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CQI/IRCA-Certified QMS Lead Auditor Based on ISO 13485:2016 and MDSAP Requirements

Dates

Times

5 days

Location

Virtual Learning

Availability

Dates

Times

5 days

Location

Virtual Learning

Availability

Dates

Times

5 days

Location

Virtual Learning

Availability

Learners will plan, conduct, report and follow up on a QMS audit in accordance with ISO 13485:2016, MDSAP and EU MDR requirements. Learn how to apply the MDSAP audit approach adopted by Auditing Organizations in the MDSAP program, to identify and grade nonconformities and to prepare an audit report in accordance with MDSAP criteria.

This CQI and IRCA medical device lead auditor certified course is currently certified to include ISO 13485:2016 and MDSAP requirements.

About This Course

This ​​course ​provides ​learners with the ​skills ​and ​knowledge ​that ​have ​taken ​many ​experienced ​auditors ​decades ​to ​develop. ​During ​the ​course, ​learners ​will ​plan ​and ​prepare ​audits ​based ​on ​case ​studies ​that ​simulate ​both ​supplier ​and ​third-party ​audits ​utilizing ​the ​MDSAP ​audit ​requirements. ​Learners ​will ​participate ​in ​simulated ​auditing ​exercises ​that ​include ​planning, ​preparing ​and ​evaluating ​audit ​evidence. ​Learners ​will ​also ​practice ​the ​application ​of ​ISO ​13485:2016 ​and ​the ​MDSAP ​requirements.

The course consists of five days of interactive instruction and auditing sessions followed by a comprehensive written examination on day six. Learners will have two hours to complete the exam, which is provided and proctored in a virtual format (additional time will be added for learners who speak English as a second language and are taking the exam in English, and learners with disabilities). Our course requires highly interactive work and ongoing instructor assessment throughout the week.

Key Learning Objectives

By the end of this training, learners will be able to:

  • Describe the purpose of:
    • Quality management system
    • Quality system standards
    • Management system audit
    • Third-party certification
  • Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011
  • Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485

This course represents one vital step required to become a certified CQI/IRCA Lead Auditor. Find out more

Prior Knowledge and Experience Requirements:

In order to sit the course, learners are required to demonstrate they fulfil the prior knowledge requirements, which includes knowledge of quality management principles and concepts, and the requirements of ISO 13485:2016.

  • Knowledge of the requirements of ISO 13485 (which may be gained by completing a CQI and IRCA Certified MD-QMS ISO 13485:2016 Foundation (FD132) course or equivalent)
  • Knowledge of the following quality management principles and concepts:
    • The Plan, Do, Check, Act (PDCA) cycle.
    • The relationship between quality management and customer satisfaction.
    • Commonly used quality management terms and definitions within ISO 13485 and ISO 9000 (including 7 quality management principles, see ISO 9000)
    • The process approach used in quality management.
    • The Model of a Process Based Quality Management System, the structure and content of ISO 9001.
  • Knowledge of at least 1 of the MDSAP country-based regulations, or similar e.g. WHO PQ requirements, EU MDR or EU IVDR etc.
  • Medical device/IVD auditing background.

Learners will receive a pre-course questionnaire via email to share prior knowledge and experience, which must be completed and returned prior to the course date.

**Learners may be tested on the above prior knowledge as part of the course examination

Who Should Attend

This class is helpful for all personnel involved in preparing, conducting, managing, participating in, or otherwise facilitating internal, supplier, or regulatory audits and their outcomes, as well as executive personnel with responsibility for the design and implementation of any aspect of a quality management system.

NSF (Health Sciences, Medical Devices) is an Approved Training Partner (ATP) of CQI and IRCA Certified Training.

Tutors

Course tutors can include:

Robert Ruff - Robert Ruff has over 35 years of experience in the medical device and public health sectors, including working in orthopaedic implant manufacturing and completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes leading the development of the Medical Device Single Audit Program as well as co-authoring the MDSAP Audit Approach and the Quality System Inspection Technique (QSIT). Since 2017, Rob has conducted audits relative to a variety of criteria for NSF. He is also responsible for NSF training on medical device manufacturing topics. In this role, Rob has developed courses on a range of subjects, including auditing against the EU MDR and EU IVDR, risk management, FDA inspection readiness, design controls, and more.

James Pink - James Pink has over 20 years of experience in the medical devices industry including 10 years as a health care technology expert and lead auditor for a leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assurance programs for active and non-active implantable and combination products. Mr. Pink is a contributor to several medical device standards committees including ISO 13485, ISO 14971 and various product-related standards.

Janet Book - Janet Book has worked in the field of quality for the past 35 years in a wide variety of industries, including blood banking, food processing, quality consulting, chemical, pharmaceuticals and medical devices. She has conducted internal and supplier audits utilizing many different industry-specific standards, due diligence evaluations as well as capability assessments. She has been involved with writing quality procedures; developing supplier, internal and corporate audit programs; developing quality management systems; and developing and presenting quality-related training and seminars. Janet is a certified Six Sigma Black Belt and served as an adjunct professor at Carnegie Mellon University. Recently, she earned her Certificate in Privacy Law and Cyber Security and worked in privacy providing guidance on quality, regulatory and compliance functions. She is a senior member of the American Society for Quality (ASQ), an ASQ Certified Quality Auditor (CQA), an ASQ Certified Quality Engineer (CQE), an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) and an RABQSA Quality Systems Lead Auditor.

Christine Brown - Christine has over 30 years of experience working with regulated medical device, combination products, and pharmaceutical manufacturers and FDA class I, II and class III devices. Her areas of expertise include Post Market Quality, CAPA), Quality Systems, Quality Management, Product Development, Production and Process Control, and External Agency Inspections (FDA-483, warning letter, and consent decree situations). She has been an expert witness and participant in the FDA 510(k) premarket applications under the FDA Accredited Person Program for medical devices, as a third party-reviewer.

Christine holds a Bachelor of Science in Biomedical Engineering along with certifications as a Certified Software Quality Engineer, Certified Reliability Engineer, and Certified Quality Auditor from the American Society for Quality in addition to being a certified Quality Systems Lead Auditor for ISO13485:2016 and MDSAP.

  • Excellent skilled, experienced trainers who knew what to deliver and how to deliver it. I am very much impressed with the tutors. Not just great tutors, but also great mentors and most likeable personalities. Just sorry that we could not meet in person and share experiences over a drink.
    Sjoerd Boomsma
    BD
  • The instructor’s ability made what could be a dry topic an engaging and enlightening discussion that has certainly made me reassess my skills as an auditor.
    Anonymous
  • The instructors were amazing, I feel privileged to have been trained by such experienced instructors.
    Colette Bazard
    BD

Additional Recommended Courses

CQI & IRCA-certified QMS Lead Auditor based on ISO 13485:2016 and MDSAP Requirements

This virtual instructor-led CQI/IRCA accredited course provides learners with the skills and knowledge that have taken many ​experienced ​auditors ​decades ​to ​develop. This course is fundamental to achieving CQI/IRCA Lead Auditor status. ​During ​the ​course, ​learners ​will ​plan, perform, ​and ​report ​audits ​based ​on ​case ​studies ​that ​simulate ​internal, ​supplier, ​and ​third-party ​audits ​utilizing ​MDSAP ​audit criteria. ​Learners ​will ​participate ​in ​simulated ​auditing ​exercises ​that ​include ​planning and performing audit activities, ​evaluating ​audit ​evidence, and documenting audit findings.

The course consists of five days of interactive instruction and auditing sessions followed by a comprehensive written examination on day six. Learners will have two hours to complete the exam, which is provided and proctored in a virtual format (additional time will be added for non-native English-speaking learners, and learners with disabilities).

Learners should enter the QMS Lead Auditor course with a basic understanding of ISO 13485:2016. Mandatory prerequisite reading and a prerequisite competency assessment will be provided upon enrollment. These prerequisites must be completed in advance of the course start date.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

This class is helpful for all personnel involved in preparing, conducting, managing, participating in, or otherwise facilitating internal, supplier, or regulatory audits and their outcomes, as well as executive personnel with responsibility for the design and implementation of any aspect of a quality management system.

By the end of this course you should be able to:

· Describe the purpose of:

  • Quality management systems
  • Quality management system standards
  • Management system audits
  • Third-party certification

· Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011:2018

· Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485:2016 and MDSAP participating country-specific requirements.

Price: $2800.00

EU IVDR Internal Auditor

This virtual instructor-led two-day course provides guidance on how to prepare for, plan, and conduct an internal or supplier audit based on the EU IVDR. This course also focuses on ISO 13485:2016 relative to its correspondence with the EU IVDR.

This course provides practical instruction for auditors and managers performing, facilitating, or managing internal and supplier audits against criteria contained within the European Union In Vitro Diagnostic Regulation (EU IVDR).  The instructor will review the regulation in depth from the auditor’s perspective and provide practical instruction for preparing for, planning and conducting EU IVDR audits according to NSF’s formal, documented EU IVDR Audit Model.

This course includes a two-hour eLearning prerequisite module, EU IVDR – A Comprehensive Overview, to be completed prior to the start of the live instruction. The self-paced eLearning covers every aspect of the regulation and identifies key pre- and post-market requirements associated with EU IVDR – standard regulatory requirements that must be met by all In Vitro Diagnostic manufacturers wishing to do business in the EU regardless of IVD classification.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Identify Key Articles and Annexes of the EU IVDR
  • Recognize Intent of Requirements as Described in Recitals
  • Identify Classification Implementing and Classification Rules
  • Identify General Safety and Performance Requirements (GSPRs)
  • Recognize Content of Technical Documentation
  • Identify Post-Market Surveillance Reporting and Vigilance Obligations
  • Recognize one EU IVDR Audit Model
  • Plan an EU IVDR Audit
  • Document Nonconformities against EU IVDR requirements

Who should attend:

This course is helpful for experienced internal auditors seeking to expand their auditing knowledge of the EU IVDR, for managers of audit programs, and for anyone who will be the subject of or participate in an EU IVDR audit. Delegates should have some internal audit experience and ideally have certified auditor/lead auditor qualifications in QMS audits.

Price: $1200.00

Medical Device Single Audit Program (MDSAP)

This virtual instructor-led one-day course covers the rationale for developing the Medical Device Single Audit Program (MDSAP), who the participating regulatory authorities are, and the specific audit criteria (including country-specific requirements) used during MDSAP audits.

This course discusses, in depth, the audit approach used by recognized MDSAP auditing organizations (AOs) as well as the MDSAP nonconformity grading system. Learners will also identify what MDSAP audit findings may trigger action from a participating regulatory authority.

This course pairs well as a prerequisite to MDSAP Internal Auditor Training (2 day).

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Discuss the Medical Device Single Audit Program (MDSAP)
  • Evaluate the MDSAP Quality Management System (QMS) audit nonconformity grading system and recognize grades that may trigger regulatory follow-up
  • Identify the IMDRF MDSAP requirements and documents in use
  • Explain the MDSAP Audit Approach


Price: $800.00