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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
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. Page 1
PT. Bureau Veritas Indonesia PUSKESMAS UTAN KAYU SELATAN 1
1. GENERAL INFORMATION
Address
City
Postal Code
County
Country
Contract nº 3358081
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. Page 2
PT. Bureau Veritas Indonesia PUSKESMAS UTAN KAYU SELATAN 1
2. AUDIT INFORMATION
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.
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. Page 3
PT. Bureau Veritas Indonesia PUSKESMAS UTAN KAYU SELATAN 1
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. Page 4
PT. Bureau Veritas Indonesia PUSKESMAS UTAN KAYU SELATAN 1
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.
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. Page 5
PT. Bureau Veritas Indonesia PUSKESMAS UTAN KAYU SELATAN 1
Audit Plan
Date - Time Site Name Process Auditor Comment
Activity
23/04/2015 - 08:30 PUSKESMAS UTAN KAYU SELATAN 1 All BOS-223, ARS
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 :
Break Clause :
Audit Clause :
Reporting Clause :
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. Page 6
PT. Bureau Veritas Indonesia PUSKESMAS UTAN KAYU SELATAN 1
- Clause :
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. Page 7
PT. Bureau Veritas Indonesia PUSKESMAS UTAN KAYU SELATAN 1
Comment N/A
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. Page 8
PT. Bureau Veritas Indonesia PUSKESMAS UTAN KAYU SELATAN 1
3. AUDIT PROCESS
KIA/KB
Total
BPG
BPU
All
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. Page 9
PT. Bureau Veritas Indonesia PUSKESMAS UTAN KAYU SELATAN 1
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
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. Page 10
PT. Bureau Veritas Indonesia PUSKESMAS UTAN KAYU SELATAN 1
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.
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. Page 11
PT. Bureau Veritas Indonesia PUSKESMAS UTAN KAYU SELATAN 1
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.
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.
9. Customer satisfaction
Customer satisfaction survey has been completed done by organization for period Feb 2015 (Sem 1)
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. Page 12
PT. Bureau Veritas Indonesia PUSKESMAS UTAN KAYU SELATAN 1
*) 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]
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. Page 13
PT. Bureau Veritas Indonesia PUSKESMAS UTAN KAYU SELATAN 1
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. Page 14