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Comparison Chart of ISO 13485:1996, ISO 13485:2003 and FDAs QSR

The table below lists the corresponding clauses of ISO 13485:1996, ISO 13485:2003, and the Quality System Regulation, respectively. ISO 13485:1996 ISO 13485:2003 FDA Quality System Regulation
1. Scope 4.1 Management Responsibility 4.1.1 Quality Policy 4.1.2 Organization/Resources 4.1.3 Management Review 1. Scope 5.1 Management Commitment 5.3 Quality Policy 5.4.1 Quality Objectives 5.5.1 Responsibility and Authority 6.1 Provision of Resources 6.2.1 Human Resources 5.5.2 Customer Focus 5.6.1 Management Review 8.5.1 Improvement 4.1 QMS General Requirements 4.2.2 Quality Manual 4.2.1 Documentation Requirements General 5.4.2 Quality management System Planning 7.1 Planning of Product Realization 5.2 Customer Focus 7.2.1 Determination of Requirements Related to Product 7.2.2 Review of Requirements Related to Product 7.2.3 Customer Communication 7.3 Design and Development 7.3.1 Design and Development Planning 820.1 Scope 820.1 (a) Application 820.20 Management Responsibility 820.20 (a) Quality policy 820.20 (b) Organization 820.20 (c) Management Review 820.25 (a) General

4.2 Quality System 4.2.1 General 4.2.2 Quality System Procedures 4.2.3 Quality Planning

820.5 Quality System 820.20 (b) Organization 820.20 (d) Quality Planning 820.20 (e) Quality System Procedures 820.30 (h) Design Transfer 820.181 Device Master Record 820.186 Quality System Record 820.50 (b) Purchasing Data 820.160 (b) Distribution Records

4.3 Contract Review

4 Design Control 4.4.1 General 4.4.2 Design Development and Planning 4.4.3 Organizational and Technical Interfaces 4.4.4 Design Input

820.30 Design Controls 820.30 (a) General 820.30 (b) Design & Development Planning 820.30 (h) Design Transfer 820.30 (c) Design Input

7.2.1 Determination of Requirements Related to

Quality System Requirements For Medical Devices ISO 13485:1996 ISO 13485:2003
Product 7.3.2 Design & Development Inputs 7.3.3 Design & Development Outputs 7.3.4 Design & Development Review 7.3.5 Design & Development Verification 7.3.6 Design & Development Validation 7.3.7 Control of Design & Development Changes 4.2.3 Control of Documents

FDA Quality System Regulation

4.4.5 Design Output 4.4.6 Design Review 4.4.7 Design Verification 4.4.8 Design Validation 4.4.9 Design Changes

820.30 (d) Design Output 820.30 (e) Design Review 820.30 (f) Design Verification 820.30 (g) Design Validation 820.70 (i) Automated Processes 820.30 (i) Design Changes 820.70 (b) Production & Process Changes 820.40 Document Control 820.40 (a) Document Approval & Distribution 820.40 (b) Document Changes 820.180 General 820.180 (a) Confidentiality 820.50 Purchasing Controls 820.50 (a) Evaluation of Suppliers, Contractors & Consultants 820.50 (b) Purchasing Data 820.80 (a) General

4.5 Document and Data Control 4.5.1 General 4.5.2 Document and Data Approval and Issue 4.5.3 Document and Data Changes 4.6 Purchasing 4.6.1 General 4.6.2 Evaluation of Subcontractors 4.6.3 Purchasing Data 4.6.4 Verification of Purchased Product 4.6.4.1 Supplier Verification at Subcontractor's Premises 4.6.4.2 Customer Verification of Subcontractor Product 4.7 Control of Customer-Supplied Product 4.8 Product Identification and Traceability 4.9 Process Control

7.4.1 Purchasing Process

7.4.2 Purchasing Information 7.4.3 Verification of Purchased Product

7.5.4 Customer Property 7.5.3 Identification & Traceability 6.3 Infrastructure 6.4 Work Environment 7.5.1 Control of Production & Service Provision 7.5.2 Validation of Processes for Production and Service Provisions

820.80 (a) General 820.60 Identification 820.65 Traceability

820.70 (a) Production & Process Controls -- General 820.70 (e) Environmental Control 820.70 (d) Personnel 820.70 (e) Contamination Control 820.70 (f) Buildings 820.70 (g) Equipment 820.70 (h) Manufacturing Material 820.75 (a) (b) (c) Process

Quality System Requirements For Medical Devices ISO 13485:1996 ISO 13485:2003

FDA Quality System Regulation


validation 820.170 (b) Installation 820.80 (a) Receiving, In-process & Finished Device Acceptance General 820.80 (b) Receiving Acceptance Activities 820.80 (c) In-process Acceptance Activities 820.80 (d) Final Acceptance Activities 820.80 (e) Acceptance Records 820.70 (c) Environmental Control 820.71 Inspection, Measuring & Test Equipment 820.72 (a) Control of Inspection, Measuring & Test Equipment 820.72 (b) Calibration 820.72 (b) (1) Calibration Standards 820.72 (b) (2) Calibration Records

4.10 Inspection and Testing 4.10.1 General

7.1 Planning of Product Realization 8.1 Measurement , Analysis & Improvement 7.4.3 Verification of Purchased Product 8.2.4 Monitoring & Measurement of Product 8.2.4 Monitoring & Measurement of Product 7.5.3 Identification & Traceability 7.6 Control of Monitoring & Measuring Devices

4.10.2 Receiving Inspection and Testing 4.10.3 In-process Inspection and Testing 4.10.4 Final Inspection and Testing 4.10.5 Inspection and Test Records 4.11 Inspection, Measuring and Test Equipment 4.11.1 General 4.11.2 Control Procedure

4.12 Inspection and Test Status 4.13 Control of Nonconforming Products 4.13.1 General 4.13.2 Review and Disposition of Nonconforming Product 4.14 Corrective and Preventive Action 4.14.1 General 4.14.2 Corrective Action

7.5.3 Identification & Traceability 8.3 Control of Non-conforming Product 8.3 Control of Non-conforming Product 8.5.2 Corrective Action

820.86 Acceptance Status 820.90 Nonconforming Product 820.90 (a) Control of Nonconforming Product 820.90 (b) Nonconforming Review & Disposition 820.100 Corrective & Preventive Action 820.100 (a) Procedures for Implementing Corrective & Preventive Action 820.100 (b) Documentation of All Related Activities 820.198 Complaint Files 820.100 Corrective & Preventive Action 820.100 (a) Procedures for Implementing Corrective & Preventive Action 820.100 (b) Documentation of All Related Activities

4.14.3 Preventive Action

8.5.3 Preventive Action

Quality System Requirements For Medical Devices ISO 13485:1996 ISO 13485:2003

FDA Quality System Regulation


820.198 Complaint Files

4.15 Handling, Storage, Packaging, Preservation and Delivery 4.15.1 General 4.15.2 Handling 4.15.3 Storage 4.15.4 Packaging 4.15.5 Preservation 4.15.6 Delivery 4.16 Control of Quality Records

6.4 Work Environment 7.5.1 Control of Production & Service Provision 7.5.5 Preservation of Product 7.5.5 Preservation of Product 7.5.5 Preservation of Product 7.5.5 Preservation of Product 4.2.4 Control of Records

820.120 Device Labeling 820.130 Device Packaging 820.140 Handling 820.150 Storage 820.130 Device Packaging 820.130 Device Packaging 820.160 (a) Distribution Control for Finished Products 820.30 (j) Design History File 820.180 General Requirements 820.180 (a) Confidentiality 820.180 (b) Record Retention Period 820.180 (c) Exceptions 820.181 Device Master Record 820.184 Device History Record 820.186 Quality System Record 820.22 Quality Audit

4.17 Internal Quality Audits

8.2.2 Internal Audit 8.2.3 Monitoring & Measurement of Processes 6.2.2 Competence, Awareness & Training 7.5.1 Control of Production & Service Provision 8.1 Measurement, Analysis & Improvement 8.2.3 Monitoring & Measurement of Processes 8.2.4 Monitoring & Measurement of Product 8.4 Analysis of Data

4.18 Training 4.19 Servicing 4.20 Statistical Techniques 4.20.1 Identification of Need 4.20.2 Procedures

820.25 (b) Training 820.200 Servicing 820.250 Statistical Techniques