Annex ZA (informative)
Relationship between this European Standard and the Conformity Assessment Requirements of EU Directive 90/385/EEC (as amended)
Annex ZB (informative)
Relationship between this European Standard and the Conformity Assessment Requirements of EU Directive 93/42/EEC (as amended)
Annex ZC (informative)
Relationship between this European Standard and the Conformity Assessment Requirements of EU Directive 98/79/EC (as amended)
Clause 0-3
- Introduction
- Scope
- Normative references
- Terms and definitions
Quality management system
- General requirements
- Documentation requirements
- General
- Quality manual
- Medical device file
- Control of documents
- Control of records
Management responsibility
- Management commitment
- Customer focus
- Quality policy
- Planning
- Quality objectives
- Quality management syste, planning
- Responsibility, authority and communication
- Responsibility and authority
- Management representative
- Internal communication
- Management review
- General
- Review input
- Review output
Resource management
- Provision of resources
- Human resources
- Infrastructure
- Work environment and contamination control
- Work environment
- Contamination control
Product realization
- Planning of product realization
- Customer-related processes
- Determination of requirements related to product
- Review of requirements related to product
- Communication
- Design and development
- General
- Design and development planning
- Design and development inputs
- Design and development outputs
- Design and development review
- Design and development verification
- Design and development validation
- Design and development transfer
- Control of design and development changes
- Design and development files
- Purchasing Production and service provision
- Purchasing process
- Purchasing information
- Verification of purchased product
- Control of production and service provision
- Cleanliness of product
- Installation activities
- Servicing activities
- Particular requirements for sterile medical devices
- Validation of processes for production and service provision
- Particular requirements for validation of processes for sterilization and sterile barrier systems
- Identification
- Traceability
- Customer property
- Preservation of product
- Control of monitoring and measuring equipment
Measurement, analysis and improvement
- General
- Monitoring and measurement
- Feedback
- Complaint handling
- Reporting to regulatory authorities
- Internal audit
- Monitoring and measurement of processes
- Monitoring and measurement of product
- Control of nonconforming productAnalysis of data
- General
- Actions in response to nonconforming product detected before delivery
- Actions in response to nonconforming product detected after delivery
- Rework
- Analysis of data
- Improvement
- General
- Corrective action
- 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
Terms & Definitions
For ISO 13485:2016 standard
Exam & Certification
- ISO 13485:2016 MDQMS Awareness
- "ISO 13485:2016 MDQMS Awareness" Certificate