What is ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes

ISO 13485 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.

Overview of ISO 13485:2016

While this is a stand-alone standard, it is based on ISO 9001:2008, which has been superseded by ISO 9001:2015. This third edition of ISO 13485 cancels and replaces the second edition (ISO 13485:2003) and ISO/TR 14969:2004, which have been technically revised. If any requirement in Clauses 6, 7 or 8 of this International Standard 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.

- Comparing ISO13485:2003, ISO13485:2016 is intended to

• - facilitate global alignment of appropriate regulatory requirements
• - apply a risk based approach to the control of the appropriate processes needed for the quality management system
• - supplement and clarify the requirements for verification, validation and design and development activities
• - strengthen the requirements for supplier control and outsourcing process
• - emphasize importance of feedback mechanism
• - add requirement for validation including the validation of the application of computer software used in the quality management system

Application of ISO 13485:2016

Unlike ISO13485:2003, ISO13485: 2016 specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support).

• Manufacturer

• Authorized Represent

• Importer

• Distributor

• Sterilization service

• Raw material supply

• Delivery service

• Maintenance

ISO 13485:2016 Requirements

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

77.3 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/dt

8.5 Improvement

• 8.5.1 General
• 8.5.2 Corrective action
• 8.5.3 Preventive action