Need of ISO 13485:2016 (MD-QMS) Lead Auditor Training

  • The Plan, Do, Check, Act (PDCA) cycle.
  • The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.
  • Commonly used quality management terms and definitions within ISO 13485 and ISO 9000.
  • A working knowledge of risk management principles related to the design of a medical device, for example ISO 14971.

Guidance and Deliberation are the final stages of knowledge

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The Advantages of ISO 13485:2016 (MDQMS) Lead Auditor Training

Auditing in accordance with ISO 13485:2016 requirements. Knowledge of the requirements of ISO 13485:2016, which will be gained by completing an IRCA certified MDQMS Training course :

  • Audit an MDQMS as per the requirements of the ISO 13485:2016 Standard.
  • Understand key elements of the ISO 19011 and ISO/IEC 17021 Standards and their application.
  • Successfully execute a Medical Devices Quality Management System audit.
  • nowledge of management systems audit through satisfactory completion of a CQI and IRCA Certified Lead Auditor Training course (or acceptable alternative) in another discipline.

Why Choose US ?

BSCIC is established as Training Organization and an independent Conformity Assessment Body with its main objective to provide its Lead Auditor Training & ISO Certification services in the domains of Quality Management System, Environmental Management System, Occupational Health & Safety Management System, Food Safety Management System, HACCP, Information Security Management System, Business Continuity Management System, Information Technology- Service Management System, Medical Devices-Quality Management System, GMP-Cosmetic Products, Energy Management System and Risk Management. BSCIC is established as a professional organization backed by devoted, highly qualified and experienced Assessment, Training and Certification personnel and offering a wide spectrum of normative/ customer-oriented Certification and Training services in an efficient and cost effective manner etc.

18072+

No. of Satisfied Delegates

17

Years of Experience

37

Countries

1750+

Complete Batches

BENEFITS

Benefits of ISO 13485:2016 (MD-QMS) Lead Auditor Training

  • Global Recognition
  • Gain Acknowledgment with a CQI-IRCA accreditated Training, opening doors to opportunities.
  • Career
    Advancement
  • Propel your Career forward by becoming a Certified leader in Medical Devices Quality Management System.
  • Auditing Excellence
  • Hone your Auditing process, ensure effective and meticulous assessment aligned with ISO 13485:2016.
  • Regulatory Compliance
  • Ensure compliance with evolving regulations,safeguarding organizations against legal and Operational tasks .

TESTIMONIALS

Need to know more ?

+971 54 530 8270
sunit.gill@bsc-icc.co

This course provides delegates with fundamental knowledge of assessment skills that will add value to organizations. This course complies with IRCA -2245 criteria. Successful completion of the course fulfils the formal training requirement for individuals seeking Third Party Assessments.

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