What Is ISO 13485:2016?
Developed by the International Organisation for Standardisation, ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Organisations need to implement a robust QMS that meets ISO specifications, with processes audited to qualify for certification.
Who Should Take an ISO 13485:2016 Course?
This training programme is specifically designed for delegates whose role requires an understanding of ISO 13485:2016 in order to evaluate and assess the impact that a QMS has on their organisation. It is also a great introduction to Quality Assurance for those who are looking to gain an understanding of QMS and the processes involved, as well as those currently undertaking or who are about to implement a transition from the 2013 version of ISO 13485.
Course Aims and Outcomes
By completing our full-day ISO 13485:2016 training course, you’ll be able to:
- Understand the key purposes and benefits of an ISO 13485:2016 Quality Management System (QMS)
- Find the best way to develop the QMS of their own organisation using a ‘risk-based thinking’ approach.
- Understand interactions between purchasing, design, development, manufacturing and production control activities within a QMS.
ISO 13485 Awareness Training Duration
Our ISO 13485 training course duration is a full day, with time for lunch, breaks and a Q&A session.
ISO 13485 Awareness Training Content
1. Introduction
Discover the origins and definition of the ISO 13485:2016 standard and how your organisation can use it.
2. Benefits
Learn the benefits of ISO 13485 certification and how these are achieved via a QMS within your organisation, such as qualifying as a preferred contractor, access to ISO-specific tenders and improving workforce engagement across your business.
3. Implementation
Learn what’s involved in implementing ISO 13485:2016, including:
- Risk-based thinking – understand the rigour and degree of formality required for certification.
- Processes – understand business inputs, roles, resources and criteria such as methods and controls.
- The Plan Do Check Act process – discover how the ISO structure aligns to Plan Do Check Act processes.
- Management principles – guidance on customer focus, leadership, evidence-based decision-making and continual improvement.
4. Structure
Understand a high-level QMS structure of ISO 13485:2016, encompassing planning, support, operation, performance evaluation and improvement, including sub Clauses. The importance, purpose and benefits of applying ISO 13485:2016 to a management system.
5. Organisational context and tools
How to use tools such as PESTLE analysis, process approaches and guidance on risk, along with nonconformities, corrective actions and continual improvement to support ISO 13485 certification.
How the Course Is Delivered
Our full-day ISO 13485 training course is a classroom-style, online learning approach led by industry experts. Our instructors offer real-world training based on their experience as ISO certification and audit experts. You’ll gain valuable insights into the standard and how it applies to your organisation.
Our training is delivered via remote sessions using technologies such as Microsoft Teams. Sessions are fully interactive, and participants are encouraged to actively join in with questions and discussions to get the best from the training session.
We offer a wide range of courses, from CQI and IRCA QMS Lead-Auditor courses, and we can support your certification process with bespoke in-house training also available. Ask your contact for more details.
