TRANSPACIFIC CERTIFICATIONS LIMITED Doc. No.

: F-GEN-03 Rev 14

Questionnaire Effective: 01/01/2021

This initial questionnaire is sent to clients interested in obtaining certification to obtain preliminary
information, which will enable Transpacific Certifications Limited (TCL) to process any subsequent
application, promptly and in the most effective manner. The questionnaire should be completed,
ingenuously, in as much detail as possible and returned to TCL.
Name of
BALAI BESAR PELATIHAN VOKASI DAN PRODUKTIVITAS SEMARANG
Organisation:
Address: JL. Brigjen Sudiarto No. 118 Pedurungan, Semarang - Jawa Tengah
Telephone
(024) 6712680 Fax Number: (024) 76580968
Number:
Contact: Arne Saputra, S.T. Position: MR & Kepala Bagian Umum

Email Address: bbpvpsemarang@kemnaker.go.id

Name of the PT. Gemilang Inti Solusi
Consulting
Organization if
any

Information to be furnished by client organisation

1. To which standards are you seeking certification/registration?
(tick wherever applicable)

 ISO 9001 ISO 14001

ISO 22000 ISO 27001
ISO 45001 ISO 13485
Others (please specify ____________)

2. Preferred accreditation of certificate

 JAS-ANZ Others (please specify ____________)

3. If more than one of the above standards is selected, is your organization looking for:

 Independent certification/registration Integrated certification/registration

4. If integrated certification is desired, please state the level of integration of systems.

NONE___________________________________________________________________________

5. Exclusions sought Clause 8.5.1 Control of Production and service provision point f) validation

5(a) Justification for seeking exclusion

All services can be verified______________________________________________________

6. Please give details of any approvals granted by other certifying authorities/bodies.

NONE

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7. Please give details of industrial associations/Business affiliations, of which your organization

is a member.
Ministry of Manpower ( Kementerian Ketenagakerjaan )

8. Do you have any relationship with TCL Management/ TCL employee/ TCL Auditors/ TCL
Technical Experts/ TCL Associates/ TCL Committee Member/ TCL Staff? The relationship
could be of any form, viz., (i) Finances; (ii) Commercial; (iii) Common Ownership; (iv)
Familiarity with any Individual belonging to TCL (v). Familiarity with any contracted person
of TCL; (vi) Past Association with any member of TCL as Employee/ Employer/Co-Worker/
Associate/Team Member?
Yes  No

7(a) If Yes Give Details

_______________________________________________________________________________
NONE
_______________________________________________________________________________

9. Have you used services of a consultant for development of management system, training and
internal audits?
 Yes No

8(a) If Yes, furnish details

Name and address of consultant PT. Gemilang Inti Solusi, Jakarta Indonesia

Description of services obtained prepared and appointed by the Ministry of Manpower

10.If the organization is part of a group, please specify the parent organization.

Direktorat Jenderal Pembinaan Pelatihan Vokasi dan Produktivitas, Kementerian

Ketenagakerjaan Republik Indonesia

11.If organization has multiple Sites, do you want ? NONE

Separate certificates for each facility Single certificate covering all facilities

12.If single certificate covering all Sites is required, please confirm whether management
system is centrally administered as a Corporate entity? NONE

Yes No

13.Scope of registration/certification.
(Description of products and services for which registration/certification is sought)

Pelatihan Vokasi dan Peningkatan Produktivitas

_______________________________________________________________________________

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14.Brief description of interested parties / stakeholders and their expectations

(interested parties may include – principals, parent company, legal & regulatory authorities, customers /
clients, suppliers/contractors, workers, shareholders, local community and public in general)

Kementerian Ketenagakerjaan/ Ditjen Binalavotas, pemenuhan perjanjian kinerja

OPD / SKPD / BLK Komunitas, komunitas lokal
Siswa/ Peserta Pelatihan, pelanggan langsung yang mendapatkan layanan
Pemberi Kerja/ Dunia Usaha – Dunia Industri, pengguna lulusan pelatihan
Pegawai/ instruktur/ tenaga kepelatihan, SDM terlaksananya pelayanan

15.Information about Site (for each site, site-wise)

First site Second site Third site

Number of employees: 133 Permanent
Permanent, Temporary 32 Temporarry
and Part time 0 Part Time
Number of employees 0 Employe
working away from
organization’s premises
Area/size of site 6,7 hektar
Number of departments 5 Departement
Number of shifts Non Shift

16.Brief description of key processes (site-wise; please attach extra sheets if required)
Including details of outsourced processes.

Promosi Program Pelatihan – Rekrutmen Peserta Pelatihan – Daftar Ulang – Penyediaan Bahan
Pelatihan (Rekanan) – Pelatihan Softskill (Kerjasama TNI/Polri) – Pelatihan Hardskill –
Sertifikat Pelatihan – Uji Kompetensi (LSP-Kerjasama) – Sertifikat Kompetensi

17.Primary technology
(e.g., manual assembly, software, chemical, etc.)

Laboratorium bahasa, Laboratorium Komputer, Laboratorium Administrasi Perkantoran,

Mesin/ Peralatan menjahit

18.Description of Outsourced Processes

Pelatihan Softskill FMD (Fisik, Mental dan Disiplin) bekerja sama dengan TNI/ POLRI
Uji Kompetensi, bekerja sama dengan LSP (Lembaga Sertifikasi Profesi)

19.Legal and other requirements applicable to the product/service?

(Please give details of any legislation, orders by regulatory authorities, organizational and contractual
requirements, relating to any of the products or services offered by your organization)
________________________________________________________________________________
Peraturan Menteri Ketenagakerjaan Republik Indonesia Nomor 1 Tahun 2022 Tentang
Organisasi Dan Tata Kerja Unit Pelaksana Teknis Di Kementerian Ketenagakerjaan
________________________________________________________________________________

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20.If this is application for a Recertification audit, is there any significant change(s) to the
management system, the organization, or the context in which the management system is
operating (e.g. changes to legislation)?

________________________________________________________________________________
Perubahan Nomenklatur nama Organsiasi dari Balai Besar Pengembangan Latihan Kerja
(BBPLK) menjadi Balai Besar Pelatihan Vokasi dan Produktivitas (BBPVP)
________________________________________________________________________________

21.If ISO 14001 certification/registration is sought, list the significant environmental aspects and
associated impacts. (use extra sheets if required)

________________________________________________________________________________
NONE
________________________________________________________________________________

22.If ISO 45001:2018 certification/registration is sought, statement of hazard identification,

assessment of risks and opportunities, assessment of OH&S risks and other risks to OH&S
management system. (use extra sheets if required)
________________________________________________________________________________
NONE
________________________________________________________________________________

23.If ISO 22000 certification/registration is sought, please furnish the following details:
(use extra sheets if required) NONE

a) Brief description of Infrastructure, building area, laboratory facilities ________________

____________________________________________________________________________
____________________________________________________________________________
b) Product characteristics ________________________________________________________
c) Seasonal: Yes/No. If Yes, period of season (Months_________________)
d) Number of product lines _______________________________________________________
e) Intended use for each product/product line ______________________________________
f) Flow diagram/s _______________________________________________________________
g) Process steps _________________________________________________________________
h) Control measures ______________________________________________________________
i) Number of control points _______________________________________________________
j) Number of PRPs _______________________________________________________________
k) Brief description of PRPs ______________________________________________________
_____________________________________________________________________________
l) No. of HACCP Studies __________________________________________________________
m) Brief description of HACCP Studies _______________________________________________
_____________________________________________________________________________
n) If formal FSMS is in place, areas/products covered under it __________________________
_____________________________________________________________________________
o) Number of sites/locations ______________________________________________________
p) Description of manufacturing/production company and network of sales offices ________
____________________________________________________________________________
q) Is company having branches? If yes, please furnish details __________________________
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r) Does company have service organisations with multiple branches ____________________

s) Are all sites are operating under one centrally controlled and administered FSMS ______
t) Has company conducted internal audits within past one year _______________________
u) Has company covered multi-sites during internal audits conducted ___________________
v) Whether company requires combined certification for all sites ______________________

24.If ISO 13485:2016 certification/registration is sought, furnish list of medical device files and
details of all products in the below table:
NONE

Main Technical Area Product Details (please List/write all

Technical Area
products)
Non-active Medical Devices General non-active,
non-implantable
medical devices
Non-active implants
Devices for wound
care
Non-active dental
devices and
accessories
Non-active medical
devices other than
specified above
Active Medical Devices (Non- General active medical
implantable) devices
Devices for imaging
Monitoring devices
Devices for radiation
therapy and thermo
therapy
Active (non-
implantable) medical
devices other than
specified above
Active Implantable Medical General active
Devices implantable medical
devices
Implantable medical
devices other than
specified above
In Vitro Diagnostic Medical Reagents and reagent
Devices products, calibrators
(IVD) and control materials
for: Clinical Chemistry,
Immunochemistry
(Immunology),
Haematology/Haemost
asis/Immunohematolo
gy, Microbiology,
Infectious Immunology,
Histology/Cytology,
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Genetic Testing
In Vitro Diagnostic
Instruments and
software
IVD medical devices
other than specified
above
Sterilisation Methods for Ethylene oxide gas
Medical Devices sterilization (EOG)
Moist heat
Aseptic processing
Radiation sterilization
(e.g. gamma, x-ray,
electron beam)
Sterilization method
other than specified
above
Devices Incorporating/ Medical devices
Utilising Specific Substances/ incorporating
Technologies medicinal substances
Medical devices
utilizing tissues of
animal origin
Medical devices
incorporating derivates
of human blood
Medical devices
utilizing
micromechanics
Medical devices
utilizing nanomaterials
Medical devices
utilizing biological
active coatings and/or
materials or being
wholly or mainly
absorbed
Parts or Services Raw materials
(Raw metals, plastic,
wood, ceramic)
Components
(Electrical
components,
fasteners, shaped raw
materials, machined
raw materials and
molded plastic)
Subassemblies
(Electronic
subassemblies
mechanical
subassemblies, made
to drawings and/or
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work instructions)
Calibration services
(Verification/confirmati
on services for
measuring instruments,
tools or test fixtures)
Distribution services
(Distributors providing
storage and delivery of
medical devices, not
acting as a ‘legal
manufacturer’ for
medical devices)
Maintenance services
(Electrical or
mechanical repair
services, facility
cleaning and
maintenance services,
uniform cleaning and
testing of ESD
smocks.)
Transportation services
(Trucking, shipping, air
transportation service
in general)
Other services
(Consulting services
related to medical
devices, packaging
services, etc.)

25.If ISO 27001 certification/registration is sought, please furnish the following details:
(use extra sheets if required)
NONE

a. Number of Users _______________ Number of Sites _______________

b. Number of Servers, Work stations, PCs, laptops______________________
c. Number of application development & Maintenance Staff______________
d. Network & encryption technology__________________________________
e. Significance in legal compliance_____________________________________
f. Applicability of Sector specific Law & applicable risk___________________
g. A brief on Asset Management, Access Control and Risk Assessment Process
h. A brief on Information Security Incident Management Process
i. Documents mandatory for ISMS implementation developed and submitted to TCL
such as Statement of Applicability, Risk Treatment Plan, Risk Assessment report,
Risk assessment and treatment methodology, Information security policy and
Objectives etc. Yes No
j. Any ISMS related information (records or information on design and effectiveness of
controls) that cannot be made available for review by the audit team as they
contain confidential or sensitive information. Please provide details:
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_________________________________________________________________

26.What is your approximate schedule for assessment for certification/registration?

Pre-assessment by _________________ Certification Audit by 24 Oct 2023

27.Do you intend to have Observers or Guides during the audit? If yes, please give details.

NONE
________________________________________________________________________________

It is hereby certified that the information furnished above and enclosed as extra sheets is true and
complete to the best of my knowledge.

I/We fully understand the failure to provide above necessary and true information could delay processing
of my application for certification/registration. I/We undertake to furnish any additional information or
documentary evidence as and when asked by TCL for review of application for certification/registration.

I/We understand that Transpacific Certification Ltd. has full right to accept or decline this application
and in the event of rejection of this application, reasons for declining application will be furnished by
TCL.

I/we understand that in case of combined audits for integrated certification (if applicable), combined
audit durations are based on declared levels of system integration. If these subsequently found to be
invalid, TCL audit team has right to modify or adjust audit durations.

I/we fully understand that in upon acceptance of application for registration, we shall have to undergo
audit to verify compliance to requirements of the applicable standard. If during audit, the available
evidence indicates that the audit objectives are unattainable and compliance to applicable standard is
not demonstrated, TCL shall have right to reconfirm or modify the audit programme or audit scope or
terminate audit at our expenses.

I/we agree to abide by TCL policy or use of certification marks and logos upon award of certification.
I/we declare that under no circumstances, certification marks and logos shall be used or applied to
laboratory test, calibration or inspection reports, as such reports are deemed to be products.

Arne Saputra, S.T.

Signatures Name & Seal of authorized signatory

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