Internal Audit Training (1 day)

This one-day course is intended to provide participants with the basic training and skills necessary to conduct an internal QMS audit, supplier or distributor audit, as required by ISO 13485 and Canadian requirements (CMDCAS). The course covers: an overview of the requirements of ISO 13485 and CMDCAS; audit principles and objectives; audit techniques and skills; planning and development of an effective audit program including “checklists” and documentation reviews; auditing process effectiveness and compliance; “best practice” for recording and documenting audit findings; successful communication of audit findings; evaluation of audit findings, effective implementation of CAPA’s resulting from audits; and the use of the internal audit processes as a direct input for the management review process, showing the implementation of an effective and suitable quality management system.

The emphasis in this course is on developing the basic skills required to conduct a successful audit and to effectively follow-up audit findings. Practical examples and case studies will be used to demonstrate auditing techniques.

Course Objectives:

• To provide participants with the basic knowledge and practical skills needed to effectively perform an internal quality systems audit that complies with ISO 13485
• To allow participants to effectively audit their companies suppliers and/or distributors
• To develop participants communication, evaluation, and reporting skills
• To progress participants abilities in implementing CAPA programs
• To integrate the internal audit process as a management tool

Who should attend:

Some knowledge of ISO 9001 or ISO 13485 is required. The course is intended for:

• (Internal) Auditors
• Quality Managers
• RA Managers
• Management Representatives
• Product, Project Managers

Course Materials:

Participants will receive a comprehensive course manual with reference materials, and, upon successful completion of the course a certificate of attendance.

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