Beruflich Dokumente
Kultur Dokumente
Ref:
2012/50635/SU1
Audit Report
For
UPT PUSKESMAS KECAMATAN ALAS
Date(s):
Standard(s)
audited:
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Report
Ref:
2012/50635/SU1
Code
1
Cover Sheet
Audit Administration
10
11
Total Pages
21
This report remains confidential between the client and the ROS group of companies (ROS, URS, GRI) and as such, should not be circulated to other
parties without the express permission, in writing, of both parties; with the exception of the ROS Group of Companies Regulators.
The contents of this report have been made by the impartial auditor(s) and are based on random samples selected during the audit Process.
As such, the report does not infer that the comments and/or concerns contained within this report are exhaustive in nature.
It will be assumed that the client fully accepts the findings within this report, unless notification, in writing, is made by the client to their local
office within 5 working days of the last day of this audit.
Contractual/Regulations/Liability - The client is reminded that this audit activity has been performed in connection with the quotation/contract and the
client should be aware of the scheme regulations and liability clauses which can be found on the ROS Group commercial websites (www.rosgroup.com , www.urscertification.com www.globalregistrars.com)
Whilst it is the ROS Groups policy to offer competitive fees, clients that cancel pre-arranged visits without at least 5 working days written notice,
may be charged for such a cancellation. Please refer to the Scheme Regulations that are stated on our websites, under
Regulations/Complaints/Appeals.
CODE M = mandatory report content, R = Required Content when Concerns or Comments are recorded. O = Optional report content.
Management System Requirement (MSR) is defined as a part of a clause of the standard. A total breakdown of a requirement (MSR) is a situation
where there is no evidence of implementation or, based on a reasonable audited sample size, implementation is not effective. A breakdown of a
requirement is a situation where the samples audited show some implementation but does not constitute a total breakdown.
Management System Clause (MSC) is defined as a collection of related requirements. A breakdown of a clause (MSC) is a situation where there
may not be a total breakdown of a requirement but a breakdown of more than one of the related requirements within that clause, whether the
breakdown of those requirements occur in a single department/process or more than one department/process, where that requirement is
implemented.
Note that the auditor has endeavoured to take a reasonable sample size based on the volume of the process output to test the effective
implementation of a clause or requirement. Reasonable sample size is subjective the client may request that the auditor expands the sample size
in order to confirm that the sample does not constitute a total breakdown.
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Report Ref:
2012/50635/SU1
Audit Administration
Client management
contact:
Lead Auditor:
Hadi Nugroho
Audit days
2.0
Auditor:
Auditor:
Auditor:
Specialist:
NA
Translator:
NA
Other:
NA
Certification Scope
NIL
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Report Ref:
2012/50635/SU1
Audit Objectives
This audit was conducted to confirm that the clients Management System meets internal, customer and
regulatory requirements to fulfill the Goal of the standard that has been audited (e.g. ISO14001 the
Goal is the reduction or elimination of pollution, ISO/TS16949 the Goal is the reduction of variation and
waste in the supply chain, OHSAS18001 the Goal is the elimination or reduction of risks to
Satisfactory
Unsatisfactory/Degrading
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Process Name
Satisfactory/Effective
Unsatisfactory/Degrading
Not Effective
Management
Representative (doc control,
internal audit, management
review,
customer
survey,
Resources
Management
(competence of personnel &
training, maintenance of
infrastructure procurement,
logistic)
Locket (registration, storage
of medical record)
Polyclinic (physicians, dental,
KIA-KB, MTBS (immunization) ,
etc)
Inpatient & Emergency
Response (ambulance,
emergency unit)
Supporting (pharmacy,
laboratory include calibration)
UKM (Nutrition, TBC, malaria)
Total Concerns
Total OFI/PNC
11
Enhancement/Improving means that there is evidence of improved process performance or improvements arising
from corrective actions.
Satisfactory means that there is evidence that requirements are being met but improvements have not yet been
realized due to recent implementation of systems. Or requirements are being met but no improvement plans have been
identified/implemented. This report may contain some comments: Opportunities for Improvements (OFI) or Potential NonCompliances (PNC).
Unsatisfactory/Degrading means that there is evidence of a decrease in process performance since the last audit. Or
corrective action has not been effective. Or requirements and/or client protocols have not been followed and/or
implemented fully. This report may contain some Discrepancies (Minor NCs) or Non-compliances (Major NCs).
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Report
Ref:
2012/50635/SU1
3. It was found that calibration was not conducted to all equipment as seen that calibration
record and next plan calibration was not provided
Kalibrasi belum dilakukan untuk semua peralatan
D (discrepancies) :
1. Inadequate evidence that all agenda of management review was discussed as seen that
only process performance and customer complaint has been discussed
Tinjauan Manajemen tidak dilakukan untuk semua agenda
2. It was found that some therapies was not effectively conducted as seen that SOAP note
was not completely determined in the medical record for Ophthalmologist (poli mata) : px.
295 (1/nov/2012) and dental clinic : px. 433 (7/nov/12)
Penulisan SOAP di rekam medis tidak lengkap
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Report
Ref:
2012/50635/SU1
Audit Comments
Definitions of Comments
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Report
Ref:
2012/50635/SU1
Standard/Schem
e:
Definitions of
concerns
Mark as
relevant
Standard
A defined protocol does
not exist or omits a
requirement from the
standard, regulations or
scheme rules
Defined or required
protocol has not been
followed
Defined or required
protocol has been
followed but is not
effective
Concern No:
Regulation
State
reference/clause from
standard/regulation
scheme/process
Reason
Scheme
NC
Major
or D
Minor
NC
Major
D Minor
Process
Process
8.2.2
Protocol
NC
Major
D Minor
NC
Major
D Minor
NC
Major
D Minor
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Report
Ref:
2012/50635/SU1
Standard/Schem
e:
Definitions of
concerns
Mark as
relevant
Standard
A defined protocol does
not exist or omits a
requirement from the
standard, regulations or
scheme rules
Defined or required
protocol has not been
followed
Defined or required
protocol has been
followed but is not
effective
Concern No:
Regulation
State
reference/clause from
standard/regulation
scheme/process
Reason
Scheme
NC
Major
or D
Minor
NC
Major
D Minor
Process
Process
5.4.1
Protocol
NC
Major
D Minor
NC
Major
D Minor
NC
Major
D Minor
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Report
Ref:
2012/50635/SU1
Standard/Schem
e:
Definitions of
concerns
Mark as
relevant
Standard
A defined protocol does
not exist or omits a
requirement from the
standard, regulations or
scheme rules
Defined or required
protocol has not been
followed
Defined or required
protocol has been
followed but is not
effective
Concern No:
Regulation
State
reference/clause from
standard/regulation
scheme/process
Reason
Scheme
NC
Major
or D
Minor
NC
Major
D Minor
Process
Process
7.6
Protocol
NC
Major
D Minor
NC
Major
D Minor
NC
Major
D Minor
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Report
Ref:
2012/50635/SU1
Standard/Schem
e:
Definitions of
concerns
Mark as
relevant
Standard
A defined protocol does
not exist or omits a
requirement from the
standard, regulations or
scheme rules
Defined or required
protocol has not been
followed
Defined or required
protocol has been
followed but is not
effective
Concern No:
Regulation
State
reference/clause from
standard/regulation
scheme/process
Reason
Scheme
NC
Major
or D
Minor
NC
Major
D Minor
Process
Process
5.6.2
Protocol
NC
Major
D Minor
NC
Major
D Minor
NC
Major
D Minor
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Report
Ref:
2012/50635/SU1
Standard/Schem
e:
Definitions of
concerns
Mark as
relevant
Standard
A defined protocol does
not exist or omits a
requirement from the
standard, regulations or
scheme rules
Defined or required
protocol has not been
followed
Defined or required
protocol has been
followed but is not
effective
Concern No:
Regulation
State
reference/clause from
standard/regulation
scheme/process
Reason
Scheme
NC
Major
or D
Minor
NC
Major
D Minor
Process
Process
7.5.1
Protocol
NC
Major
D Minor
NC
Major
D Minor
NC
Major
D Minor
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Report Ref:
2012/50635/SU1
Applicable Standard
ISO 9001:2008
Current Activity
On-Site
Audit
Surveillanc
e
ReCert.
Special
Required
records to
be sent to
local office
within 20 of
days as
indicated
below
Audit Conclusion
Certification is Recommended
proceed to issue Certificate(s)
Certification is Recommended
subject to any actions stated above
being satisfactorily addressed
proceed to issue certificate(s)
Suspension of Certification
Recommended
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Report Ref:
2012/50635/SU1
Clauses of the Standard(s) audited this visit
ISO10002
4.8
4.9
4.2
4.3
4.4
4.5
4.6
4.7
5.3.
3
5.3.
4
5.3.
5
6.2
6.3
6.4
7.1
7.8
7.9
8.1
8.2
8.3
8.4
8.5
4.1
4.2
7.1
7.2
4.10
5.1
5.2
5.3.
1
5.3.
2
7.2
7.3
7.4
7.5
7.6
7.7
8.6.
1
8.6.
2
8.6.
3
8.7
7.4
7.5
4.1
4.2
5.1
5.2
5.3
5.4
5.5
7.2
7.3
7.4
7.5
7.6
7.7
7.8
7.6
8.1
8.2
8.3
ISO22000
5.6
5.7
7.9
7.10
8.4
6.4
8.5
5.8
6.1
6.2
6.3
6.4
8.1
8.2
8.3
8.4
8.5
3.1
3.2
3.3.
1
3.3.
2
BS EN 16001
3.3.
3.4.
3.4.
3
1
2
3.4.
3
3.4.
4
3.4.5
3.4.6
3.5.
1
3.5.
2
3.5.
3
3.5.
4
3.6.
2
3.6.
3
Annex 1
3.1
3.2
3.3
4.1
4.2
4.3
6.3
6.4
6.5
6.6
7.1
7.2
4.1
4.2
4.3.1
4.3.
2
4.4.5
4.4.6
4.4.7
4.5.
1
4.1
4.2
4.3.
1
4.4.
5
4.4.
6
4.4.
7
4.
1
4.
2
4.
3
3.5.
5
3.6.
1
ISO20000
4.4
4.4.
1
7.3
8.1
ISO 14001
4.3.
4.4.
3
1
4.5.
2
4.5.
3
OHSAS 18001
4.3.2
4.3.
4.4.
3
1
4.5.1
5.
1
5.
2
4.5.
2
4.5.
3
ISO27001
6.
7.
8.
0
0
1
4.4.
2
4.4.
3
6.1
6.2
8.2
8.3
9.1
9.2
10.
1
4.4.
2
4.4.
3
4.4.4
4.5.
4
4.5.
5
4.6
4.4.
2
4.4.
3
4.4.4
4.5.
4
4.5.
5
4.6
8.
2
8.
3
7.1
Annex
A
Policy
Document &
Data Control
Reviews
Corrective
Actions
Complaints
Use of Logos
(After Stage
2)
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Confirm that the Client Management Contact has been made aware that PNCs raised during
this activity could result in concerns (Ds or NCs) being raised at the next visit.
Confirmed
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Report Ref:
2012/50635/SU1
ISO 9001:2008
November 2013
On-site
audit
DAY
1
Process
Opening Meeting
Surveillanc
e
DAY
Start
Time
Auditor
08.3
0
To be
Special
2
Process
TBA
Re-cert
Start
Time
Auditor
Advise
d
Report preparation
16.0
0
Closing (wash-up/final)
meeting
16.3
0
The plan MUST reflect the client's processes, planning by clause of a standard is NOT acceptable If the
audit duration exceeds 2 audit days use more sheets.
The exact date of the next activity will be notified to the client by letter, e-mail or telephone and shall
be agreed mutually between both parties.
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Appendix 1
Corrective Action Plan (CAP) Template - (Client copy one CAP for each concern)
This format is optional but has been created to assist the client in addressing the Concerns raised,
however, if the client chooses to use their own format, the headings below should be used.
Report Ref:
2012/50635/SU1
Enter below, the EXACT details of the objective evidence for the omission/concern in the related concern report - :
It was found that internal audit was not conducted to all area in accordance with quality manual
PM-8.2, that internal audit should be conducted in every 6 months
Internal audit belum dilakukan di semua area
Who will be responsible for managing the corrective and preventive actions (if necessary establish a team of
people with product/service/process knowledge)?
What immediate actions are to be taken to contain the problem and protect your company and your
customers?
Identify all potential causes that could explain why the problem occurred. Ask what in our processes failed or
was missing, to make this problem occur? (a useful method to identify root cause is 5Y)
Choose and state Permanent Corrective Actions (and consider the impact the actions may have on other
processes, documentation, personnel awareness etc.)
Planned date of
implementation of
Organizations
Representative Signature:
Auditor Name:
Auditor Sign:
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Report Ref:
2012/50635/SU1
Appendix 1
Corrective Action Plan (CAP) Template - (Client copy one CAP for each concern)
This format is optional but has been created to assist the client in addressing the Concerns raised,
however, if the client chooses to use their own format, the headings below should be used.
Report Ref:
2012/50635/SU1
Enter below, the EXACT details of the objective evidence for the omission/concern in the related concern report - :
Quality objective was not effectively monitored as seen that monitoring of quality objective was
not conducted to all area
Sasaran Mutu tidak dipantau secara efektif
Who will be responsible for managing the corrective and preventive actions (if necessary establish a team of
people with product/service/process knowledge)?
What immediate actions are to be taken to contain the problem and protect your company and your
customers?
Identify all potential causes that could explain why the problem occurred. Ask what in our processes failed or
was missing, to make this problem occur? (a useful method to identify root cause is 5Y)
Choose and state Permanent Corrective Actions (and consider the impact the actions may have on other
processes, documentation, personnel awareness etc.)
Planned date of
implementation of
Organizations
Representative Signature:
Auditor Name:
Auditor Sign:
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Report Ref:
2012/50635/SU1
Appendix 1
Corrective Action Plan (CAP) Template - (Client copy one CAP for each concern)
This format is optional but has been created to assist the client in addressing the Concerns raised,
however, if the client chooses to use their own format, the headings below should be used.
Report Ref:
2012/50635/SU1
Enter below, the EXACT details of the objective evidence for the omission/concern in the related concern report - :
It was found that calibration was not conducted to all equipment as seen that calibration record
and next plan calibration was not provided
Kalibrasi belum dilakukan untuk semua peralatan
Who will be responsible for managing the corrective and preventive actions (if necessary establish a team of
people with product/service/process knowledge)?
What immediate actions are to be taken to contain the problem and protect your company and your
customers?
Identify all potential causes that could explain why the problem occurred. Ask what in our processes failed or
was missing, to make this problem occur? (a useful method to identify root cause is 5Y)
Choose and state Permanent Corrective Actions (and consider the impact the actions may have on other
processes, documentation, personnel awareness etc.)
Planned date of
implementation of
Organizations
Representative Signature:
Auditor Name:
Auditor Sign:
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Report Ref:
2012/50635/SU1
Appendix 1
Corrective Action Plan (CAP) Template - (Client copy one CAP for each concern)
This format is optional but has been created to assist the client in addressing the Concerns raised,
however, if the client chooses to use their own format, the headings below should be used.
Report Ref:
2012/50635/SU1
Enter below, the EXACT details of the objective evidence for the omission/concern in the related concern report - :
Inadequate evidence that all agenda of management review was discussed as seen that only
process performance and customer complaint has been discussed
Tinjauan Manajemen tidak dilakukan untuk semua agenda
Who will be responsible for managing the corrective and preventive actions (if necessary establish a team of
people with product/service/process knowledge)?
What immediate actions are to be taken to contain the problem and protect your company and your
customers?
Identify all potential causes that could explain why the problem occurred. Ask what in our processes failed or
was missing, to make this problem occur? (a useful method to identify root cause is 5Y)
Choose and state Permanent Corrective Actions (and consider the impact the actions may have on other
processes, documentation, personnel awareness etc.)
Planned date of
implementation of
Organizations
Representative Signature:
Auditor Name:
Auditor Sign:
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Report Ref:
2012/50635/SU1
Appendix 1
Corrective Action Plan (CAP) Template - (Client copy one CAP for each concern)
This format is optional but has been created to assist the client in addressing the Concerns raised,
however, if the client chooses to use their own format, the headings below should be used.
Report Ref:
2012/50635/SU1
Enter below, the EXACT details of the objective evidence for the omission/concern in the related concern report - :
It was found that some therapies was not effectively conducted as seen that SOAP note was not
completely determined in the medical record for Ophthalmologist (poli mata) : px. 295 (1/nov/2012)
and dental clinic : px. 433 (7/nov/12)
Penulisan SOAP di rekam medis tidak lengkap
Who will be responsible for managing the corrective and preventive actions (if necessary establish a team of
people with product/service/process knowledge)?
What immediate actions are to be taken to contain the problem and protect your company and your
customers?
Identify all potential causes that could explain why the problem occurred. Ask what in our processes failed or
was missing, to make this problem occur? (a useful method to identify root cause is 5Y)
Choose and state Permanent Corrective Actions (and consider the impact the actions may have on other
processes, documentation, personnel awareness etc.)
Planned date of
implementation of
Organizations
Representative Signature:
Auditor Name:
Auditor Sign:
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1