ISO 13485 Standard’s table of contents The book is organized like the standard itself — the table of contents is identical to the ISO 13485 Standard’s table of contents — making it user friendly, familiar, and unintimidating.  Each chapter contains the information, explanations, interpretations and examples regarding the requirements stated in the parallel standard clause. 


Table of Contents:
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
4.2.1. General
4.2.2. Quality manual
4.2.3. Control of documents
4.2.4. Control of records
5. Management Responsibility
5.1. Management commitment requirements
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 Requirements
6.2.1. General
6.2.2. Competence, awareness and training
6.3. Infrastructures requirements
6.4. Work Environment requirements
7. Product Realization
7.1. Planning of Product Realization
7.2. Customer Related Processes Requirements
7.2.1. Determination of Requirements related to the Product
7.2.2. Review of requirements related to the product requirements
7.2.3. Customer Communication
7.3. Design and Development
7.3.1. Design and Development Planning
7.3.2. Design and Development Inputs
7.3.3. Design and Development Outputs requirements
7.3.4. Design and Development Review
7.3.5. Verification requirements
7.3.6. Design and development validation
7.3.7. Control of Design and Development Changes
7.4. Purchasing
7.4.1. Purchasing process
7.4.2. Purchasing Information
7.4.3. Verification of purchased product requirements
7.5. Production and service provision
7.5.1. Control of production and service provision General requirements Control of production and service provision - Specific requirements Cleanliness of product and contamination control Installation activities Servicing activities Particular requirements for sterile medical devices
7.5.2. Validation of processes for production and service provision General requirements Particular requirements for sterile medical devices
7.5.3. Identification and traceability Identification Traceability Traceability - General Particular requirements for active implantable medical devices and implementable medical devices Status identification
7.5.4. Customer property requirements
7.5.5. Preservation of product
7.6. Control of Monitoring and Measuring Devices requirements
8. Measurement, analysis and improvement
8.1. Measurement, analysis and improvement general requirements
8.2. Monitoring and measurement
8.2.1. Feedback
8.2.2. Internal Audit requirements
8.2.3. Monitoring and Measurement of Processes
8.2.4. Monitoring and Measurement of Product requirement Monitoring and measurement of product – general requirements Particular requirement for active implantable devices and implantable devices
8.3. Control of Nonconforming Product
8.4. Analysis of Data requirements
8.5. Improvement
8.5.1. General
8.5.2. Corrective Action
8.5.3. Preventive Action

This website contains only a fragment from the book: ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry published by:

CRC Press

 You may purchase the book through:



Complete Guide to Quality Management in the Medical Device Industry



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