Internal Audit Checklist (2 Bahasa)

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Internal Audit Checklist

for ISO 9001:2015 based Implementation Gap Analysis
ISO 9001:2015
ISO 9001:2015 Quality Management System Audit Checklist
Quality Assurance Solutions ISO 9001:2015 Gap Analysis Audit

Solusi Jaminan Mutu ISO 9001: 2015 Audit Analisis Kesenjangan
Disclaimer and Approved Use:

Penolakan dan Penggunaan yang Disetujui:
• Disclaimer
Penolakan
 This audit is intended for use within one organization. The audit may be customized to suit your needs and preferences.
Audit ini dimaksudkan untuk digunakan dalam satu organisasi. Audit dapat disesuaikan dengan kebutuhan dan pilihan Anda.
 THE AUDIT IS DISTRIBUTED ON AN "AS IS" BASIS WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESSED OR
IMPLIED.
AUDIT DIDISTRIBUSIKAN "SEBAGAIMANA ADANYA" TANPA JAMINAN APA PUN, BAIK TERSURAT MAUPUN TERSIRAT.
• Copyright
Hak Cipta
 This presentation is created and copyrighted by Quality Assurance Solutions / The Art of Quality.
Presentasi ini dibuat dan dilindungi hak cipta oleh Solusi Jaminan Mutu / Seni Kualitas.
 Copyrights of all the questions used in this presentation are held by their respective owners.
Hak cipta dari semua pertanyaan yang digunakan dalam presentasi ini dipegang oleh masing-masing pemiliknya
• Approved Use
Penggunaan yang dsetujui
 Each copy of this audit can be used throughout a single Customer location, such as a manufacturing plant. Multiple copies may
reside on computers within that location, or on the intranet for that location. Contact us for authorization to use this presentation
at multiple locations.
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Setiap salinan audit ini dapat digunakan diseluruh lokasi Pelanggan tunggal, seperti pabrik. Beberapa salinan dapat berada di
komputer didalam lokasi itu, atau di internet untuk lokasi itu. Hubungi kami untuk otorisasi untuk menggunakan presentasi ini di
beberapa lokasi
 The presentation may be customized to satisfy the customer’s application.
Presentasi dapat disesuaikan untuk memenuhi kebutuhan pelanggan.
 The presentation, or portions or modifications thereof, may not be re-sold or re-distributed without our prior written consent.
Presentasi, atau bagian atau modifikasinya, tidak boleh dijual kembali atau didistribusikan kembali tanpa persetujuan tertulis
sebelumnya dari kami.
Alat cheklist
Current contact information can be found at: http://www.quality-assurance-solutions.com
Informasi kontak saat ini dapat ditemukan di: http://www.quality-assurance-solutions.com
INSTRUCTIONS:
PETUNJUK :
The best value you can get out of this ISO 9001:2015 Transition Gap Analysis Internal Audit Checklist Tool is by conducting first the 100%
compliance Internal Audit and then fill out page 4, which is the REPORT on all findings. This is a great way to list and present all transition gap
artefacts within one concise report.
Nilai terbaik yang dapat Anda peroleh dari ISO 9001: 2015 Alat Checklist Audit Internal Analisis Transisi Kesenjangan ini adalah dengan
mematuhi terlebih dahulu 100% Audit Internal dan kemudian mengisi halaman 4, yang merupakan LAPORAN pada semua temuan. Ini adalah
cara terbaik untuk membuat daftar dan menyajikan celah dari semua temuan dalam satu ringkasan laporan.
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AUDIT PLAN
RENCANA AUDIT
Name of our organization audited:
Nama organisasi yang kami audit:
Audit Number:
Nomer Audit
Date and Time of Audit:
Tanggal dan waktu Audit
Functional Area covered: All ISO 9001:2015 QMS related process areas
Area Fungsional tertutup Semua area proses yang terkait ISO 9001:2015 SMM
Name(s) of Auditor(s): (Internal Auditor Team names)
Nama Auditor : (Nama Tim Auditor Internal)
Name(s) of Auditees/QMS Process Owners(s): (QMS Process owners)
Nama yang diaudit /Pemilik Proses SMM (Pemilik Proses SMM)
ISO 9001:2015 Quality Management System Clause Overview
ISO 9001:2005 Sistem Manajemen Mutu Ikhtisar Pasal
Nr CLAUSE PDCA CYCLE 309 Requirements Requirement #
No PASAL SIKLUS PDCA 309 Persyaratan Persyaratan
4 Context of our Organization Plan 1-24 24
Konteks Organisasi kami Rencana
5 Leadership Plan, Do, Check, Act 25-50 26
Kepemimpinan Rencana, Aksi, Cek, Tindakan
6 Planning Plan 51-77 27
Perencanaan Rencana
7 Support Do 78-120 43
Dukungan Aksi
8 Operation Do 121-248 128
Operasi Aksi
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9 Performance Evaluation Check 249-291 43

Evaluasi Performa Cek
10 Improvement Act 292-309 18
Perbaikan Tindakan
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GAP ANALYSIS Affected QMS Gap Analysis Results Responsibility Due Date
Process Opportunity for Improvement (Who?) (Until
EVALUATION Proses SMM yang (OFI) Recommendation Tanggung when?)
Audit Result Summary (Clause) terdampak Rekomendasi Peluang Hasil Analisis jawab Tanggal
EVALUASI ANALISIS GAP GAP untuk perbaikan (OFI) (Siapa?) jatuh tempo
(Sampai
Rangkuman Hasil Audit (Pasal) kapan?)
Name the Clause Name the affected (Write all justification artifacts like... Who will take care of Calculate due
Nama Pasal QMS Process Levels of current implementation at organization, that particular QMS dates for the
(Existing/New) Nonconformity to ISO 9001:2015 facts, Easy to upgrade? Implementation
Nama proses SMM yang implement or accomplish, potential remedy or Siapa yang akan Project Plan
terdampak solution to become compliant, etc... menangangi Hitung tanggal
(lama/baru) (Tulis semua temuan yang benar seperti ... peningkatan SMM jatuh tempo
Tingkat implementasi saat ini diorganisasi, tertentu? untuk rencana
Ketidaksesuaian pada fakta ISO 9001: 2015, proyek
Mudah diimplementasikan atau dicapai, atau implementasi.
solusi potensial untuk mematuhi, dll ...
Signature of Lead Auditor :………………… Reviewed and Approved - Signature of CEO :…………………………….….
Tanda tangan kepala auditor : Ditinjau dan Disetujui – Tanda tangan CEO :
Date: …………………………………………… Date: …………………………..

Tanggal Tanggal
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Clause 4: CONTEXT OF OUR ORGANIZATION

Pasal 4: KONTEKS ORGANISASI KAMI
4.1 Understanding our organization and its context
4.1 Memahami organisasi kami dan konteksnya
Sl. SI.#Au Audit Question Au Audit Result Au Describe the Gap

Au Pertanyaan Audit Hasil Audit Au Deskripsikan Gap nya
11 Has our organization determined the external and internal issues that are relevant to its
1
purpose and its strategic direction and that affect our ability to achieve the intended result(s)
of our quality management system?
(Are documents available like Business Plans, SWOT Analysis, Stakeholder Analysis, etc…)
Sudahkah organisasi kami menentukan masalah eksternal dan internal yang relevan dengan
tujuannya dan arahan strategisnya dan yang mempengaruhi kemampuan kami untuk
mencapai hasil yang diharapkan dari sistem manajemen mutu kami?
(Apakah dokumen tersedia seperti Rencana Bisnis, Analisis SWOT, Analisis Stakeholder,dll)
2 2 Is our organization monitoring and reviewing information about these external and internal
issues? How is it done?
Apakah organisasi kami memantau dan meninjau informasi tentang masalah-masalah
eksternal dan internal ini? Bagaimana ini dilakukan?
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4.2 Understanding the needs and expectations of interested parties

4.2 Memahami kebutuhan dan harapan pihak yang berkepentingan
SI.# Audit Question Audit Result Describe the Gap

Pertanyaan Audit Hasil Audit Deskripsi Gap
1 Due to their effect or potential effect on our organization’s ability to consistently provide
products and services that meet our customer and applicable statutory and regulatory
requirements, has our organization determined in documented format ...
Karena dampaknya atau dampak potensinya pada kemampuan organisasi kita untuk secara
terus-menerus menyediakan produk dan layanan yang sesuai dengan pelanggan kita dan
persyaratan hukum dan peraturan yang berlaku, sudahkah organisasi kita menetapkannya
dalam formar yang terdokumentasi...
a) the interested parties that are relevant to our quality management system?
pihak yang berkepentingan yang relevan dengan sistem manajemen mutu kami?
b) the requirements of these interested parties that are relevant to our quality management
system? (Any documentation available as evidence for that?)
persyaratan pihak-pihak yang berkepentingan yang relevan dengan sistem manajemen
mutu kami? (Adakah dokumentasi yang tersedia sebagai bukti untuk itu?)
2 Whether and how our organization monitors and reviews information about these interested
parties and their relevant requirements?
Apakah dan bagaimana organisasi kami memantau dan meninjau informasi tentang pihak-
pihak yang berkepentingan ini dan persyaratan yang relevan?
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4.3 Determining the scope of our quality management system

4.3 Menentukan ruang lingkup sistem manajemen mutu kami
Sl. # Audit Question Audit Result Describe the Gap
1 Has our organization determined the boundaries and applicability of our quality
management system to establish its scope? (Scope Statement available?)
Sudahkah organisasi kami menentukan batasan dan penerapan sistem manajemen mutu
kami untuk menetapkan cakupannya? (Pernyataan Lingkup tersedia?)
2 When determining this scope, did our organization consider:

Saat menentukan ruang lingkup ini, apakah organisasi kami mempertimbangkan:
a) the external and internal issues referred to in 4.1?

masalah eksternal dan internal sebagaimana dimaksud dalam 4.1
b) the requirements of relevant interested parties referred to in 4.2?
persyaratan pihak terkait yang relevan sebagaimana dimaksud dalam 4.2?
c) the products and services of our organization.
produk dan layanan dari organisasi kami.
3 Did our organization apply all the requirements of the ISO 9001:2015 standard if they
were applicable within the determined scope of our QMS?
Apakah organisasi kami menerapkan semua persyaratan standar ISO 9001: 2015 jika
mereka berlaku dalam lingkup yang ditentukan dari SMM kami?
4 Is the scope of our organization’s quality management system visually available and
maintained as documented information somewhere?
Apakah ruang lingkup sistem manajemen mutu organisasi kami tersedia secara visual
dan dikelola sebagai informasi yang terdokumentasi di suatu tempat?
5 Does the scope state the types of our products and services covered, and provide
justification for any requirement of the ISO 9001:2015 standard that our organization
determines as not applicable to the scope of our quality management system?
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Apakah ruang lingkup yang menyatakan jenis produk dan layanan kita terpenuhi, dan
berikan dasar pembenaran untuk setiap persyaratan standar dari ISO 9001: 2015 bahwa
organisasi kita menentukan tidak berlakunya ruang lingkup dari sistem manajemen mutu
tersebut?
6 Are we aware that conformity to the ISO 9001:2015 standard may only be claimed if the
requirements determined as not applicable do not affect our organization’s ability or
responsibility to ensure the conformity of our products and services and the enhancement
of customer satisfaction?
Apakah kita menyadari bahwa kesesuaian dengan standar ISO 9001: 2015 hanya dapat
dinyatakan jika persyaratan yang ditentukan ‘tidak berlaku’ tidak memengaruhi
kemampuan atau tanggung jawab organisasi kita untuk memastikan kesesuaian dari
produk dan layanan kita dan peningkatan kepuasan pelanggan?
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4.4 Quality management system and its core processes

4.4 Sistem manajemen mutu dan proses intinya

(4.4.1)
1 Has our organization determined the main QMS related processes needed for our quality
management system and their application throughout our organization?
Sudahkah organisasi kami menentukan proses utama terkait SMM yang diperlukan untuk
sistem manajemen mutu kami dan penerapannya di seluruh organisasi kami?
(4.4.1)
2 Has our organization ...
Sudahkah organisasi kami...
a) determined the inputs required and the outputs expected from these processes?
menentukan input yang diperlukan dan output yang diharapkan dari proses ini?
b) determined the sequence and interaction of these processes? (Flow charts?)
menentukan urutan dan interaksi proses-proses ini? (Diagram alir?)
c) determined and applied the criteria and methods (including monitoring, measurements
and related performance indicators) needed to ensure the effective operation and
control of these processes?
menentukan dan menerapkan kriteria dan metode (termasuk pemantauan,
pengukuran dan indikator kinerja terkait) yang diperlukan untuk memastikan operasi
dan kontrol yang efektif dari proses ini?
d) determined the resources needed for these processes and ensured their availability?
menentukan sumber daya yang dibutuhkan untuk proses ini dan memastikan
ketersediaannya?
e) assigned the responsibilities and authorities for these processes?
diberikan tanggung jawab dan wewenang untuk proses ini?
f) addressed the risks and opportunities as determined in accordance with the
requirements of 6.1 (planning)?
menangani risiko dan peluang sebagaimana ditentukan sesuai dengan persyaratan
6.1 (perencanaan)?
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g) evaluated these processes and implemented any changes needed to ensure that
these processes achieve their intended results?
mengevaluasi proses ini dan mengimplementasikan perubahan yang diperlukan untuk
memastikan bahwa proses ini mencapai hasil yang diharapkan?
h) tried to improve these processes and also our entire quality management system?
mencoba memperbaiki proses ini dan juga seluruh sistem manajemen kualitas kami?
(4.4.2)
3 To the extent necessary, does our organization ...

Sejauh diperlukan, apakah organisasi kami ...
a) maintain documented information to support the operation of our QMS related

processes? Please cite some examples like Core Process Map, Quality Manual, etc...
memelihara informasi yang terdokumentasi untuk mendukung operasi terkait proses
SMM kami? Tolong kutip beberapa contoh seperti Core Process Map, Quality Manual,
dll
b) retain documented information to have confidence that all QMS related processes are
being carried out as planned? Records keeping? Please cite some examples.
menyimpan informasi yang terdokumentasi agar memiliki keyakinan bahwa semua
proses terkait SMM sedang dilaksanakan sesuai rencana? Penyimpanan catatan?
Tolong kutip beberapa contoh
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Clause 5: LEADERSHIP
Pasal 5: KEPEMIMPINAN
5.1 Leadership and commitment

5.1 Kepemimpinan dan komitmen

(5.1.1 - General)
(5.11 – Umum)
1 In order to demonstrate its leadership and commitment with respect to our quality
management system, is our top management “Hands on” ...
Untuk menunjukkan kepemimpinan dan komitmennya sehubungan dengan sistem
manajemen mutu kami, Apakah manajemen puncak kami "terlibat langsung" ...
a) taking accountability for the effectiveness of our quality management system? Please
cite some examples.
mengambil akuntabilitas untuk efektivitas sistem manajemen mutu kita? Tolong kutip
beberapa contoh
b) ensuring that our quality policy and quality objectives are established for our quality
management system and are compatible with the context and strategic direction of our
organization? Please cite some examples (Quality Policy signed, etc…?).
memastikan bahwa kebijakan mutu dan sasaran mutu ditetapkan untuk sistem
manajemen mutu kita dan kompatibel dengan konteks dan arahan strategis organisasi
kita? Tolong kutip beberapa contoh (Kebijakan Mutu ditandatangani, dll ...?).
c) ensuring the integration of our quality management system requirements into our
organization’s business processes? Please cite some examples.
memastikan integrasi persyaratan sistem manajemen mutu kami kedalam proses
bisnis organisasi kami? Tolong kutip beberapa contoh
d) promoting the use of the process approach and risk-based thinking? Please cite some
examples. (Quality training, E-newsletter, any other documented evidence, etc…)
mempromosikan penggunaan pendekatan proses dan pemikiran berbasis risiko?
Tolong kutip beberapa contoh. (Pelatihan mutu, buletin elektronik, bukti
terdokumentasi lainnya, dll ...)
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e) ensuring that the resources needed for our quality management system are available?
Please cite some examples. Is there are Employee Handbook available?
memastikan bahwa sumber daya yang diperlukan untuk sistem manajemen mutu kami
tersedia? Tolong kutip beberapa contoh. Apakah ada Buku Pegangan Karyawan yang
tersedia?
f) communicating the importance of effective quality management and of conforming to
our quality management system requirements? Please cite some examples.
mengomunikasikan pentingnya manajemen mutu yang efektif dan memenuhi
persyaratan sistem manajemen mutu kita? Tolong kutip beberapa contoh.
g) ensuring that our quality management system achieves its intended results? Please
cite some examples. Is there a List of Authorities/Responsibilities, Org-Chart available?
memastikan bahwa sistem manajemen mutu kami mencapai hasil yang diinginkan?
Tolong kutip beberapa contoh. Apakah ada Daftar Otoritas / Tanggung Jawab, Org-
Chart tersedia?
h) engaging, directing and supporting persons to contribute to the effectiveness of our
quality management system? Please cite some examples.
melibatkan, mengarahkan, dan mendukung orang untuk berkontribusi pada efektivitas
sistem manajemen mutu kita? Tolong kutip beberapa contoh.
i) promoting improvement? Please cite some examples. Improvement plans, etc…
mempromosikan peningkatan? Tolong kutip beberapa contoh. Rencana
penyempurnaan, dll ...
j) supporting other relevant management roles to demonstrate their leadership as it
applies to their areas of responsibility? Please cite some examples. QMS Process
owner plan, Masterlist of approved SOP’s, Records, Job descriptions, advanced quality
training evidence records (Lean, Six Sigma, etc…)
mendukung peran manajemen lain yang masih terkait untuk menunjukkan
kepemimpinan mereka dibidang yang menjadi tanggung jawabnya? Tolong kutip
beberapa contoh. Rencana pemilik proses SMM, Daftar Master dari SOP yang
disetujui, Catatan, deskripsi pekerjaan, catatan bukti pelatihan mutu lanjutan (Lean, Six
Sigma, dll ...)
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2 (5.1.2 - Customer focus)

(5.1.2 – Fokus Pelanggan)
In order to demonstrate its leadership and commitment with respect to customer focus, is
our top management ensuring that ...
Untuk menunjukkan kepemimpinan dan komitmennya sehubungan dengan fokus
pelanggan, manajemen puncak kami memastikan bahwa ..
a) customer and applicable statutory and regulatory requirements are determined,

understood, monitored and consistently met?
pelanggan dan persyaratan hukum dan peraturan yang berlaku ditentukan, dipahami,
dipantau, dan dipenuhi secara konsisten?
b) the risks and opportunities that can affect conformity of products and services and the
ability to enhance customer satisfaction are determined and addressed? (Risk plan?)
risiko dan peluang yang dapat mempengaruhi kesesuaian produk, layanan dan
kemampuan untuk meningkatkan kepuasan pelanggan ditentukan dan diatasi?
(Rencana risiko?)
c) the focus on enhancing customer satisfaction is maintained?
Apakah fokus pada peningkatan kepuasan pelanggan dipertahankan?
NOTES:
Page 15 of 50
5.2 Policy
5.2 Kebijakan
Sl.# Audit Question Audit Result Describe the Gap

(5.2.1 - Establishing the quality policy)
(5.2.1 – Menetapkan Kebijakan Mutu)
1
Has our top management established, implemented and maintaining a quality policy that ...
Apakah manajemen puncak kami telah menetapkan, menerapkan, dan memelihara kebijakan
mutu yang ..
a) is appropriate to the purpose and context of our organization and supports its strategic
direction?
sesuai dengan tujuan dan konteks organisasi kami dan mendukung arahan strategisnya?
b) provides a framework for setting our quality objectives?
menyediakan kerangka kerja untuk menetapkan sasaran mutu kita?
c) includes a commitment to satisfy applicable requirements?
termasuk komitmen untuk memenuhi persyaratan yang berlaku?
d) includes a commitment to continual improvement of the quality management system?
termasuk komitmen untuk peningkatan berkelanjutan dari sistem manajemen mutu?
(5.2.2 - Communicating the quality policy)

(5.2.2 – Mengkomunikasikan kebijakan mutu)
2
Whether the quality policy ...
Apakah kebijakan mutu.....
a) is available and is maintained as documented information?
tersedia dan dikelola sebagai informasi yang terdokumentasi?
b) is communicated, understood and applied within our organization? Posters, e-newsletter?
dikomunikasikan, dipahami, dan diterapkan dalam organisasi kita? Poster, buletin
elektronik?
c) is available to relevant interested parties, as appropriate?
tersedia untuk pihak-pihak yang berkepentingan yang relevan, jika perlu?
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NOTES:
CATATAN:
Page 17 of 50
5.3 Organizational roles, responsibilities and authorities

5.3 Peran, tanggung jawab, dan wewenang organisasi
1 Does our top management ensure that the responsibilities and authorities for relevant QMS
related process roles are assigned, communicated and understood within our organization?
(Responsibility Charts, Org-Chart, etc…)
Apakah manajemen tertinggi kita memastikan bahwa tanggung jawab dan wewenang untuk
yang bersangkutan dengan QMS sesuai peran proses yang ditugaskan, dikomunikasikan
dan dipahami dalam organisasi kita?
(Grafik Tanggung Jawab, Skema Organisasi, dll ...)
2 Has our top management assigned the responsibility and authority for ...
Apakah manajemen puncak kami menetapkan tanggung jawab dan wewenang untuk ...
a) ensuring that our quality management system conforms to the requirements of the ISO
9001:2015 standard?
memastikan bahwa sistem manajemen mutu kami sesuai dengan persyaratan standar
ISO 9001: 2015?
b) ensuring that all QMS related processes are delivering their intended outputs?
memastikan bahwa semua proses terkait SMM memberikan hasil yang diharapkan?
c) reporting on the performance of our quality management system and on opportunities for
improvement, in particular to our top management?
melaporkan kinerja sistem manajemen mutu kami dan peluang untuk perbaikan,
khususnya kepada manajemen puncak kami?
d) ensuring the promotion of customer focus throughout our organization?
Apakah memastikan promosi pada fokus pelanggan di seluruh organisasi kita?
e) ensuring that the integrity of our quality management system is maintained when changes
to our quality management system are planned and implemented?
memastikan bahwa integritas sistem manajemen mutu kami dipertahankan ketika terjadi
perubahan pada sistem manajemen mutu yang telah direncanakan dan
diimplementasikan?
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NOTES:
Page 19 of 50
Clause 6: PLANNING
Pasal 6 : PERENCANAAN
6.1 Actions to address risks and opportunities

6.1 Tindakan untuk mengatasi risiko dan peluang

(6.1.1)
1 When planning for our quality management system, did our organization consider the
issues referred to in 4.1 and the requirements referred to in 4.2 and determine all
risks and relevant new opportunities that need to be addressed to:
Ketika merencanakan sistem manajemen mutu kami, apakah organisasi kami
mempertimbangkan masalah yang dirujuk pada 4.1 dan persyaratan yang disebutkan
dalam 4.2 dan menentukan semua risiko dan peluang baru yang relevan yang perlu
ditangani:
a) give assurance that our quality management system can achieve its intended
result(s)? Global Risk plan if needed? Inclusive Supplier risk evaluation?
memberi jaminan bahwa sistem manajemen mutu kami dapat mencapai hasil
yang diharapkan? Rencana Risiko Global jika diperlukan? Termasuk pemasok
melakukan evaluasi risiko?
b) enhance desirable effects?
Meningkatkan efek yang diinginkan?
c) prevent, or reduce, undesired effects? (FMEA, or any other Risk planning tool?)
mencegah, atau mengurangi, efek yang tidak diinginkan? (FMEA, atau alat
perencanaan Risiko lainnya?)
d) achieve improvement?
Mencapai peningkatan?
Page 20 of 50
(6.1.2)
2 Has our organization planned ...

Sudahkah organisasi kami merencanakan......
a) actions to address these risks and opportunities? (Continuity/Contingency plan?)

tindakan untuk mengatasi risiko dan peluang ini? (Kontuinitas/Rencana
Cadangan ?)
b) how to:
Bagaimana untuk
1) integrate and implement the actions into its quality management system
processes (see 4.4)? Do we have a Risk and/or Safety Committee?
mengintegrasikan dan mengimplementasikan tindakan ke dalam proses
sistem manajemen mutu (lihat 4.4)? Apakah kita memiliki Komite Risiko dan /
atau Keselamatan?
2) evaluate the effectiveness of these actions? Regular Risk status meetings?
mengevaluasi efektivitas dari tindakan-tindakan tersebut? Pertemuan teratur
terkait status resiko ?
(6.1.2)
3 Whether the actions taken to address risks and opportunities shall be proportionate
to the potential impact on the conformity of products and services? Global and local?
Apakah tindakan yang diambil untuk mengatasi risiko dan peluang harus
proporsional dengan dampak potensial pada kesesuaian produk dan layanan?
Global dan lokal?
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(6.1.2)
4 Do the options to address all to our organization relevant risks include avoiding risk,
taking risk in order to pursue an opportunity, eliminating the risk source, changing the
likelihood or consequences, sharing the risk, or retaining risk by informed decision?
Apakah opsi untuk menangani semua risiko yang relevan dengan organisasi kita
termasuk menghindari risiko, mengambil risiko untuk mengejar peluang,
menghilangkan sumber risiko, mengubah kemungkinan atau konsekuensi, berbagi
risiko, atau mempertahankan risiko dengan keputusan berdasarkan informasi?
(6.1.2)
5 Has any opportunity led to the adoption of new practices, launching new products,
opening new markets, addressing new customers, building partnerships, using new
technology and other desirable and viable possibilities to address our organization’s
or its customers’ needs? Please cite some instances.
Apakah ada peluang yang mengarah pada penerapan praktik baru, meluncurkan
produk baru, membuka pasar baru, menangani pelanggan baru, membangun
kemitraan, menggunakan teknologi baru dan kemungkinan lain yang diinginkan dan
memungkinkan untuk memenuhi kebutuhan organisasi atau pelanggannya? Tolong
kutip beberapa contoh.
NOTES:
Page 22 of 50
6.2 Quality objectives and planning to achieve them

6.2 Sasaran dan perencanaan mutu untuk mencapainya

(6.2.1)
1 Has our organization established and connected our quality objectives with relevant functions,
levels and processes needed to achieve our quality management system objectives?
Sudahkah organisasi kami menetapkan dan menghubungkan sasaran mutu kami dengan
fungsi, tingkat, dan proses yang diperlukan untuk mencapai sasaran sistem manajemen mutu
kami?
(6.2.1)
Whether the chosen quality objectives ...
2
Apakah sasaran mutu yang dipilih....
a) are consistent with our quality policy? Any SOP for QMS planning?
konsisten dengan kebijakan mutu kami? Adakah SOP untuk perencanaan SMM?
b) are measurable and broken down visible in our QMS processes?
dapat diukur dan dipecah,dapat terlihat di proses QMM kita?
c) take into account applicable requirements? Key Performance Indicator (KPI) Plan?
mempertimbangkan persyaratan yang berlaku? Rencana Key Performance Indicator
(KPI)?
d) are relevant to conformity of our products and services and focus on enhancement of
customer satisfaction?
relevan dengan kesesuaian produk dan layanan kami dan fokus pada peningkatan
kepuasan pelanggan?
e) are monitored? Do we have a Records keeping plan?
dipantau? Apakah kita memiliki rencana penyimpanan Catatan?
f) are communicated throughout our organization?
Dikomunikasikan ke seluruh organisasi kita?
g) are updated, as appropriate?
diperbaharui, sebgaimana mestinya?
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(6.2.1)
3 Does our organization maintain documented information on the QMS quality objectives?
Apakah organisasi kami memelihara informasi yang tersimpan tentang sasaran mutu SMM?
(6.2.2)
4 When planning how to achieve our quality objectives, does our organization determine ...
Ketika merencanakan bagaimana mencapai sasaran mutu kami, apakah organisasi kami
menentukan...
a) what will be done? Do we collect and track monthly KPI Records for status update?
apa yang akan dilakukan? Apakah kita mengumpulkan dan melacak catatan KPI bulanan
untuk pembaharuan status?
b) what resources will be required?
sumber daya apa yang akan dibutuhkan
c) who will be responsible? Process owners responsible for tracking process interruptions?
siapa yang akan bertanggung jawab? Pemilik proses yang bertanggung jawab untuk
melacak gangguan proses?
d) when it will be completed? Quarterly, Monthly, weekly?
kapan akan selesai? Triwulan, Bulanan, mingguan
e) how the results will be evaluated? Is the Quality team tracking/analyzing KPI trends?
Bagaimana hasil akan dievaluasi? Apakah tim mutu melacak/menganalisis tren KPI?
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6.3 Planning of changes

6.3 Perencanaan perubahan
1 When our organization determines the need for changes to our quality
management system, are the changes carried out in a planned manner?
Any SOP for that available?
Ketika organisasi kami menentukan kebutuhan akan perubahan pada sistem
manajemen mutu kami, apakah perubahan tersebut dilakukan secara
terencana? Adakah SOP yang tersedia?
Does our organization consider ...

Apakah organisasi kita mempertimbangkan...
a) the purpose of the changes and their potential consequences?

Tujuan dari perubahan dan konsekuensi potensial mereka?
b) the integrity of our quality management system?
Integritas dari sistem manajmen mutu kita?
c) the availability of resources to cover the changes?
Ketersediaan dari sumber daya untuk menutupi perubahan?
d) the allocation or reallocation of responsibilities and authorities?
alokasi atau realokasi tanggung jawab dan wewenang?
NOTES:
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Clause 7: SUPPORT
Pasal 7. DUKUNGAN
7.1 Resources
7.1 Sumber Daya

(7.1.1 – General)
(7.1.1 – Umum)
1
Has our organization determined and is providing the resources needed for the
establishment, implementation, maintenance and continual improvement of our quality
management system? Is that a constant item line of our QMS Management Reviews?
Sudahkah organisasi kami menentukan dan menyediakan sumber daya yang dibutuhkan
untuk pendirian, implementasi, pemeliharaan, dan peningkatan berkelanjutan dari sistem
manajemen mutu kami? Apakah itu item yang konstan dari Tinjauan Manajemen SMM
kami?
Has our organization considered ...
Sudahkah organisasi kami mempertimbangkan....
a) the capabilities of, and constraints on, existing internal resources?

Kemampuan dari dan kendala pada sumber daya internal yang ada?
b) what needs to be obtained from external providers?
Apa yang perlu diperoleh dari penyedia eksternal?
(7.1.2 - People)
(7.1.2 – Manusia)
2
Does our organization determine and provide the persons necessary for the effective
implementation of our quality management system and for the operation and control of its
relevant processes? Job Skill Matrix? Annual Training plan in place? etc...
Apakah organisasi kami menentukan dan menyediakan orang-orang yang diperlukan
untuk implementasi efektif dari sistem manajemen mutu kami dan untuk operasi dan
kontrol dari proses yang relevan? Matriks Keterampilan Kerja? Sudah ada rencana
pelatihan tahunan? dll ...
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(7.1.3 - Infrastructure)
(7.1.3 Infrastruktur)
3 Does our organization determine, provide and maintain the infrastructure necessary for
the operation of its processes and to achieve conformity of products & services?
Apakah organisasi kami menentukan, menyediakan, dan memelihara infrastruktur yang
diperlukan untuk pengoperasian prosesnya dan untuk mencapai kesesuaian produk &
layanan?
What is the status of the following infrastructure (if applicable) ...

Apa status infrastruktur berikut (jika ada) ..
a) buildings and associated utilities?

Bangunan dan utilitas terkait?
b) equipment, including hardware and software?
Peralatan, termasuk perangkat keras dan perangkat lunak?
c) transportation resources?
Sumber daya transportasi?
d) information and communication technology?
Teknologi informasi dan komunikasi?
(7.1.4 - Environment for the operation of our QMS processes)
(7.1.4 – lingkungan untuk pengoperasian proses SMM kami)
4 Has our organization determined, provided and is maintaining the environment necessary
for the operation of its processes and to achieve conformity of our products and services?
Sudahkah organisasi kami menentukan, menyediakan, dan memelihara lingkungan yang
diperlukan untuk operasi prosesnya dan untuk mencapai kesesuaian produk dan layanan
kami?
What is the status of the following environmental factors (if relevant) ...
Apa status faktor lingkungan berikut (jika relevan) ..
a) social (e.g. non-discriminatory, calm, non-confrontational)?

Sosial (sebagai contoh: tanpa diskriminasi, tenang dan anti konfrontasi)
b) psychological (such as stress-reducing, burnout prevention, emotionally protective)?
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Psikologi (seperti mengurangi stres, pencegahan kelelahan, protektif secara

emosional)?
c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise)?
Fisik (sebagai contoh: temperatur,panas, kelembabam, cahaya, aliran udara,
kebersihan, kebisingan)?
SOP’s for our Operations/business activities in place, Flow charts, etc…?

SOP untuk Operasi / kegiatan bisnis kami di tempat, Diagram alir, dll ...?
(7.1.5.1 Monitoring and measuring resources – general)

(7.1.5.1 Pemantauan dan pengukuran sumber daya – umum)
5 Has our organization determined and is providing the resources needed to ensure valid
and reliable results when monitoring or measuring is used to verify the conformity of
products and services to requirements with focus on non-conformities? Who is doing
Legal Watch and Statutory/Regulatory Watch in our organization?
Sudahkah organisasi kami menentukan dan menyediakan sumber daya yang diperlukan
untuk memastikan hasil yang valid dan dapat diandalkan ketika pemantauan atau
pengukuran digunakan untuk memverifikasi kesesuaian produk dan layanan dengan
persyaratan dengan fokus pada ketidaksesuaian? Siapa yang melakukan Pengawasan
Hukum dan Pengawasan Hukum / Peraturan di organisasi kami?

(7.1.5.1 Pemantauan dan Pengukuran sumber daya – umum)
6 Whether and how does our organization ensure that the resources provided ...
Apakah dan bagaimana organisasi kami memastikan bahwa sumber daya yang
disediakan ...
a) are suitable for the specific type of monitoring and measurement activities being
undertaken?
sesuai untuk jenis kegiatan pemantauan dan pengukuran tertentu yang dilakukan?
b) are maintained to ensure their continuing fitness for their purpose?
diperhatikan untuk memastikan kebugaran berkelanjutan untuk tujuan mereka?
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(7.15.1 Pemantauan dan pengukuran sumber daya – umum)
7 Does our organization retain appropriate documented information as evidence of fitness

for purpose of the monitoring and measurement resources? What documents are they?
Apakah organisasi kami menyimpan informasi terdokumentasi yang sesuai sebagai bukti
kesesuaian untuk keperluan sumber daya pemantauan dan pengukuran? Dokumen apa
itu?
(7.1.5.2 Monitoring and measuring resources - Measurement traceability)

(7.1.5.2 Pemantauan dan pengukuran sumber daya – penelusuran pengukuran)
8 When measurement traceability is a requirement, or is considered by our organization to

be an essential part of providing confidence in the validity of measurement results, are the
measuring equipment ...
Ketika penelusuran pengukuran merupakan persyaratan, atau dianggap oleh organisasi
kami sebagai bagian penting dari memberikan kepercayaan pada validitas hasil
pengukuran, apakah peralatan pengukuran ...
a) calibrated or verified, or both, at specified intervals, or prior to use, against

measurement standards traceable to international or national measurement standards;
when no such standards exist, the basis used for calibration or verification shall be
retained as documented information?
dikalibrasi atau diverifikasi, atau keduanya, pada interval yang ditentukan, atau
sebelum digunakan, terhadap standar pengukuran yang dapat dilacak ke standar
pengukuran internasional atau nasional; ketika tidak ada standar seperti itu, dasar
yang digunakan untuk kalibrasi atau verifikasi harus dipertahankan sebagai informasi
yang terdokumentasi?
b) identified in order to determine their status?
diidentifikasi untuk menentukan status mereka?
c) safeguarded from adjustments, damage or deterioration that would invalidate the
calibration status and subsequent measurement results?
dilindungi dari penyetelan, kerusakan atau penurunan kualitas yang akan membuat
status kalibrasi menjadi tidak valid pada hasil pengukuran selanjutnya?
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(7.1.5.2 Monitoring and measuring resources - Measurement traceability)

(7.1.5.2 Pemantauan dan pengukuran sumber daya – penelusuran pengukuran)
9 Does our organization determine if the validity of previous measurement results has been
adversely affected when measuring equipment is found to be unfit for its intended
purpose, and take appropriate action as necessary?
Apakah organisasi kami menentukan jika validitas hasil pengukuran sebelumnya telah
terpengaruh buruk ketika peralatan pengukur ditemukan tidak layak untuk tujuan yang
dimaksudkan, dan mengambil tindakan yang sesuai sebagaimana diperlukan?
(7.1.6 - Organizational knowledge)
(7.1.6 – Pengetahuan organisasi)
10 Has our organization determined the knowledge necessary for the operation of its QMS
processes and to achieve conformity of products and services?
Sudahkah organisasi kami menentukan pengetahuan yang diperlukan untuk
pengoperasian proses SMM dan untuk mencapai kesesuaian produk dan layanan?

(7.1.6 - Pengetahuan Organisasi)
11 Whether this knowledge is maintained within documented information and made available
to the extent necessary?
Apakah pengetahuan ini dipertahankan dalam informasi yang terdokumentasi dan
tersedia sejauh diperlukan?
Page 30 of 50

(7.16 – Pengetahuan Organisasi)
12 When addressing changing needs and trends, does our organization consider its current
knowledge and determine how to acquire or access any necessary additional knowledge
and required updates?
Ketika menangani perubahan kebutuhan dan tren, apakah organisasi kami
mempertimbangkan pengetahuannya saat ini dan menentukan bagaimana cara
memperoleh atau mengakses pengetahuan tambahan yang diperlukan dan pembaruan
yang diperlukan?
(7.1.6 – Pengetahuan Organisasi)
13 Whether our organizational knowledge is based on:

Apakah pengetahuan organisasi kita didasarkan pada:
a) internal sources (e.g. intellectual property; knowledge gained from experience; lessons
learned from failures and successful projects; capturing and sharing undocumented
knowledge and experience; the results of improvements in processes, products and
services)?
sumber internal (sebagai contoh: kekayaan intelektual; pengetahuan yang diperoleh
dari pengalaman; pelajaran yang didapat dari kegagalan dan proyek yang berhasil;
menangkap dan berbagi pengetahuan dan pengalaman yang tidak berdokumen; hasil
peningkatan dalam proses, produk dan layanan)?
b) external sources ( e.g. standards; academia; conferences; gathering knowledge from
customers or external providers)?
sumber eksternal (sebagai contoh: standar; akademisi; konferensi; pengumpulan
pengetahuan dari pelanggan atau penyedia eksternal)?
NOTES:
Page 31 of 50
7.2 Competence
7.2 Kompetensi
1 Does our organization ...

Apakah organisasi kami ....
a) determine the necessary competence of person(s) doing work under its control that
affects the performance and effectiveness of our quality management system?
menentukan kompetensi yang diperlukan orang yang melakukan pekerjaan di bawah
kendalinya yang memengaruhi kinerja dan efektivitas sistem manajemen mutu kita?
b) ensure that these persons are competent on the basis of appropriate education,
training, or experience? Job Skill matrix, HR Competency plan for growth, etc…
memastikan bahwa orang-orang ini kompeten berdasarkan pendidikan, pelatihan, atau
pengalaman yang sesuai? Matriks Keterampilan Kerja, rencana Kompetensi SDM
untuk pertumbuhan, dll ...
c) where applicable, take actions (for example, the provision of training to, the mentoring
of, or the reassignment of currently employed persons; or the hiring or contracting of
competent persons) to acquire the necessary competence, and evaluate the
effectiveness of the actions taken?
jika dapat diterapkan, mengambil tindakan (misalnya, penyediaan pelatihan untuk,
pendampingan, atau penugasan kembali orang-orang yang saat ini dipekerjakan; atau
mempekerjakan atau mengontrak orang-orang yang kompeten) untuk memperoleh
kompetensi yang diperlukan, dan mengevaluasi keefektifan dari tindakan yang
diambil?
d) retain appropriate documented information as evidence of competence?
menyimpan informasi terdokumentasi yang sesuai sebagai bukti kompetensi?
NOTES:
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7.3 Awareness
7.3 Kesadaran
1 Whether and how does our organization ensure that persons doing work
under our organization’s control are aware of:
Apakah dan bagaimana organisasi kami memastikan bahwa orang yang
melakukan pekerjaan di bawah kendali organisasi kami mengetahui:
a) our quality policy? Training evidence?

Kebijakan mutu kami? Bukti pelatihan?
b) our relevant quality objectives? Training records?
sasaran mutu kita yang relevan? Catatan pelatihan?
c) their contribution to the effectiveness of our quality management system,
including the benefits of improved qulaity performance?
kontribusi mereka terhadap efektivitas sistem manajemen mutu kami,
termasuk manfaat dari peningkatan kualitas qulaity?
d) the implications of not conforming with our quality management system
requirements? Any training on Process owners responsibility?
implikasi tidak sesuai dengan persyaratan sistem manajemen mutu kami?
Adakah pelatihan tentang tanggung jawab pemilik proses?
Page 33 of 50
7.4 Communication
7.4 Komunikasi
1 Has our organization determined the internal and external communications

relevant to our quality management system, including:
Apakah organisasi kami menentukan komunikasi internal dan eksternal yang
relevan dengan sistem manajemen kualitas kami, termasuk:
a) on what we will communicate? Marketing Plan/Customer engagement?

tentang apa yang akan kami komunikasikan? Rencana Pemasaran /
Keterlibatan Pelanggan?
b) when to communicate?
Kapan berkomunikasi?
c) with whom to communicate?
Dengan siapa berkomunikasi?
d) how to communicate?
Bagaimana berkomunikasi?
e) who communicates?
Siapa yang berkomunikasi?
7.5 Documented information

7.5 Informasi yang terdokumentasi
7.5.1 General
7.5.1 Umum
Page 34 of 50
1 Does our organization’s quality management system include:
a) documented information required by the ISO 9001:2015 standard?

b) documented information determined by our organization as being
necessary for the effectiveness of our quality management system?
7.5.2 Creating and updating
1 When creating and updating documented information, does our organization

ensure appropriate:
Saat membuat dan memperbarui informasi yang terdokumentasi, apakah
organisasi kami memastikan yang sesuai:
a) identification and description (e.g. a title, date, author, or reference

number)?
identifikasi dan deskripsi (mis. judul, tanggal, penulis, atau nomor
referensi)?
b) format (e.g. language, software version, graphics) and media (e.g. paper,
electronic)?
format (mis. bahasa, versi perangkat lunak, grafik) dan media (mis.
kertas, elektronik)?
c) review and approval for suitability and adequacy?
meninjau dan menyetujui kesesuaian dan kecukupan?
Page 35 of 50
NOTES:
Page 36 of 50
7.5.3 Control of documented information

7.5.3 Kontrol informasi yang terdokumentasi

(7.5.3.1)
1 Are the documented information (relevant to our quality management system

and required by the ISO 9001:2015 standard) controlled to ensure that ...
Apakah informasi yang didokumentasikan (relevan dengan sistem
manajemen mutu kami dan disyaratkan oleh standar ISO 9001: 2015)
dikendalikan untuk memastikan bahwa ...
a) it is available and suitable for use, where and when it is needed?

tersedia dan cocok untuk digunakan, dimana dan kapan dibutuhkan?
b) it is adequately protected (e.g. from loss of confidentiality, improper use,
or loss of integrity)? Does our Email policy help to preserve emails?
dilindungi secara cukup (sebagai contoh dari hilangnya kerahasiaan,
penggunaan yang tidak tepat, atau hilangnya integritas)? Apakah
kebijakan surat elektronik kita membantu menjaga surat elektronik
tersebut?
(7.5.3.2)
2 For the control of documented information, has our organization addressed

the following activities to maintain documented information, as applicable:
Untuk mengendalikan informasi yang terdokumentasi, organisasi kita telah
menangani kegiatan berikut untuk menjaga informasi yang terdokumentasi,
sebagaimana berlaku:
a) distribution, access, retrieval and use?

distribusi, akses, pengambilan dan penggunaan?
b) storage and preservation, including preservation of legibility?
penyimpanan dan pelestarian, termasuk pelestarian keterbacaan?
c) control of changes (e.g. version control)?
Page 37 of 50
kontrol perubahan (sebagai contoh. kontrol versi)?

d) retention and disposition?
retensi dan disposisi?
(7.5.3.2)
3 Are the documented information of external origin necessary for the planning
and operation of our quality management system identified (as appropriate)?
Are they controlled in some form or way? Any SOP’s/Records obsolete?
Apakah informasi yang didokumentasikan yang berasal dari luar diperlukan
untuk perencanaan dan pengoperasian sistem manajemen mutu kami
diidentifikasi (sebagaimana diperlukan)? Apakah mereka dikendalikan dalam
beberapa bentuk atau cara? Apakah SOP / Catatan sudah usang?
(7.5.3.2)
4 Are QMS related documented information retained as evidence of conformity

protected from unintended alterations?
Apakah informasi yang didokumentasikan terkait SMM disimpan sebagai
bukti kesesuaian dilindungi dari perubahan yang tidak disengaja?
Page 38 of 50
Clause 8: OPERATION
8.1 Operational planning and control
1 Has our organization planned, implemented and controlling the processes needed to meet
the requirements for the provision of products and services, and to implement the actions
determined in Clause 6 (Planning)?
2 Are we are doing these by:

a) determining the requirements for our products and services? Which SOP?
b) establishing criteria for the processes and the acceptance of products and services?
c) determining the resources needed to achieve conformity to the product and service
requirements? (Supplier evaluations, Annual evaluation of all Third Party vendors?)
d) implementing control of the processes in accordance with the criteria?
e) determining, maintaining and retaining documented information to the extent necessary
to have confidence that the processes have been carried out as planned, and, to
demonstrate the conformity of products and services to their requirements?
3 Is the output of this planning suitable for our organization’s operations? Can we defend that
with some examples from recent past?
4 Whether and how our organization is controlling planned changes and reviewing the
consequences of unintended changes, taking action to mitigate any adverse effects, as
necessary?
5 How does our organization ensure that outsourced processes are controlled?
Page 39 of 50
8.2 Requirements for our products and services
8.2.1 Customer communication
1 Does our communication with customers include ...
a) providing information relating to products and services? And how?

b) handling enquiries, contracts or orders, including changes? And how?
c) obtaining customer feedback relating to products and services, including
customer complaints? And how? Any Customer Survey records?
d) handling or controlling customer property? And how?
e) establishing specific requirements for contingency actions, when
relevant? And how?
8.2.2 Determining the requirements for products and services
1 When determining the requirements for our products and services to be

offered to customers, does our organization ensure that ...
a) the requirements for our products and services are defined, including any
applicable statutory and regulatory requirements, and, those considered
necessary by our organization?
b) our organization can meet the claims we make for our products and
services we offer? Sales terms/Purchase order terms recent version?
Page 40 of 50
8.2.3 Review of the requirements for products and services

(8.2.3.1)
1
How does our organization ensure that it has the ability to meet the
requirements for products and services to be offered to our customers?
(8.2.3.1)
2 Does our organization conduct a documented review before committing to

supply products and services to a customer?
(8.2.3.1)
3 Does this review include ...
a) requirements specified by our customer, including the requirements for

delivery and post-delivery activities?
b) requirements not stated by the customer, but necessary for the specified
or intended use, when known?
c) requirements specified by our organization?
d) statutory and regulatory requirements applicable to our products and
services?
e) contract or order requirements differing from those previously
expressed?
NOTES:
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(8.2.3.1)
4 How does our organization ensure that contract or order requirements

differing from those previously defined are resolved?
(8.2.3.1)
5 Do the customer’s requirements be confirmed by our organization before

acceptance, when the customer does not provide a documented statement
of their requirements?
(8.2.3.1)
6 In situations such as internet sales, does our organization review the

coverage of relevant product information, such as catalogues?
(8.2.3.2)
7 Does our organization retain documented information, as applicable, ...
a) on the results of the review? Please show some samples.

b) on any new requirements for our products and services? Please show
some samples.
NOTES:
Page 42 of 50
8.2.4 Changes to requirements for products and services
1 How does our organization ensure that relevant documented information is

amended, and that relevant persons are made aware of the changed
requirements, when the requirements for our products and services are
changed?
8.3 Design and development of products and services
8.3.1 General
1 Has our organization established, implemented and is maintaining a design

and development process that is appropriate to ensure the subsequent
provision of our products and services?
NOTES:
Page 43 of 50
8.3.2 Design and development planning
1 In determining the stages and controls for design and development, does our
organization consider ...
a) the nature, duration and complexity of all design and development

activities?
b) the required process stages, including applicable design and development
reviews?
c) the required design and development verification and validation activities?
d) the responsibilities and authorities involved in the design and development
process?
e) the internal and external resource needs for the design and development of
products and services?
f) the need to control interfaces between persons involved in the design and
development process? Is our ERP handling that process?
g) the need for involvement of customers and users in the design and
development process?
h) the requirements for subsequent provision of our products and services?
i) the level of control expected for the design and development process by
customers and other relevant interested parties?
j) the documented information needed to demonstrate that all design and
development requirements have been met?
NOTES:
Page 44 of 50
8.3.3 Design and development inputs
1 Does our organization determine the requirements essential for the specific
types of our products and services to be designed and developed?
2 Does our organization consider ...
a) functional and performance requirements?

b) information derived from previous similar design and development
activities?
c) statutory and regulatory requirements?
d) standards or codes of practice that our organization has committed to
implement?
e) potential consequences of failure due to the nature of our products &
services?
3 How do you make sure that the inputs are adequate for design and
development purposes, complete and unambiguous? And who approves this?
4 In case of conflicting design and development inputs, how do we resolve them

before proceeding further?
5 Does our organization retain documented information on all design and

development inputs? Please show some samples.
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8.3.4 Design and development controls
1 Does our organization apply controls to our design and development process to
ensure that ...
a) the results to be achieved are defined?

b) reviews are conducted to evaluate the ability of the results of design and
development to meet requirements?
c) verification activities are conducted to ensure that our design and development
outputs meet the input requirements?
d) validation activities are conducted to ensure that our resulting products and
services meet the requirements for the specified application or intended use?
e) any necessary actions are taken on problems determined during the reviews, or
verification and validation activities?
f) documented information of these activities is retained?
8.3.5 Design and development outputs
1 Does our organization ensure that all design and development outputs ...
a) meet the input requirements?

b) are adequate for the subsequent processes for the provision of our products and
services?
c) include or reference monitoring and measuring requirements, as appropriate, and
acceptance criteria?
d) specify the characteristics of our products and services that are essential for their
intended purpose and their safe and proper provision?
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2 Does our organization retain documented information on all design and development
outputs?
8.3.6 Design and development changes
1 Does our organization identify, review and control all changes made during, or
subsequent to, the design and development of our products and services, to the extent
necessary to ensure that there is no adverse impact on conformity to requirements?
2 Whether and what documented information does our organization retaining on ...
a) design and development?

b) the authorization of all changes?
c) the actions taken to prevent adverse impacts?
Do we have Flow Charts/Routing for customer complaints for our internal routing?
NOTES:
Page 47 of 50
8.4 Control of externally provided processes, products and services
8.4.1 General
1 How does our organization ensure that externally provided processes, products and
services conform to the proposed product and service requirements?
Non-conformity Register in place?
2 Has our organization determined the controls to be applied to externally provided

processes, products and services when ...
a) products and services from external providers are intended for incorporation into
our organization’s own products and services?
b) products and services are provided directly to the customer(s) by external
providers on behalf of our organization?
c) a process, or part of a process, is provided by an external provider as a result of
a decision by our organization?
3 Whether and how does our organization determine and apply criteria for the
evaluation, selection, monitoring of performance, and re-evaluation of external
providers? Is it based on their ability to provide processes or products and services in
accordance with requirements?
4 What documented information does our organization retain for these activities and
any necessary actions arising from these evaluations?
Page 48 of 50
8.4.2 Type and extent of control
1 How does our organization ensure that externally provided processes, products and
services do not adversely affect our organization’s ability to consistently deliver
conforming products and services to our customers?
2 Does our organization ...
a) ensure that externally provided processes remain within the control of our quality
management system?
b) define both the controls that it intends to apply to an external provider and those it
intends to apply to the resulting output?
c) take into consideration:
1) the potential impact of the externally provided processes, products and
services on our organization’s ability to consistently meet customer and
applicable statutory and regulatory requirements?
2) the effectiveness of the controls applied by the external provider?
d) determine the verification, or other activities, necessary to ensure that the

externally provided processes, products and services meet all requirements?
NOTES:
Page 49 of 50
8.4.3 Information for external providers
1 How does our organization ensure the adequacy of requirements prior to their
communication to the external provider?
2 Does our organization communicate to external providers its requirements for ...
a) the processes, products and services to be provided?

b) the approval of:
1) products and services?
2) methods, processes and equipment?
3) the release of products and services?
c) competence, including any required qualification of persons?

d) the external providers’ interactions with our organization?
e) control and monitoring of the external providers’ performance to be applied by our
organization?
f) verification or validation activities that our organization, or its customer, intends to
perform at the external providers’ premises?
NOTES:
Page 50 of 50
8.5 Production and service provision
8.5.1 Control of production and service provision
1 Has our organization implemented production and service provision under controlled
conditions?
2 Do these controlled conditions include, as applicable ...
a) the availability of documented information that defines:

1) the characteristics of the products to be produced, the services to be provided,
or the activities to be performed?
2) the results to be achieved?
b) the availability and use of suitable monitoring and measuring resources?

c) the implementation of monitoring and measurement activities at appropriate stages
to verify that criteria for control of processes or outputs, and acceptance criteria for
products and services, have been met? Calibration Log? Etc…
d) the use of suitable infrastructure and environment for the operation of processes?
e) the appointment of competent persons, including any required qualification?
f) the validation, and periodic revalidation, of the ability to achieve planned results of
the processes for production and service provision, where the resulting output
cannot be verified by subsequent monitoring or measurement?
g) the implementation of actions to prevent human error?
h) the implementation of release, delivery and post-delivery activities?
Page 51 of 50
8.5.2 Identification and traceability
1 Does our organization use suitable means to identify all outputs when it is necessary to
ensure the conformity of our products and services?
2 How does our organization identify the status of all outputs with respect to monitoring and
measurement requirements throughout production and service provision?
3 How does our organization control the unique identification of the outputs when traceability
is a requirement, and shall retain the documented information necessary to enable
traceability?
8.5.3 Property belonging to customers or external providers
1 Does our organization exercise care with property belonging to customers or external
providers while it is under our organization’s control or being used by our organization?
2 Does our organization identify, verify, protect and safeguard customers’ or external
providers’ property provided for use or incorporation into our products and services?
Page 52 of 50
3 When the property of a customer or external provider is lost, damaged or otherwise found
to be unsuitable for use, does our organization report this to the customer or external
provider and retain documented information on what has occurred?
4 Does your definition (and coverage) of customer’s or external provider’s property include
materials, components, tools and equipment, premises, intellectual property and personal
data?
8.5.4 Preservation
1 How does our organization preserve the outputs during production and service provision, at
least to the extent necessary to ensure conformity to requirements?
2 Does our definition (and coverage) of preservation include identification, handling,

contamination control, packaging, storage, transmission or transportation, and protection?
NOTES:
Page 53 of 50
8.5.5 Post-delivery activities
1 How does our organization meet requirements for post-delivery activities associated
with our products and services?
2 In determining the extent of post-delivery activities that are required, does our
organization consider ...
a) statutory and regulatory requirements?

b) the potential undesired consequences associated with our products and services?
c) the nature, use and intended lifetime of our products and services?
d) customer requirements?
e) customer feedback?
3 Does our definition (and coverage) of post-delivery activities include actions under
warranty provisions, contractual obligations such as maintenance services, and
supplementary services such as recycling or final disposal?
8.5.6 Control of changes
1 Does our organization review and control changes for production or service provision, to
the extent necessary to ensure continuing conformity with all requirements?
2 Does our organization retain documented information describing the results of the
review of any changes, the person(s) authorizing the change, and any necessary
actions arising from the review?
Page 54 of 50
8.6 Release of products and services
1 Has our organization implemented planned arrangements, at appropriate stages, to

verify that the product and service requirements have been met?
2 How do we ensure that the release of our products and services to the customer do not
proceed until the planned arrangements have been satisfactorily completed, unless
otherwise approved by a relevant authority and, as applicable, by our customer?
3 Does our organization retain documented information on the release of our products and
services? Are the records up-to-date? Please show some samples.
4 Does the documented information include ...
a) evidence of conformity with the acceptance criteria (inspection / test results)?

b) traceability to the person(s) authorizing the release (i.e., who has authorized the
release)?
NOTES:
Page 55 of 50
8.7 Control of nonconforming outputs

(8.7.1)
1 How does our organization ensure that outputs that do not conform to their requirements
are identified and controlled to prevent their unintended use or delivery?
(8.7.1)
2 Does our organization take appropriate action based on the nature of the nonconformity
and its effect on the conformity of our products and services?
(8.7.1)
3 Does this also apply to nonconforming products and services detected after delivery of
products, during or after the provision of services?
(8.7.1)
4 Is our organization dealing in appropriate ways with nonconforming outputs in one or

more of the following ways ...
a) correction? Corrective Action tools? Please give some examples.
b) segregation, containment, return or suspension of provision of our delivered products

and services? Please give some examples.
c) informing the customer? Please give some examples.
d) obtaining authorization for acceptance under concession? Please give some
examples.
Page 56 of 50
(8.7.1)
5 Is the new conformity to the requirements verified when nonconforming outputs are
corrected (i.e., re-inspection)?
(8.7.2)
6 Does our organization retain documented information that ...
a) describes the nonconformity?

b) describes the actions taken?
c) describes any concessions obtained?
d) identifies the authority deciding the action in respect of the nonconformity?
NOTES:
Page 57 of 50
Clause 9: PERFORMANCE EVALUATION
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
1 Has our organization determined ...
a) what needs to be monitored and measured within our QMS?

b) the methods for monitoring, measurement, analysis and evaluation of our QMS
needed to ensure valid results within our QMS?
c) when the monitoring and measuring of our QMS shall be performed?
d) when the results from monitoring and measurement shall be analyzed and
evaluated?
2 Whether and how does our organization evaluate the performance of our QMS and the
effectiveness of our quality management system?
3 Does our organization retain appropriate documented information as evidence of the

results? Please show some samples.
NOTES:
Page 58 of 50
9.1.2 Customer satisfaction

Whether and how does our organization monitor customers’ perceptions of the degree
1 to which their needs and expectations have been fulfilled?
2 Has our organization determined the methods for obtaining, monitoring and reviewing
this information? Do we evaluate also Internal Customer satisfaction? How?
3 Does your system / method of monitoring customer perceptions include customer

surveys, customer feedback on delivered products and services, meetings with
customers, market-share analysis, compliments, warranty claims and dealer reports?
9.1.3 Analysis and evaluation

Whether and how does our organization analyze and evaluate appropriate data and
1 information arising from monitoring and measurement of our QMS?
2 Do we use the results of analysis to evaluate ...

a) conformity of products and services?
b) the degree of customer satisfaction?
c) the performance and effectiveness of our quality management system?
d) if planning of all QMS related activities has been implemented effectively?
e) the effectiveness of actions taken to address risks and opportunities?
f) the performance of external providers (Suppliers, vendors, etc.)?
g) the need for improvements to the quality management system?
3 Does our organization use any statistical techniques to analyze our QMS related data?
Are our people trained on using statistical techniques for QMS related data analysis?
Page 59 of 50
9.2 Internal audit

(9.2.1)
Does our organization conduct internal audits at planned intervals?
1
(9.2.1)
Do our internal audits provide information on whether our quality management system ...
2
a) conforms to:
1) our organization’s own requirements for its quality management system?
2) the requirements of the ISO 9001:2015 standard?
b) is effectively implemented and maintained?

(9.2.2)
Does our organization ...
3
a) plan, establish, implement and maintain an audit program including the frequency,
methods, responsibilities, planning requirements and reporting, which takes into
consideration the importance of the processes concerned, changes affecting our
organization, and the results of previous audits?
b) define the audit criteria and scope for each audit with focus on improvement?
c) select auditors and conduct audits to ensure objectivity and the impartiality of the
audit process? Annual Audit Plan? Lesson Learned plan? etc…
d) ensure that the results of the audits are reported to relevant management?
e) take appropriate correction and corrective actions without undue delay?
f) retain documented information as evidence of the implementation of the audit
program and the audit results?
(9.2.2)
4 Are our internal auditors aware of / trained on the audit standard (i.e., ISO19011:2011)?
Page 60 of 50
9.3 Management review
9.3.1 General
1 Does our top management review our organization’s quality management system
at planned intervals, to ensure its continuing suitability, adequacy, effectiveness
and alignment with the strategic direction of our organization?
9.3.2 Management review inputs
1 Is the QMS management review planned/carried out taking into consideration ...
a) the status of actions from previous QMS management reviews?
b) changes in external and internal issues that are relevant to our quality
management system?
c) information on the performance and effectiveness of the quality management
system, including trends in:
1) customer satisfaction and feedback from relevant interested parties?
2) the extent to which quality objectives have been met?
3) process performance and conformity of products and services?
4) non-conformities and corrective actions?
5) monitoring and measurement results?
6) other audit results?
7) the performance of external providers (Supplier evaluations, etc.)?
d) the adequacy of resources?

e) the effectiveness of actions taken addressing risks and opportunities?
f) opportunities for improvement?
Page 61 of 50
9.3.3 Management review outputs
1 Do the outputs of our last QMS management review include top management
decisions and concise actions with responsibilities and due date for accomplishment
related to ...
a) opportunities for improvement of our QMS?

b) any need for changes to our quality management system?
c) Resources or any other needs?
2 Does our organization retain documented information as evidence of the results of

management reviews? Please show some sample.
NOTES:
Page 62 of 50
Clause10: IMPROVEMENT
10.1 General
1 Does our organization have a system in place to determine and select

opportunities for improvement and implement any necessary actions to meet
customer requirements and enhance customer satisfaction?
2 Does this system include focus on ...
a) improving products and services to meet requirements as well as to

address future needs and expectations?
b) correcting, preventing or reducing undesired effects?
c) improving the performance and effectiveness of our quality management
system?
3 Can we show evidence and cite some examples of improvement our

organization has achieved through correction, corrective action, continual
improvement, breakthrough change, innovation, or, re-organization at least
over the last three months?
NOTES:
Page 63 of 50
10.2 Nonconformity and corrective action

(10.2.1)
1 When a nonconformity (NC) occurs, including any nonconformity arising from complaints,
whether internal or external complaint nature, does our organization ...
a) react to the nonconformity and, as applicable:

1) take action to control and correct it?
2) deal with the consequences?
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order
that it does not recur or occur elsewhere, by:
1) reviewing and analyzing the nonconformity?
2) determining the causes of the nonconformity?
3) determining if similar non-conformities exist, or could potentially occur?
c) implement any action needed to solve the nonconformity/problem/complaint?

d) regular review the effectiveness of any corrective action taken?
e) update risks and opportunities determined during QMS planning, if necessary?
f) make changes to the quality management system, if necessary?
(10.2.1)
2 How does our organization make sure that all corrective actions are appropriate to the
effects of the non-conformities encountered? Any follow-up done to check whether the
corrective actions were effective?
(10.2.2)
3 What documented information does our organization retains as evidence of ...
a) the nature of the non-conformities and any subsequent actions taken?

b) the results of any corrective action?
Page 64 of 50
10.3 Continual improvement
1 How does our organization continually improve the suitability, adequacy and
effectiveness of our quality management system?
Bagaimana organisasi kami terus meningkatkan kesesuaian, kecukupan, dan
efektivitas sistem manajemen mutu kami?
2 Does our organization consider the results of analysis and evaluation, and the outputs
from our QMS management reviews, to determine if there are needs or opportunities
that shall be addressed as part of continual improvement?
3 Can our organization show any trend charts / graphs to prove that our organization is
showing efforts for continual improvement on critical parameters of our QMS (such as
material rejections management, field-failures management, warranty claims-, repairs-,
reworks-, customer complaints management, and service response time management,
etc.)?
Signature of Auditors : (1) ……………………………… (2) …………………………… (3) ………………………………. (4)…………………
Date : ……………………..
Signature of Auditees: (1) ……………………………… (2) …………………………… (3) ………………………………. (4)…………………

(Optional)
Date : ……………………..
Page 65 of 50
Page 66 of 50

Internal Audit Checklist (2 Bahasa)

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Internal Audit Checklist (2 Bahasa)

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Internal Audit Checklist

Quality Assurance Solutions ISO 9001:2015 Gap Analysis Audit

Disclaimer and Approved Use:

9 Performance Evaluation Check 249-291 43

Date: …………………………………………… Date: …………………………..

Clause 4: CONTEXT OF OUR ORGANIZATION

Sl. SI.#Au Audit Question Au Audit Result Au Describe the Gap

4.2 Understanding the needs and expectations of interested parties

SI.# Audit Question Audit Result Describe the Gap

4.3 Determining the scope of our quality management system

Sl. # Audit Question Audit Result Describe the Gap

2 When determining this scope, did our organization consider:

a) the external and internal issues referred to in 4.1?

4.4 Quality management system and its core processes

Sl. # Audit Question Audit Result Describe the Gap

3 To the extent necessary, does our organization ...

a) maintain documented information to support the operation of our QMS related

5.1 Leadership and commitment

Sl. # Audit Question Audit Result Describe the Gap

2 (5.1.2 - Customer focus)

a) customer and applicable statutory and regulatory requirements are determined,

Sl.# Audit Question Audit Result Describe the Gap

(5.2.2 - Communicating the quality policy)

5.3 Organizational roles, responsibilities and authorities

Sl. # Audit Question Audit Result Describe the Gap

6.1 Actions to address risks and opportunities

Sl. # Audit Question Audit Result Describe the Gap

2 Has our organization planned ...

a) actions to address these risks and opportunities? (Continuity/Contingency plan?)

6.2 Quality objectives and planning to achieve them

Sl. # Audit Question Audit Result Describe the Gap

6.3 Planning of changes

Sl. # Audit Question Audit Result Describe the Gap

Does our organization consider ...

a) the purpose of the changes and their potential consequences?

Sl. # Audit Question Audit Result Describe the Gap

a) the capabilities of, and constraints on, existing internal resources?

What is the status of the following infrastructure (if applicable) ...

a) buildings and associated utilities?

a) social (e.g. non-discriminatory, calm, non-confrontational)?

Psikologi (seperti mengurangi stres, pencegahan kelelahan, protektif secara

SOP’s for our Operations/business activities in place, Flow charts, etc…?

(7.1.5.1 Monitoring and measuring resources – general)

(7.1.5.1 Monitoring and measuring resources – general)

(7.1.5.1 Monitoring and measuring resources – general)

7 Does our organization retain appropriate documented information as evidence of fitness

(7.1.5.2 Monitoring and measuring resources - Measurement traceability)

8 When measurement traceability is a requirement, or is considered by our organization to

a) calibrated or verified, or both, at specified intervals, or prior to use, against

(7.1.5.2 Monitoring and measuring resources - Measurement traceability)

(7.1.6 - Organizational knowledge)

(7.1.6 - Organizational knowledge)

13 Whether our organizational knowledge is based on:

1 Does our organization ...

Sl. # Audit Question Audit Result Describe the Gap

a) our quality policy? Training evidence?

Sl. # Audit Question Audit Result Describe the Gap

1 Has our organization determined the internal and external communications

a) on what we will communicate? Marketing Plan/Customer engagement?

7.5 Documented information

Sl. # Audit Question Audit Result Describe the Gap

1 Does our organization’s quality management system include: