Integrated Management System Training

Day 1 - 28 February 2013

Pelaksanaan integrasi management system diawali dengan penetapan common requirements dalam
masing-masing management system. Dasar dari seluruh management system adalah quality
management system, jadi environment management system dan safety health management system
dapat berjalan bila kita implementasi quality management system.

Gunakan PAS 99 untuk memudahkan menyusun manual untuk integrated management system.
Mengapa management system harus diintegrasi?
- Konsisten dalam organisasi
- Meningkatkan komunikasi internal dan eksternal (ISO 9001 pasal 5.5.3 dan 7.2.3)
- Menghindari duplikasi dan hemat biaya
- Mengurangi resiko
- Menemukan sasaran dan target yang bersinggungan
- Mengidentifikasi dan menjembatani tanggung jawab dan hubungan yang bersinggungan
- Mencapai keseimbangan kepemimpinan
- Berfokus pada tujuan organisasi
- Menciptakan formalitas pada system yang informal
- Mengharmonisasi dan mengoptimalkan proses
- Mengidentifikasi dan memfasilitasi pengembangan dan kebutuhan pelatihan staff

Standard audit untuk integrated management system adalah ISO 19011 yaitu risk-based and
evidence-based auditing.

Prinsip dasar PAS 99:2012 mengacu pada ISO 14001 dan memiliki 6 common requirements yaitu :
- Policy
- Planning
- Implementation & operation
- Performance assessment
- Improvement
- Management review

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Saat integrasi, ISO 9001 pun harus membuat risk assessment. Product certification mewajibkan
perusahaan memiliki ISO 9001 atau quality management system. Setelah era perdagangan bebas
(AFTA), perusahaan harus memiliki standard pemenuhan terhadap Technical Barrier to Trade yaitu
product certification. Yang difokuskan adalah product certification, bukan kepemilikan standard ISO
9001.
Pemenuhan PAS 99 pasal 4.5.2 (Evaluation of Compliance) berlaku juga untuk ISO 9001 dengan
menggunakan pemenuhan persyaratan produk sebagai tolak ukur.

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ISO 9001 dapat diintegrasi dengan sectorial management system. Sectorial management system
adalah management system yang sesuai dengan bidang usaha, contohnya : food, safety, health, etc.
ISO 50001 Energy Management System bukan sectorial management system.

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Penerapan ISO 9001 dapat memberikan benefit secara financial. Hal ini dapat diukur dengan
membuat objective target dari masing-masing proses dengan korelasi terhadap financial.

Understanding your business :

- Marketing (core process)
- Research & Development (core process)
- Purchasing (core process)
- Operation & Production (core process)
- PPIC (supporting process)
- Quality Control (supporting process)
- Warehouse & Delivery (supporting process)

Dalam ISO 9001 pembahasan tentang root cause analysis tercantum dalam pasal 8.2.2 (internal
audit).

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WORKSHOP:
1. Gunakan PAS 99 untuk mengetahui referensi article masing-masing standard.
2. Copy article standard dan jabarkan perbandingannya
3. Gunakan ISO Guide 83 sebagai kerangka manual
4. Gunakan ISO Guide 72 sebagai justification yang menyeimbangkan kesenjangan yang ada
5. Buat integrasi untuk ISO 9001, ISO 14001 dan OHSAS 18001
6. Kemas manual yang baru dengan tata dokumentasi yang standard dan rapi

Pilihan topic workshop :

Leadership
Support
Performance Evaluation

Performance Evaluation
1. Monitoring, measurement, analysis and evaluation
The organization shall determine:
- what needs to be measured and monitored; (customer satisfaction, control & evaluation of nonconformity,
significant environmental impact, effectiveness of health & safety controls, legal compliance, calibration,
- the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results are
customer satisfaction survey, internal audit, risk assessment, investigation, verification, calibration, proactive
measures to monitor conformance with the OH&S programme(s), controls and operational criteria, reactive
measures to monitor ill health, incidents (including accidents, near-misses, etc.), and other historical evidence
of deficient OH&S performance,
- the monitoring and measuring shall be performed in periodic evaluation, where applicable
- the analysis and evaluation of monitoring and measurement results shall be performed periodically,

The organization shall evaluate the QUALITY, HEALTH, SAFETY & ENVIRONMENTAL performance and the
effectiveness of the QUALITY, HEALTH, SAFETY & ENVIRONMENTAL management system.
Additionally, the organization shall:
- take action when necessary to address adverse trends or results before a nonconformity occurs.
- retain relevant documented information as evidence of the results.

ISO 9001 article 8.2, 8.2.1, 8.3, 8.4

8.2.1 Customer satisfaction
As one of the measurements of the performance of the quality management system, the organization
shall monitor information relating to customer perception as to whether the organization has met
customer requirements. The methods for obtaining and using this information shall be determined.
NOTE Monitoring customer perception can include obtaining input from sources such as customer
satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business
analysis, compliments, warranty claims and dealer reports.
8.2.2 Internal audit
The organization shall conduct internal audits at planned intervals to determine whether the quality
management system
a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard
and to the quality management system requirements established by the organization, and
b) is effectively implemented and maintained.
An audit programme shall be planned, taking into consideration the status and importance of the
processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope,
frequency and methods shall be defined. The selection of auditors and conduct of audits shall ensure
objectivity and impartiality of the audit process. Auditors shall not audit their own work.
A documented procedure shall be established to define the responsibilities and requirements for
planning and conducting audits, establishing records and reporting results.
Records of the audits and their results shall be maintained (see 4.2.4).
The management responsible for the area being audited shall ensure that any necessary corrections
and corrective actions are taken without undue delay to eliminate detected nonconformities and their
causes.

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Follow-up activities shall include the verification of the actions taken and the reporting of verification
results
(see 8.5.2).
8.3 Control of nonconforming product
The organization shall ensure that product which does not conform to product requirements is
identified and
controlled to prevent its unintended use or delivery. A documented procedure shall be established to
define the
controls and related responsibilities and authorities for dealing with nonconforming product.
Where applicable, the organization shall deal with nonconforming product by one or more of the
following ways:
a) by taking action to eliminate the detected nonconformity;
b) by authorizing its use, release or acceptance under concession by a relevant authority and, where
applicable, by the customer;
c) by taking action to preclude its original intended use or application;
d) by taking action appropriate to the effects, or potential effects, of the nonconformity when
nonconforming product is detected after delivery or use has started.
When nonconforming product is corrected it shall be subject to re-verification to demonstrate
conformity to the requirements.
Records of the nature of nonconformities and any subsequent actions taken, including concessions
obtained, shall be maintained (see 4.2.4).
8.4 Analysis of data
The organization shall determine, coiiect and analyse appropriate data to demonstrate the suitability
and effectiveness of the quality management system and to evaluate where continual improvement of
the effectiveness of the quality management system can be made. This shall include data generated
as a result of monitoring and measurement and from other relevant sources.
The analysis of data shall provide information relating to
a) customer satisfaction (see 8.2.1),
b) conformity to product requirements (see 8.2.4),
c) characteristics and trends of processes and products, including opportunities for preventive action
(see 8.2.3 and 8.2.4), and
d) suppliers (see 7.4).

ISO 14001 article 4.5.1

4.5.1 Monitoring and measurement
The organization shall establish, implement and maintain a procedure(s) to monitor and measure, on
a regular basis, the key characteristics of its operations that can have a significant environmental
impact. The procedure(s) shall include the documenting of information to monitor performance,
applicable operational controls and conformity with the organization's environmental objectives and
targets. The organization shall ensure that calibrated or verified monitoring and measurement
equipment is used and maintained and shall retain associated records

OHSAS 18001 article 4.5.1, 4.5.2

The organization shall establish, implement and maintain a procedure(s) to monitor and measure
OH&S performance on a regular basis. This procedure(s) shall provide for:
a) both qualitative and quantitative measures, appropriate to the needs of the organization;
b) monitoring of the extent to which the organization’s OH&S objectives are met;
c) monitoring the effectiveness of controls (for health as well as for safety);
d) proactive measures of performance that monitor conformance with the OH&S programme(s),
controls and operational criteria;
e) reactive measures of performance that monitor ill health, incidents (including accidents, near-
misses, etc.), and other historical evidence of deficient OH&S performance;
f) recording of data and results of monitoring and measurement sufficient to facilitate subsequent
corrective action and preventive action analysis.
If equipment is required to monitor or measure performance, the organization shall establish and
maintain procedures for the calibration and maintenance of such equipment, as appropriate.
Records of calibration and maintenance activities and results shall be retained.

4.5.2.1 Consistent with its commitment to compliance [see 4.2c)],

the organization shall establish, implement and maintain a procedure(s) for periodically evaluating
compliance with applicable legal requirements (see 4.3.2).
The organization shall keep records of the results of the periodic evaluations.
NOTE The frequency of periodic evaluation may vary for differing

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legal requirements.
4.5.2.2 The organization shall evaluate compliance with other requirements to which it subscribes
(see 4.3.2). The organization may wish to combine this evaluation with the evaluation of
legal compliance referred to in 4.5.2.1 or to establish a separate procedure(s).
The organization shall keep records of the results of the periodic evaluations.
NOTE The frequency of periodic evaluation may vary for differing
other requirements to which the organization subscribes.

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2. Internal audit
The organization shall conduct internal audits at planned intervals to provide information to assist in the
determination of whether the QUALITY, HEALTH, SAFETY & ENVIRONMENTAL management system
a) conforms to
the organization’s own requirements for its QUALITY, HEALTH, SAFETY & ENVIRONMENTAL management
system
the requirements of this International Standard.

b) is effectively implemented and maintained.

The organization shall
- plan, establish, implement and maintain an audit programme(s), including the frequency, methods,
responsibilities, planning requirements and reporting, while taking into consideration the importance of the
processes concerned and the results of previous audits.
- define the audit criteria and scope for each audit
- select auditors and conduct audits to ensure objectivity and the impartiality of the audit process.
- ensure that the results of the audits are reported to relevant management
- retain documented information as evidence of the results.

ISO 9001 article 8.2.2

8.2.2 Internal audit
The organization shall conduct internal audits at planned intervals to determine whether the quality
management system
a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard
and to the quality management system requirements established by the organization, and
b) is effectively implemented and maintained.
An audit programme shall be planned, taking into consideration the status and importance of the
processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope,
frequency and methods shall be defined. The selection of auditors and conduct of audits shall ensure
objectivity and impartiality of the audit process. Auditors shall not audit their own work.
A documented procedure shall be established to define the responsibilities and requirements for
planning and conducting audits, establishing records and reporting results.
Records of the audits and their results shall be maintained (see 4.2.4).
The management responsible for the area being audited shall ensure that any necessary corrections
and corrective actions are taken without undue delay to eliminate detected nonconformities and their
causes.
Follow-up activities shall include the verification of the actions taken and the reporting of verification
results
(see 8.5.2).

ISO 14001 article 4.5.5

The organization shall ensure that internal audits of the environmental management system are
conducted at planned intervals to
a) determine whether the environmental management system
1) conforms to planned arrangements for environmental management including the requirements of
this International Standard, and
2) has been properly implemented and is maintained, and
b) provide information on the results of audits to management.
Audit programme(s) shall be planned, established, implemented and maintained by the organization,
taking into consideration the environmental importance of the operation(s) concerned and the results
of previous audits.
Audit procedure(s) shall be established, implemented and maintained that address
— the responsibilities and requirements for planning and conducting audits, reporting results and
retaining associated records,
— the determination of audit criteria, scope, frequency and methods.
Selection of auditors and conduct of audits shall ensure objectivity and the impartiality of the
audit process.

OHSAS 18001 article 4.5.5

The organization shall ensure that internal audits of the OH&S management system are conducted at
planned intervals to:
a) determine whether the OH&S management system:

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1) conforms to planned arrangements for OH&S management including the requirements of this
OHSAS Standard; and
2) has been properly implemented and is maintained; and
3) is effective in meeting the organization’s policy and objectives;
b) provide information on the results of audits to management.
Audit programme(s) shall be planned, established, implemented and maintained by the organization,
based on the results of risk assessments of the organization’s activities, and the results of previous
audits.

Audit procedure(s) shall be established, implemented and maintained that address:

the responsibilities, competencies, and a) requirements for planning and conducting audits, reporting
results and retaining associated records; and
b) the determination of audit criteria, scope, frequency and
methods.
Selection of auditors and conduct of audits shall ensure objectivity and the impartiality of the audit
process.

3. Management Review
Top management shall review the organization's QUALITY, HEALTH, SAFETY & ENVIRONMENTAL
management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. The
management review shall include consideration of:
- the status of actions from previous management reviews;
- changes in external and internal issues that are relevant to the QUALITY, HEALTH, SAFETY &
ENVIRONMENTAL management system,
- information on the QUALITY, HEALTH, SAFETY & ENVIRONMENTAL performance, including trends in:
nonconformities and corrective actions
monitoring and measurement evaluation results and
audit results,
- opportunities for continual improvement.
- external & internal communication, including customer & society feedback

The outputs of the management review shall include decisions related to continual improvement opportunities
and the possible need for changes to the QUALITY, HEALTH, SAFETY & ENVIRONMENTAL management
system
The organization shall retain documented information as evidence of the results of management reviews.

ISO 9001 article 5.6

5.6.1 General
Top management shall review the organization's quality management system, at planned intervals, to
ensure its
continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities
for
improvement and the need for changes to the quality management system, including the quality policy
and
quality objectives.
Records from management reviews shall be maintained (see 4.2.4).
5.6.2 Review input
The input to management review shall include information on
a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement.
5.6.3 Review output
The output from the management review shall include anv decisions and actions related to
a) improvement of the effectiveness of the quality management system and its processes,
b) improvement of product related to customer requirements, and
c) resource needs.

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ISO 14001 article 4.6

Top management shall review the organization's environmental management system, at planned
intervals, to ensure its continuing suitability, adequacy and effectiveness. Reviews shall include
assessing opportunities for improvement and the need for changes to the environmental management
system, including the environmental policy and environmental objectives and targets. Records of the
management reviews shall be retained.
Input to management reviews shall include
a) results of internal audits and evaluations of compliance with legal requirements and with other
requirements to which the organization subscribes,
b) communication(s) from external interested parties, including complaints,
c) the environmental performance of the organization,
d) the extent to which objectives and targets have been met,
e) status of corrective and preventive actions,
f) follow-up actions from previous management reviews,
g) changing circumstances, including developments in legal and other requirements related to its
environmental aspects, and h) recommendations for improvement.
The outputs from management reviews shall include any decisions and actions related to possible
changes to environmental policy, objectives, targets and other elements of the environmental
management system, consistent with the commitment to continual improvement.

OHSAS 18001 article 4.6

Top management shall review the organization’s OH&S management system, at planned intervals, to
ensure its continuing suitability, adequacy and effectiveness. Reviews shall include assessing
opportunities for improvement and the need for changes to the OH&S management system, including
the OH&S policy and OH&S objectives. Records of the management reviews shall be retained.
Input to management reviews shall include:
a) results of internal audits and evaluations of compliance with applicable legal requirements and with
other requirements to which the organization subscribes;
b) the results of participation and consultation (see 4.4.3);
c) relevant communication(s) from external interested parties, including complaints;
d) the OH&S performance of the organization;
e) the extent to which objectives have been met;
f) status of incident investigations, corrective actions and preventive actions;
g) follow-up actions from previous management reviews;
h) changing circumstances, including developments in legal and
other requirements related to OH&S; and
i) recommendations for improvement.
ii) The outputs from management reviews shall be consistent with the
iii) organization’s commitment to continual improvement and shall
iv) include any decisions and actions related to possible changes to:
v) a) OH&S performance;
vi) b) OH&S policy and objectives;
vii) c) resources; and
viii) d) other elements of the OH&S management system.
ix) Relevant outputs from management review shall be made
x) available for communication and consultation (see 4.4.3).

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