Writing Effective Nonconformity Statements During a Medical Device QMS Audit

NSF International, Health Sciences
Course summary
Professional Training
1 day
600 USD excl. VAT
Full time
Professional Training
Course Dates
Online courses
600 USD

Online courses
600 USD

Online courses
600 USD

Online courses
600 USD

Course description

Writing Effective Nonconformity Statements During a Medical Device QMS Audit

This one-day course will introduce you to the importance of writing effective nonconformity statements during medical device manufacturer quality management systems audits.

Learners will identify the fundamentals of medical device QMS auditing that influence the writing of effective nonconformity statements. Learners will recognize when to communicate nonconformities during an audit and identify tools and tips for writing effective nonconformity statements. Learners will also demonstrate how to assess nonconformity statements to confirm they are free from opinion and bias.

In addition, learners will apply the knowledge gained during the course through the practical application of the concepts presented. Working in groups, learners will review multiple nonconformity scenarios, develop nonconformity statements relative to the scenarios and participate in instructor-led analysis of the nonconformity statements.

Suitability - Who should attend?

This course is vital for anyone who conducts or manages internal, supplier or third-party audits within the medical device manufacturing space. The tools and tips shared in this training will help ensure that the auditee organization clearly understands the nonconformities, so that they can identify and implement effective investigations and subsequent containment, correction, corrective action and systemic corrective actions, as appropriate.

Outcome / Qualification etc.

Key Learning Objectives

  • Identify valuable techniques to apply when writing effective nonconformity statements
  • Review fundamental terminology important to writing effective nonconformity statements, including “audit,” “objective evidence,” “audit criteria” and “nonconformity”
  • Evaluate the use of the acronym FOCAL as a tool for developing an effective nonconformity statement
  • Apply the three key principles when writing a nonconformity statement
  • Demonstrate through practical application the knowledge gained

Why choose NSF International, Health Sciences

Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course

Provided expert health sciences training for over 30 years

More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider


General Registration $600.00

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About provider

NSF - Professional Health and Life Sciences Courses

NSF provides training and education services for leading organisations in the health care industries. Our health sciences courses have one objective – to bring about change that drives improvements in your workplace. Known globally for high-quality content, we are passionate...

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NSF International, Health Sciences

The Georgian House, 22/24 West End
YO62 6AF York

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