YY/T 0287-2017 PDF English
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Medical devices -- Quality management systems -- Requirements for regulatory purposes
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| YY/T 0287-2003 | English | 290 |
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Medical devices. Quality management systems. Requirements for regulatory purposes
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| YY/T 0287-1996 | English | 519 |
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Quality system - Medical devices - Particular requirements for the application of GB/T 19001 - ISO 9001
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YY/T 0287-2017: Medical devices -- Quality management systems -- Requirements for regulatory purposes
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0287-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.01; 03.120.10
C 30
YY/T 0287-2017 / ISO 13485.2016
Replacing YY/T 0287-2003
Medical Devices – Quality Management Systems –
Requirements for Regulatory Purposes
(ISO 13485.2016, IDT)
Issued on. JANUARY 19, 2017
Implemented on. MAY 01, 2017
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 6
Introduction... 7
1 Scope... 11
2 Normative References... 12
3 Terms and Definitions... 12
4 Quality Management System... 18
4.1 General requirements... 18
4.2 Documentation requirements... 19
4.2.1 General... 19
4.2.2 Quality manual... 20
4.2.3 Medical device file... 20
4.2.4 Control of documents... 20
4.2.5 Control of records... 21
5 Management Responsibility... 22
5.1 Management commitment... 22
5.2 Customer focus... 22
5.3 Quality policy... 22
5.4 Planning... 22
5.4.1 Quality objectives... 22
5.4.2 Quality management system planning... 23
5.5 Responsibility, authority and communication... 23
5.5.1 Responsibility and authority... 23
5.5.2 Management representative... 23
5.5.3 Internal communication... 23
5.6 Management review... 24
5.6.1 General... 24
5.6.2 Review input... 24
5.6.3 Review output... 24
6 Resource Management... 25
6.1 Provision of resources... 25
6.2 Human resources... 25
6.3 Infrastructure... 26
6.4 Work environment and contamination control... 26
6.4.1 Work environment... 26
6.4.2 Contamination control... 26
7 Product Realization... 27
7.1 Planning of product realization... 27
7.2 Customer-related processes... 27
7.2.1 Determination of requirements related to product... 27
7.2.2 Review of requirements related to product... 28
7.2.3 Communication... 28
7.3 Design and development... 29
7.3.1 General... 29
7.3.2 Design and development planning... 29
7.3.3 Design and development inputs... 29
7.3.4 Design and development outputs... 30
7.3.5 Design and development review... 30
7.3.6 Design and development verification... 31
7.3.7 Design and development validation... 31
7.3.8 Design and development transfer... 31
7.3.9 Control of design and development changes... 32
7.3.10 Design and development files... 32
7.4 Purchasing... 32
7.4.1 Purchasing process... 32
7.4.2 Purchasing information... 33
7.4.3 Verification of purchased product... 34
7.5 Production and service provision... 34
7.5.1 Control of production and service provision... 34
7.5.2 Cleanliness of product... 34
7.5.3 Installation activities... 35
7.5.4 Servicing activities... 35
7.5.5 Particular requirements for sterile medical devices... 36
7.5.6 Validation of processes for production and service provision... 36
7.5.7 Particular requirements for validation of processes for sterilization and
sterile barrier systems... 36
7.5.8 Identification... 37
7.5.9 Traceability... 37
7.5.10 Customer property... 38
7.5.11 Preservation of product... 38
7.6 Control of monitoring and measuring equipment... 38
8 Measurement, Analysis and Improvement... 39
8.1 General... 39
8.2 Monitoring and measurement... 40
8.2.1 Feedback... 40
8.2.2 Complaint handling... 40
8.2.3 Reporting to regulatory authorities... 41
8.2.4 Internal audit... 41
8.2.5 Monitoring and measurement of processes... 41
8.2.6 Monitoring and measurement of product... 42
8.3 Control of nonconforming product... 42
8.3.1 General... 42
8.3.2 Actions in response to nonconforming product detected before delivery 42
8.3.3 Actions in response to nonconforming product detected after delivery.. 43
8.3.4 Rework... 43
8.4 Analysis of data... 43
8.5 Improvement... 44
8.5.1 General... 44
8.5.2 Corrective action... 44
8.5.3 Preventive action... 44
Appendix A (Informative) Comparison of Content between YY/T 0287-2017
and YY/T 0287-2003... 46
Appendix B (Informative) Correspondence between YY/T 0287-2017 and
GB/T 19001-2016... 51
Bibliography... 58
Foreword
This Standard was drafted as per the rules specified in GB/T 1.1-2009.
This Standard replaced YY/T 0287-2003 Medical Devices – Quality Management
Systems – Requirements for Regulatory Purposes; compared with YY/T 0287-2003,
this Standard has the major technical changes as follows.
--- Highlight the importance of regulatory requirements;
--- Expand the applicable scope;
--- Strengthen the risk management requirements;
--- Add the requirements to communicate and report to the supervision agency;
--- Strengthen the requirements of supervision management after being listed;
--- Add the requirements to form files and records.
The translation method of this Standard equivalently adopts international standard ISO
13485.2016 Medical Devices – Quality Management System – Requirements for
Regulatory Purposes.
Please note that some contents of this document may involve patents. The issuing
agency of this document doesn’t assume responsibility for identifying these patents.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee for
Standardization of Medical Device Quality Management and General Requirements
(SAC/TC 221).
Drafting organization of this Standard. Beijing Hua Guang Certification of Medical
Devices Co., Ltd.
Chief drafting staffs of this Standard. Mi Lanying, Chang Jia, Zheng Yihan, Li Chaohui,
Li Xin, Wang Meiying, and Chen Zhigang.
The historical editions replaced by this Standard are as follows.
--- YY/T 0287-1996, YY/T 0287-2003.
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.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
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.
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.
4 Quality Management System
For each medical device type or medical device family, the organization shall establish
and maintain one or more files either containing or referencing documents generated
to demonstrate conformity to the requirement of this International Standard and
compliance with applicable regulatory requirements.
The organization shall retain the records for at least the lifetime of the medical device
as defined by the organization, or as specified by applicable regulatory requirements,
but not less than two years from the medical device release by the organization.
5 Management Responsibility
Top management shall ensure that quality objectives, including those needed to meet
applicable regulatory requirements and requirements for product, are established at
relevant functions and levels within the organization.
6 Resource Management
The organization shall document the requirements for the infrastructure needed to
achieve conformity to product requirements, prevent product mix-up and ensure
orderly handling of product. Infrastructure includes, as appropriate.
7 Product Realization
The organization shall review the requirements related to product. This review shall be
conducted prior to the organization’s commitment to supply product to the customer
(e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes
to contracts or orders) and shall ensure that.
The organization shall plan and document arrangements for communicating with
customers in relation to.
8 Measurement, Analysis and Improvement
As one of the measurements of the effectiveness of the quality management system,
the organization shall gather and monitor information relating to whether the
organization has met customer requirements. The methods for obtaining and using this
information shall be documented.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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