11oasmk Farmasi Nasional

Report
2011/farmasi/OA1
Ref:
Audit Report
For
Client Name
SMK FARMASI NASIONAL SURAKARTA
Date(s): February 2011

Standard(s)
ISO 9001:2008
audited:
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. © ROS 2011
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Report
2011/farmasi/OA1
Ref:
Audit Report Content

Cod Number of
e Pages
1 M Cover Sheet 1
2 M Audit Report Content – Includes disclaimers 1
3 M Audit Administration 1
4 M Audit Executive Summary 1
5 O Audit Team Summary 1
6 R Audit Findings - Comments 2
7 R Audit Findings - Concerns 1
8 M Audit Recommendation and Conclusion 1
9 M Clauses of the standard(s) audited this visit 1
1 M Next audit plan 1

0
1 R Appendix 1 – Corrective Action Plan Templates 1

1
Total Pages 12
Disclaimers and Notes
• 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.ros-group.com , www.urscertification.com www.globalregistrars.com)
• Whilst it is the ROS Group’s 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
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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.
Report Ref: 2011/farmasi/OA1
Audit Administration
Client management
Mr. Joko Audit days
contact:
Lead Auditor: Basuki Rachmat 1.0
Auditor: Ayu 1.0
Auditor:
Auditor:
Total audit
Specialist:
days
Translator:
2.0
Other:
Certification Scope
MANAGEMENT of JUNIOR HIGH SCHOOL
Temporary sites audited this visit (e.g.

Permanent sites audited this visit
construction)
N/A

Notification of changes or other requests by the audit team or client
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Please issue certificate ASAP
Audit Executive Summary

Enhancement/Improv Unsatisfactory/Degrad
Satisfactory
ing ing
Overall Commitment to the System
Effectiveness of System Controls
Effectiveness of Close-out to Issues,

e.g. Audits, Internally Raised Issues,
Customer audits
Customer Complaints Control
Setting of Targets & Objectives
Effectiveness of Achieving
Targets/Objectives/Improvements
Overall Compliance to the

Standard(s)/Scheme(s)
If the Audit Team confirms that the corrective actions taken to address any previous concerns
raised are Unsatisfactory then a Concern must be raised.
Effectiveness of close-out of the

Corrective Actions regarding the
Concerns raised from previous
audits by ROS, URS, GRI
• Enhancement/Improving – means that there is evidence of improved process

performance or improvements arising from corrective actions.
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• Satisfactory – means that there is evidence that requirements are being met but
improvements have not yet been realised 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 Non-Compliances (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).
Total Comments Total Concerns
Number of Findings Total OFI/PNC Total D (Minor NCs) Total NC (Major NCs)
10 1 0
Report
2011/farmasi/OA1
Ref:
Audit Team Summary
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The operations of a Quality Management System are largely complying with ISO
9001:2008 requirements. The PNC and OFI were raised for the organization to
continually improve the established system. During this visit, also seen good points
such as: high commitment of Top Management & enthusiasm from management
staffs.
The PNC and OFI are listed in Audit Comments page; whilst the discrepancies as
follows:
Implementation of monitoring student activity within On the Job Training (OJT) was
not effective in terms of:
• Plotting of supervisory team within OJT monitoring has not been established.
• Monitoring agenda was not retrieved during audit.
[D, Clause 7.5.5]
SMK FARMASI NASIONAL SURAKRTA is being recommended for registration status of

ISO 9001:2008 certification, upon closure of all above findings within 10 days from
the date of audit.
Report
2011/farmasi/OA1
Ref:
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Audit Comments
Definitions of Comments
A situation where the

evidence presented Due to the short
indicates a period of
requirement has been implementation of a
effectively new or changed
Describe Comment(s) below implemented but process, or the audit
based on auditor sample taken, the
experience and effectiveness of the
knowledge, additional system element could
effectiveness or not yet be determined
robustness may be
possible with a PNC
modified approach
OFI
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Monitoring checklist data of submitted learning instrument
should be analyzed in numeric or variable data to enable
statistical evaluation of compliance level against time
variable. [clause 8.4]
Development of curriculum 2011/2011 has appropriately

administered in line with structure spectrum 2008,
including the input. However the development plan was
not established to ensure that all stages fullfilled by the
relevant PIC, & address the relevant documentation.
[clause 7.3.1]
Academic calendar 2011/2011 was revised with regard to

changed national examination. The agenda was up to
dated with legal requirement, however the revision
number was not indicated in document, also the reason of
change. [clause 4.2]
Final evaluation score within semester 1st 2011/2011 for

subject Chemistry class XC was refer to the norm
evaluation, however the data was different between ledger
& evaluation administration, e.g.: NIS# 5921 79 VS 77.
Although the score was above the acceptance criteria.
[clause 8.2.4]
Verification of the matrix evaluation instrument/‘kisi-kisi

soal’ was applied, but it was limited to the level XII
semester VI. Plotting of relevancy of competency &
difficulty level C1-C6 was also not yet indicated. The
evaluation instruments were compiled to curriculum.
[clause 7.6]
All competencies of subject Mathematic for level XII were

evaluated within daily test except for competency
‘probability’ on class XIIC. Although those all competencies
evaluated within semester test. [clause 8.2.4]
Student & General Affair’s Objective related with ratio job

placement of alumnus was accessible with handover data
of professional & graduate certificate. However monitoring
method has not accessed with the date information which
may lead difficulty to monitor the time variable. Monitoring
subject would be addressed to student being on level XII
year 2010/2011. [clause 8.2.3]
Report 2011/farmasi/OA1
Ref:
Audit Comments
Describe Comment(s) below Definitions of Comments
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A situation where the
evidence presented Due to the short
indicates a period of
requirement has been implementation of a
effectively new or changed
implemented but process, or the audit
based on auditor sample taken, the
experience and effectiveness of the
knowledge, additional system element could
effectiveness or not yet be determined
robustness may be
possible with a PNC
modified approach
OFI
Consider to add objective for student & general affair

department related with championship of academic scope
(i.e. LKS Pharmacy at province level & non academic scope
(i.e. sports, etc). [clause 5.4]
Norm evaluation of OJT related with evaluator perspective

to the attribute performance of student was established.
However the final norm evaluation was not available to
outline overall score data in ledger. Score data from OJT
phase II has not been received from RS Muwardi. [clause
7.1]
Scope of disciplinary monitoring for student should access

to the aspect of safety riding (i.e. completeness of glass on
motor cycle, etc) as same with established aspect in
school regulation. [clause 8.5]
Report
2011/farmasi/OA1
Ref:
Standard/Schem Concern No:
ISO 9001:2008 1
e: (One Concern per Page only)
Definitions of Mark as State Reason NC
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reference/clause from Major
concerns relevant standard/regulation or D
scheme/process Minor
Standard NC
Protocol does not address one or more ‘shall(s)’ of
A defined protocol a requirement
Major
does not exist or omits
a requirement from Regulation
the standard, D
A protocol exists but only partly addresses a Minor
regulations or scheme
Scheme requirement
rules

The process is customer facing (the last process NC

prior to delivery of product or service) - Major
One or more
verification of acceptability to deliver
process(s) observed Process product/service
has/have not been
defined in the client’s The process is not customer facing and occurs D
management system before the last process which verifies the Minor
product/service prior to delivery -verification of
acceptability to deliver product/service
Non-conforming product or service could be NC

delivered to the customer e.g.: the process is final Major
inspection, and there is no other process to
capture the product/service under consideration.
Defined or required Process Non-conforming product or service has not been
protocol has not been delivered to the customer e.g.: the process is NOT
followed final inspection, there is another process to D
confirm the product/service is suitable after this Minor
process that has been the subject of the concern,
records prove that no non-
conforming product/service has been delivered.
The defined protocol has failed to ensure that the

process is effective in achieving process
objectives and as a result, non-conforming NC
product or service has been delivered to the Major
customer (or for TS16949, could be delivered
Defined or required
Protocol 7.5.5 based on process capability studies): or, there is a
protocol has been
total breakdown of an MSR or a breakdown of
followed but is not
an MSC (see contents page)
effective
The defined protocol has failed to ensure that the
process is effective in achieving objectives/targets D
(e.g. ISO9001, 5.4.1) and no improvement action Minor
has been implemented: or, there is a breakdown
of a requirement (see contents page)
Describe below, the objective evidence for the omission/concern

highlighted above:
Audit Recommendation and Conclusion

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A copy of this page must be used for each standard/scheme that has been audited during this visit.
Applicable Standard ISO 9001:2008
Current Activity
On-Site Surveillanc Re-

Special
Indicate current audit activity Audit e Cert.
Client Required Action
Consider the Comments Raised

For the Next Activity
Required
Send in a Corrective Action Plan for records to be
the Discrepancy Point(s) Raised sent to local
Send in a Corrective Action Plan plus office within
Evidence for the Discrepancy
Point(s) Raised 20 working
Send in a Corrective Action Plan plus days
Evidence for the Non-compliance
Point(s) Raised
Audit Conclusion
Certification is Recommended – Continued Certification and/or Re-

proceed to issue Certificate(s) Certification is Recommended
Certification is Recommended – Continued Certification and/or Re-
subject to any actions stated above Certification is Recommended –
being satisfactorily addressed – subject to any actions stated above
proceed to issue certificate(s) being satisfactorily addressed
Suspension of Certification Withdrawal of Certification
Recommended Recommended
A successful Special Visit is required prior to Certification proceeding or continuation of

Certification
Client acceptance of the recommendations and conclusion

Client representative name: Mr. Joko, Spt. Apt.
Client representative sign:

Clauses of the Standard(s) audited this visit
ISO10002
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4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 5.1 5.2 5.3. 5.3.
1 2
5.3. 5.3. 5.3. 6.2 6.3 6.4 7.1 7.2 7.3 7.4 7.5 7.6 7.7
3 4 5
7.8 7.9 8.1 8.2 8.3 8.4 8.5 8.6. 8.6. 8.6. 8.7
1 2 3
ISO9001 (Inc. TS16949, AS9100, ISO13485, PAS43)

4.1 4.2 5.1 5.2 5.3 5.4 5.5 5.6 6.1 6.2 6.3 6.4
7.1 7.2 7.3 7.4 7.5 7.6 8.1 8.2 8.3 8.4 8.5
ISO22000
4.1 4.2 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 6.1 6.2 6.3 6.4 7.1
7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 8.1 8.2 8.3 8.4 8.5
BS EN 16001
3.1 3.2 3.3. 3.3. 3.3. 3.4. 3.4. 3.4. 3.4. 3.4.5
1 2 3 1 2 3 4
3.4.6 3.5. 3.5. 3.5. 3.5. 3.5. 3.6. 3.6. 3.6. Annex 1
1 2 3 4 5 1 2 3
ISO20000
3.1 3.2 3.3 4.1 4.2 4.3 4.4 4.4. 4.4. 4.4. 5 6.1 6.2
1 2 3
6.3 6.4 6.5 6.6 7.1 7.2 7.3 8.1 8.2 8.3 9.1 9.2 10.
1
ISO 14001
4.1 4.2 4.3.1 4.3. 4.3. 4.4. 4.4. 4.4. 4.4.
2 3 1 2 3 4
4.4.5 4.4.6 4.4.7 4.5. 4.5. 4.5. 4.5. 4.5. 4.6

1 2 3 4 5
OHSAS 18001
4.1 4.2 4.3. 4.3.2 4.3. 4.4. 4.4. 4.4. 4.4.4
1 3 1 2 3
4.4. 4.4. 4.4. 4.5.1 4.5. 4.5. 4.5. 4.5. 4.6

5 6 7 2 3 4 5
ISO27001
4. 4. 4. 5. 5. 6. 7. 8. 8. 8. Annex
1 2 3 1 2 0 0 1 2 3 A
Other standard - (auditor to complete matrix)

Mandatory processes to audit each visit

Document Use of Logos
Internal Corrective
Policy & Data Reviews Complaints (After Stage
Audits Actions 2)
Control
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Confirm that the Client Management Contact has been made aware that PNC’s raised during Confirmed
this activity could result in concerns (Ds or NCs) being raised at the next visit.
Audit Plan for Next Visit

Standard(s) / Scheme(s) to be audited next ISO 9001:2008
activity
Month/year for next activity February 2012
On-site
The Plan below relates to the next Audit Surveillanc Re-cert Special
Activity audit
e
DAY 1 DAY
Start Start
Process Time Auditor Process Time Auditor
Opening meeting 08.3 To be

0
Curriculum [incl. learning instrument, 09.0 advise
0 d
learning process & evaluation, program,
Verification of curriculum, etc]

11.0
0
Break/ Lunch
12.0
0
Student Affair [incl. registration, MOS,
13.0
0
extracurricular, health clinic, etc]
Infrastructure [incl.laboratory, 14.0
inventory, 0
procurement, maintenance, school
environment, etc]
15.0
Administration [incl. copy legalize of
0
certificate, general administration, etc]
QMR [incl. Internal audit, doc.control, 16.0

0
Management review, CPAR, etc]
16.3
Report Preparation
0
17.0
Closing (wash-up/final) meeting
0
Notes and disclaimer:
• 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.
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• 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.
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: 2011/farmasi/OA1 CAP for Concern No: 1
Enter below, the EXACT details of the objective evidence for the omission/concern in the related
concern report - :
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 Organization’s
Representative Signature:
permanent corrective Mr. Joko, Spt. Apt.
actions:
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Auditor Name: Basuki R. Auditor Sign:
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Report

Date(s): February 2011

Audit Report Content

2 M Audit Report Content – Includes disclaimers 1

4 M Audit Executive Summary 1

5 O Audit Team Summary 1

6 R Audit Findings - Comments 2

7 R Audit Findings - Concerns 1

8 M Audit Recommendation and Conclusion 1

9 M Clauses of the standard(s) audited this visit 1

1 M Next audit plan 1

1 R Appendix 1 – Corrective Action Plan Templates 1

Report Ref: 2011/farmasi/OA1

Auditor:

MANAGEMENT of JUNIOR HIGH SCHOOL

Temporary sites audited this visit (e.g.

Notification of changes or other requests by the audit team or client

Report Ref: 2011/farmasi/OA1

Audit Executive Summary

Overall Commitment to the System

Effectiveness of System Controls

Effectiveness of Close-out to Issues,

Customer Complaints Control

Setting of Targets & Objectives

Overall Compliance to the

Effectiveness of close-out of the

• Enhancement/Improving – means that there is evidence of improved process

• Unsatisfactory/Degrading – means that there is evidence of a decrease in process

Total Comments Total Concerns

Audit Team Summary

SMK FARMASI NASIONAL SURAKRTA is being recommended for registration status of

A situation where the

Development of curriculum 2011/2011 has appropriately

Academic calendar 2011/2011 was revised with regard to

Final evaluation score within semester 1st 2011/2011 for

Verification of the matrix evaluation instrument/‘kisi-kisi

All competencies of subject Mathematic for level XII were

Student & General Affair’s Objective related with ratio job

Consider to add objective for student & general affair

Norm evaluation of OJT related with evaluator perspective

Scope of disciplinary monitoring for student should access

Definitions of Mark as State Reason NC

The process is customer facing (the last process NC

Non-conforming product or service could be NC

The defined protocol has failed to ensure that the

Describe below, the objective evidence for the omission/concern

Report Ref: 2011/farmasi/OA1

Audit Recommendation and Conclusion

Applicable Standard ISO 9001:2008

On-Site Surveillanc Re-

Client Required Action

Consider the Comments Raised

Certification is Recommended – Continued Certification and/or Re-

A successful Special Visit is required prior to Certification proceeding or continuation of

Client acceptance of the recommendations and conclusion

Client representative sign:

Report Ref: 2011/farmasi/OA1

ISO9001 (Inc. TS16949, AS9100, ISO13485, PAS43)

4.4.5 4.4.6 4.4.7 4.5. 4.5. 4.5. 4.5. 4.5. 4.6

4.4. 4.4. 4.4. 4.5.1 4.5. 4.5. 4.5. 4.5. 4.6

Other standard - (auditor to complete matrix)

Mandatory processes to audit each visit