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Qserve Consultancy in conjunction with Qserve America has developed several internal auditing training courses. Qserve delivers these courses in English and Dutch at Qserve offices, external locations and on-site at your own organization, both in the Europe and the US. These courses can be concluded, if required with an examination and/or certificate. Qserve’s audit training consultants are a highly qualified team of certified Lead Auditors with a wealth of practical experience, thus guaranteeing your organization a high-quality audit training session.
Training plays an important role in developing competence in conducting audits, the “Practical Approach” stressed in Qserve’s audit training programs is essential to developing the ability and expertise to conduct efficient and effective audits. Using the principles of ISO 19011:2002, “Guidelines for Quality and/or Environmental Management Systems Auditing” the following standards and regulations are considered:
- ISO 13485:2003 Quality Management systems - Medical Devices-system requirements for regulatory purposes
- Quality Systems Regulations (QSR/FDA)
- CMDCAS (Canadian)
The training courses cover the auditing processes listed below:
- Internal Quality Management System (QMS) auditing
- Supplier auditing
- Distributor auditing
Course code AT1
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. [read more...]
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Course code AT2
This one-day course is intended to provide participants with the basic training and skills necessary for participants 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. [read more...]
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Course code AT3
Refresher course Internal Audit Training (half day)
This short course is designed as a “refresher course” for Internal Auditors who are already familiar with ISO 13485 and other regulatory requirements, but, who wish to improve on their expertise. It can therefore be customized to participants needs, for example, improving and refining internal auditor’s communication or reporting skills, etc. Please contact Qserve if you have identified an element in your internal auditing process which requires improvement so that we can discuss a training program customized to your specific requirements.
For more information on any of the above courses, please complete the info request form in the "Contact Us" section, quoting the course code.
