Development of Certification of

Quality Management System

Medical Devices

25 Feb 2014 Asosiasi Lembaga Sertifikasi Indonesia 1

 Executive Board
2

 Ngakan Timur Antara Chairman

(Balai Besar Pulp dan Kertas) (Ketua Umum)
 Muhammad Bascharul Asana Secretary General
(PT TUV Rheinland Indonesia) (Sekretaris Jenderal)
 Toni Arifiarachman Tresurer
(PT Mutu Agung Lestari) (Bendahara Umum)
 Boneanto A. Kahar Head of Internal Affairs
(PT Sucofindo (Persero)) (Ketua Bidang Internal)
 Nyoman Susila Head of External Affairs
(PT SAI Global Indonesia) (Ketua Bidang Eksternal)
 Titiek Sudarti Head of Research & Dev.
(PT SGS Indonesia) (Ketua Bidang Litbang)

Asosiasi Lembaga Sertifikasi Indonesia 2013-10-02

 Member Profile
3

 Total member = 25
Wilayah Jumlah Anggota
Jabodetabek 11
Jawa Barat 5
Jawa Tengah 3
Jawa Timur 1
Sumatera 3
Indonesia Bagian 2
Timur (IBT)
Total 25

Asosiasi Lembaga Sertifikasi Indonesia 2013-10-02

 Main Programs 2013-2016
4

 Increase number of members

 Extend cooperation with all stakeholders especially
BSN and KAN
 Improve communications with members
 Improve competence of the members and its
auditors and technical experts

Asosiasi Lembaga Sertifikasi Indonesia 2013-10-02

 Current Trend Medical Devices
business in Indonesia
5

Asosiasi Lembaga Sertifikasi Indonesia

 Trend Medical Devices
business in Asia
6

Development from 2009 to 2013 (in Mio.Euro)

10 1.4
9
1.2
8
7 1

6 0.8
5
4 0.6

3 0.4
2
0.2
1
0 0
2009 2010 2011 2012 2013
Source: data sales from TIC Company in Asia region

Asosiasi Lembaga Sertifikasi Indonesia

7

How about the fact the

development of medical
devices business in Indonesia

Asosiasi Lembaga Sertifikasi Indonesia

 Turn Over Medical Devices
business in Indonesia
8

(In hundred million IDR )

Asosiasi Lembaga Sertifikasi Indonesia

 Certified Companies in Indonesia
9

Asosiasi Lembaga Sertifikasi Indonesia

 Why there is no development ??
10

Characteristic
company
market
Mostly MDD Industries
(non active category):
enough with ISO 9000
No requirement
from client
Lack of market
awareness

Limited of certified company : used

affiliated auditor so become expensive
(not competitive)
Asosiasi Lembaga Sertifikasi Indonesia
 Overview ISO 13485
11

-Meeting the customer and

business partners requirements -Limited of certified company :
and the legal requirements used affiliated auditor so
-Evidence of adherence to become expensive (not
legal and regulatory or competitive)
contractual requirements
-Minimize and manage risks
-Error prevention instead of
error correction
-Improved performance quality
-Transparency and clarity of
internal processes
-Time and cost savings
Asosiasi Lembaga Sertifikasi Indonesia
 Comparison
12

ISO 13485 ISO 9001

The requirement are specific to The requirement are generic and

organizations providing medical
devices regardless of type or size the
organization
Emphasis on maintaining regulatory
compliance
Wants organization to document
procedures, requirement, activities
and special arrangements, and
should implement and maintain them,
must retain documents for at least the
lifetime of medical device
applicable to all organizations,
regardless of type, size and product
provided
Emphasis on continual improvement
and customer satisfaction
Wants organization to document
procedure, implement and maintain it

Asosiasi Lembaga Sertifikasi Indonesia

 Comparison
continued..
13

ISO 13485 ISO 9001

Maintain the Effectiveness of these processes Section 4.1 Continual Improvement of these Processes

Organization must define the period for Section 4.2.3 Does not specify retention times
retention of obsolete documents (Duration must
be for the life of the device)

Additional Requirement in this section that are Section 4.2.4

not in 9001

Does not require Continually Improving its Section 5.1 Does require
effectiveness
Focus is on meeting the customers needs Section 5.2 Focused on meeting and exceeding the
customers needs
Emphasizes maintaining the system Section 5.3 Continual Improvement
Requires Procedure for training Section 6.2.2 Does not
More detailed, i.e: health records, cleanliness Section 6.4
of clothing and personnel, environmental
monitoring)

Asosiasi Lembaga Sertifikasi Indonesia

 Comparison
continued..
14

ISO 13485 ISO 9001

Design and development references of risk Section 7.3 Does not
analysis
About packaging and labelling, Cleanliness of Section 7.5.1 None
product and contamination, Installation, Servicing
Procedure Validation of processes for production Section 7.5.2 None
and services provision
Procedure Preservation of products Section 7.5.5 None

Documented Procedure Measurement, analysis, Section 8.1 None

and Improvement
19 Procedures Minimum Procedure 6 Procedures

Asosiasi Lembaga Sertifikasi Indonesia

15

Thank you!
Asosiasi Lembaga Sertifikasi Indonesia
(Indonesia Certification Body Association)
c/o PT TUV Rheinland Indonesia,
Menara Karya 10th Floor
Jl. H.R. Rasuna Said Block X-5 Kav. 1-2
Jakarta 12950, Indonesia
Tel: (021) 57944579 ext 304 Fax: (021) 57944575
http://www.alsi.or.id

Asosiasi Lembaga Sertifikasi Indonesia 2013-10-02