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

1. CERTIFIED ISO 13485
LEAD IMPLEMENTER
MASTERING THE IMPLEMENTATION AND MANAGEMENT OF A QUALITY MANAGEMENT
SYSTEM (QMS) BASED ON ISO 13485
SUMMARY
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).
WHO SHOULD ATTEND?
▶▶ Project managers or consultants wanting to prepare and to support an organization in the implementation of a Quality
Management System (QMS)
▶▶ Quality executives
▶▶ SO 13485 auditors who wish to fully understand the Quality Management System implementation process
I
▶▶ ndividuals responsible for the quality or conformity in an organization
I
▶▶ embers of a quality team
M
▶▶ xpert advisors in Quality Management Systems
E
▶▶ Regulatory affairs managers
▶▶ Technical experts wanting to prepare for a quality function or for a QMS project management function in the medical device industry
COURSE AGENDA
DURATION: 5 DAYS
DAY 1
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
DAY 3
Implementing a QMS based on ISO 13485
▶▶ mplementation of a document management
I
framework
▶▶ esign of controls and writing of procedures
D
▶▶ evelopment of a training and awareness program
D
and communicating about the quality
▶▶ roduct realization processes
P
▶▶ Operations management of a QMS
DAY 5
DAY 2
Planning the implementation of a QMS
based on ISO 13485
▶▶ Writing a business case and a project plan for the
implementation of a QMS
▶▶ efinition of the scope of the QMS
D
▶▶ evelopment of a QMS policy
D
DAY 4
Controlling, monitoring and measuring a
QMS and the certification audit of a QMS
in accordance with ISO 13485
▶▶
▶▶
▶▶
▶▶
▶▶
C
ontrolling and monitoring a QMS
I
SO 13485 internal audit
M
anagement review of a QMS
I
mplementation of an improvement program
Preparing for an ISO 13485 certification audit
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.
www.pecb.org

2. EXAMINATION
▶▶ 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:
»» omain 1: Fundamental principles and concepts of quality and medical devices
D
»» omain 2: Quality Management System best practice based on ISO 13485
D
»» omain 3: Planning a QMS based on ISO 13485
D
»» omain 4: Implementing a QMS based on ISO 13485
D
»» omain 5: Performance evaluation, monitoring and measurement of a QMS based on ISO 13485
D
»» omain 6: Maintaining the effectiveness of a QMS based on ISO 13485
D
»» omain 7: Preparing for a QMS certification audit
D
▶▶ or more information about the exam, please visit: www.pecb.org
F
CERTIFICATION
▶▶ 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
Professional
Experience
QMSMD
Audit
Experience
QMSMD
Project
Experience
Other
Requirements
ISO 13485
Provisional
Implementer
ISO 13485 Lead
Implementer
Exam
None
None
None
Signing the
PECB
code of ethics
ISO 13485
Implementer
ISO 13485 Lead
Implementer
Exam
Two years
One year of
Medical Devices
work experience
None
Project activities
totaling
200 hours
Signing the
PECB
code of ethics
ISO 13485
Lead
Implementer
ISO 13485 Lead
Implementer
Exam
Five years
Two years of
Medical Devices
work experience
None
Project activities
totaling
300 hours
Signing the
PECB
code of ethics
GENERAL INFORMATION
▶▶ 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
For additional information,
please contact us at info@pecb.org
www.pecb.org
PECB
Certified
ISO 13485
Lead Implementer