| Certification of Quality Management Systems of Manufacturers of Medical Devices |
| Home 9001Qms 14001EMS Six Sigma Calender Step- by-Step ISO On-line Registration 13485 16949 Statistic Feedback Customer Contact us SPC PAPP FMEA SCM APQA CSM 22000:2005 8000SA OHSAS 18001 |
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: -
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: - 9am to 6pm (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:- 9am to 6pm (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:- 9am to 6pm. [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:- August & October 2006 in Mumbai.
e) Fees:- Rs. 19,663/- (17,500 + @12.36%ST) per person.
f) Time:- 9am to 6pm. [Tuesday to Saturday - Five (5) Full Days (8 x 5 = 40 hrs)]
Mode Of Payment:- Cash or Pay Order / Demand Draft in favour of," Quality Management
Institute”, payable at Mumbai.
Venue: - a) QMI's seminar Hall,10, New Gokul Plaza, Ground floor, Opposite Gokul Hospital,
Near Videocon Towers, Thakur Complex, Kandivali (East), Mumbai - 400 101.
[ For less than 15 participants / candidates]
OR
b) Hotel Atithi, Near Domestic Airport, Vile-parle (East), Mumbai.
[ For more than 15 Candidates]
c) If we receive payments from more than 15 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 @
QMI's seminar hall, Kandivali, only.
Contact Us : - Quality Management Institute, 10, New Gokul Plaza, Ground floor, Opposite
Gokul Hospital, 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
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: - 9am to 6pm (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:- 9am to 6pm (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:- 9am to 6pm. [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:- August & October 2006 in Mumbai.
e) Fees:- Rs. 19,663/- (17,500 + @12.36%ST) per person.
f) Time:- 9am to 6pm. [Tuesday to Saturday - Five (5) Full Days (8 x 5 = 40 hrs)]
Mode Of Payment:- Cash or Pay Order / Demand Draft in favour of," Quality Management
Institute”, payable at Mumbai.
Venue: - a) QMI's seminar Hall,10, New Gokul Plaza, Ground floor, Opposite Gokul Hospital,
Near Videocon Towers, Thakur Complex, Kandivali (East), Mumbai - 400 101.
[ For less than 15 participants / candidates]
OR
b) Hotel Atithi, Near Domestic Airport, Vile-parle (East), Mumbai.
[ For more than 15 Candidates]
c) If we receive payments from more than 15 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 @
QMI's seminar hall, Kandivali, only.
Contact Us : - Quality Management Institute, 10, New Gokul Plaza, Ground floor, Opposite
Gokul Hospital, 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
|
|
|
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |