Quality and safety is crucial when it comes to medical devices while regulations are becoming progressively demanding. The internationally recognised ISO 13485 Quality Management System for Medical Devices, was developed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.
Learn the key principles about the key requirements for establishing, implementing, maintaining, reviewing and improving a medical devices quality management system with our ISO 13485 MDQMS Awareness training course.
Aims & Objectives
- Provide the key requirements and guidelines of ISO 13485:2016
- Provide guidance in measures to be taken to ensure the medical devices management
- Outline the concepts towards effective Medical Devices management
Learning Outcomes
Having successfully completed this course you will be able to:
- Understand the rems and definitions of ISO 13485:2016 and its structure
- Describe the importance and benefits of an ISO 13485:20156 MDQMS
- Describe the interaction of ISO 13485 requirements
- Implement ISO 13485 standard to operational processes
Who should attend?
Professional working in the Medical Devices Manufacturing Industry as:
- Management representatives
- Compliance Managers
- Quality Managers
- Management System auditors
- Consultants
Prerequisite skills & knowledge: None required
Available in-house/distant learning? Yes
Created by: LiberoAssurance Continuous Professional Development Training Centre Level 1 – Accredited by Univab
ISO 13485:2016 Requirements
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
- PurchasingProduction 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
Teaching Methods
- Detailed seminar presentations (available for download)
- Terms and definitions
- No. of slides: 198
Resources
- Reading lists & Resources: Available in the presentations
Study time allocation
- Private study hours: 24
- Trainer contact hours: Availability and competence of instructors upon request
- Enrollment Duration: 90 days (starting from the date of purchase)
Credits
- CPD Points: 24
- ECTS/ECVET Points: 0.8
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Assessment methods
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Hours
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% contribution to final mark
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% Minimum passing grade
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Exam for ISO 13485:2016 Quality Management System for Medical Devices Awareness
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1
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100
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60
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Outcomes/Certificates
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On successful completion of the course assessment, participants will be issued with a ‘Certificate of Success’.
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