Assessment Report (tentative).

Puskesmas Lubuk Buaya

Report
Author

Agus Komara

Visit Start Date

09/11/2015

Page 1 of 8

Assessment Report.

Introduction.
This report has been compiled by Agus Komara and relates to the assessment activity detailed below:

Visit ref/Type/Date/Duration

Certificate/Standard

Site address

8433030

FS 644904

Stage 1 Audit

ISO 9001:2008

Puskesmas Lubuk Buaya

Jl. Adinegoro KM 15
Kel. Lubuk Buaya, Kec. Koto Tangah
Padang, Sumatera Barat
25172
Indonesia

09/11/2015
0.5 day(s)
Effective no. of employees : 15
Total no. of employees : 15

The objective of the assessment was to determine the organisation's readiness for the stage 2 audit and to ensure its effective
planning.

Management Summary.
Overall Conclusion
I am pleased to confirm your readiness to proceed to the Stage Two assessment.
The stage 2 audit duration is planned to be 2 day(s). As a result of this visit the duration is to be reviewed and confirmed by our
Sales department.
The scope of the audit is refer to below.
The objectives of this assessment have been achieved. I would like to thank all the audit participants for their assistance and cooperation which enabled the audit to run smoothly and to schedule.
Based on the objective evidence detailed within this report, the areas assessed during the course of the visit were generally found to
be effective.
There were no outstanding nonconformities to review from previous assessments.
3 nonconformities requiring attention were identified. These, along with other findings, are contained within subsequent
sections of the report.
A nonconformity relates to a single identified lapse, which in itself would not indicate a breakdown in the management system's
ability to effectively control the processes for which it was intended. It is necessary to investigate the underlying cause of any issue to
determine corrective action. The proposed action will be reviewed for effective implementation at the next assessment.
Please submit a plan to BSI detailing the nonconformity, the cause, correction and your proposed corrective action, with
responsibilities and timescales allocated. The plan is to be submitted no later than 17/11/2015 by e-mail or fax to the correspondence
address below, referencing the report number.

Report
Author

Agus Komara

Visit Start Date

09/11/2015

Page 2 of 8

Assessment Report.

Mandatory Requirements.
Justified Exclusions 7.3

Areas Assessed & Findings.

Confirmation of the scope activity to be covered and implementation of the system to be audited : QMS 1.2;4.1
Organization documentation system : QMS 4.2

Observations.
Type

Area/Process

Clause

Observations

Organization documentation system

4.2.4

Scope

FS 644904

Details:

Daftar Disribusi Dokumen perlu ditandatangani oleh penerima dokumen

Policy, Objective, Roles and Responsibility : QMS 5.1;5.2;5.3;5.4.1;5.4.2;5.5.1;5.5.2;5.5.3

Observations.
Type

Area/Process

Clause

Observations

Policy, Objective, Roles and Responsibility

5.4.1

Scope

FS 644904

Details:

a) Target Sasaran mutu perlu ditinjau ulang, disesuaikan dengan kemampuan dan riwayat pelayanan. Cth.
Sasaran mutu Peningkatan kualitas pelayanan UGD 80%
b) Formula perhitungan realisasi Sasaran Mutu perlu ditetapkan dengan jelas. Cth. Formula untuk
perhitungan Sasaran Mutu pelaporan sebelum tanggal 5
c) Realisasi pencapaian Sasaran Mutu perlu didukung dengan data-data real

Review of operation of the QMS and identification of relevant operations and processes : QMS
6.1;6.2;6.3;6.4;7.1;7.2;7.4;7.5;8.1;8.2.1;8.2.3;8.2.4;8.3;8.4

Observations.
Type

Area/Process

Clause

Observations

Review of operation of the QMS and identification of relevant operations and

processes

6.3

Scope

FS 644904

Details:

Jadwal dan realisasi pemeliharaan alat non-alkes perlu disediakan

Report
Author

Agus Komara

Visit Start Date

09/11/2015

Page 3 of 8

Assessment Report.

Opportunity for improvement.

Type

Area/Process

Clause

Opportunity for
improvement

Review of operation of the QMS and identification of relevant operations and

processes

4.2.2

Scope

FS 644904

Details:

Terdapat kesalahan penulisan dalam Pedoman Mutu Bagian 7.0 Realisasi Produk, point 7.4.2 yang perlu
dikoreksi

Internal Audit and Management Review : QMS 8.2.2;5.6

Observations.
Type

Area/Process

Clause

Observations

Internal Audit and Management Review

4.2.4

Scope

FS 644904

Details:

Evidence of present internal auditor in the internal audit training, or certification of internal audit training
needs to be provided
---------Bukti hadir Auditor internal dalam pelatihan internal audit, atau sertifikasi pelatihan internal audit perlu
disediakan

Readiness and Plan for Stage-2 :

Report
Author

Agus Komara

Visit Start Date

09/11/2015

Page 4 of 8

Assessment Report.

Minor Nonconformities Arising from this Assessment.

Ref

Area/Process

Clause

1262827N1

Confirmation of the scope activity to be covered and implementation of the

system to be audited

4.2.2

Scope

FS 644904

Statement of non
conformance:

a) Mengacu ke Pedoman Mutu Bagian 1.0 Tujuan dan Ruang Lingkup, dan Bagian 7.0 Realisasi Produk,
organisasi menetapkan pengecualian terhadap klausul 7.6 Pengendalian peralatan Pemantauan dan
pengukuran. Pengecualian ini tidak sesuai karena organisasi menggunakan alat-alat ukur dalam melakukan
pelayanan
b) Bisnis proses yang mengacu ke Pedoman Mutu didokumentasikan dalam "Interaksi Proses", tidak
tersedia

Requirements:

Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions
(see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.

Objective
Evidence:

Pedoman Mutu Bagian 1.0 Tujuan dan Ruang Lingkup, dan Bagian 7.0 Realisasi Produk

Ref

Area/Process

Clause

1262827N2

Review of operation of the QMS and identification of relevant operations and

processes

7.4.1

Scope

FS 644904

Statement of non
conformance:

Berdasarkan informasi, dalam kondisi tertentu, Puskesmas memungkinkan untuk melakukan pemilihan
supplier untuk beberapa supplier yang direkomendasi dari DKK. Penerimaan barang dan jasa dilakukan oleh
Puskesmas, namun kriteria evaluasi dan bukti pelaksanaan evaluasinya belum ditetapkan

Requirements:

Purchasing process
The organization shall ensure that purchased product conforms to specified purchase requirements. The
type and extent of control applied to the supplier and the purchased product shall be dependent upon the
effect of the purchased product on subsequent product realization or the final product.
The organization shall evaluate and select suppliers based on their ability to supply product in accordance
with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be
established.
Records of the results of evaluations and any necessary actions arising from the evaluation shall be
maintained (see 4.2.4).

Objective
Evidence:

Pedoman Mutu Bagian 7.0 Realisasi Produk

Report
Author

Agus Komara

Visit Start Date

09/11/2015

Page 5 of 8

Assessment Report.
Ref

Area/Process

Clause

1262827N3

Review of operation of the QMS and identification of relevant operations and

processes

6.2.1

Scope

FS 644904

Statement of non
conformance:

Standard kompetensi belum lengkap untuk seluruh level yang ada di Puskesmas, misalnya Perawat, Bidan,
UGD, Klinik Bersalin, dll

Requirements:

General
Personnel performing work affecting conformity to product requirements shall be competent on the basis of
appropriate education, training, skills and experience.
NOTE Conformity to product requirements can be affected directly or indirectly by personnel performing
any task within the quality management system

Objective
Evidence:

Standard kompetensi

Assessment Participants.
On behalf of the organisation:

Name

Position

Refer to atendance list

Refer to atendance list

The assessment was conducted on behalf of BSI by:

Name

Position

Agus Komara

Team Leader

Next Visit Plan.

Visit objectives:
Stage 2
The objective of the assessment is to conduct a certification assessment to ensure the elements of the proposed scope of registration
and the requirements of the management standard are effectively addressed by the organisation's management system and to
confirm the forward strategic plan.
Visit Criteria
Stage-2
Visit Scope
Refer to above

Date

Assessor

Report
Author

Agus Komara

Visit Start Date

09/11/2015

Time

Page 6 of 8

Area/Process

Clause

Assessment Report.

Please note that BSI reserves the right to apply a charge equivalent to the full daily rate for cancellation of the visit by the
organisation within 30 days of an agreed visit date.

Scope of Certificate FS 644904 (ISO 9001:2008).

Main Scope
The provision of health services including Poliklinik (Poli Umum, Poli Gigi, Poli KIA, Poli KB, Poli Lansia), Pharmacy, Emergency,
Ambulance, Laboratory and Administration services
Location

Scope

Puskesmas Lubuk Buaya

Jl. Adinegoro KM 15
Kel. Lubuk Buaya, Kec. Koto Tangah
Padang, Sumatera Barat
25172
Indonesia

Main Certificate Scope applies.

PUSKES-0047580207-000

Notes.
The assessment was based on sampling and therefore nonconformities may exist which have not been identified.
If you wish to distribute copies of this report external to your organisation, then all pages must be included.
BSI, its staff and agents shall keep confidential all information relating to your organisation and shall not disclose any such
information to any third party, except that in the public domain or required by law or relevant accreditation bodies. BSI staff, agents
and accreditation bodies have signed individual confidentiality undertakings and will only receive confidential information on a 'need
to know' basis.
This report and related documents is prepared for and only for BSIs client and for no other purpose. As such, BSI does not accept or
assume any responsibility (legal or otherwise) or accept any liability for or in connection with any other purpose for which the Report
may be used, or to any other person to whom the Report is shown or in to whose hands it may come, and no other persons shall be
entitled to rely on the Report.
Should you wish to speak with BSI in relation to your registration, please contact your customer service officer.
PT BSI Group Indonesia
Menara Bidakara 2
17th Floor, Unit 5
Jl. Jend. Gatot Subroto Kav. 71-73
Komplek Bidakara, Pancoran
Jakarta Selatan 12870 - Indonesia
Tel: +62 21 8379 3174 - 77 Fax:+62 21 8379 3287

Regulatory Compliance.
Report
Author

Agus Komara

Visit Start Date

09/11/2015

Page 7 of 8

Assessment Report.
BSI requires to be informed of all relevant regulatory non-compliance or incidents that require notification to any regulatory authority.
Acceptance of this report by the client signifies that all such issues have been disclosed as part of the assessment process and
agreement that any such non-compliance or incidents occurring after this visit will be notified to BSI as soon as practical after the
event.

Expected Outcomes for Accredited Certification.

What accredited certification means:
The accredited certification process provides confidence that the organization has a management system that conforms to the
applicable requirements of the certified standards covered within this assessment and scope of certification.
What accredited certification does not mean:
It is important to recognize that certification defines the requirements for an organization's management system, not for its products
or services. It does not imply that the organization is providing a superior product or service, or that the product, service or
performance itself is certified as meeting the requirements of an ISO standard or specification or that the organisation can
guarantee 100% product, service or performance conformity, though this should of course be a permanent goal.

Report
Author

Agus Komara

Visit Start Date

09/11/2015

Page 8 of 8