Document No.

: Page: 1 of 7
MDSAP QMS P0014.003
Version Date: Effective Date:
Responsible Office/Division 2016-10-22 2013-07-15
Title: Project Manager:
MDSAP QMS Training Procedure Liliane Brown, USFDA

Table of Contents

1. Purpose/Policy ............................................................................................... 1
2. Scope............................................................................................................. 1
3. Definitions/Acronyms ..................................................................................... 2
4. Authorities/Responsibilities ............................................................................ 2
5. Procedures .................................................................................................... 2
5.1 Types of Training Required .................................................................... 3
5.2 Training Methods .................................................................................... 3
5.3. Identification of Training Needs .............................................................. 4
5.4. Evaluation of Training Effectiveness ....................................................... 5
5.5. Maintenance and Retention of Training Records .................................... 5
5.6. Training Documentation.......................................................................... 5
6. Forms............................................................................................................. 6
7. Reference Documents ................................................................................... 6
8. Document History .......................................................................................... 6
Approval Sign-Off Sheet

1. Purpose/Policy
The purpose of this document is to define the Medical Device Single Audit
Program (MDSAP) Team training requirements. This procedure will assist to
assure that MDSAP Team members have the knowledge, skills and abilities to
perform their respective roles successfully by developing proficiency through
various methods of training. This document is separate from the
IMDRF/MDSAP WG/N4:2013 Competency and Training Requirements for
Auditing Organizations which may not apply to all MDSAP Team Members.

2. Scope
This procedure applies to all MDSAP Team members of each participating
Regulatory Authority (RA).

Uncontrolled when printed:

For the most current copy, contact [email protected]
 Document No.: Page 2 of 7
MDSAP QMS Training Procedure
MDSAP QMS P0014.003

3. Definitions/Acronyms

Training: Act of developing a particular skill or type of behavior through

demonstration, instruction an practice.

Competence: Ability to apply knowledge, and skills to achieve intended

results. (ISO 9000:2015)

Regulatory Authority (RA): A government body or other entity that exercises a

legal right to control the use or sale of medical devices within its jurisdiction,
and that may take enforcement action to ensure that medical products
marketed within its jurisdiction comply with legal requirements.
(GHTF/SG1/N78:2012)

4. Authorities/Responsibilities

RAC Secretariat: Responsible for notifying the MDSAP Team, through the
participating RA Training Representative, when new or revised procedures and
policies are released.

MDSAP Team Member: All MDSAP Team Members are responsible for
assessing their individual training needs. Team Members should document
their training and coordinate with their RA Training Representative, to ensure
that training records are current.

Regulatory Authority (RA) Training Representative: Responsible for overseeing

the MDSAP Training Program within their Regulatory Authority; coordinating
with the RA’s MDSAP Team members to satisfy training requirements; and
compiling, storing and maintaining training records from each MDSAP Team
Member.

Note: Each RA is responsible for assigning a RA Training

Representative.

5. Procedures

Training Requirements

MDSAP Team Members shall be initially qualified to perform their assigned

tasks and responsibilities on the basis of education, training and/or prior
experience. Team Members must be appropriately trained in, and have
knowledge of, the applicable regulations, standards and policies associated
with a specific job function before independently performing MDSAP specific
roles. It is essential that MDSAP Team Members are aware of the relevance
Uncontrolled when printed:
For the most current copy, contact [email protected]
 Document No.: Page 3 of 7
MDSAP QMS Training Procedure
MDSAP QMS P0014.003

and importance of their activities and how they contribute to the achievement
of the quality objectives of the MDSAP.
5.1 Types of Training Required

All MDSAP Team Members shall become proficient with the MDSAP
Standard Operating Procedures (SOPs) which pertain to the Team
Member’s role. A Team Member’s proficiency with an SOP may be
demonstrated through self-certification, classroom work, other documented
learning experiences (e.g. On-The-Job Training) or through a combination
of these. Additionally, for training not available through an MDSAP course,
a Team Member must participate in an internal RA course and/or
recognized external coursework relating to their role. The Team Member’s
supervisor will evaluate their proficiency and, if a deficiency in performance
is observed, provide constructive feedback, and / or arrange specific
additional training for the Team Member.

The Training Document Review Checklist available as an attachment

outlines the internal SOPs, Standards and Guidance Documents in which
Team Members may need to develop proficiency, or where appropriate,
familiarity. The MDSAP Team Member’s Supervisor shall determine which
of these are necessary for the Team Member to perform their role.

Refer to the MDSAP QMS F0014.1 Training Document Review Checklist.

The following external courses are recommended for MDSAP Personnel

conducting Audits and Assessments:
• American Society for Quality (ASQ) Certified Biomedical Auditor Exam
Preparation
• ISO 9001 Lead Auditor Course (with emphasis on ISO 13485 if possible)
• Other courses that comply with the requirements of the RABQSA
Qualification based approach to training for Quality Management
System Auditors – (http://www.rabqsa.com/docs/downloads/TCD32.pdf)
5.2 . Training Methods

5.2.1. Self-Training (i.e. Required Reading)

MDSAP Team Members will undertake the majority of their MDSAP training
via a supervised or personal review of SOPs, Standards, Regulations,
Policy, Manuals, Guidance Documents and others, and then applying the
learned material to their daily work processes. This involves the MDSAP
Team Member taking the time to review and ensure understanding of the
applicable material. If the Team Member has questions regarding the
material, it is incumbent on the Team Member to seek clarification.

Uncontrolled when printed:

For the most current copy, contact [email protected]
 Document No.: Page 4 of 7
MDSAP QMS Training Procedure
MDSAP QMS P0014.003

The MDSAP Team Member’s supervisor and the RA Training

Representative, in consultation with the employee, will evaluate the
success of self-training methods on an annual basis. The MDSAP Team
Member’s supervisor will share the results of this evaluation with the Team
Member.

5.2.2. Instructor Led Training

5.2.2.1. Classroom Training - Includes internal and external training

courses in a classroom setting and used to impart knowledge
regarding MDSAP associated programs, procedures and
policies. This type of training generally includes a defined
schedule of subject material instruction and may include written
examinations to determine the level of understanding and the
effectiveness of the course. The MDSAP Secretariat, or an RA,
may conduct classroom training internally or arrange an
accredited external course.

5.2.2.2. “On the Job” Training (OJT) – MDSAP Team Member training
at the place of work while performing MDSAP assigned roles
under the close supervision of a supervisor or delegate (e.g., a
mentor). This type of training must ensure that it provides the
Team Member the knowledge or skills essential to the full and
adequate performance of the assigned role.

5.2.2.3. Webinars (Web-based Seminar) and other Virtual Courses –

May be interactive or one-way presentation, lecture, workshop
or seminar conducted over the internet using web conferencing
technologies.
5.2.3. eLearning Modules

Generally considered to be any instruction (either instructor-led or self-

led) delivered over the internet, a local network, CD/DVD-ROM,
computer, satellite broadcast, etc. Currently, the U.S. Food & Drug
Administration’s Center for Devices and Radiological Health maintains a
website where many eLearning Modules in English, Spanish and
Chinese may be accessed for free at:
http://www.fda.gov/training/cdrhlearn/default.htm
5.3. Identification of Training Needs

Unless otherwise specified, MDSAP supervisors and Team Members

shall assess training needs on an annual basis (once per calendar
year). An MDSAP supervisor may perform the assessment as part of
the Team Members annual performance review.

Uncontrolled when printed:

For the most current copy, contact [email protected]
 Document No.: Page 5 of 7
MDSAP QMS Training Procedure
MDSAP QMS P0014.003

Training needs may also be identified more frequently (e.g. when a new
or revised procedure or policy affecting the MDSAP Team Member’s
role is released; or when the evaluation of training effectiveness
demonstrates a need for further training).
5.4. Evaluation of Training Effectiveness
The RA Training Representative is to perform an annual evaluation of
the MDSAP Training Program. The Representative may presume that
MDSAP Team Members who have participated in all required MDSAP
training are competent unless a Supervisor observes substandard
performance. The methods to be used by the RA Training
Representative for reviewing the effectiveness of training may include:
• Monitoring MDSAP Team Member performance
• Interviews with MDSAP Team Members
• Observations made by the RA Training Representative or other
members of the MDSAP Team
• Group discussions
• Input from subject matter experts

The RA Training Representative shall document the evaluation of the

annual MDSAP Training Program using the form MDSAP QMS
F0014.2 Training Program Evaluation. The RA Training Representative
must record any observed gaps in the MDSAP Training Program and
document a plan on the form to correct the deficiency. The RA Training
Representative must relay any gaps in the competency of an MDSAP
Team Member to the relevant MDSAP supervisor who is to ensure that
a remediation plan is developed and implemented for the affected
Team Member.
5.5. Maintenance and Retention of Training Records

Once an MDSAP Team Member completes the required training,

evidence of completion of the training must be provided to the RA
Training Representative who will; verify completion of the training and
record completion in the RA’s personnel files. The RA Training
Representative may record the evidence of completion in the form of a
completed Training Document review checklist, self-certification, course
transcript, certificates, travel records, instructor emails/notes, results
letters, etc. The RA shall retain training records for not less than 2
calendar years.

5.6. Training Documentation

The MDSAP Team Member and RA Training Representative are

Uncontrolled when printed:

For the most current copy, contact [email protected]
 Document No.: Page 6 of 7
MDSAP QMS Training Procedure
MDSAP QMS P0014.003

responsible for maintaining appropriate records of education, training,

skills and experience. The MDSAP Team Member has the ultimate
responsibility for ensuring individual training records are current.

6. Forms
MDSAP QMS F0014.1 - Training Review Checklist Form
MDSAP QMS F0014.2 - Training Evaluation Form

7. Reference Documents
ISO 10015:1999(E). Quality Management - Guidelines for Training. (1999,
December 15).
International Organization for Standardization (ISO).
IMDRF/MDSAP WG/N6FINAL:2013 – Regulatory Authority Assessor
Competence and Training Requirements

8. Document History

AUTHOR
VERSION VERSION
DESCRIPTION OF CHANGE NAME/PROJECT
NO. DATE
MANAGER

001 2013-07-15 Initial Release Liliane Brown

USFDA

Uncontrolled when printed:

For the most current copy, contact [email protected]
 Document No.: Page 7 of 7
MDSAP QMS Training Procedure
MDSAP QMS P0014.003

002 2013-08-01 Page 1 and 2; Section 3 Definitions Liliane Brown

/Acronyms: Definition –Training: revised USFDA
to reflect correct definition according to
ISO 9001:2008.
Definition – Competence: revised to
reflect correct definition according to ISO
9000:2006 clause 3.9.14 and as
suggested by IMDRF “Competency and
Training Requirements for AOs, July 11,
2013.
Definition - Regulatory Authority (RA)
was added to the list as defined in
GHTF/SG1/N78:2012.

Page 9; Section 7 Reference

Documents: added the info on IMDRF
“Competency and Training
Requirements for AOs” dated July 11,
2013 document.
003 2016-10-11 Revisions were made mostly in section 3 Liliane Brown/
Definition/Acronyms to reflect the ISO Patricia Serpa
9001;2015/ISO 9000:2015 revisions

Version 003
Approval

Approved: Signature on file______________ Date: 2016-10-24___

CHAIR MDSAP RAC

Uncontrolled when printed:

For the most current copy, contact [email protected]