Internal Quality Management System Audit Checklist (ISO9001:2015)
Q# ISO 9001:2015 Clause Audit Question
4 Context of the Organization
4.1 Understanding the organization and its context
4.1q1 The organization shall determine external and
internal issues that are relevant to its purpose and
its strategic direction and that affect its ability to
achieve the intended result(s) of its quality
managementsystem.
4.1q2 The organization shall monitor and review the
information about these external and internal
issues.
NOTE 1 Understanding the external context can be facilitated by considering issues arising from legal,
technological, competitive, market, cultural, social, and economic environments, whether international,
national, regional or local.
NOTE 2 Understanding the internal context can be facilitated by considering issues related to values, culture
knowledge and performance of the organization.
4.2 Understanding the needs and expectations of interested parties
4.2q1 Due to their impact or potential impact on the
organization’s ability to consistently provide
products and services that meet customer and
applicable statutory and regulatory requirements,
the organization shall determine:
a) the interested parties that are relevant to the
quality management system;
b) the requirements of these interested parties
that are relevant to the quality management
system.
4.2q2 The organization shall monitor and review the
information about these interested parties and their
relevant requirements.
4.3 Determining the scope of the quality management system
4.3q1 The organization shall determine the boundaries
and applicability of the quality management system
to establish its scope.
4.3q2 When determining this scope, the organization
shall consider:
a) the external and internal issues referred to in
4.1;
b) the requirements of relevant interested parties
referred to in 4.2;
c) the products and services of the organization.
4.3q3 Where a requirement of this International Standard
within the determined scope can be applied, then it
shall be applied by the organization.
Audit Evidence
How has the organization determined
external and internal issues relevant to its
purpose and strategic direction?
How do these affect the ability to achieve
the intended result of the QMS?
How do you monitor and review information
about these internal and external issues?
How have you determined what interested
parties are relevant to the QMS?
How have you determined what
requirements those parties have that are
relevant to the QMS?
How has impact or potential impact been
determined?
How do you monitor and review the
information about interested parties and
their relevant requirements?
How have the boundaries and applicability
of the QMS been used to establish the
scope of the organization?
How have:
The external and internal issues;
The requirements of relevant interested
parties and;
The products and services of the
organization been considered when
determining the scope of the organization?
How has the application of the International
Standard within the scope been determined,
and how has it been applied by the
organization?
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Q# ISO 9001:2015 Clause
4.3q4 If any requirement(s) of this International Standard
cannot be applied, this shall not affect the
organization’s ability or responsibility to ensure
conformity of products and services.
4.3q5 The scope shall be available and be maintained as
documented information stating the:
- products and services covered by the
quality management system;
- justification for any instance where a
requirement of this International Standard
cannot be applied.
4.4 Quality management system and its processes
4.4q1 The organization shall establish, implement,
maintain and continually improve a quality
management system, including the processes
needed and their interactions, in accordance with
the requirements of this International Standard.
4.4q2 The organization shall determine the processes
needed for the quality management system and
their application throughout the organization and
shall determine:
a) the inputs required and the outputs expected
from these processes;
b) the sequence and interaction of these
processes;
c) the criteria, methods, including measurements
and related performance indicators needed to
ensure the effective operation, and control of these
processes;
d) the resources needed and ensure their
availability;
e) the assignment of the responsibilities and
authorities for these processes;
f) the risks and opportunities in accordance with the
requirements of 6.1, and plan and implement the
appropriate actions to address them;
g) the methods for monitoring, measuring, as
appropriate, and evaluation of processes and, if
needed, the changes to processes to ensure that
they achieve intended results;
h) opportunities for improvement of the processes
and the quality management system.
Audit Question Audit Evidence
How have any requirements of the
International Standard been determined as
not applicable? Show me how conformity of
products and services are not affected by
this.
Where is the scope available? Where is it Scope required as documented information.
maintained as documented information?
Does it state what products and services
are covered by the QMS?
Does it justify how instances of
requirements of the QMS cannot be
applied?
How has the QMS been established? Show
me how this is implemented. How is it
maintained and continually improved? How
have the processes been determined and
how do they interact?
How have the processes been determined
for the QMS?
What are the inputs and outputs for those
processes?
What is the sequence and interaction of the
processes?
What are the criteria, methods,
measurement and related performance
indicators needed to operate and control
those processes?
What resources are needed and how are
these made available?
How are responsibilities and authorities
assigned for those processes?
How are risks and opportunities considered
and what plans are made to implement
actions to address them?
What methods are used to monitor,
measure and evaluate processes and, if
needed, what changes are made to achieve
intended results?
How are opportunities to improve the
processes and the QMS determined?
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Q# ISO 9001:2015 Clause
4.4q3 The organization shall maintain documented
information to the extent necessary to support the
operation of processes and retain documented
information to the extent necessary to have
confidence that the processes are being carried out
as planned.
5 Kepemimpinan
5.1 Kepemimpinan dan Komitmen
5.1.1 Kepemimpinan dan komitmen untuk kualitas sistem manejemen
Audit Question Audit Evidence
What documented information exists to Documented information to support the operation of
support the operation of processes? How is processes.
this documented information retained? How
is confidence that the processes are being
carried out as planned determined?
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Q# ISO 9001:2015 Clause
5.1.1q1 Manajemen puncak (Manajemen tingkat Atas)
harus menunjukkan kepemimpinan dan komitmen
sehubungan dengan mutu sistem manajemen
dengan:
a) bertanggung jawab atas efektivitas sistem
manajemen mutu;
b) memastikan bahwa kebijakan mutu dan sasaran
mutu ditetapkan untuk sistem manajemen mutu
dan kompatibel dengan arahan strategis dan sesuai
konteks organisasi;
c) memastikan bahwa kebijakan mutu
dikomunikasikan, dipahami, dan diterapkan dalam
organisasi;
d) memastikan integrasi persyaratan sistem
manajemen mutu ke dalam proses bisnis
organisasi;
e) mempromosikan kesadaran akan pendekatan
proses;
f) memastikan bahwa sumber daya yang
diperlukan untuk sistem manajemen mutu tersedia;
g) mengomunikasikan pentingnya manajemen
mutu yang efektif dan memenuhi persyaratan
sistem manajemen mutu;
h) memastikan bahwa sistem manajemen mutu
mencapai hasil yang diharapkan;
i) melibatkan, mengarahkan, dan mendukung
orang untuk berkontribusi pada efektivitas sistem
manajemen mutu;
j) mempromosikan peningkatan berkelanjutan;
k) mendukung peran manajemen terkait lainnya
untuk menunjukkan kepemimpinan mereka
sebagaimana berlaku untuk bidang tanggung jawab
mereka.
Audit Question Audit Evidence
Tunjukkan pada saya bagaimana
manajemen puncak menunjukkan
kepemimpinan dan komitmen berkenaan
dengan sistem manajemen mutu dalam
pengambilan akuntabilitas efektivitas
sistem manajemen mutu.
Bagaimana kebijakan dan tujuan kualitas
ditetapkan untuk Sistem Manajemen Mutu
dan bagaimana mereka sesuai dengan
arahan strategis dan konteks organisasi?
Bagaimana kebijakan mutu
dikomunikasikan dalam organisasi?
Tunjukkan pada saya bagaimana ini
dipahami dan diterapkan.
Bagaimana persyaratan sistem manajemen
mutu diintegrasikan ke dalam proses bisnis?
Bagaimana Anda mempromosikan
kesadaran akan pendekatan proses?
Bagaimana Anda memastikan bahwa
sumber daya yang diperlukan untuk area
sistem manajemen mutu tersedia?
Bagaimana Anda mengomunikasikan
pentingnya manajemen kualitas yang
efektif?
Bagaimana Anda mengomunikasikan
pentingnya mematuhi persyaratan Sistem
Manajemen Mutu?
Bagaimana Anda memastikan bahwa
Sistem Manajemen Mutu mencapai hasil
yang diinginkan?
Bagaimana Anda melibatkan,
mengarahkan, dan mendukung orang untuk
berkontribusi pada efektivitas Sistem
Manajemen Mutu?
Bagaimana Anda mempromosikan
peningkatan berkelanjutan?
Bagaimana Anda mendukung peran
manajemen lainnya untuk menunjukkan
kepemimpinan dalam bidang tanggung
jawab mereka?
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Q# ISO 9001:2015 Clause
CATATAN Rujukan ke "bisnis" dalam Standar Internasional ini dapat diartikan
secara luas sebagai aktivitas yang merupakan inti dari tujuan keberadaan
organisasi; apakah organisasi itu publik, pribadi, untuk untung atau tidak untuk
untung.
5.1.2 Fokus Pelanggan
5.1.2q1 Manajemen puncak (Manajemen tingkat
Atas) harus menunjukkan kepemimpinan
dan komitmen sehubungan dengan fokus
pelanggan dengan memastikan bahwa:
a) persyaratan pelanggan dan persyaratan
hukum dan peraturan yang berlaku
ditentukan dan dipenuhi;
b) risiko dan peluang yang dapat
memengaruhi kesesuaian produk dan
layanan serta kemampuan untuk
meningkatkan kepuasan pelanggan
ditentukan dan diatasi;
c) fokus pada penyediaan produk dan
layanan yang memenuhi pelanggan secara
konsisten dan persyaratan hukum dan
peraturan yang berlaku dipertahankan;
d) fokus pada peningkatan kepuasan
pelanggan dipertahankan
Audit Question Audit Evidence
Tunjukkan pada saya bagaimana
manajemen puncak menunjukkan
kepemimpinan dan komitmen
berkenaan dengan fokus pelanggan,
memastikan persyaratan dan
persyaratan hukum dan peraturan
yang berlaku ditentukan dan
dipenuhi.
Bagaimana risiko dan peluang yang
dapat memengaruhi kesesuaian
produk dan layanan ditentukan?
Bagaimana kemampuan untuk
meningkatkan kepuasan pelanggan
ditentukan dan diatasi?
Bagaimana fokus pada penyediaan
produk dan layanan yang memenuhi
pelanggan secara konsisten dan
persyaratan hukum dan peraturan
yang berlaku dipertahankan?
Bagaimana menjaga kepuasan
pelanggan?
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Q# ISO 9001:2015 Clause
5.2 Kebijakan Mutu
5.2.1
5.2.1q1 Manajemen puncak harus menetapkan,
meninjau, dan memelihara kebijakan mutu
yang:
a) sesuai dengan tujuan dan konteks
organisasi;
b) menyediakan kerangka kerja untuk
menetapkan dan meninjau tujuan kualitas;
c) termasuk komitmen untuk memenuhi
persyaratan yang berlaku;
d) termasuk komitmen untuk peningkatan
berkelanjutan dari sistem manajemen
mutu
5.2.2
5.2.2q1 Kebijakan mutu harus:
a) tersedia sebagai informasi yang
terdokumentasi;
b) dikomunikasikan, dipahami dan
diterapkan dalam organisasi;
c) tersedia untuk pihak-pihak yang
berkepentingan yang relevan,
sebagaimana diperlukan.
5.3 Peran Organisasi, Tanggung jawab dan Wewenang
Audit Question Audit Evidence
Bagaimana manajemen puncak
menetapkan, meninjau, dan
memelihara kebijakan mutu?
Bagaimana itu ditentukan agar
sesuai dengan tujuan dan konteks
organisasi?
Apakah ini memberikan kerangka
kerja untuk menetapkan dan
meninjau tujuan kualitas?
Apakah itu mengandung komitmen
untuk memenuhi persyaratan yang
berlaku?
Apakah itu termasuk komitmen
untuk perbaikan berkelanjutan dari
Sistem Manajemen Mutu?
Di mana kebijakan mutu tersedia Kebijakan Mutu sebagai informasi dokumen
sebagai informasi yang
terdokumentasi?
Bagaimana ini dikomunikasikan?
Tunjukkan pada saya bagaimana itu
dipahami dan diterapkan dalam
organisasi.
Bagaimana Anda membuatnya
tersedia untuk pihak penting yang
terkait?
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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
5.3q1 Manajemen puncak harus memastikan How does top management ensure that
responsibilities and authorities for relevant
bahwa tanggung jawab dan wewenang roles are assigned, communicated and
untuk peran yang relevan ditugaskan, understood within the organization?
dikomunikasikan dan dipahami dalam
organisasi.
Manajemen puncak harus menetapkan
tanggung jawab dan wewenang untuk:
a) memastikan bahwa sistem manajemen
mutu sesuai dengan persyaratan Standar
Internasional ini;
b) memastikan bahwa proses
menghasilkan keluaran yang diinginkan;
c) melaporkan kinerja sistem manajemen
mutu, peluang untuk perbaikan dan
kebutuhan akan perubahan atau inovasi,
dan terutama untuk pelaporan ke
manajemen puncak;
d) memastikan promosi fokus pelanggan
di seluruh organisasi;
e) memastikan bahwa integritas sistem
manajemen mutu dipertahankan ketika
perubahan pada sistem manajemen mutu
direncanakan dan diimplementasikan.

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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
5.3q2 Manajemen puncak harus memastikan Bagaimana manajemen puncak
bahwa tanggung jawab dan wewenang menetapkan tanggung jawab dan
untuk peran yang relevan ditugaskan, wewenang untuk:
dikomunikasikan dan dipahami dalam Memastikan bahwa Sistem
organisasi. Manajemen Mutu sesuai dengan
Manajemen puncak harus menetapkan standar Internasional?
tanggung jawab dan wewenang untuk: Memastikan proses memberikan
a) memastikan bahwa sistem manajemen hasil yang diinginkan?
mutu sesuai dengan persyaratan Standar Bagaimana kinerja Sistem
Internasional ini; Manajemen Mutu, peluang untuk
b) memastikan bahwa proses perbaikan dan kebutuhan untuk
menghasilkan keluaran yang diinginkan; perubahan atau inovasi dilaporkan
c) melaporkan kinerja sistem manajemen kepada manajemen puncak?
mutu, peluang untuk perbaikan dan Bagaimana fokus pelanggan
kebutuhan akan perubahan atau inovasi, dipromosikan dalam organisasi?
dan terutama untuk pelaporan ke Bagaimana integritas Sistem
manajemen puncak; Manajemen Mutu dipertahankan
d) memastikan promosi fokus pelanggan ketika perubahan pada Sistem
di seluruh organisasi; Manajemen Mutu direncanakan dan
e) memastikan bahwa integritas sistem diimplementasikan?
manajemen mutu dipertahankan ketika
perubahan pada sistem manajemen mutu
direncanakan dan diimplementasikan.
6 Planning for the quality management system
6.1 Actions to address risks and opportunities
6.1.1
6.1.1q1 When planning for the quality management system, How are the internal and external issues
the organization shall consider the issues referred and interested parties considered when
to in 4.1 and the requirements referred to in 4.2 planning for the QMS?
and determine the risks and opportunities that How are risks and opportunities determined
need to be addressed to: and addressed so that the QMS can::
a) give assurance that the quality management a) achieve its intended results;
system can achieve its intended result(s); b) Prevent or reduce undesired effects;
b) prevent, or reduce, undesired effects; c) Achieve continual improvement?
c) achieve continual improvement.
6.1.2

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Q# ISO 9001:2015 Clause
6.1.2q1 The organization shall plan:
a) actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its
quality management system processes (see 4.4);
2) evaluate the effectiveness of these actions.
6.1.2q2 Actions taken to address risks and opportunities
shall be proportionate to the potential impact on the
conformity of products and services.
6.2.2.1 Product design skills
6.2.2.1q The organization shall ensure that personnel with
1 product design responsibility are competent to
achieve design requirements and are skilled in
applicable tools and techniques.
Applicable tools and techniques shall be identified
by the organization.
NOTE Options to address risks and opportunities can 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.
6.2Quality objectives and planning to achieve them
6.2.1
6.2.1q1 The organization shall establish quality objectives
at relevant functions, levels and processes.
The quality objectives shall:
a) be consistent with the quality policy,
b) be measurable;
c) take into account applicable requirements;
d) be relevant to conformity of products and
services and the enhancement of customer
satisfaction;
e) be monitored;
f) be communicated;
g)be updated as appropriate.
The organization shall retain documented
information on the quality objectives.
6.2.2
6.2.2q1 When planning how to achieve its quality
objectives, the organization shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.
6.3 Planning of changes
Audit Question Audit Evidence
How are actions planned to address risks
and opportunities?
How are actions integrated and
implemented into the QMS processes?
How do you evaluate the effectiveness of
the actions?
How are actions taken to address risks and
opportunities determined as being
appropriate to the potential impact on the
conformity of products and services?
How do you determine that personnel with
product design responsibility are competent
to achieve design requirements? How do
you determine skills required in applicable
tools and techniques? How do you identify
applicable tools and techniques?
Where are the quality objectives and are Documented information on quality objectives
these at all relevant functions, levels and
processes?
Are they consistent with the quality policy?
Are they measureable?
Do they consider applicable requirements?
Are they relevant to the conformity of
products and services and do they enhance
customer satisfaction?
Are they monitored? How? How often?
How are they communicated?
How are they updated?
Where is the documented information on
the quality objectives?
How does the organization determine what
will be done, with what resources, when
completed and how will results be evaluated
for quality objectives?
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Q# ISO 9001:2015 Clause
6.3q1 Where the organization determines the need for
change to the quality management system (see
4.4) the change shall be carried out in a planned
and systematic manner.
The organization shall consider:
a) the purpose of the change and any of its
potential consequences;
b) the integrity of the quality management system;
c) the availability of resources;
d) the allocation or reallocation of responsibilities
and authorities.
7 Dukungan
7.1 Sumber Daya
7.1.1 Umum
7.1.1q1 Organisasi harus menentukan dan
menyediakan sumber daya yang
diperlukan untuk pembentukan,
implementasi, pemeliharaan dan
peningkatan berkelanjutan dari sistem
manajemen mutu.
Organisasi harus mempertimbangkan:
a) kemampuan, dan kendala, sumber daya
internal yang ada;
b) apa yang perlu diperoleh dari penyedia
eksternal.
7.1.2 Orang
Audit Question Audit Evidence
How are changes to the QMS planned
systematically?
Demonstrate the purpose and potential
consequences of changes;
Demonstrate the integrity of the QMS;
Demonstrate how resources are made
available?
Demonstrate how responsibility and
authority is allocated or reallocated.
Tunjukkan bagaimana sumber daya
ditentukan untuk pendirian,
implementasi, pemeliharaan, dan
peningkatan berkelanjutan dari
Sistem Manajemen Mutu.
Tunjukkan pada saya bagaimana
kemampuan dan kendala sumber
daya internal dipertimbangkan.
Tunjukkan pada saya bagaimana
kebutuhan dari penyedia eksternal
dipertimbangkan.
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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
7.1.2q1 Untuk memastikan bahwa organisasi Bagaimana Anda menyediakan
dapat secara konsisten memenuhi orang yang diperlukan secara
pelanggan dan persyaratan hukum dan konsisten bertemu dengan
peraturan yang berlaku, organisasi harus pelanggan, persyaratan hukum dan
menyediakan orang-orang yang peraturan yang berlaku untuk Sistem
diperlukan untuk operasi efektif sistem Manajemen Mutu termasuk proses
manajemen mutu, termasuk proses yang yang diperlukan?
diperlukan.
7.1.3 Infrastruktur
7.1.3q1 Organisasi harus menentukan, Bagaimana Anda menentukan,
menyediakan, dan memelihara menyediakan, dan memelihara
infrastruktur untuk mencapai kesesuaian infrastruktur untuk mencapai
produk dan layanan. kesesuaian produk dan layanan?
CATATAN 1 Setiap perubahan realisasi produk yang mempengaruhi
persyaratan pelanggan memerlukan pemberitahuan kepada, dan persetujuan dari,
pelanggan.
7.1.4 Lingkungan untuk pengoperasian proses
7.1.4q1 Organisasi harus menentukan, Bagaimana Anda menentukan,
menyediakan, dan memelihara lingkungan menyediakan, dan memelihara
yang diperlukan untuk pengoperasian lingkungan untuk pengoperasian
prosesnya dan untuk mencapai kesesuaian proses dalam rangka untuk
produk dan layanan. mencapai kesesuaian produk dan
layanan?
CATATAN Lingkungan untuk pengoperasian proses dapat mencakup faktor
fisik, sosial, psikologis, lingkungan, dan lainnya (seperti suhu, kelembaban,
ergonomi, dan kebersihan).
7.1.5 Memantau dan mengukur sumber daya
7.1.5q1 Jika pemantauan atau pengukuran Bagaimana sumber daya ditentukan
digunakan untuk bukti kesesuaian produk untuk memastikan hasil pemantauan
dan layanan dengan persyaratan yang dan pengukuran yang valid dan
ditentukan, organisasi harus menentukan handal, dimana digunakan?
sumber daya yang diperlukan untuk
memastikan hasil pemantauan dan
pengukuran yang valid dan dapat
diandalkan.

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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
7.1.5q2 Organisasi harus memastikan bahwa Bagaimana Anda memastikan
sumber daya yang disediakan: bahwa sumber daya yang disediakan
a) cocok untuk jenis spesifik kegiatan cocok untuk kegiatan pemantauan
pemantauan dan pengukuran yang dan pengukuran khusus dan
dilakukan; dipertahankan untuk memastikan
b) dipertahankan untuk memastikan kesesuaian dengan tujuan?
kebugaran mereka yang berkelanjutan
untuk tujuan mereka.
7.1.5q3 Organisasi harus menyimpan informasi Tunjukkan pada saya informasi Informasi kebugaran yang terdokumentasi untuk
terdokumentasi yang sesuai sebagai bukti yang didokumentasikan yang keperluan pemantauan & pengukuran sumber daya.
kesesuaian untuk keperluan pemantauan merupakan bukti kesesuaian untuk
dan sumber daya pengukuran. tujuan pemantauan dan sumber daya
pengukuran.
7.1.5q4 Di mana keterlacakan pengukuran adalah: Jika ada, tunjukkan padaku Informasi yang didokumentasikan untuk dasar kalibrasi
persyaratan hukum atau peraturan; bagaimana instrumen pengukuran: atau verifikasi dimana tidak ada standar.
harapan pelanggan atau pihak terkait yang Diverifikasi atau dikalibrasi pada
relevan; atau dianggap oleh organisasi interval waktu tertentu terhadap
sebagai bagian penting dari memberikan standar pengukuran nasional atau
kepercayaan pada validitas hasil internasional;
pengukuran; instrumen pengukur harus: Jika tidak ada standar, tunjukkan
-diverifikasi atau dikalibrasi pada interval pada saya informasi yang
yang ditentukan atau sebelum digunakan didokumentasikan yang digunakan
terhadap standar pengukuran yang dapat sebagai dasar untuk kalibrasi atau
dilacak ke standar pengukuran verifikasi.
internasional atau nasional. Jika tidak ada Tunjukkan pada saya bagaimana
standar seperti itu, dasar yang digunakan instrumen pengukuran diidentifikasi
untuk kalibrasi atau verifikasi harus untuk menentukan status kalibrasi
dipertahankan sebagai informasi yang mereka.
terdokumentasi; Tunjukkan pada saya bagaimana
-dikidentifikasi untuk menentukan status mereka dilindungi dari penyesuaian.
kalibrasi mereka; Tunjukkan pada saya bagaimana
-terlindungi dari penyesuaian, kerusakan, mereka dilindungi dari kerusakan.
atau kerusakan yang akan membatalkan
status kalibrasi dan hasil pengukuran
selanjutnya.

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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
7.1.5q5 Organisasi harus menentukan apakah Bagaimana Anda menentukan
validitas hasil pengukuran sebelumnya validitas pengukuran sebelumnya
telah dipengaruhi secara merugikan ketika jika Anda menemukan instrumen
suatu instrumen ditemukan rusak selama cacat saat verifikasi atau kalibrasi?
verifikasi atau kalibrasi yang Tindakan tepat apa yang bisa Anda
direncanakan, atau selama ambil?
penggunaannya, dan mengambil tindakan
korektif yang diperlukan sebagaimana
diperlukan.
7.1.6 Pengetahuan Organisasi
7.1.6q1 Organisasi harus menentukan Bagaimana Anda menentukan
pengetahuan yang diperlukan untuk pengetahuan yang diperlukan untuk
operasi prosesnya dan untuk mencapai pengoperasian proses? Bagaimana
kesesuaian produk dan layanan. Anda menentukan pengetahuan
yang diperlukan untuk mencapai
kesesuaian produk dan layanan?
7.1.6q2 Bagaimana Anda mempertahankan
Pengetahuan ini harus dipertahankan, dan
tersedia selama diperlukan. pengetahuan ini dan bagaimana
Anda membuatnya tersedia selama
diperlukan?
7.1.6q3 Ketika menangani perubahan kebutuhan Bagaimana Anda
dan tren, organisasi harus mempertimbangkan pengetahuan
mempertimbangkan pengetahuannya saat saat ini dan bagaimana Anda
ini dan menentukan bagaimana memperoleh pengetahuan tambahan
memperoleh atau mengakses pengetahuan saat menangani perubahan
tambahan yang diperlukan. kebutuhan dan tren?

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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
CATATAN 1 Pengetahuan organisasi dapat mencakup informasi seperti
kekayaan intelektual dan pelajaran yang dipetik.
CATATAN 2 Untuk mendapatkan pengetahuan yang diperlukan, organisasi
dapat mempertimbangkan:
a) sumber internal (mis. belajar dari kegagalan dan proyek yang berhasil,
menangkap pengetahuan tidak berdokumen dan pengalaman para ahli topikal
dalam organisasi);
b) sumber eksternal (mis. standar, akademisi, konferensi, pengumpulan
pengetahuan dengan pelanggan atau
penyedia layanan).

7.2 Kompetensi
7..2q1 Organisasi harus:
a) menentukan kompetensi yang
diperlukan orang yang melakukan
pekerjaan di bawah kendalinya yang
mempengaruhi kualitasnya;
b) memastikan bahwa orang-orang ini
kompeten berdasarkan pendidikan,
pelatihan, atau pengalaman yang sesuai;
c) jika berlaku, mengambil tindakan untuk
memperoleh kompetensi yang diperlukan,
dan mengevaluasi efektivitas tindakan
yang diambil;
d) menyimpan informasi terdokumentasi
yang sesuai sebagai bukti kompetensi.
Tunjukkan pada saya bagaimana Informasi yang didokumentasikan sebagai bukti
caranya: kompetensi jika diperlukan.
Anda menentukan kompetensi yang
diperlukan dari orang yang
melakukan pekerjaan di bawah
kendali Anda yang memengaruhi
kinerja kualitas;
Bagaimana Anda menentukan
kompetensi berdasarkan pendidikan,
pelatihan, atau pengalaman yang
sesuai?
Bagaimana Anda mengambil
tindakan untuk memperoleh
kompetensi yang diperlukan di
mana berlaku dan bagaimana Anda
mengevaluasi efektivitas tindakan
tersebut?
Tunjukkan pada saya informasi
yang terdokumentasi yang sesuai
dengan kompetensi

Page 14
Q# ISO 9001:2015 Clause
CATATAN Tindakan yang dapat diterapkan dapat mencakup, misalnya,
penyediaan pelatihan untuk, pendampingan, atau penugasan kembali orang-
orang yang saat ini dipekerjakan; atau mempekerjakan atau mengontrak orang
yang kompeten.
7.3 Kesadaran
7.3q1 Orang yang melakukan pekerjaan di
bawah kendali organisasi harus
mengetahui:
a) kebijakan mutu;
b) sasaran mutu yang relevan;
c) kontribusinya pada efektivitas sistem
manajemen mutu, termasuk manfaat dari
peningkatan kualitas kinerja;
d) implikasi tidak sesuai dengan
persyaratan sistem manajemen mutu.
7.4 Komunikasi
7.4q1 Organisasi harus menentukan komunikasi
internal dan eksternal yang relevan
dengan sistem manajemen mutu termasuk:
a) tentang apa yang akan
dikomunikasikan;
b) kapan berkomunikasi;
c) dengan siapa berkomunikasi;
d) bagaimana berkomunikasi.
7.5 Informasi yang terdokumentasi
7.5.1 General
7.5.1q1 Sistem manajemen mutu organisasi harus
mencakup:
a) informasi terdokumentasi yang
diperlukan oleh Standar Internasional ini;
b) informasi yang didokumentasikan
ditentukan oleh organisasi sebagai
diperlukan untuk efektivitas sistem
manajemen mutu.
Audit Question Audit Evidence
Bagaimana orang-orang sadar:
Kebijakan mutu?
Sasaran mutu yang relevan?
Kontribusi mereka terhadap
efektivitas Sistem Manajemen
Mutu?
Manfaat dari peningkatan kinerja?
Implikasi dari tidak sesuai dengan
persyaratan Sistem Manajemen
Mutu?
Bagaimana Anda menentukan
komunikasi internal dan eksternal
yang relevan dengan Sistem
Manajemen Mutu?
Bagaimana Anda menentukan:
Apa?
Kapan?
Dengan siapa?
Bagaimana?
Informasi terdokumentasi apa yang Informasi yang terdokumentasi diperlukan oleh standar
Anda miliki seperti yang ini.
disyaratkan oleh standar ini? Informasi yang terdokumentasi diperlukan untuk
Apa informasi terdokumentasi yang keefektifan Siatem Manajemen Mutu.
Anda miliki yang diperlukan untuk
efektivitas Sistem Manajemen Mutu
Anda?
Page 15
Q# ISO 9001:2015 Clause Audit Question Audit Evidence
CATATAN Tingkat informasi yang terdokumentasi untuk sistem manajemen
mutu dapat berbeda dari satu
organisasi ke yang lain karena:
a) ukuran organisasi dan jenis kegiatan, proses, produk dan layanannya;
b) kompleksitas proses dan interaksinya;
c) kompetensi orang.

7.5.2 Menciptakan dan Pembaruan

7.5.2q1 Ketika membuat dan memperbarui Tunjukkan pada saya bahwa Informasi yang terdokumentasi (di berbagai media) perlu
informasi yang terdokumentasi, organisasi
informasi Anda yang identifikasi, deskripsi.
harus memastikan yang sesuai: terdokumentasi berisi: Proses peninjauan / persetujuan?
a) identifikasi dan deskripsi (mis. judul,
Identifikasi;
tanggal, penulis, atau nomor referensi);
Deskripsi;
b) format (mis. bahasa, versi perangkatDalam format media apa?
lunak, grafik) dan media (mis. kertas, Tunjukkan pada saya bagaimana
elektronik); informasi yang didokumentasikan
c) meninjau dan menyetujui kesesuaian ditinjau dan disetujui untuk
dan kecukupan.
kesesuaian dan kecukupan.
7.5.3 Kontrol informasi yang terdokumentasi
7.5.3.1
7.5.3.1q Informasi terdokumentasi yang diperlukan Tunjukkan pada saya bagaimana Kontrol informasi yang terdokumentasi.
1
oleh sistem manajemen mutu dan oleh Anda mengontrol informasi yang Kesesuaian dan ketersediaan untuk digunakan.
Standar Internasional ini harus terdokumentasi. Bagaimana itu dilindungi?
dikendalikan untuk memastikan: Tunjukkan pada saya bagaimana
a) tersedia dan cocok untuk digunakan, di Anda membuatnya tersedia dan
mana dan kapan dibutuhkan; cocok untuk digunakan.
b) dilindungi secara memadai (mis. dari Bagaimana Anda melindungi
kehilangan kerahasiaan, penggunaan yang informasi yang Anda
tidak tepat, atau hilangnya integritas). dokumentasikan?
7.5.3.2

Page 16
Q# ISO 9001:2015 Clause Audit Question Audit Evidence
7.5.3.2q Untuk mengendalikan informasi yang Saat mengendalikan informasi yang Kontrol informasi yang terdokumentasi.
1
terdokumentasi, organisasi harus didokumentasikan, bagaimana Anda Ubah kontrol, distribusi, akses, pengambilan, penggunaan,
membahas hal-hal berikut mengatasi: penyimpanan, pelestarian, keterbacaan, retensi, dan disposisi.
kegiatan, sebagaimana berlaku: Distribusi;
a) distribusi, akses, pengambilan dan Mengakses;
penggunaan; Pengambilan;
b) penyimpanan dan pelestarian, termasuk Menggunakan;
pelestarian keterbacaan; Penyimpanan dan pelestarian;
c) kontrol perubahan (mis. kontrol versi); Keterbacaan;
d) retensi dan disposisi. Kontrol perubahan;
Retensi dan disposisi.
7.5.3.2q Informasi terdokumentasi yang berasal Bagaimana Anda mengidentifikasi Kontrol informasi eksternal yang didokumentasikan.
2
dari luar ditentukan oleh organisasi untuk sebagai tepat dan mengendalikan
keperluan perencanaan dan pengoperasian informasi yang didokumentasikan
sistem manajemen mutu harus dari asal eksternal yang telah Anda
diidentifikasi sebagaimana mestinya, dan tentukan sebagaimana diperlukan
dikendalikan. untuk Sistem Manajemen Mutu?

CATATAN Akses dapat menyiratkan keputusan mengenai izin untuk melihat

informasi yang didokumentasikan saja, atau izin dan wewenang untuk melihat
dan mengubah informasi yang didokumentasikan.

8 Operation
8.1 Operational planning and control

Page 17
Q# ISO 9001:2015 Clause
8.1q1 The organization shall plan, implement and control
the processes, as outlined in 4.4, needed to meet
requirements for the provision of products and
services and to implement the actions determined
in 6.1, by:
a) determining requirements for the product and
services;
b) establishing criteria for the processes and for the
acceptance of products and services;
c) determining the resources needed to achieve
conformity to product and service requirements;
d) implementing control of the processes in
accordance with the criteria;
e) retaining documented information to the extent
necessary to have confidence that the processes
have been carried out as planned and to
demonstrate conformity of products and services to
requirements.
8.1q2 The output of this planning shall be suitable for the
organization's operations.
8.1q3 The organization shall control planned changes
and review the consequences of unintended
changes, taking action to mitigate any adverse
effects, as necessary.
8.1q4 The organization shall ensure that outsourced
processes are controlled in accordance with 8.4.
8.2 Determination of requirements for products and services
8.2.1 Customer communication
8.2.1q1 The organization shall establish the processes for
communicating with customers in relation to:
a) information relating to products and services;
b) enquiries, contracts or order handling, including
changes;
c) obtaining customer views and perceptions,
including customer complaints;
d) the handling or treatment of customer property, if
applicable;
e) specific requirements for contingency actions,
when relevant.
8.2.2 Determination of requirements related to products and services
Audit Question Audit Evidence
How are processes needed to meet Documented information to show processes have been
requirements for provision of products and carried out as planned and can demonstrate conformity of
services planned, implemented and products and services.
controlled?
How are requirements for products and
services determined?
How is criteria for processes and
acceptance for products and services
determined?
How are resources determined?
How is process control implemented?
Show me the documented information
that shows confidence in that the processes
have been carried out as planned and can
demonstrate conformity of products and
services.
How have you determined that the output
from the planning process is suitable for
your operations?
How do you control planned changes? How
do you review the consequences of
unintended changes? What action is taken
to mitigate any adverse effects?
How do you control outsourced processes?
What are your processes for communicating
with customers? How do you communicate
information relating to:
Products;
Services;
Enquiries;
Contracts;
Order handling;
Customer views, perceptions and
complaints;
Handling or treatment of customer property;
Specific requirements for contingency
actions?
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Q# ISO 9001:2015 Clause
8.2.2q1 The organization shall establish, implement and
maintain a process to determine the requirements
for the products and services to be offered to
potential customers.
8.2.2q2 The organization shall ensure that:
a) product and service requirements (including
those considered necessary by the organization),
and applicable statutory and regulatory
requirements, are defined;
b) it has the ability to meet the defined
requirements and substantiate the claims for the
products and services it offers.
8.2.3Review of requirements related to products and services
8.2.3q1 The organization shall review, as applicable:
a) requirements specified by the customer,
including the requirements for delivery and post-
delivery activities;
b) requirements not stated by the customer, but
necessary for the customers' specified or intended
use, when known;
c) additional statutory and regulatory requirements
applicable to the products and services;
d) contract or order requirements differing from
those previously expressed.
NOTE Requirements can also include those arising from relevant interested parties.
8.2.3q2 This review shall be conducted prior to the
organization’s commitment to supply products and
services to the customer and shall ensure contract
or order requirements differing from those
previously defined are resolved.
8.2.3q3 Where the customer does not provide a
documented statement of their requirements, the
customer requirements shall be confirmed by the
organization before acceptance.
8.2.3q4 Documented information describing the results of
the review, including any new or changed
requirements for the products and services, shall
be retained.
8.2.3q5 Where requirements for products and services are
changed, the organization shall ensure that
relevant documented information is amended and
that relevant personnel are made aware of the
changed requirements.
Audit Question Audit Evidence
What is your process to determine the
requirements for products and services to
be offered to potential customers? How do
you establish, implement and maintain this
process?
How do you define product and service
requirements including statutory and
regulatory requirements?
How do you ensure that you have the ability
to meet the defined requirements and
substantiate any claims for your products
and services?
How do you review:
Customer requirements for delivery and
post-delivery?
Requirements necessary for customers’
specified or intended use, where known;
Additional statutory and regulatory
requirements applicable to products and
services;
Any other contract or order requirements.
Show me that the review is conducted prior
to your commitment to supply products and
services to your customers. How do you
resolve contract or order requirements
which differ from those previously defined?
How do you confirm customer requirements
where the customer does not provide a
documented statement?
Show me where you retain documented Documented information of reviews describing new or
information which describes results of the changed requirements to products and services.
review including any new or changed
requirements.
Show me the documented information Documented information of amended reviews and how
containing changes to products and relevant personnel are made aware of those changes.
services. How do you ensure that relevant
personnel are made aware of those
changes?
Page 19
Q# ISO 9001:2015 Clause Audit Question Audit Evidence
8.3 Design and development of products and services
8.3.1 General
8.3.1q1 Where the detailed requirements of the How do you establish, implement and
organization’s products and services are not maintain a design and development process
already established or not defined by the customer (where detailed requirements of your
or by other interested parties, such that they are products and services are not already
adequate for subsequent production or service established or defined by the customer or
provision, the organization shall establish, other parties).
implement and maintain a design and development
process.
NOTE 1 The organization can also apply the requirements given in 8.5 to the development of processes for
production and services provision.
NOTE 2 For services, design and development planning can address the whole service delivery process. The
organization can therefore choose to consider the requirements of clauses 8.3 and 8.5 together.
8.3.2 Design and development planning

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Q# ISO 9001:2015 Clause
8.3.2q1 In determining the stages and controls for design
and development, the organization shall consider:
a) the nature, duration and complexity of the design
and development activities;
b) requirements that specify particular process
stages, including applicable design and
development reviews;
c) the required design and development verification
and validation;
d) the responsibilities and authorities involved in
the design and development process;
e) the need to control interfaces between
individuals and parties involved in the design and
development process;
f) the need for involvement of customer and user
groups in the design and development process;
g) the necessary documented information to
confirm that design and development requirements
have been met.
8.3.3 Design and development inputs
Audit Question Audit Evidence
When determining the stages and control Documented information that confirms design & development
for design and development, show me how requirements have been met.
you consider:
The nature, duration and complexity of the
activities;
Requirements that specify particular
process stages including applicable
reviews;
Required verification and validation;
Responsibilities and authorities;
How interfaces are controlled between
individuals and parties;
The need for involvement of customer and
user groups.
Show me documented information that
confirms design and development
requirements have been met.
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Q# ISO 9001:2015 Clause
8.3.3q1 The organization shall determine:
a) requirements essential for the specific type of
products and services being designed and
developed, including, as applicable, functional and
performance requirements;
b) applicable statutory and regulatory
requirements;
c) standards or codes of practice that the
organization has committed to implement;
d) internal and external resource needs for the
design and development of products and services;
e) the potential consequences of failure due to the
nature of the products and services;
f) the level of control expected of the design and
development process by customers and other
relevant interested parties.
8.3.3q2 Inputs shall be adequate for design and
development purposes, complete, and
unambiguous. Conflicts among inputs shall be
resolved.
8.3.4 Design and development controls
8.3.4q1 The controls applied to the design and
development process shall ensure that:
a) the results to be achieved by the design and
development activities are clearly defined;
b) design and development reviews are conducted
as planned;
c) verification is conducted to ensure that the
design and development outputs have met the
design and development input requirements;
d) validation is conducted to ensure that the
resulting products and services are capable of
meeting the requirements for the specified
application or intended use (when known).
8.3.5 Design and development outputs
8.3.5q1 The organization shall ensure that design and
development outputs:
a) meet the input requirements for design and
development;
b) are adequate for the subsequent processes for
the provision of products and services;
c) include or reference monitoring and measuring
requirements, and acceptance criteria, as
applicable;
d) ensure products to be produced, or services to
be provided, are fit for intended purpose and their
safe and proper use.
Audit Question Audit Evidence
Can you show me how you determine:
Requirements essential for the type of
products and services being designed and
developed, including as applicable:
Functional & performance requirements;
Statutory and regulatory requirements;
Standards or codes of practice where there
is a commitment to implement;
Internal and external resources needed for
the design and development of products
and services;
Potential consequences of failure;
Level of control expected of the design and
development process by customers and
other relevant parties.
How do you determine that inputs are
adequate, complete and unambiguous for
design and development? How do you
resolve conflicts among inputs?
How do controls that are applied to the
design and development process ensure:
Results achieved by design and
development activities are clearly defined?
Design and development reviews are
conducted as planned?
Outputs meet the input requirements by
verification/
Validation is conducted to ensure that the
resulting products and services are capable
of meeting the requirements for the
specified application or intended use (when
known)?
How do you ensure that design and
development outputs:
Meet the input requirements for design and
development?
Are adequate for the subsequent processes
for the provision of products and services?
Include or reference monitoring and
measuring requirements, and acceptance
criteria, as applicable?
Ensure products to be produced, or services
to be provided, are fit for intended purpose
and their safe and proper use?
Page 22
Q# ISO 9001:2015 Clause
8.3.5q2 The organization shall retain the documented
information resulting from the design and
development process.
8.3.6 Design and development changes
8.3.6q1 The organization shall review, control and identify
changes made to design inputs and design outputs
during the design and development of products and
services or subsequently, to the extent that there is
no adverse impact on conformity to requirements.
8.3.6q2 Documented information on design and
development changes shall be retained.
8.4 Control of externally provided products and services
8.4.1 General
8.4.1q1 The organization shall ensure that externally
provided processes, products, and services
conform to specified requirements.
8.4.1q2 The organization shall apply the specified
requirements for the control of externally provided
products and services when:
a) products and services are provided by external
providers for incorporation into the organization’s
own products and services;
b) products and services are provided directly to
the customer(s) by external providers on behalf of
the organization;
c) a process or part of a process is provided by an
external provider as a result of a decision by the
organization to outsource a process or function.
8.4.1q3 The organization shall establish and apply criteria
for the evaluation, selection, monitoring of
performance and re-evaluation of external
providers based on their ability to provide
processes or products and services in accordance
with specified requirements.
Audit Question Audit Evidence
Show me the documented information Documented information from the design and development
which results from the design and process.
development process.
How do you review, control and identify
changes made to the design inputs and
outputs during design and development of
products and services ensuring no impact
on conformity to requirements?
Show me the documented information for Documented information for design and development
design and development changes. changes.
How do you ensure externally provided
processes, products and services conform
to specified requirements?
Show me how you apply specified
requirements for the control of externally
provided products and services when:
Products and services are provided by
external providers for incorporation into your
own products and services;
You provide products and services directly
to customers by external providers on your
behalf;
A process or part-process is provided by an
external provider as a result of a decision to
outsource a process or function.
Show me how you establish and apply
criteria for evaluation, selection, monitoring
of performance and re-evaluation of
external providers. How do you assess their
ability to provide processes or products and
services in accordance with specified
requirements?
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Q# ISO 9001:2015 Clause
8.4.1q4 The organization shall retain appropriate
documented information of the results of the
evaluations, monitoring of the performance and re-
evaluations of the external providers.
8.4.2 Type and extent of control of external provision
8.4.2q1 In determining the type and extent of controls to be
applied to the external provision of processes,
products and services, the organization shall take
into consideration:
a) the potential impact of the externally provided
processes, products and services on the
organization’s ability to consistently meet customer
and applicable statutory and regulatory
requirements;
b) the perceived effectiveness of the controls
applied by the external provider.
8.4.2q2 The organization shall establish and implement
verification or other activities necessary to ensure
the externally provided processes, products and
services do not adversely affect the organization's
ability to consistently deliver conforming products
and services to its customers.
8.4.2q3 Processes or functions of the organization which
have been outsourced to an external provider
remain within the scope of the organization’s
quality management system; accordingly, the
organization shall consider a) and b) above and
define both the controls it intends to apply to the
external provider and those it intends to apply to
the resulting process output.
8.4.3Information for external providers
Audit Question Audit Evidence
What documented information do you Documented information of external providers’ performance.
have of the results of evaluations,
monitoring of performance and re-
evaluations of external providers?
How do you determine the controls applied
to the external provision of processes,
products and services and take into
consideration:
a) The potential impact of the externally
provided processes, products and services
on the ability to consistently meet customer
and applicable statutory and regulatory
requirements?
b) The perceived effectiveness of the
controls applied by the external provider?
What verification or other activities do you
have to ensure externally provided
processes, products and services do not
adversely affect your ability to consistently
deliver conforming products and services to
your customers?
When processes or functions have been
outsourced to external providers, how do
you consider a) and b) in 8.4.1 and how do
you define the controls intended to be
applied to the external provider and to the
resulting process output?
Page 24
Q# ISO 9001:2015 Clause
8.4.3q1 The organization shall communicate to external
providers applicable requirements for the following:
a) the products and services to be provided or the
processes to be performed on behalf of the
organization;
b) approval or release of products and services,
methods, processes or equipment;
c) competence of personnel, including necessary
qualification;
d) their interactions with the organization's quality
management system;
e) the control and monitoring of the external
provider’s performance to be applied by the
organization;
f) verification activities that the organization, or its
customer, intends to perform at the external
provider’s premises.
8.4.3q2 The organization shall ensure the adequacy of
specified requirements prior to their communication
to the external provider.
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.1q1 The organization shall implement controlled
conditions for production and service provision,
including delivery and post-delivery activities.
Audit Question Audit Evidence
Show me how you communicate to external
providers, applicable requirements for:
Products and services to be provided or the
processes to be performed on behalf of the
organization;
Approval or release of products and
services, methods, processes or equipment;
Competence of personnel, including
necessary qualification;
Their interactions with the organization's
quality management system;
The control and monitoring of the external
provider’s performance to be applied by the
organization;
Verification activities that the organization,
or its customer, intends to perform at the
external provider’s premises.
Before you communicate with external
providers, how do you ensure the adequacy
of specified requirements?
What controlled conditions do you have for
production and service provision, including
delivery and post-delivery activities?
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Q# ISO 9001:2015 Clause
8.5.1q2 Controlled conditions shall include, as applicable:
a) the availability of documented information that
defines the characteristics of the products and
services;
b) the availability of documented information that
defines the activities to be performed and the
results to be achieved;
c) monitoring and measurement activities at
appropriate stages to verify that criteria for control
of processes and process outputs, and acceptance
criteria for products and services, have been met.
d) the use, and control of suitable infrastructure
and process environment;
e) the availability and use of suitable monitoring
and measuring resources;
f) the competence and, where applicable, required
qualification of persons;
g) the validation, and periodic revalidation, of the
ability to achieve planned results of any process for
production and service provision where the
resulting output cannot be verified by subsequent
monitoring or measurement;
h) the implementation of products and services
release, delivery and post-delivery activities.
8.5.2 Identification and traceability
8.5.2q1 Where necessary to ensure conformity of products
and services, the organization shall use suitable
means to identify process outputs.
8.5.2q2 The organization shall identify the status of process
outputs with respect to monitoring and
measurement requirements throughout production
and service provision.
8.5.2q3 Where traceability is a requirement, the
organization shall control the unique identification
of the process outputs, and retain any documented
information necessary to maintain traceability.
NOTE Process outputs are the results of any activities which are ready for delivery to the organization’s
customer or to an internal customer (e.g. receiver of the inputs to the next process); they can include
products, services, intermediate parts, components, etc.
8.5.3 Property belonging to customers or external providers
Audit Question Audit Evidence
Can you show me controlled conditions for: Documented information defining characteristics of the
a) the availability of documented information products and services
defining the characteristics of the products
and services;
b) the availability of documented
informationdefining the activities to be
performed and the results to be achieved;
c) monitoring and measurement activities at
appropriate stages to verify that criteria for
control of processes and process outputs,
and acceptance criteria for products and
services, have been met.
d) the use, and control of suitable
infrastructure and process environment;
e) the availability and use of suitable
monitoring and measuring resources;
f) the competence and, where applicable,
required qualification of persons;
g) the validation, and periodic revalidation,
of the ability to achieve planned results of
any process for production and service
provision where the resulting output cannot
be verified by subsequent monitoring or
measurement;
h) the implementation of products and
services release, delivery and post-delivery
activities.
What means do you use to identify process
outputs to ensure conformity of products
and services?
How do you identify the status of process
outputs?
How do you control the unique identification Documented information of traceability, where required.
of process outputs, where applicable? What
documented information do you retain?
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Q# ISO 9001:2015 Clause
8.5.3q1 The organization shall exercise care with property
belonging to the customer or external providers
while it is under the organization's control or being
used by the organization. The organization shall
identify, verify, protect and safeguard the
customer’s or external provider’s property provided
for use or incorporation into the products and
services.
8.5.3q2 When property of the customer or external provider
is incorrectly used, lost, damaged or otherwise
found to be unsuitable for use, the organization
shall report this to the customer or external
provider.
NOTE Customer property can include material, components, tools and equipment, customer premises,
intellectual property and personal data.
8.5.4 Preservation
8.5.4q1 The organization shall ensure preservation of
process outputs during production and service
provision, to the extent necessary to maintain
conformity to requirements.
NOTE Preservation can include identification, handling, packaging, storage, transmission or transportation,
and protection.
8.5.5 Post-delivery activities
8.5.5q1 As applicable, the organization shall meet
requirements for post-delivery activities associated
with the products and services.
8.5.5q2 In determining the extent of post-delivery activities
that are required, the organization shall consider:
a) the risks associated with the products and
services;
b) the nature, use and intended lifetime of the
products and services;
c) customer feedback;
d) statutory and regulatory requirements.
NOTE Post-delivery activities can 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
8.5.6q1 The organization shall review and control
unplanned changes essential for production or
service provision to the extent necessary to ensure
continuing conformity with specified requirements.
Audit Question Audit Evidence
What care do you provide for customer or
external provider’s property while under
your control?
How do you identify, verify, protect and
safeguard that property which is provided
for use or incorporation into your products
or services?
What means do you use to report to the
customer or external provider if their
property is incorrectly used, lost, damaged
or found to be unsuitable for use?
How do you ensure preservation of process
outputs during production and service
provision to maintain conformity to product
requirements?
How do you meet requirements for post-
delivery activities associated with products
and services?
How do you determine:
Risk;
Nature, use and intended lifetime;
Customer feedback;
Statutory and Regulatory requirements,
when determining the extent of post-delivery
activities required with products and
services?
How do you review and control unplanned
changes to ensure continuing conformity
with specified requirements?
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Q# ISO 9001:2015 Clause
8.5.6q2 The organization shall retain documented
information describing the results of the review of
changes, the personnel authorizing the change,
and any necessary actions.
8.6 Release of products and services
8.6q1 The organization shall implement the planned
arrangements at appropriate stages to verify that
product and service requirements have been met.
Evidence of conformity with the acceptance criteria
shall be retained.
8.6q2 The release of products and services to the
customer shall not proceed until the planned
arrangements for verification of conformity have
been satisfactorily completed, unless otherwise
approved by a relevant authority and, as
applicable, by the customer. Documented
information shall provide traceability to the
person(s) authorizing release of products and
services for delivery to the customer.
8.7 Control of non-conforming process outputs, products and services
8.7q1 The organization shall ensure process outputs,
products and services that do not conform to
requirements are identified and controlled to
prevent their unintended use or delivery.
8.7q2 The organization shall take appropriate corrective
action based on the nature of the nonconformity
and its impact on the conformity of products and
services. This applies also to nonconforming
products and services detected after delivery of the
products or during the provision of the service.
8.7q3 As applicable, the organization shall deal with
nonconforming process outputs, products and
services in one or more of the following ways:
a) correction;
b) segregation, containment, return or suspension
of provision of products and services;
c) informing the customer;
d) obtaining authorization for:
- use “as-is’;
- release, continuation or re-provision of the
products and services;
-acceptance under concession.
8.7q4 Where nonconforming process outputs, products
and services are corrected, conformity to the
requirements shall be verified.
Audit Question Audit Evidence
What documented information can you Documented information describing results of review of
show me which describes the results of changes, personnel and actions.
reviews of changes, the personnel
authorizing change and any necessary
actions?
Show me how planned arrangement have
been implemented at appropriate stages to
verify product and service requirements
have been met. Show me what evidence
you retain.
Show me how the release of products and Documented information providing traceability, authorizing
services is held until planned arrangements release of products and services.
for verification of conformity have been
satisfactorily completed, unless approved by
a relevant authority, or the customer if
applicable. Show me documented
information which shows traceability to the
person authorizing release of products and
services.
How do you identify and control process
outputs, products and services that do not
conform to requirements and prevent their
unintended use or delivery?
What appropriate corrective actions are
taken based on the nature of the
nonconformity and its impact on the
conformity of products and services? How
do you apply this to nonconformity detected
after delivery?
How you deal with nonconforming process
outputs, products and services in terms of:
Correction;
Segregation, containment, return or
suspension of provision of products and
services?
Informing the customer?
Obtaining authorization for use as-is?
Release, continuation or re-provision of the
products and service?
Acceptance under concession?
How do you verify conformance where
process outputs, products and services are
corrected following nonconformance?
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Q# ISO 9001:2015 Clause
8.7q5 The organization shall retain documented
information of actions taken on nonconforming
process outputs, products and services, including
on any concessions obtained and on the person or
authority that made the decision regarding dealing
with the nonconformity.
9. Evaluasi Kinerja
9.1 Pemantauan, pengukuran, analisis dan evaluasi
9.1.1 Umum
9.1.1q1 Organisasi harus menentukan:
a) apa yang perlu dipantau dan diukur;
b) metode untuk pemantauan, pengukuran,
analisis dan evaluasi, sebagaimana
berlaku, untuk memastikan hasil yang
valid;
c) ketika pemantauan dan pengukuran
harus dilakukan;
d) ketika hasil dari pemantauan dan
pengukuran harus dianalisis dan
dievaluasi.
9.1.1q2 Organisasi harus memastikan bahwa
kegiatan pemantauan dan pengukuran
dilaksanakan sesuai dengan persyaratan
yang ditentukan dan akan menyimpan
informasi terdokumentasi yang sesuai
sebagai bukti hasil.
9.1.1q3 Organisasi harus mengevaluasi kinerja
kualitas dan efektivitas sistem manajemen
mutu.
9.1.2 Kepuasan Pelanggan
9.1.2q1 Organisasi harus memantau persepsi
pelanggan tentang sejauh mana
persyaratan telah dipenuhi.
Audit Question Audit Evidence
What documented information do you Documented information for actions taken following
keep following actions taken to address nonconformance, including concessions and authority
nonconformities, including any concessions granted.
obtained and on the person or authority that
made the decision regarding dealing with
the nonconformance.
Tunjukkan pada saya bagaimana
Anda menentukan:
Apa yang perlu dipantau dan
diukur?
Metode untuk pemantauan,
pengukuran, analisis dan evaluasi
untuk memastikan hasil yang valid?
Kapan melakukan pemantauan dan
pengukuran?
Kapan hasil harus dianalisis dan
dievaluasi?
Informasi apa yang terdokumentasi Informasi yang terdokumentasi dari kegiatan
yang dapat Anda tunjukkan kepada pemantauan dan pengukuran sesuai dengan persyaratan
saya bahwa kegiatan pemantauan yang ditentukan.
dan pengukuran telah dilaksanakan
sesuai dengan persyaratan yang
ditentukan?
Tunjukkan pada saya bagaimana
Anda mengevaluasi kinerja kualitas
dan efektivitas Sistem Manajemen
Mutu.
Bagaimana Anda memonitor
persepsi pelanggan tentang sejauh
mana persyaratan telah dipenuhi?
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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
9.1.2q2 Organisasi harus memperoleh informasi Bagaimana Anda mendapatkan
yang berkaitan dengan pandangan dan informasi yang berkaitan dengan
pendapat pelanggan tentang organisasi pandangan dan pendapat pelanggan
dan produk serta layanannya. tentang produk dan layanan Anda?
9.1.2q3 Metode untuk memperoleh dan Metode apa untuk mendapatkan
menggunakan informasi ini harus dan menggunakan informasi ini
ditentukan. yang Anda miliki?
CATATAN Informasi yang terkait dengan pandangan pelanggan dapat
mencakup kepuasan pelanggan atau survei pendapat, data pelanggan tentang
kualitas produk atau layanan yang disampaikan, analisis pangsa pasar, pujian,
klaim garansi, dan laporan dealer.
9.1.3 Analisis dan Evaluasi
9.1.3q1 Organisasi harus menganalisis dan Jadi bagaimana Anda menganalisis
mengevaluasi data dan informasi yang dan mengevaluasi data dan
sesuai yang timbul dari pemantauan, informasi yang timbul dari
pengukuran, dan sumber lainnya. pemantauan, pengukuran, dan
sumber lainnya?
9.1.3q2 Keluaran analisis dan evaluasi harus Tunjukkan pada saya bagaimana
digunakan untuk: hasil analisis dan evaluasi
a) menunjukkan kesesuaian produk dan digunakan untuk:
layanan dengan persyaratan; Menunjukkan kesesuaian produk
b) menilai dan meningkatkan kepuasan dan layanan dengan persyaratan?
pelanggan; Menilai dan meningkatkan kepuasan
c) memastikan kesesuaian dan efektivitas pelanggan?
sistem manajemen mutu; Pastikan kesesuaian dan efektivitas
d) menunjukkan bahwa perencanaan telah Sistem Manajemen Mutu?
berhasil dilaksanakan; Menunjukkan bahwa perencanaan
e) menilai kinerja proses; telah berhasil dilaksanakan?
f) menilai kinerja penyedia eksternal; Menilai kinerja proses?
g) menentukan kebutuhan atau peluang Menilai kinerja penyedia eksternal?
untuk perbaikan dalam sistem manajemen Menentukan kebutuhan atau peluang
mutu. untuk perbaikan dalam Sistem
Manajemen Mutu?
9.1.3q3 Hasil analisis dan evaluasi juga harus Tunjukkan pada saya dimana hasil
digunakan untuk memberikan masukan analisis dan evaluasi digunakan
bagi tinjauan manajemen. untuk memberikan masukan bagi
tinjauan manajemen.
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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
9.2 Audit Internal
9.2.1
9.2.1q1 Organisasi harus melakukan audit internal Apakah audit internal dilakukan
pada interval yang direncanakan untuk pada interval yang direncanakan?
memberikan informasi apakah sistem Apakah mereka menentukan apakah
manajemen mutu; Siistem Manajemen Mutu sesuai
a) sesuai dengan: dengan persyaratan ISO 9001 dan
1) persyaratan organisasi sendiri untuk persyaratan lain yang ditetapkan
sistem manajemen kualitasnya; oleh Organisasi? (Tinjau catatan
2) persyaratan Standar Internasional ini; untuk menunjukkan kesesuaian)
b) diimplementasikan dan dipelihara Apakah mereka menentukan apakah
secara efektif. Sistem Manajemen Mutu diterapkan
dan dipelihara secara efektif?
(Tinjau catatan)
9.2.2

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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
9.2.2q1 Organisasi harus: Dapatkah Anda menunjukkan Informasi yang terdokumentasi dari program dan hasil
a) merencanakan, menetapkan, kepada saya program audit yang audit.
mengimplementasikan dan memelihara mempertimbangkan tujuan kualitas,
program audit termasuk frekuensi, pentingnya proses, umpan balik
metode, tanggung jawab, persyaratan pelanggan, perubahan yang
perencanaan dan pelaporan, yang harusberdampak pada organisasi dan hasil
mempertimbangkan tujuan kualitas, audit sebelumnya?
pentingnya proses yang terkait, umpanDimana kriteria dan ruang lingkup
balik pelanggan, perubahan audit untuk setiap audit?
berdampak pada organisasi, dan hasil Dapatkah Anda menunjukkan
audit sebelumnya; bahwa pemilihan auditor dan
b) menetapkan kriteria dan ruang lingkup
pelaksanaan audit adalah objektif
audit untuk setiap audit; dan tidak memihak dan bahwa
c) memilih auditor dan melakukan audit
auditor tidak mengaudit pekerjaan
untuk memastikan objektivitas dan mereka sendiri?
ketidakberpihakan proses audit; Bagaimana hasil audit dilaporkan
d) memastikan bahwa hasil audit kepada manajemen yang relevan?
dilaporkan kepada manajemen terkait; Dapatkah Anda menunjukkan
e) mengambil koreksi yang diperlukan bahwa koreksi yang diperlukan dan
dan tindakan korektif tanpa penundaantindakan korektif diambil tanpa
yang tidak semestinya; penundaan yang tidak semestinya?
f) menyimpan informasi yang Dapatkah Anda menunjukkan
terdokumentasi sebagai bukti pelaksanaan
kepada saya informasi yang
program audit dan hasil audit. didokumentasikan dari program
audit dan hasil audit?
CATATAN Lihat ISO 19011 untuk panduan.
9.3 Ulasan Manajemen
9.3.1
9.3.1q1 Manajemen puncak harus meninjau sistem Berapa frekuensi manajemen
manajemen mutu organisasi, pada interval puncak meninjau organisasi Sistem
yang direncanakan, untuk memastikan Manajemen Mutu? Bagaimana
kesesuaian, kecukupan, dan efektivitasnya Sistem Manajemen Mutu dianggap
yang berkelanjutan. cocok, memadai dan efektif?

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Q# ISO 9001:2015 Clause
9.3.1q2 Tinjauan manajemen harus direncanakan
dan dilaksanakan dengan
mempertimbangkan:
a) status tindakan dari tinjauan
manajemen sebelumnya;
b) perubahan dalam masalah eksternal dan
internal yang relevan dengan sistem
manajemen mutu termasuk arahan
strategisnya;
c) informasi tentang kinerja kualitas,
termasuk tren dan indikator untuk:
1) ketidaksesuaian dan tindakan korektif;
2) hasil pemantauan dan pengukuran;
3) hasil audit;
4) kepuasan pelanggan;
5) masalah tentang penyedia eksternal dan
pihak berkepentingan terkait lainnya;
6) kecukupan sumber daya yang
dibutuhkan untuk memelihara sistem
manajemen mutu yang efektif;
7) proses kinerja dan kesesuaian produk
dan layanan;
d) efektivitas tindakan yang diambil untuk
mengatasi risiko dan peluang (lihat pasal
6.1);
e) peluang potensial baru untuk perbaikan
berkelanjutan.
9.3.2
9.3.2q1 Output dari tinjauan manajemen harus
mencakup keputusan dan tindakan yang
terkait dengan:
a) peluang peningkatan berkelanjutan;
b) segala kebutuhan untuk perubahan pada
sistem manajemen mutu, termasuk
kebutuhan sumber daya.
Audit Question Audit Evidence
Jenis informasi apa yang ditinjau
dalam tinjauan manajemen? Ini
harus mencakup:
status tindakan dari ulasan
sebelumnya;
perubahan pada masalah internal /
eksternal yang relevan dengan
Sistem Manajemen Mutuss;
masalah yang mempengaruhi
strategi;
KPI untuk ketidaksesuaian dan
tindakan korektif;
memantau dan mengukur hasil;
hasil audit;
kepuasan pelanggan;
masalah tentang penyedia eksternal;
masalah tentang pihak terkait
lainnya;
kecukupan sumber daya dan
efektivitas Sistem Manajemen
Mutu;
kinerja proses;
kesesuaian produk dan layanan;
tindakan yang diambil untuk
mengatasi risiko dan peluang serta
efektivitasnya;
peluang potensial baru untuk
perbaikan berkelanjutan.
Tunjukkan pada saya bahwa ulasan
manajemen mencakup keputusan
dan tindakan yang berkaitan dengan:
Peluang peningkatan berkelanjutan;
Kebutuhan akan perubahan pada
QMS termasuk kebutuhan sumber
daya.
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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
9.3.2q2 Organisasi harus menyimpan informasi Tunjukkan pada saya informasi Informasi dokumentasi tinjauan manajemen.
yang didokumentasikan sebagai bukti dari terdokumentasi apa yang Anda
hasil tinjauan manajemen. miliki sebagai bukti ulasan
manajemen.
10 Improvement
10.1 General
10.1q1 The organization shall determine and select How do you determine and select
opportunities for improvement and implement opportunities for improvement? What
necessary actions to meet customer requirements necessary actions have you implemented
and enhance customer satisfaction. so that you have met customer
requirements and enhanced customer
satisfaction?
10.1q2 This shall include, as appropriate: Show me how you have:
a) improving processes to prevent nonconformities; Improved processes to prevent
b) improving products and services to meet known nonconformities;
and predicted requirements; Improved products and services to meet
c) improving quality management system results. known and predicted requirements;
Improved QMS results.
NOTE Improvement can be effected reactively (e.g. corrective action), incrementally (e.g. continual
improvement), by step change (e.g. breakthrough), creatively (e.g. innovation) or by re-organization (e.g.
transformation).
10.2 Nonconformity and corrective action
10.2.1
10.2.1q1 When a nonconformity occurs, including those When nonconformities occur, show me how;
arising from complaints, the organization shall: You react;
a) react to the nonconformity, and as applicable: Take action to control and correct it;
1) take action to control and correct it; Deal with the consequences;
2) deal with the consequences; Evaluate the need for action to eliminate the
b) evaluate the need for action to eliminate the cause so that it does not recur or occur
cause(s) of the nonconformity, in order that it does elsewhere by:
not recur or occur elsewhere, by: Reviewing the nonconformity;
1) reviewing the nonconformity; Determining the cause of the nonconformity;
2) determining the causes of the nonconformity; Determining if similar nonconformities exist
3) determining if similar nonconformities exist, or or could potentially occur;
could potentially occur; Actions needed are implemented;
c) implement any action needed; Review the effectiveness of corrective
d) review the effectiveness of any corrective action actions taken, if any;
taken; Make necessary changes to the QMS.
e) make changes to the quality management
system, if necessary.
10.2.1q2 Corrective actions shall be appropriate to the Show me how correction actions were
effects of the nonconformities encountered. appropriate to the effects of the
nonconformities encountered.
NOTE 1 In some instances, it can be impossible to eliminate the cause of a nonconformity.
NOTE 2 Corrective action can reduce the likelihood of recurrence to an acceptable level.
10.2.2
10.2.2q1 The organization shall retain documented What documented information can you Documented information of the nature of nonconformities,
information as evidence of: show me as evidence of: subsequent actions and results of corrective action.
a) the nature of the nonconformities and any The nature of the nonconformities and
subsequent actions taken; subsequent actions taken;
b) the results of any corrective action. The results of any corrective action.
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Q# ISO 9001:2015 Clause
10.3 Continual improvement
10.3q1 The organization shall continually improve the
suitability, adequacy, and effectiveness of the
quality management system.
10.3q2 The organization shall consider the outputs of
analysis and evaluation, and the outputs from
management review, to confirm if there are areas
of underperformance or opportunities that shall be
addressed as part of continual improvement.
10.3q3 Where applicable, the organization shall select and
utilise applicable tools and methodologies for
investigation of the causes of underperformance
and for supporting continual improvement.
Audit Question Audit Evidence
Demonstrate that you continually improve
the suitability, adequacy and effectiveness
of the QMS.
Demonstrate that outputs of analysis and
evaluation and the outputs from
management review are considered to
confirm if there are areas of
underperformance or opportunities that shall
be addressed as part of continual
improvement.
What applicable tools and methodologies
for investigation of the causes of
underperformance and to support continual
improvement are selected?
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