ISO 13485: 2003 Certification of
Quality Management Systems of
Manufacturers of Medical Devices
Overview: - The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to
EEC-decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The
preferred method to prove the conformity is the certification of the Quality Management System
according ISO 9001 and/or ISO 13485, ISO 13488 by a Conformity Assessment Body (CAB). The
result of a positive assessment is the authorisation for the CE-identification and the permission to
sell the high quality medical device.

This interactive course provides the basic knowledge and understanding of the key requirements and
significant changes to the new ISO 13485:2003 Medical devices Quality management Systems —
Requirements for regulatory purposes.

Participants: - Quality Managers, RA Managers, Auditors of Medical Device, manufacturing firms
(internal and external), Executives & Senior Management,
Cross functional team members of implementation project

Benefits to Your Business: - Delegates are given an understanding of the relevance of various
Medical Devices standards to industry in general, and to their own organisation in particular.

Seminar Contents: -
  • Understanding proper use of ISO 14969
  • Understanding differences between ISO 13485:1996 and 2003 version
  • Interpret all clauses of ISO 13485:2003
  • Understand the essentials of ISO 14971 – The Medical Device Risk Management Standard
  • Recognize the role of management in implementing and maintaining ISO 13485

Course objectives & Seminar Contents: -

1) ISO 13485: 2003 Medical devices Quality management Systems Awareness Training: -
a) Course Objective:- To create a basic awareness about Food Safety Management System (FSMS)
based on ISO 13485: 2003 Standard and its benefits.
b) Eligibility:- Understand English language (as the seminar will be in English) & Basic knowledge of
ISO 9001 Quality System
c) Schedule:- Currently we are conducting in-house (within your company) trainings only.
d) Fees: - As per in-house training charges.
e) Time: - 8am to 4pm (Full Day - 7 hrs)

2) ISO 13485: 2003 Medical devices Quality Management Systems Documentation Training: -
a) Course Objective:- To provide information related to documentation requirements for ISO 13485:
2003 MDQMS Certification.
b) Eligibility:- Participants should be aware about ISO 13485:2003 & its benefits.(or should have
attended awareness training)  
c) Schedule:- Currently we are conducting in-house (within your company) trainings only.
d) Fees:- As per in-house training charges.
e) Time:- 8am to 4pm (Full Day - 7 hrs)

3) ISO 13485:2003 Medical devices Quality Management Systems Internal Audit Training: -
a) Course Objective:- To develop skills for conducting internal audits of ISO 13485:2003 Medical
devices Quality Mgt. System.
b) Seminar Contents:- Details of ISO 13485:2003 clauses / requirements, Types of Audits, Audit
Process, Preparation & Planning of Audits, Audit Checklist, Preparation of checklist & Identification of
Non-Conformities [N/C's].
c) Eligibility:- Participants should know about Awareness & documentation of ISO 13485:2003 or
should have attended awareness & documentation training).
d) Schedule:- Currently we are conducting in-house (within your company) trainings only.
e) Fees: - As per in-house training charges.
f) Time:- 8am to 4pm. [Two (2) Full Days (8 hrs x 2 days = 16 hrs)]

4) ISO 13485:2003 Medical devices Quality Management Systems Lead Auditor Training: -
a) Course Objective:- 1) To develop skills for becoming a successful Management Representative
(M. R.) / ISO (MDQMS) Coordinator,
2) To develop skills for becoming a competent member of your company’s core team, which is
responsible for developing, implementing, maintaining & improving your company’s Medical Device
Quality Management System (MDQMS) based on ISO 13485:2003 Standard,
3) To develop skills for conducting Medical Device Quality Management System Audits on Suppliers
(Vendors) on behalf of your company.
4) To develop skills for conducting third party / external audits on behalf of a Certification Body
b) Seminar Contents: - Details of ISO 13485:2003 clauses / requirements, Types of Audits, Audit
Process, Preparation & Planning of Audits, Audit Checklist, Preparation of checklist and Identification
of Non-Conformities [N/C's] . Various case studies with role play practice.
c) Eligibility: - Participants should know about Awareness & documentation of ISO 13485:2003 (or
should have attended awareness & documentation training).
d) Schedule:- As per calendar.
e) Fees:- As per calendar.
f) Time:- 8am to 4pm.

Mode Of Payment:- Cash or Pay Order / Demand Draft in favour of," Six Sigma Quality
Management Institute”
, payable at Mumbai.

Venue: -   a) SSQMI's seminar Hall, Shop # 2, New Gokul Plaza, Ground floor, Opposite Videocon
Towers, Thakur Complex, Kandivali (East), Mumbai - 400 101.
[ For less than 6 participants / candidates]
OR
b) Hotel Atithi, Near Domestic Airport, Vile-parle (East), Mumbai.
[ For more than 8 Candidates]
c) If we receive payments from more than 8 participants, then  we will be communicate to
participants, two days prior to seminar date and then seminar will be held at Hotel Atithi .
d) If you will not receive any communication regarding change in Venue, then it will be held @
SSQMI's seminar hall, Kandivali, only.

Contact Us : -  Six Sigma Quality Management Institute, Shop # 2, New Gokul Plaza, Ground floor,
Opposite Videocon Towers, Gokul Hospital Lane, Thakur Complex, Kandivali (East), Mumbai - 400 101.

E-mail: -  info@ssqmi.com

Trainers: - We have a team of eight (8) competent trainers (including two Six Sigma trainers).We
have conducted more than 1500 such seminars & having more than 15 years of Industrial &
Professional experience

Six Sigma Quality Management Institute
An ISO 9001:2008 Certified
(Six Sigma Trainings & Certification - Green Belt & Black Belt,
ISO 9001 QMS, ISO 14001 EMS, TS 16949 Automotive,
ISO 13485 Medical Devices, ISO 22000 Food Safety, ISO 18001 OHSAS,
Statistical Tools {SPC, MSA, FMEA, PAPP, APQP} & Other  Trainings)