2 a)]. The processes required by this standard, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system [see 4.1 a)]. In this standard the terms “if appropriate” and “where appropriate” are used several times. Where a requirement is qualified by either of these phrases, it is deemed to be “appropriate” unless the organization can document a justification otherwise. A requirement is considered “appropriate” if it is necessary in order for - the product to meet specified requirements, and/or - the organization to carry out corrective action. 2 Normative References The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments to (excluding amending errors in the text), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this standard are encouraged to study whether the latest edition of the normative document is applicable. For undated references, the latest edition of the normative document applies. GB/T 19000-2000 Quality Management Systems - Fundamentals and Vocabulary (idt ISO 9000:2000) 3 Terms and Definitions For the purposes of this standard, the terms and definitions given in GB/T 19000-2000 apply, together with the following. The following terms, used in this standard to describe the supply chain, have been changed to reflect the vocabulary currently used: suplier→orgnization→customer The term “organization” replaces the term “supplier” used in YY/T 0287-1996, and refers to the unit to which this standard applies. Also, the term “supplier” now replaces the term “subcontractor”. Throughout the text of this standard, wherever the term “product” occurs, it can also mean “service”. Wherever requirements are specified as applying to “medical devices”, the requirements apply equally to related services as supplied by the organization. The following definitions should be regarded as generic, as definitions provided in national regulations can differ slightly and take precedence.
Contents of YY/T 0287-2003
Foreword I Introduction II 0.1 General II 0.2 Process Approach II 0.3 Relationship with Other Standards II 0.4 Compatibility with Other Management Systems III 1 Scope 1.1 General 1.2 Application 2 Normative References 3 Terms and Definitions 4 Quality Management System 4.1 General Requirements 4.2 Documentation Requirements 5 Management Responsibility 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, Authority and Communication 5.6 Management Review 6 Resource Management 6.1 Provision of Resources 6.2 Human Resources 6.3 Infrastructure 6.4 Work Environment 7 Product Realization 7.1 Planning of Product Realization 7.2 Customer-related Processes 7.3 Design and Development 7.4 Purchasing 7.5 Production and Service Provision 7.6 Control of Monitoring and Measuring Devices 8 Measurement, Analysis and Improvement 8.1 General 8.2 Monitoring and Measurement 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5 Improvement Appendix A (Informative) Correspondence between YY/T 0287-1996 and YY/T 0287- Appendix B (Informative) Explanation of Differences between YY/T 0287-2003 and GB/T 19001- Bibliography
About Us   |    Contact Us   |    Terms of Service   |    Privacy   |    Cancellation & Refund Policy   |    Payment
Tel: +86-10-8572 5655 | Fax: +86-10-8581 9515 | Email: coc@codeofchina.com | QQ: 672269886
Copyright: TransForyou Co., Ltd. 2008-2040
 
 
Keywords:
YY/T 0287-2003, YY 0287-2003, YYT 0287-2003, YY/T0287-2003, YY/T 0287, YY/T0287, YY0287-2003, YY 0287, YY0287, YYT0287-2003, YYT 0287, YYT0287