ISO 13485 : 2003 Medical Devices
Lead Auditor Training Course
Our innovative techniques boost confidence to conduct effective audits
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 internal 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.
Course Content
- Medical devices, quality and auditing terminology
- Structure & intent of the medical devices standard ISO 13485 :2003
- Types of audit
- Audit objectives
- Audit scope and criteria
- The audit process
- Roles and responsibilities of the internal auditor
- Auditing skills
- Planning, preparation and management of audits
- Verifying corrective action
- Processes, procedures, documents and records
- The opening meeting
- Checklist development
- Document review
- Conducting and leading on-site audit activities
- The closing meeting
- Reporting audit findings
- Audit responsibilities
- Interviewing skills
- Team leader skills
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 9001: 2008 auditing skills.
In-company training courses
This course is only available as 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
Associated courses
The following training courses are closely associated with this ISO 13485 internal auditor training course.
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