MIM-120 Understanding the Requirements of ISO 13485:2016 & ISO 9001:2015
Integrated Management Systems
.Understanding the Requirements of ISO 13485:2016 & ISO 9001:2015 Integrated Management System is a comprehensive 2-day training designed to provide participants with an in-depth understanding of the structure, requirements, and key differences of both standards. The course focuses on how organisations, particularly in the medical device industry, can effectively align and integrate ISO 13485:2016 (Medical Device Quality Management System) with ISO 9001:2015 (General Quality Management System).
Participants will gain practical insights into common and specific clauses, risk-based thinking, and process-based approaches that drive continuous improvement and regulatory compliance. The training also addresses critical aspects such as documentation, internal audits, and the preparation required for successful certification and ongoing compliance of integrated systems.
By the end of the course, attendees will be equipped with the knowledge and skills to conduct gap analysis, develop integrated management frameworks, and implement best practices tailored to their organisational needs. Ultimately ensuring alignment with both international standards and applicable regulatory requirements.
Participants will gain practical insights into common and specific clauses, risk-based thinking, and process-based approaches that drive continuous improvement and regulatory compliance. The training also addresses critical aspects such as documentation, internal audits, and the preparation required for successful certification and ongoing compliance of integrated systems.
By the end of the course, attendees will be equipped with the knowledge and skills to conduct gap analysis, develop integrated management frameworks, and implement best practices tailored to their organisational needs. Ultimately ensuring alignment with both international standards and applicable regulatory requirements.
Upon completion of this course, participants will be able to:
• Understand the purpose, structure, and key requirements of ISO 13485:2016 and ISO 9001:2015
• Identify common and unique clauses in both standards and understand how to align them for an integrated management system
• Apply risk-based thinking and process-based approaches across business operations and quality management systems
• Conduct effective gap analysis to identify areas for improvement and integration opportunities
• Develop practical strategies for implementing and maintaining an integrated management system
• Understand documentation and record-keeping requirements for compliance with both standard
• Understand the purpose, structure, and key requirements of ISO 13485:2016 and ISO 9001:2015
• Identify common and unique clauses in both standards and understand how to align them for an integrated management system
• Apply risk-based thinking and process-based approaches across business operations and quality management systems
• Conduct effective gap analysis to identify areas for improvement and integration opportunities
• Develop practical strategies for implementing and maintaining an integrated management system
• Understand documentation and record-keeping requirements for compliance with both standard
- Module 1: Overview and Key Requirements of ISO 13485:2016
- Module 2: Overview and Key Requirements of ISO 9001:2015
- Module 3: Understanding Common and Specific Clauses
- Module 4: Risk-Based Thinking and Process Approaches for Integrated Systems
- Module 5: Gap Analysis and Implementation Strategies
- Module 6: Documentation and Record-Keeping Practices
- Module 7: Audit and Monitoring Techniques for Integrated Systems
- Module 8: Preparing for Certification and Ongoing Compliance
This course is ideal for personnel across all departments who are:
- Involved in implementing or maintaining an Integrated Management System
- Responsible for auditing ISO 13485 and ISO 9001 management systems
- Part of a quality, regulatory, or supply chain role within medical device or manufacturing sectors
- Seeking to deepen their understanding of both standards to drive quality improvement and operational efficiency
This is a 1-day programme.
This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.
This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.
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