ISO 13485:2016 Lead Auditor Course
This is a CQI IRCA Professional level course, providing a globally recognised qualification for those with a deep knowledge of medical device quality management and audits of medical device quality management systems (MD-QMS) designed to meet the requirements of ISO 13485:2016.
To celebrate the launch of our new website we are offering this course at a discounted price of £1,300 compared to our normal cost £2,195! This is a limited time offer and is available for any course on our current programme.
£1,300.00 +VAT per delegate
Course Details
£1,300.00 +VAT per delegate
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What will I learn?
This training course will cover the following topics:
- Skills to ensure you get maximum benefits from medical device quality system audits
- The purpose of a Medical Device Quality Management Systems
- Steps to become a value-added quality auditor
- Steps you should follow to plan, prepare, perform & lead effective MD-QMS audits
- How to perform effective quality audits by knowing the right questions to ask
- To become a process-based auditor & why this is important for ISO 13485 systems
- How to plan for and make sampling plans
- How to write a nonconformity to deliver effective corrective action every time
- How to ‘calibrate’ your audit technique and nonconformities with your approved body
- The skills required to lead an audit team
- Key system elements such as: links to ISO 9001, risk management, validation, & post-market surveillance
This 5-day course is for anyone who wishes to lead and conduct effective medical device quality management system audits to the requirements of certification bodies or to that level, where specifically applied to ISO 13485.
The IRCA Pre Knowledge requirements for delegates to attend are successfully met through successful completion of a IRCA Registered ISO 13485:2016 Foundation Course or IRCA Registered ISO 913485:2016 Internal Audit Course.
Lead Auditor status is ‘must have’ for individuals who have completed Foundation or Internal Auditor courses and are practising at a mid to senior level.
Developing advanced expertise to lead and manage quality and audit functions, preparing delegates for certification body audit positions, supply chain audit roles, leadership or senior quality management positions
This course, combined with an ISO 13485 Foundation course, satisfies the formal training requirements for those wishing to register with CQI and IRCA as a Medical Device Quality Management System Lead Auditor (Separate fees apply).
Our experienced trainers will assist in the interpretation of ISO 13485:2016, sharing their knowledge and experience, combining both audit skills and an appreciation of the standard’s requirements and the likely evidence available to you as an auditor. The ability to plan for and to conduct an audit are key. Gaining this ability will support your audits time after time allowing you to benefit from a defined framework, structured to consistently allow you to undertake effective internal audits. A real ‘how to’ guide for the audit of management systems at an advanced level.
We are proud to be an IRCA approved training partner and this course is CQI and IRCA certified (2473). Our company and our trainers undergo intensive inspection and assessment every year with the International Register of Certificated Auditors (IRCA). This means that the qualifications obtained from completion of this course are valid and will be recognised by your customers and certification body.
BSI Standards
A copy of ISO 13485:2016 will be available to you for the duration of your training – you now have the opportunity to obtain your own copy of the standard for use during and after the course.
QCS International are an authorised BSI Distributor of publications and can make available to purchase a full, licenced copy of the standard.
On the launch of the new QCS website we are excited to offer special discounts on all our training. This ISO 13485 Auditor / Lead Auditor course will be available for £1,300, compared to our normal cost of £2,195! This is available for a limited time and has been applied to all courses on our current programme.
Take advantage of this offer before it’s removed.
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