Quality Assurance Employee Excels in ISO Auditor Course

Paul Bickmore, Quality Assurance Coordinator – Medical Devices, at Parafix has recently passed the BSI ISO 13485:2016 Lead Auditor Training Course with an impressive grade of 95% in his final exam. Paul was also acknowledged as a “very strong candidate” overall for his written assignments and communication skills.

The course is highly credible within the Medical devices industry; Paul’s fellow trainees included auditors from UL (Underwriters Laboratories) the SFDA (Saudi FDA) and QA/Regulatory professionals from various ‘Legal Manufacturers’ around the world.

The purpose of the course is to enhance the skills, abilities and practices of managing the entire audit process for 1st, 2nd and 3rd party audits of Quality Management Systems against 13485:2016, whilst maintaining the six principles of auditing:

• Integrity: the foundation of professionalism
• Fair presentation: the obligation to report truthfully and accurately
• Due professional care: the application of diligence and judgement in auditing
• Confidentiality: security of information
• Independence: the basis for the impartiality of the audit and objectivity of the audit conclusions
• Evidence-based approach: the rational method for reaching reliable and reproducible audit conclusions in a systematic audit process

Paul’s qualification will ensure high standards of internal auditing and will potentially identify opportunities for improvement. This is critical as we see continued growth in our healthcare business and will be invaluable whilst we prepare for our transition of the ISO 13485 Medical Devices Quality Standard to 2016. It also offers reassurance to our customers and suppliers of our commitment to Medical Devices best practice.

Paul commented: “I’m very pleased to have successfully passed this course and appreciate the opportunity to broaden my skill set, both personally and professionally. The course was purposefully conducted to put trainees under pressure and it certainly achieved this. It was challenging and tough, but immensely enjoyable”.

Mike Punter, Managing Director at Parafix commented: “We are incredibly proud when an employee achieves successes such as this. Paul is a dedicated and valued member of our Quality Assurance Department; his achievement demonstrates both his aptitude and his dedication to total quality”.