MASTERING THE IMPLEMENTATION AND MANAGEMENT OF A QUALITY MANAGEMENT SYSTEM (QMS) BASED ON ISO 13485

DAY 1 DAY 2

DAY 3 DAY 4

DAY 5

DURATION: 5 DAYSCOURSE AGENDA

WHO SHOULD ATTEND?

SUMMARY

▶ Project managers or consultants wanting to prepare and to support an organization in the implementation of a Quality Management System (QMS)

▶ Quality executives ▶ ISO 13485 auditors who wish to fully understand the Quality Management System implementation process ▶ Individuals responsible for the quality or conformity in an organization ▶ Members of a quality team ▶ Expert advisors in Quality Management Systems ▶ Regulatory affairs managers ▶ Technical experts wanting to prepare for a quality function or for a QMS project management function in the medical device industry

Introduction to Quality Management System (QMS) concepts as required by ISO 13485 and initiation of a QMS

▶ Introduction to management systems and the process approach

▶ Normative frameworks and methodologies related to Quality and Medical Devices

▶ Understanding the requirements of ISO 13485 ▶ Fundamental principles of Quality and Medical Devices ▶ Initiating the QMS implementation

Implementing a QMS based on ISO 13485 ▶ Implementation of a document management

framework ▶ Design of controls and writing of procedures ▶ Development of a training and awareness program

and communicating about the quality ▶ Product realization processes ▶ Operations management of a QMS

Certification Exam ▶ PECB’s 3 Hour Certified ISO 13485 Lead Implementer Exam is available in different languages. The candidates

who do not pass the exam will be able to retake it for free within 12 months from the initial exam date.

Planning the implementation of a QMS based on ISO 13485

▶ Writing a business case and a project plan for the implementation of a QMS

▶ Definition of the scope of the QMS

▶ Development of a QMS policy

Controlling, monitoring and measuring a QMS and the certification audit of a QMS in accordance with ISO 13485

▶ Controlling and monitoring a QMS ▶ ISO 13485 internal audit ▶ Management review of a QMS ▶ Implementation of an improvement program ▶ Preparing for an ISO 13485 certification audit

www.pecb.org

This five-day intensive course enables the participants to develop the necessary expertise to support an organization in implementing and managing a Quality Management System (QMS) based on ISO 13485. Participants will also gain a thorough understanding of best practices used to implement Quality Management processes based on requirements from of the ISO 13485. This training is consistent with the project management practices established in ISO 10006 (Quality Management Systems – Guidelines for Quality Management in Projects). This training is fully compatible with ISO 14969 guidance’s (Medical devices – Quality Management Systems – Guidance on the application of ISO 13485).

CERTIFIED ISO 13485 LEAD IMPLEMENTER

▶ Certification fees are included in the exam price ▶ Participant manual contains over 450 pages of information and practical examples ▶ A participation certificate of 31 CPD (Continuing Professional Development) credits will be issued to participants

▶ The “Certified ISO 13485 Lead Implementer” exam fully meets the requirements of the PECB Examination and Certification Program (ECP). The exam covers the following competence domains:

» Domain 1: Fundamental principles and concepts of quality and medical devices

» Domain 2: Quality Management System best practice based on ISO 13485

» Domain 3: Planning a QMS based on ISO 13485

» Domain 4: Implementing a QMS based on ISO 13485

» Domain 5: Performance evaluation, monitoring and measurement of a QMS based on ISO 13485

» Domain 6: Maintaining the effectiveness of a QMS based on ISO 13485

» Domain 7: Preparing for a QMS certification audit

▶ For more information about the exam, please visit: www.pecb.org

▶ After successfully completing the exam, the participants can apply for the credentials of Certified ISO 13485 Provisional Implementer, Certified ISO 13485 Implementer or Certified ISO 13485 Lead Implementer, depending on their level of experience

▶ A certificate will be issued to participants who successfully pass the exam and comply with all the other requirements related to the selected credential:

Credential Exam ProfessionalExperience

QMSMD Audit

Experience

QMSMD Project

Experience

OtherRequirements

ISO 13485Provisional

Implementer

ISO 13485 LeadImplementer

ExamNone None None

Signing thePECB

code of ethics

ISO 13485Implementer

ISO 13485 LeadImplementer

Exam

Two yearsOne year of

Medical Devices work experience

NoneProject activities

totaling200 hours

Signing thePECB

code of ethics

ISO 13485Lead

Implementer

ISO 13485 LeadImplementer

Exam

Five yearsTwo years of

Medical Devices work experience

NoneProject activities

totaling300 hours

Signing thePECB

code of ethics

EXAMINATION

CERTIFICATION

GENERAL INFORMATION

For additional information, please contact us at info@pecb.org

www.pecb.org

PECBCertified

ISO

Lead Implementer

13485