ISO 13485 : 2003 Medical Devices Lead Auditor Training Course

Title:	ISO 13485 Auditor/Lead Auditor Training
Category:	Medical Devices
Duration:	5 days
Location:	Various venues , see course dates below
Course fee:	From £975

The Batalas ISO 13485 Lead Auditor training course is suitable for those wishing to conduct internal and external audits to ISO 13485.

Course objectives

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. This course meets the training requirements for registration to IRCA as a Lead Auditor.

What will you learn?

	Medical devices, quality and auditing terminology		Processes, procedures, documents and records
	Structure & intent of the medical devices standard ISO 13485 :2003		The opening meeting
	Types of audit		Checklist development
	Audit objectives		Document review
	Audit scope and criteria		Conducting and leading on-site audit activities
	The audit process		The closing meeting
	Roles and responsibilities of the internal auditor		Reporting audit findings
	Auditing skills		Audit responsibilities
	Planning, preparation and management of audits		Interviewing skills
	Verifying corrective action		Team leader skills

ISO 13485 Public Lead Auditor Course Schedule - 2012
Course	Venue	Price	May	Jun	Jul	Aug
Lead Auditor (5 days)	Birmingham	£975	-	25-29	-	-
	Can't see a date that fits your diary - please call 023 8000 9001 for details

Aims of the Lead Auditor Course

Delegates completing the Batalas ISO 13485 Lead Auditor training course will be able to audit their management system (MS) for conformity to ISO 13485; the effectiveness of their business processes, and to identify opportunities for improvement. Improving MS performance and continual improvement are key elements of this ISO 13485 Lead Auditor training course.

Enhancing Supplier Performance

The skills developed will enable you to improve supplier performance which in turn will assist your own organisation’s improvement efforts.

Become a Certification Body Auditor

For those who wish to become certification body auditors this ISO 13845 course satisfies the training requirements for being an IRCA registered Lead Auditor.

Course Format

The format of the ISO 13485 Lead Auditor course utilises accelerated learning techniques and is therefore highly interactive, with tutor-led sessions interspersed with individual and group exercises. A realistic case study and role-play activities provide an excellent opportunity to practice ISO 13485 auditing skills.

Certificate

A Batalas approved certificate for those who successfully complete all elements of the course, including written and practical skills assessment.

Attendance on this quality management training course will provide delegates with 40 CPD points/hours.

Why Batalas?

For over 50 years we continue to provide innovative and cost-effective training and consultancy solutions to organisations from every sector of the economy, both in the UK and through Batalas partners in 11 countries. The Batalas clients' list includes multi-national companies and organisations employing less than 20 people.

In-company training courses

This course is available as a Public Scheduled course (see dates above) or an in-company event. ISO 13485 medical devices training courses can be tailored to your own requirements. Our training advisors can provide more details on the options available to your organisation.

More information

• An ISO 13485 lead auditing training course description in pdf format
• Make an enquiry for more information
• Read articles relating to management systems and auditing

Associated courses

The following training courses are closely associated with this ISO 13485 lead auditor training course.

• Supplier Auditing - Evaluating and re-evaluating supplier performance
• ISO 9001:2008 Internal Auditing - For those conducting internal audits only to ISO 9001:2008
• ISO 9001:2008 Lead Auditor - For audit team leaders and external auditors
• ISO 9001 Advanced Auditor - Auditing to improve the automotive quality management system