ISO 13485: Medical Device Quality Management Systems

Learn How To Build ISO 13485 Quality System that Consistently Meets Customer & Applicable Regulatory Requirements.

Instructor :
Charles H. Paul

Webinar ID:
3063

Date: 22 July 22, FRI

Start Time: 10 am PT

Duration: 2 Hrs

What you will learn

  • Overview/basic elements of the quality management system
  • Typical quality system elements
  • Key attributes of a functional quality system
  • QSR vs ISO Compliance
  • ISO 13485 content overview and evolution of revisions
  • Overview/basic elements of the quality management system
  • Typical quality system elements
  • Key attributes of a functional quality system
  • QSR vs ISO Compliance
  • ISO 13485 content overview and evolution of revisions
  • Implementing your quality system in conformance with the standard

Course Description

Learn How to Successfully Apply the Principles of Quality Management to Your Organization.

ISO 13485 is the international quality management system standard for medical devices. The function of this standard is to “specify requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.”

The standard has its beginnings in ISO 9001 but as a standalone standard, it has evolved over the years through various versions.

In this interactive webinar:

  • We will begin this webinar by overviewing the quality management system concept extended to both the QSR and the ISO standard to provide a solid and appropriate background to the further discussion of the standard.
  • We will next discuss the overall intent and impact of ISO 13485 in terms of why it is important and what it is intended to accomplish.
  • Once those basic concepts are covered, we’ll overview the contents of the standard, and the impact of the various revisions and their specific change focus up to and including ISO 13485:2016.
  • We will spend some time discussing the differences between 21 CFR820 and the ISO Standard to fully realize the concept of conformance versus compliance.
  • We will end this webinar by discussing the process of implementing your quality system in conformance with the standard.

Join Us to Learn More…

Learn How to Successfully Apply the Principles of Quality Management to Your Organization.

ISO 13485 is the international quality management system standard for medical devices. The function of this standard is to “specify requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.”

The standard has its beginnings in ISO 9001 but as a standalone standard, it has evolved over the years through various versions.

In this interactive webinar:

  • We will begin this webinar by overviewing the quality management system concept extended to both the QSR and the ISO standard to provide a solid and appropriate background to the further discussion of the standard.
  • We will next discuss the overall intent and impact of ISO 13485 in terms of why it is important and what it is intended to accomplish.
  • Once those basic concepts are covered, we’ll overview the contents of the standard, and the impact of the various revisions and their specific change focus up to and including ISO 13485:2016.
  • We will spend some time discussing the differences between 21 CFR820 and the ISO Standard to fully realize the concept of conformance versus compliance.
  • We will end this webinar by discussing the process of implementing your quality system in conformance with the standard.

Join Us to Learn More…

Why you should attend

ISO 13485 is a standard and not a regulation. In the US, it is vital to understand the differences between a standard and a regulation to avoid serious compliance failures.

That said, the standard is just that, a standard, and is the standard of choice for medical device manufacturers as it pertains to their quality management system.

  • Certification under this standard is essential to the organization’s ability to conduct business in the various markets that require conformity to this standard and compliance to its country’s regulations.
  • The ISO standard is also a valuable tool to the establishment, maintenance, and execution of the organization’s QMS as long as any variances to existing country regulations are understood i.e. the difference between a regulation and a standard.

This webinar will establish above foundation. Join us now!

ISO 13485 is a standard and not a regulation. In the US, it is vital to understand the differences between a standard and a regulation to avoid serious compliance failures.

That said, the standard is just that, a standard, and is the standard of choice for medical device manufacturers as it pertains to their quality management system.

  • Certification under this standard is essential to the organization’s ability to conduct business in the various markets that require conformity to this standard and compliance to its country’s regulations.
  • The ISO standard is also a valuable tool to the establishment, maintenance, and execution of the organization’s QMS as long as any variances to existing country regulations are understood i.e. the difference between a regulation and a standard.

This webinar will establish above foundation. Join us now!

Areas Covered

  • Overview/basic elements of the quality management system
  • Typical quality system elements
  • Key attributes of a functional quality system
  • QSR vs ISO Compliance
  • ISO 13485 content overview and evolution of revisions
  • Implementing your quality system in conformance with the standard
  • Overview/basic elements of the quality management system
  • Typical quality system elements
  • Key attributes of a functional quality system
  • QSR vs ISO Compliance
  • ISO 13485 content overview and evolution of revisions
  • Implementing your quality system in conformance with the standard

Who is this course for

FUNCTIONS

  • marketing
  • research & development
  • technical services
  • manufacturing
  • compliance and regulatory
  • logistics/supply chain
  • service and maintenance

POSITIONS

  • Associates
  • Supervisors
  • Managers
  • Directors
  • Vice Presidents

FUNCTIONS

  • marketing
  • research & development
  • technical services
  • manufacturing
  • compliance and regulatory
  • logistics/supply chain
  • service and maintenance

POSITIONS

  • Associates
  • Supervisors
  • Managers
  • Directors
  • Vice Presidents

Instructor Profile

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant to the life sciences industry for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex human performance and compliance-related problems.

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant to the life sciences industry for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex human performance and compliance-related problems.

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