112 Newton House, Birchwood Park, Warrington, WA3 6FW
01925 377150

ISO 13485 Lead Auditor Course

The ISO 13485 Lead Auditor training course is suitable for those wishing to conduct internal and external audits to ISO 13485 and enables delegates to plan, lead and report audits within their own organisation.

The ISO 13485 Lead Auditor training course is suitable for those wishing to conduct internal and external audits to ISO 13485 and enables delegates to plan, lead and report audits within their own organisation. The course also allows delegates to audit their suppliers and third party organisations.

This 5-day ISO 13485 lead auditor training course will enable you to conduct effective audits in any auditing situation and follows a highly interactive format, with tutor-led sessions interspersed with individual and group exercises. A case study is used to practice auditing skills.

COURSE INFORMATION

Price

£1595 + VAT

Course Duration

5 Days

Course Dates and Venues

ISO 13485 Lead Auditor Course Content

The ISO 13485 lead auditor course consists of a mixture of presentations and group exercises.  Upon completion of the course you can expect to have gained a detailed understanding of the following areas:

  • The different types of audit
  • Setting objectives for your ISO 13485 audit
  • Audit scope and criteria
  • Audit responsibilities
  • Interviewing skills
  • Team leader skills
  • The audit process for ISO 13485

Who Should Attend?

The ISO 13485 lead auditor course is vital for any professional that is involved in implementing and/or auditing quality management systems for medical devices, or those leading a supplier quality assurance program. ISO 13485 specifically requires that staff are trained and that auditors are competent, this course satisfies this requirement.

Course Outcome

By the end of this ISO 13485 internal auditor course, delegates will be able to:

  • Plan, lead and report audits within your organisation or against third parties, measuring against the requirements of ISO 13485
  • Be able to explain the process model for quality management systems, referencing the Plan, Do, Check, Act cycle.
  • Create audit checklists and write follow up reports to improve the effectiveness of your organisations QMS.

What’s Included?

Comprehensive delegate folder and certificates. Public courses include lunch and refreshments throughout the day.

Related Courses

We Can Deliver This Course At Your Workplace

To find out how much this course would cost you to hold in-house simply complete the form below for a free, no obligation quote.