ISO 13485 MD QMS Foundation Self-Study Training Course (PECB)

The objective of each Course is to provide students with the knowledge and skills required to perform an internal audit of part of a quality management system based on ISO 9001 (or equivalent) and report on the effective implementation and maintenance of the management system in accordance with ISO 19011 and to contribute to the continual improvement of the management system.The Course refers to ISO 9001:2015 as the management system standard that provides the context for internal audit

This course is useful and designed as an introduction for anyone involved in the food industry. It is to cater for all levels in the organisation, from Senior Management and Business Owners or Supervisors to shop-floor food handlers. It is particularly beneficial for those who have a role in the maintenance of a HACCP Plan, but do not need technical detail to carry out their responsibilities, nor involvement in the development of food safety programmes Furthermore, this course provides a general introduction to the 7 principles of the HACCP system.

ISO/IEC 17025 Lead Implementer training enables you to develop the necessary expertise to support laboratories to meet the requirements of the standard by implementing a quality control system based on ISO/IEC 17025. During this training course, you will also gain a thorough understanding of the best practices of an LMS in testing and calibration laboratories in order to produce reliable measurement results and open your laboratory`s doors for accreditation and international recognition.After mastering all the necessary concepts of Laboratory Management Systems, you can sit for the exam and apply for a “PECB Certified ISO/IEC 17025 Lead Implementer” credential. By holding a PECB Lead Implementer Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO/IEC 17025 in your laboratory.CertificationAfter successfully passing the exam, you can apply for one of the following credentials shown. You will receive a certificate once you comply with all the requirements related to the selected credential. PECB Certified ISO/IEC 17025 Provisional ImplementerPECB Certified ISO/IEC 17025 ImplementerPECB Certified ISO/IEC 17025 Lead ImplementerPECB Certified ISO/IEC 17025 Senior Lead ImplementerEnrolment informationBy enrolling on this course you agree to your personal information being passed to PECB.Learners enrolling onto this course will receive an email from PECB to set up your Learner Account, course registration, access to the course materials and final exam.If you have not received this information within 5 working days please contact Global.PECB.Training@sgs.comGeneral informationPECB will provide over 450 pages of instructional materials containing explanations, guidance, and practical examples. Learners may reach out to PECB to request the Attestation of Course Completion as proof of taking the course, this can be requested before taking the exam or after and is worth 16 CPD (Continuing Professional Development) credits.In case of exam failure, the candidate can retake the exam once for free within 12 months following the initial exam date.PrerequisitesIn order to fully benefit from this training course, participants should have a comprehensive knowledge of ISO/IEC 17025 and comprehensive knowledge of implementation principles.The fee for this course covers:Course Materials (for lifetime, please note that updated course materials are not included)First ExamOne resit exam (if required)PECB Certification FeeFirst Year PECB Annual Maintenance Fee (AMF)