CERTIFICATION AUDIT REPORT
PUSKESMAS UTAN KAYU SELATAN 1
3358081
PT. Bureau Veritas Indonesia
Audit on site 1. surveillance visit / ISO 9001
Audit on site 1. surveillance visit / ISO 9001 Audit Start Date: 23/04/2015 - Audit End Date: 23/04/2015
This report is confidential and distribution is limited to the audit team, the company and the Bureau Veritas Certification office.
PT. Bureau Veritas Indonesia PUSKESMAS UTAN KAYU SELATAN 1
INDEX
1. GENERAL INFORMATION
1.1 ORGANIZATION INFORMATION
1.2 CONTACT INFORMATION
2. AUDIT INFORMATION
2.1 AUDIT STANDARDS
2.2 SCOPE OF CERTIFICATION
2.3 AUDITOR INFORMATION
2.4 AUDIT SCOPE
- Audit Objectives
- Audit Plan
- General & legal compliance requirements
3. AUDIT PROCESS
3.1 AUDIT SUMMARY REPORT PER STANDARD
4. EXECUTIVE AUDIT SUMMARY
4.1 AUDIT CONCLUSIONS
4.2 SUMMARY OF AUDIT FINDINGS
4.3 MANAGEMENT SYSTEM EFFECTIVENESS
4.4 BEST PRACTICES
4.5 OBSERVATIONS
5. TEAM LEADER RECOMMENDATIONS
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1. GENERAL INFORMATION
1.1 ORGANIZATION INFORMATION
Organization Name PUSKESMAS UTAN KAYU SELATAN 1
Address
City
Postal Code
County
Country
Phone Nº 021-8511129, 08156859527 Fax Nº N/A
Contract nº 3358081
1.2 CONTACT INFORMATION
Contact Name Mrs. dr. Nina Triana
Email Address natri_71@yahoo.co.id Phone Nº 021-8511129,
08156859527
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2. AUDIT INFORMATION
2.1 AUDIT STANDARDS
Audit Standard(s) ISO 9001
2.2 SCOPE OF CERTIFICATION
Language Site Name Head Scope of Certification
Office
English PUSKESMAS UTAN BASIC MEDICAL SERVICES
KAYU SELATAN 1
Nº of Sites 1
Nº of Employees 9
Head Office
If this is a multi-site audit an Appendix listing all the relevant sites and/or remote locations has been established and attached to
the audit report.
Type Audit on site 1. surveillance visit
Audit Start Date 23/04/2015 Audit End Date 23/04/2015 Duration 1
Audit on site 1. surveillance visit / ISO 9001 Audit Start Date: 23/04/2015 - Audit End Date: 23/04/2015
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2.3 AUDITOR INFORMATION
Team Leader Team Members
BONARDO SIANTURI ARMIDA SIMANUNGKALIT
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2.4 AUDIT SCOPE
Audit Objectives
1. To confirm that the management system conforms with all the requirements of the audit standard(s);
2. To confirm that the organization has effectively implemented its planned arrangements;
3. To confirm that the management system is capable of achieving the organization’s policies and objectives and
evaluation of the ability of the management system to ensure the client organization meets applicable statutory,
regulatory and contractual requirements;
4. If applicable to identify areas for potential improvement of the management system.
5. To confirm that the certified management system(s) conforms with requirements of to the standard, including, but
not limited to :
a) internal audits and management review,
b) a review of actions taken on nonconformities identified during the previous audit,
c) treatment of complaints,
d) effectiveness of the management system with regard to achieving the certified client's objectives,
e) progress of planned activities aimed at continual improvement,
f) continuing operational control,
g) review of any changes, and
h) use of marks and/or any other reference to certification.
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Audit Plan
Date - Time Site Name Process Auditor Comment
Activity
23/04/2015 - 08:30 PUSKESMAS UTAN KAYU SELATAN 1 All BOS-223, ARS
Opening meeting Clause :
23/04/2015 - 09:00 PUSKESMAS UTAN KAYU SELATAN 1 MR/DCC/IA BOS-223, ARS Include Verification of NCs (if any)
Audit Clause :
23/04/2015 - 10:30 PUSKESMAS UTAN KAYU SELATAN 1 Loket & Administrasi BOS-223, ARS
Audit Clause :
23/04/2015 - 12:00 PUSKESMAS UTAN KAYU SELATAN 1 All BOS-223, ARS
Break Clause :
23/04/2015 - 13:00 PUSKESMAS UTAN KAYU SELATAN 1 BPU BOS-223, ARS
Audit Clause :
23/04/2015 - 16:00 PUSKESMAS UTAN KAYU SELATAN 1 BOS-223, ARS
Reporting Clause :
23/04/2015 - 17:00 PUSKESMAS UTAN KAYU SELATAN 1 All BOS-223, ARS
Closing meeting Clause :
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Date - Time Site Name Process Auditor Comment
Activity
23/04/2015 - 17:30 PUSKESMAS UTAN KAYU SELATAN 1 BOS-223, ARS End of Audit
- Clause :
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Audit plan preparation date 23/04/2015
Comment N/A
General & legal compliance requirements
List of applicable legal requirements related to Products / Services of organization:
1. UU No. 36 Tahun 2009 Tentang Kesehatan,
2. Kepmenkes No 296/Menkes/SK/III/2008 tentang Pedoman Pengobatan Dasar di Puskesmas,
3. Permenkes No 269/Menkes/Per/III/2006 tentang Rekam Medis,
4. Kepmenkes No. 679/Menkes/SK/V/2003 tentang Registrasi dan Izin Kerja Apoteker,
5. Permenkes No. 363/Menkes/Per/IV/1998 tentang Pengujian dan Kalibrasi Alat Kesehatan.
6. Keputusan Menteri Kesehatan Republik Indonesia No. 1204 Year 2004 about Persyaratan Kesehatan Lingkungan
Rumah Sakit.
7. Permenkes RI No. 889/MENKES/PER/V/ Year 2011 about Registrasi, Izin Praktik dan Izin Kerja Tenaga Kefarmasian.
8. Permenkes RI No. 2052/MENKES/PER/X/ Year 2011 about Izin Praktik dan Pelaksanaan Praktik Kedokteran.
Result of compliance to above applicable requirements:
The compliance of the applicable customer requirement / government regulation which relate to product and / or service
has been verified and the implementation was found to be followed and complied properly.
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3. AUDIT PROCESS
3.1 AUDIT SUMMARY REPORT PER STANDARD ISO 9001
Clauses Department / Activity / Process
Loket & Administrasi
Kamar Obat
MR/DCC/IA
KIA/KB
Total
BPG
BPU
All
9K-4 Quality management system -
9K-4.1 General requirements
9K-4.2.1 General Documentation Requirements
9K-4.2.2 Quality Manual
9K-4.2.3 Control of Documents
9K-4.2.4 Control of Records
9K-5 Management responsibility
9K-5.1 Management commitment
9K-5.2 Customer focus
9K-5.3 Quality policy
9K-5.4.1 Quality Objectives (Planning)
9K-5.4.2 Quality Management system Planning
9K-5.5 Responsibility. authority and communication
9K-5.6 Management review
9K-6 Resource management
9K-6.1 Provision of resources
9K-6.2 Human resources
9K-6.2.2 Competence, Awareness and Training
9K-6.3 Infrastructure
9K-6.4 Work Environment
9K-7 Product realization
9K-7.1 Planning of Product Realization
9K-7.2 Customer-related processes
9K-7.3 Design and Development
9K-7.4 Purchasing
9K-7.5.1 Control of Production and Service
9K-7.5.2 Validation of Processes for Production and Service
9K-7.5.3 Identification and Traceability
9K-7.5.4 Customer Property
9K-7.5.5 Preservation of Product
9K-7.6 Control of monitoring and measuring devices
9K-8 Measurement. analysis and improvement
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Department / Activity / Process
Loket & Administrasi
Kamar Obat
MR/DCC/IA
KIA/KB
Total
BPG
BPU
All
-
9K-8.1 General
9K-8.2.1 Customer Satisfaction
9K-8.2.2 Internal Audit
9K-8.2.3 Monitoring and Measurement of Processes
9K-8.2.4 Monitoring and Measurement of Product
9K-8.3 Control of non-conforming product
9K-8.4 Analysis of data
9K-8.5.1 Continual Improvement
9K-8.5.2 Corrective Action
9K-8.5.3 Preventive Action
9K-Use of Logo
Total
Exclusions justification
- 9K-7.3 Design and development The justification of exclusion has been asessed and verified.
- 9K-7.4.1 Purchasing process 1. Clause 7.3 was excluded since the health services program
- 9K-7.4.2 Purchasing information are established by the Dinas Kesehatan
2. Clause 7.4.1 & 7.4.2 were excluded since all material,
services and equipment purchased are provided by
Puskesmas Kecamatan Matraman
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4. EXECUTIVE AUDIT SUMMARY
4.1 AUDIT CONCLUSIONS
This report is a summary of the results of the QMS ISO 9001:2008 Main Audit that was conducted at PUSKESMAS
UTAN KAYU SELATAN 1 on 23 April 2015 by Mr. Bonardo Sianturi (BOS) and Mr. dr. Armida Simanungkalit (ARS -
Technical Expert) from Bureau Veritas Certification Indonesia and covered PQC 38. The following scope was verified:
BASIC MEDICAL SERVICES. The basis of this audit was the Pedoman Mutu (PDM - 1.1 ; Rev00 ; effective dated on
1 April 2011) and other associated documentation and records. All the elements of the QMS were audited and
covered accordingly. For detail information of Mandatory Requirement Review, please refer to "Mandatory Auditors
Notes" Section in this Audit Report.
The auditor conducted a process-based audit focusing on customer requirements, standard requirements and
company procedures. The audit methods used were interviews, observations, sampling of activities and review of
documentation and records. The structure of the audit was in accordance with the audit plan and audit planning
matrix included in the Appendices to this summary report.
Throughout 1 ManDay of QMS ISO 9001:2008 assessment, the audit team concludes that the organization has
established and maintained its management system in line with the requirements of the standard(s) and
demonstrated the ability of the system to achieve requirements for products and/or services within the scope and the
organization’s policy and objectives. The management system documentation demonstrated conformity with the
requirements of the audit standard and provided sufficient structure to support implementation and maintenance of
the management system. The organisation has demonstrated effective implementation and maintenance /
improvement of its management system. The internal audit programme has been fully implemented and
demonstrates effectiveness as a tool for maintaining and improving the management system.
Therefore the audit team recommends that, based on the results of this audit and the system’s demonstrated state of
development and maturity, that this management system certification could be maintained.
The Strength points of the Management System could be referred to "Best Practices" Section in this 1st Surveillance
Audit Report.
4.2 SUMMARY OF AUDIT FINDINGS
N° of Non Conformities recorded Major 0 Minor 0
Is a follow up audit required No
Follow up audit start date
Duration (days) 0
Actual follow up date(s) ~
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4.3 MANAGEMENT SYSTEM EFFECTIVENESS
MANDATORY REQUIREMENT REVIEW OF :
1. Management system Documentation;
The management system documentation demonstrated conformity with the requirements of audit standard and
provided sufficient structure to support the implementation and maintenance of management system. The Pedoman
Mutu of company was identified comprehensively with relevant processess and its interaction of function level. Each
process identified and its interaction with function level were defined in the QMS procedures which refer to ISO
9001:2008 Standard. The QMS documented procedures, business process and procedures were required to
enhance the effectiveness of QMS implementation which were included in Pedoman Mutu. The applicable working
instructions have been established for ensuring the product / service of realization process, supporting process and
management process to be aligned with Quality Policy and Quality Objectives.
2. Effective implementation and maintenance;
The organization has demonstrated effective implementation and maintenance / improvement of its management
system.
3. Improvement;
Continual improvement was taken by using the information of Customer's feedback and analysis, suppliers
performance, internal audit, data’s of corrective and preventive action implementation. Review on Quality
Management System was conducted once a year.
4. Key performance objectives and the monitoring of these towards achievement;
Top Management established Quality Policy and Quality Objectives as their commitment to focus on meeting
Customer requirements and continual improvements with relevant function to departments / sections; BPU, loket
registration, Administration. The monitoring and measurement of Quality Objectives for the achievements were
reported to Top Management through Management Review Meeting.
5. Internal Audit programme;
The internal audit programme has been fully implemented and demonstrated effectiveness as a tool for maintaining
and improving the management system. Internal Audit has been conducted as per Internal Audit Programme. The
Nonconformities identified within internal audit finding have been solved and been closed properly. The identification
of root cause analysis was effective to eliminate the cause of Nonconformity found.
6. Management Review;
Management Review has been well-conducted as planned by Company Schedule. The outputs of Management
Review were recorded in minute of management review meeting. The outputs would be basis to consider the
continual improvement.
7. Corrective and preventive action;
Corrective and Preventive action have been taken properly by organization to eliminate the causes of NC and
potential NC. Based on Management Review implementation recorded, there was no outstanding status of
Corrective and Preventive action. The corrective action has been carried out for internal audit findings accordingly.
8. Validation of Scope & Exclusion;
The audit team has validated the scope of certification in the following manner:
*) Clause 7.3 was excluded since the health services program are established by the Dinas Kesehatan.
*) Clause 7.4 was excluded since all material, services and equipment purchased are provided by Puskesmas
Kecamatan Matraman
*) Organization has the ability to conduct product realization as determined on the business process and its
supported by relevance quality procedures.
*) Scope of supply, the scope coverage is relevant to the contract.
9. Customer satisfaction
Customer satisfaction survey has been completed done by organization for period Feb 2015 (Sem 1)
10. Use of logo
No issue about this item. Logo is used for business card name, header of company letter.
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4.4 BEST PRACTICES
*) The commitment of PUSKESMAS KELURAHAN UTAN KAYU SELATAN 1 management was well-performed to
develop and implement the QMS and continually improved its effectiveness by communicating to the organization
about the importance on meeting Customer as well as statutory and regulatory requirements and establishing the
Quality Policy.
*) Organization has maintained & comitment to keep the personnel competences that needed for their business.
*) The organization is eager to improve themselves through QMS and determination of the customer requirement.
*) Organization was effectivelly in QMS implementation and maintained the QMS system, it was captured from
management responsibility and product realization implementation.
*) Continual improvement is regularly implemented through Internal audit, Management Review, Measuring of
objectives & program and every decision from Top Management
*) Top management established QMS Policy and Objective & programme as their commitment to focus in customer
satisfaction and continual improvements. Monitoring and measurement of Objectives for the achievements were
reported to top management through management review meeting by annually .
*) Internal audit was effectivelly conducted by internal auditor team and consistent in conducting of internal audit,
Some improvements in their finding to improve QMS system
*) Management review was one of system monitoring the system was effectivelly conducted and commitment
management was captured in the meeting where the top management always attending to the meeting
*) According to customer complaint and internal audit finding that corrective and preventive action has been fully
implemented
4.5 OBSERVATIONS
1. Perhatian khusus bagi organisasi untuk menetapkan sasaran mutu supaya lebih spesifik [BPU]
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5. TEAM LEADER RECOMMENDATIONS
Standard Accreditation Certificate Copies Language
ISO 9001 KAN 0 Indonesian
Standard ISO 9001
Recommendation Maintain Certification
Reason for issue or change of
the certificate
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