BS EN ISO 13485:2016 – TC:2019 Edition
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Tracked Changes. Medical devices. Quality management systems. Requirements for regulatory purposes
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 179 |
ISO 13485:2016 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). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of ISO 13485:2016 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 ISO 13485:2016 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 ISO 13485:2016 reflect any exclusion of design and development controls. If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | compares BS EN ISO 13485:2016 Incorporating corrigenda March 2016 and December 2016 |
| 2 | TRACKED CHANGES Test example 1 |
| 3 | ISO 13485:2016 to ISO 13485:2003 |
| 5 | Compliance with a British Standard cannot confer immunity from legal obligations. Amendments/corrigenda issued since publication |
| 6 | Medical devices — Quality management systems — Requirements for regulatory purposes — Technical Corrigendum 1 (ISO 13485:2003+Cor 1:20092016) |
| 9 | Endorsement notice |
| 11 | Table ZA.1 ― Relationship Correspondence between this European Standard and Annex 2 of Directive 90/385/EEC and the clauses of EN ISO 13485 (as amended) |
| 13 | Table ZA.2 ― Relationship Correspondence between this European Standard and Annex 5 of Directive 90/385/EEC and the clauses of EN ISO 13485(as amended) |
| 16 | ZB.2ZB.1 Relationship with Annex II of Directive 93/42/EEC (as amended) Table ZB.1 ― Relationship Correspondence between this European Standard and Annex II of Directive 93/42/EEC and the clauses of EN ISO 13485 (as amended) |
| 19 | ZB.3ZB.2 Relationship with Annex V of Directive 93/42/EEC (as amended) Table ZB.2 ― Relationship between this European Standard and Annex V of Directive 93/42/EEC and the clauses of EN ISO 13485 |
| 21 | ZB.4ZB.3 Relationship with Annex VI of Directive 93/42/EEC (as amended) Table ZB.3 ― Relationship Correspondence between this European Standard and Annex VI of Directive 93/42/EEC and the clauses of EN ISO 13485 (as amended) |
| 24 | ZC.2ZC.1 Relationship with Annex III of Directive 98/79/EC Table ZC.1 ― Relationship Correspondence between Correspondence Annex III of Directive 98/79/EC and the clauses of EN ISO 13485 |
| 26 | Table ZC.2 ― RelationshipCorrespondence between this European Standard and Annex IV of Directive 98/79/EC and the clauses of EN ISO 13485 |
| 28 | Table ZC.3 ― Relationship Correspondence between this European Standard and Annex VII of Directive 98/79/EC and the clauses of EN ISO 13485 |
| 29 | WARNING: The preceding text and tables are specifically intended for organizations that need to comply with the European Directive 98/79/EC in order to affix CE marking on their products and for other parties involved in that process. Other Directive… |
| 30 | Foreword XXXIX |
| 31 | Foreword |
| 32 | 0 Introduction 0.1 General |
| 33 | 0.2 Clarification of concepts 0.20.3 Process approach |
| 34 | 0.40.5 Compatibility with other management systems |
| 35 | BS EN ISO 13485:20122016 INTERNATIONAL STANDARD ISO 13485:20032016(E) 1.1 General 1.2 Application |
| 36 | 3 Terms and definitions supplier ————-> organization ———-> customer |
| 37 | 3.2 |
| 38 | 3.7 3.9 |
| 39 | 3.73.11 |
| 41 | 4 Quality management system 4.1 General requirements |
| 42 | 4.2 Documentation requirements 4.2.1 General |
| 43 | 4.2.2 Quality manual 4.2.3 Medical device file 4.2.3 4.2.4 Control of documents |
| 44 | 4.2.44.2.5 Control of records 5 Management responsibility 5.1 Management commitment |
| 45 | 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 |
| 46 | 5.5.3 Internal communication 5.6 Management review 5.6.1 General 5.6.2 Review input 5.6.3 Review output |
| 47 | 6 Resource management 6.1 Provision of resources 6.2 Human resources 6.2.1 General 6.2.2 Competence, awareness and training 6.3 Infrastructure |
| 48 | 6.4 Work environment and contamination control 6.4.2 Contamination control 7 Product realization 7.1 Planning of product realization |
| 49 | 7.2 Customer-related processes 7.2.1 Determination of requirements related to the product 7.2.2 Review of requirements related to the product |
| 50 | 7.2.3 Customer communication Communication 7.3 Design and development 7.3.1 General 7.3.1 7.3.2 Design and development planning |
| 51 | 7.3.27.3.3 Design and development inputs 7.3.37.3.4 Design and development outputs 7.3.47.3.5 Design and development review |
| 52 | 7.3.57.3.6 Design and development verification 7.3.67.3.7 Design and development validation |
| 53 | 7.3.1.7.3.8 Design and development transfer 7.3.77.3.9. Control of design and development changes 7.3.10 Design and development files 7.4 Purchasing 7.4.1 Purchasing process |
| 54 | 7.4.2 Purchasing information 7.4.3 Verification of purchased product |
| 55 | 7.5 Production and service provision 7.5.1 Control of production and service provision |
| 56 | 7.5.1.37.5.5 Particular requirements for sterile medical devices 7.5.27.5.6 Validation of processes for production and service provision |
| 57 | 7.5.2.27.5.7 Particular requirements for sterile medical devices validation of processes for sterilization and sterile barrier systems 7.5.37.5.8 Identification and traceability |
| 58 | 7.5.3.27.5.9 Traceability 7.5.3.2.17.5.9.1 General 7.5.3.2.27.5.9.2 Particular requirements for active implantable medical devices and implantable medical devices 7.5.47.5.10 Customer property 7.5.57.511 Preservation of product |
| 59 | 7.6 Control of monitoring and measuring devices equipment 8 Measurement, analysis and improvement 8.1 General |
| 60 | 8.2 Monitoring and measurement 8.2.2 Complaint handling 8.2.3 Reporting to regulatory authorities |
| 61 | 8.2.38.2.5 Monitoring and measurement of processes 8.2.48.2.6 Monitoring and measurement of product |
| 62 | 8.3 Control of nonconforming product 8.3.1 General 8.3.2 Actions in response to nonconforming product detected before delivery |
| 63 | 8.3.1.8.3 4 Rework 8.4 Analysis of data 8.5 Improvement |
| 64 | 8.5.3 Preventive action |
| 65 | Annex A (informative) Table A.1 — CorrespondenceComparison of content between ISO 13485:19962003 and ISO 13485:20032016 |
| 70 | Table A.2 — Correspondence between ISO 13485:2003 and ISO 13485:1996 |
| 72 | Annex B (informative) |
| 94 | 7.5.1.2.2 Installation activities |
| 96 | 7.5.3.1 Identification |
| 100 | 8.2.4 Monitoring and measurement of product 8.2.4.1 General requirements |
| 104 | Table B.1 — Correspondence between ISO 13485:2016 and ISO 9001:2015 |
| 107 | Table B.2 — Correspondence between ISO 9001:2015 and ISO 13485:2016 |
| 110 | Bibliograpy |
| 115 | European foreword |
| 116 | Table 1 — Correlation between normative references and dated EN and ISO standards Endorsement notice |
| 117 | Annex ZA (informative) Relationship between this European Standard and the ˜Conformity Assessment™ Requirements of EU Directive 90/385/EEC (as amended) ZA.0 General |
| 118 | ZA.1 Relationship with Annex 2 of Directive 90/385/EEC (as amended) Table ZA.1 — Correspondence between this European Standard and Annex 2 of Directive 90/385/EEC (as amended) |
| 119 | ZA.2 Relationship with Annex 5 of Directive 90/385/EEC (as amended) |
| 120 | Table ZA.2 — Correspondence between this European Standard and Annex 5 of Directive 90/385/EEC (as amended) |
| 122 | Annex ZB (informative) Relationship between this European Standard and the ˜Conformity Assessment™ Requirements of EU Directive 93/42/EEC (as amended) ZB.0 General |
| 123 | ZB.1 Relationship with Annex II of Directive 93/42/EEC (as amended) Table ZB.1 — Correspondence between this European Standard and Annex II of Directive 93/42/EEC (as amended) |
| 125 | ZB.2 Relationship with Annex V of Directive 93/42/EEC (as amended) Table ZB.2 — Correspondence between this European Standard and Annex V of Directive 93/42/EEC |
| 126 | ZB.3 Relationship with Annex VI of Directive 93/42/EEC (as amended) |
| 127 | Table ZB.3 — Correspondence between this European Standard and Annex VI of Directive 93/42/EEC (as amended) |
| 129 | Annex ZC (informative) Relationship between this European Standard and the ˜Conformity Assessment™ Requirements of EU Directive 98/79/EC ZC.0 General |
| 130 | ZC.1 Relationship with Annex III of Directive 98/79/EC Table ZC.1 — Correspondence between this European Standard and Annex III of Directive 98/79/EC |
| 131 | ZC.2 Relationship with Annex IV of Directive 98/79/EC |
| 132 | Table ZC.2 — Correspondence between this European Standard and Annex IV of Directive 98/79/EC |
| 134 | ZC.3 Relationship with Annex VII of Directive 98/79/EC Table ZC.3 — Correspondence between this European Standard and Annex VII of Directive 98/79/EC |
| 142 | 1 Scope 2 Normative references 3 Terms and definitions |
| 147 | 4 Quality management system 4.1 General requirements |
| 148 | 4.2 Documentation requirements 4.2.1 General 4.2.2 Quality manual 4.2.3 Medical device file |
| 149 | 4.2.4 Control of documents 4.2.5 Control of records |
| 150 | 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 |
| 151 | 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 |
| 152 | 5.6.3 Review output 6 Resource management 6.1 Provision of resources 6.2 Human resources |
| 153 | 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 |
| 154 | 7.2 Customer-related processes 7.2.1 Determination of requirements related to product 7.2.2 Review of requirements related to product |
| 155 | 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 |
| 156 | 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 |
| 157 | 7.3.8 Design and development transfer 7.3.9 Control of design and development changes 7.3.10 Design and development files |
| 158 | 7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased product |
| 159 | 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 |
| 160 | 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 |
| 161 | 7.5.8 Identification 7.5.9 Traceability 7.5.10 Customer property 7.5.11 Preservation of product |
| 162 | 7.6 Control of monitoring and measuring equipment |
| 163 | 8 Measurement, analysis and improvement 8.1 General 8.2 Monitoring and measurement 8.2.1 Feedback 8.2.2 Complaint handling |
| 164 | 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 |
| 165 | 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 |
| 166 | 8.5 Improvement 8.5.1 General 8.5.2 Corrective action 8.5.3 Preventive action |
| 168 | Annex A (informative) Comparison of content between ISO 13485:2003 and ISO 13485:2016 |
| 171 | Annex B (informative) Correspondence between ISO 13485:2016 and ISO 9001:2015 |
| 177 | Bibliography |
