What is a ISO 13485 Lead Auditor?
The Batalas ISO 13485 Lead Auditor training course is suitable for those wishing to conduct internal and external audits to ISO 13485.
This 5-day ISO 13485 Lead Auditor training course enables delegates to plan, lead and report audits within their own organisation, their suppliers and with third party organisations. Our ISO 13485 lead auditor training course will enable you to conduct effective audits in any auditing situation.
The format of the ISO 13485 lead auditing training course is highly interactive, with tutor-led sessions interspersed with individual and group exercises. An case study is used to practice auditing skills.
Who should attend?
This 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 13485Â specifically requires that staff are trained and that auditors are competent, this course satisfies this requirement.
What will you learn?
A detailed understanding of:
- Types of audit
- Audit objectives
- Audit scope and criteria
- Audit responsibilities
- Interviewing skills
- Team leader skills
- The audit process
- Preparation and planning
- The opening meeting
- Checklist development
- Document review
- Conducting and leading on-site audit activities
- The closing meeting
- Reporting audit findings
£1795 + vat
Monday to Thursday 08:45 to 18:45, Friday 08:45 to 13:00
Includes full delegate manual, lunch, refreshments & certificate
In-house courses from £975 per person
IRCA course ref 1746
Important – Course Requirement
To attend this course you must have prior knowledge of ISO 13485
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Our classroom courses run at training venues across the UK.
Our virtual courses are taught live by an expert tutor via Zoom. You can interact with other delegates and ask questions, just as you would in a traditional classroom.
We offer a ‘BOOK-NOW-PAY-LATER’ policy which allows you to secure a no obligation place on the course whilst seeking approval from within your company (t&c’s apply) – please email sales@batalas.com for more information.
If you require in-house training for 4-10 people, we can come to your premises and teach your team which can be a more cost-effective training option – please email sales@batalas.com for a quote.
Course | wdt_ID | Start Date | End Date | Book | Location | Location - filter | Price (+VAT) |
---|---|---|---|---|---|---|---|
9001F | 56 | Online Self-Paced | Online Self-Paced | £325 | |||
14001C | 519 | 16 Apr 2024 | 18 Apr 2024 | Marriott - Portsmouth | Portsmouth | £1095 | |
14001C | 520 | 16 Apr 2024 | 18 Apr 2024 | Virtual Classroom - Live Tutor | Virtual | £1095 | |
14001F | 521 | 15 Apr 2024 | 15 Apr 2024 | Virtual Classroom - Live Tutor | Virtual | £445 | |
27001C | 523 | 22 Apr 2024 | 24 Apr 2024 | Virtual Classroom - Live Tutor | Virtual | £1095 | |
45001C | 533 | 08 May 2024 | 10 May 2024 | Marriott - Portsmouth | Portsmouth | £1095 | |
45001C | 534 | 08 May 2024 | 10 May 2024 | Virtual Classroom - Live Tutor | Virtual | £1095 | |
45001F | 536 | 07 May 2024 | 07 May 2024 | Virtual Classroom - Live Tutor | Virtual | £445 | |
ASF | 538 | 29 Apr 2024 | 29 Apr 2024 | Virtual Classroom - Live Tutor | Virtual | £445 | |
ASIA | 541 | 30 Apr 2024 | 01 May 2024 | Marriott - Portsmouth | Portsmouth | £945 |
Don’t take our word for it
He was a fantastic engaging trainer, interactive and challenging ways of thought and approach in audit situations. He approached everyone fairly and equally and always actively listened and responded to queries.
When I called to book my place on the course, the 2 ladies I spoke with were very friendly and a pleasure to deal with. Prior to the course, it was nice that Batalas called to confirm I had everything I needed and was ready.
I just want to say that the course was well constructed given that it was virtual training, and I did enjoy participating in the course. Please convey my thanks to the tutor for his support and for being a good trainer … his method of training made us all feel at ease and comfortable in assimilating the course material. I will certainly be recommending your course to my colleagues.
Trainer answered all questions posed and provided excellent understanding using scenario based answers, and used personal experience.
Great service from Batalas, very supportive admin support with pre-course. Great course well pace from an expert instructor.
Superb. A very experienced trainer who made learning fun and engaging who really cared about everyone on the course and did his best to help.
The contact persons at Batalas were very helpful in answering our queries and in the pre-course preparation. The trainer was very engaging and the teaching method was very effective.
Tutor was brilliant in how he worked the room. Thoroughly enjoyed the course. It was very intense but I was starting at complete novice level. I feel I improved massively by the end of the course.
We had an excellent trainer, animated, focus and his delivery methods were perfect. I loved the way he made the training so varied, with lots of opportunities to interact. Second to none. Highly recommendable.
Thoroughly informative and appropriately intimate sessions, overall a very enjoyable experience
Richard Lloyd tells us about this experience on the ISO 13485:2016 Lead Auditor Course (video above)
Read written client testimonials here >
Some recent clients
Have you seen our fantastic Course Bundles?
Enjoy a discounted price when you book any of the below course bundles. This offer applies to public courses on ANY date** at ANY venue listed on the website.
Our course bundles also include our ‘Book now pay later’ guarantee*
Please email training@batalas.com or call 0333 700 9001 to book your Course Bundle!
**Course dates must be consecutive. *t&c’s apply
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