This two day intensive course is designed to provide the comprehensive training and skills necessary for participants to conduct an internal QMS audit, supplier or distributor audit, as required by ISO 13485, and/or the FDA’s Quality Systems Regulation’s (FDA/QSR), and/or Canadian requirements (CMDCAS). The principles of ISO 19011:2002, “Guidelines for Quality and/or Environmental Management Systems Auditing” and how they can be used to develop an effective internal audit program for medical device manufacturers are examined. The concepts of ISO14971 “Application of Risk Management to Medical Devices”, as linked to the auditing process, are also introduced in this course. Preparation for, and the effective management of audits by external authorities such as Notified Bodies or the FDA is also considered.

The course covers: an overview of the requirements of ISO 13485 and/or FDA/QSR and/or CMDCAS (depending upon your company’s particular needs); 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 practical and communication skills required to conduct a successful audit and to effectively follow-up audit findings. Practical examples, case studies and interactive role play using “simulated audits”, which can be directly implemented will therefore be used.

At the end of the two days, participants will be required to demonstrate that they have acquired the relevant know-how and skills by taking a short exam.

Course Objectives:

• To provide participants with the knowledge and practical skills needed to effectively perform a comprehensive internal quality systems audit that complies with ISO 13485 and other regulatory requirements
• To allow participants to effectively audit their companies suppliers and/or distributors
• To guide participants in the management of audits by external authorities
• To guide participants in the application of ISO 19011
• To refine and improve 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:

Experience of medical device manufacturing and knowledge of ISO 13485 are pre-requisites for this course. The course is suitable 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 and exam, a “certificate of attendance and successful completion”.

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