This programme is funded by Irish Medtech Skillnet
Irish Medtech Skillnet is co-funded by Skillnet Ireland and network companies. Skillnet Ireland is funded from the National Training Fund through the Department of Further and Higher Education, Research, Innovation and Science
Objectives
This CQI & IRCA Certified Blended ISO 13485:2016 Lead Auditor Course is ideal for anyone that wants to gain the knowledge and skills required to perform first, second and third-party audits of quality management systems against ISO 13485:2016, in accordance with ISO 19011:2018 and ISO/IEC 17021-1:2015
Content includes
Three learning objectives/outcomes:
At the end of this course, participants will be able to:
1. Explain the purpose of a quality management system, of quality management systems standards, of management system audit, of third-party certification and the business benefits of improved performance of the quality management system
2. Explain the role and responsibilities of an auditor to plan, conduct, report and follow-up a quality management system audit in accordance with ISO 19011, and ISO/IEC 17021, as applicable
3. Plan, conduct, report and follow-up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485 and in accordance with ISO 19011, and ISO/IEC 17021, as applicable
Delivery
This is a blended learning program, consisting of:
16 hrs of online & self-paced modules (= 2 days training)
4 hr virtual course introduction one week before virtual workshops (9am - 1pm)
3 virtual classroom days (Practical Workshops)
Exam at the end of day 3 (via eAssessment)
Entry Criteria (Prior Learning Requirements)
In registering for this course, each Learner must have the following prior knowledge before completing this course:
Management Systems
• The Plan, Do, Check, Act (PDCA) Cycle
• The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review and continual improvement.
ISO 13485
• Knowledge of the requirements of ISO 13485 and the commonly used quality management terms and definitions
• Knowledge of the requirements is a key pre-requisite in attending this course as without a good understanding, the course may be very challenging.
If any Learner does not meet the above entry criteria, successful completion of Comply Guru’s Online ISO 13485:2016 Foundation Course will ensure that they meet the above prior learning requirements.
FREE Foundation Course Included
Every participant will receive a complimentary license to Comply Guru’s CQI & IRCA Certified Online ISO 13485:2016 Foundation Course (8hrs). This course is recommended for everyone, both new & experienced Quality Professionals. For any Learners who declare that they fully meet the entry criteria, this course is not mandatory to complete but it is still recommended. A separate CQI & IRCA recognised certificate will be issued upon successful completion.
Qualification
Successful completion of this course will entitle each Participant to a CQI & IRCA Recognised ISO 13485:2016 Lead Auditor Certificate of Achievement.
Course accreditation held by Comply Guru (Course No. 2244)
Dates
12, 16, 17, 18 Feb 2021 [16 hours online & self paced (= 2 days)] [4 hr introduction is 12 Feb. 9am-1pm] [3 virtual classroom days 16, 17, 18 Feb] (The self paced 16 hrs need to be completed before the intro on 12 Feb)