2月2016

ISO 13485:2016規格の発行

ISO 13485:2016規格「Medical devices – Quality management systems – Requirements for regulatory purposes(医療機器-品質マネジメントシステム-規制目的のための要求事項)」が発行(発売開始)されました。規格文書上の日付は2016年3月1日付となっています。13年ぶりの改訂となったこの規格は、ISO 9001:2015のようにAnnex SL(上位文書)に示されたような規格構成となっていません。従いまして、品質マニュアルをISO 9001と併用していらっしゃる場合、区分(分離しての文書化)することが必要になります。

この規格の要求事項項目は下記のとおりです。

Foreword
Introduction
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 ISO 13485:2003 and ISO 13485:2016
Annex B (informative) Correspondence between ISO 13485:2016 and ISO 9001:2015
Bibliography

以上です。