Awareness & Transition To ISO 9001 - 2008 - Rev02-2

Awareness and Transition to
ISO 9001:2008* New version
1 PT TUV International Indonesia

12/28/2018
Agenda
Latar belakang Perubahan Standard

ISO Standard Development Process
Tujuan Perubahan Standard
Benefit / Impact Analysis
Cakupan Perubahan Standard ISO/ 9001:2008
Schedule of Transition to new ISO 9001:2008
Rekomendasi Transisi

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3 Alasan Utama Perubahan Standard
 Proses Peninjauan (Process Review) dari Komite Teknis TC 176

 Bertujuan untuk memastikan kesesuaian standard dengan perubahan dan
perkembangan industri.
 Diadakan minimum 5 Tahun sekali
 Input dari System Users
 Hasil survey dan questionnaire
 Termasuk rekomendasi-rekomendasi yang diberikan oleh user dari hasil
interpretasi proses
 Trend yang berlaku
 Untuk menyesuaikan dengan perkembangan dibidang management
system

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Proses Pengembangan standard ISO

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Tujuan dari Perubahan Standard ISO 9001:2008
 Untuk meningkatkan persyaratan standard yang ada

 Untuk meningkatkan pemahaman dan interpretasi standard dan
memudahkan penerapannya.
 Untuk meningkatkan “kompatabilitas” dengan persyaratan sistem manajemen
yang lain (ie. ISO 14001:2004)
 Untuk meningkatkan konsistensi dengan standard ISO 9000 series yang lain
Kriteria Perubahan yang diadopsi “High Benefit / Low Impact”

Addresses a widely expressed specific user need by improving clarity and eliminating
confusion
Corrects an error in the existing standard
Eliminates inconsistencies within ISO 9001
Eliminates inconsistencies within the ISO 9000 family
Eliminates major problems of translation

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Dampak & Manfaat Perubahan (Impact & Benefit)
 Amandemen di ISO 9001:2008 lebih difokuskan pada “High Benefit / and Low
Impact” Perubahan dan revisi major yang bersifat “High Benefit / High
Impact” baru akan diberlakukan pada revisi “2012”

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Matrix kriteria manfaat / dampak perubahan ISO 9001
IMPACT CATEGORY CRITERIA
Additional or reduced requirement significantly affecting many users

HIGH
Change in intent of requirement
Need for urgent revision of related QMS standards
Need for extensive changes of organization documentation
Decreased compatibility with ISO 14001
Inconsistency with the ISO 9000 family
Need for re-certification or significant transition period
Need for extensive user education or training
MEDIUM Minor additional or reduced requirements for some users

Possible impact on understanding by many users
Need for limited changes of organization documentation
Need for eventual revision of other QMS standards
No signification or additional training for users
Create minimal requirement for re-certification or transition period
LOW No increased or reduced requirement
No change in intent of requirement
No impact on most users
Need only minimum or marginal changes in organization documentation

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Matrix kriteria manfaat / dampak perubahan ISO 9001
BENEFIT CRITERIA
CATEGORY
Address a widely expressed specific users by improving clarity and eliminating
HIGH confusion
Corrects errors in the existing standard
Eliminates inconsistencies within the ISO 9001
Eliminate inconsistencies within the ISO 9000 families
Eliminates major problem of translation
MEDIUM Improved clarity in regard to widely expressed user need but may not eliminate
confusion and/or translation difficulty
Improves clarity in response to needs identified by some users
Increases compatibility with ISO 14001
Reduces problems of translation
LOW Improves clarity only in response to low number of request for improvement
Marginal improvement in clarity where benefit maybe offset by risk of unintended
consequences eg. With respect to translation and interpretation
Changes not addressing a clear user need

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Hasil Survey Users ISO 9001:2000
 “Most Commented Areas of Confusion”

813 (55%) of total 1477 comments related to:
􀁺 4.1 General requirements
􀁺 4.2 Documentation
􀁺 6.2 Human resources
􀁺 7.3 Design and development
􀁺 7.5 Production and Service Provision
􀁺 8.2 Monitoring and Measurement
􀁺 8.5 Improvement

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Scope perubahan pada ISO 9001:2008
 Tidak ada penambahan atau pengurangan klausul dari ISO 9001:2000
 Penekanan terhadap legal requirement termasuk “statutory requirement”
yang terkait dengan produk selain regulatory requirement di element 1.1, 1.2,
4.1, 7.2.1, 7.3.2
 Penekanan pada pengendalian “Outsourced Process” lebih dipertegas lagi
dengan penambahan catatan di klausul 4.1
 Klarifikasi terkait dengan penggunaan “External Documents” yang dimaksud
di klausul 4.2.3
 Penegasan bahwa “Management Representative” adalah salah satu
anggota dari manajemen organisasi tersebut bukan dari luar organisasi.
 Klarifikasi terhadap “Documented Procedure” di klausul 4.2.1
 Klarifikasi terkait parameter yang dapat digunakan sebagai ukuran untuk
“Work Environment” di klausul 6.4
 Beberapa perubahan redaksional seperti penggantian judul, penambahan
dan penghilangan kata-kata guna memperjelas maksud dari klausul.

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Scope Perubahan pada ISO 9001:2008
 1.1 General (Umum)
a) needs to demonstrate its ability to consistently provide product that

meets customer and applicable statutory and regulatory requirements,
 Penambahan kata statutory selain regulatory requirement

 Penambahan NOTE 1 dan NOTE 2
 NOTE 1 In this International Standard the term "product only applied to

- a product intended for or required by a customer
- any intended output resulting from the product realization process
 NOTE 2 Statutory and regulatory requirements can be expressed as legal
requirements

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 Clause 2 and 3 Terms and Definition (Terminologi dan definisi)

 Referensi pada normative reference ke ISO 9000:2000 dirubah
menjadi ISO 9000:2005
 Penjelasan pada paragraph 2 dan 3 terkait dengan terminologi
Supplier  Organization  Customer dihilangkan
 Clause 4.1 General Requirement (Persyaratan umum)

 Point a) – kata “identify” diganti dengan kata “determine” agar
lebih konsisten dengan point-point berikutnya.
 Penambahan catatan / notes terkait dengan penekanan pada
outsourced process

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 Clause 4.1 General Requirement (Note on outsourced process)
Where an organization chooses to outsource any process that affects product conformity with
requirements, the organization shall ensure control over such processes. The type and
extent of control to be applied to these processes shall be defined within the quality
management system
NOTE 2 An outsourced process is identified as one needed for the organization quality
management system but chosen to be performed by a party external to organization.
NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the
responsibility of conformity to all customer, statutory and regulatory requirements. The
type and extent of control to be applied to the outsourced process can be influenced by
factors such as:
a) The potential impact of the outsourced process on the organization capability to provide
product that conforms to requirements
b) The degree to which the control of the process is shared
c) The capability of achieving the necessary controls through the application of 7.4

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 Clause 4.2.1 Persyaratan Dokumentasi

 perubahan redaksi di point c), dan d), tapi tidak merubah persyaratan
c) documented procedures and records required by this International Standard, and

d) documents including records, needed determined by the organization to be
necessary to ensure the effective planning, operation and control of its processes.
e) Records required by this international standard (see 4.2.4)
 Tambahan note terkait dengan “Documented Procedure”
NOTE 1 Where the term "documented procedure" appears within this

International Standard, this means that the procedure is established, documented.
implemented and maintained. A single document may address the requirements
for one or more procedures. A requirement for a documented procedure may be
covered by more than one document.

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 Clause 4.2.3 Pengendalian dokumen

 Penambahan keterangan terkait dengan “External Document” pada
point f)
f) to ensure that documents of external origin determined by the organization to be
necessary for the planning and operation of the quality management system are identified
and their distribution are controlled.
 Clause 4.2.4 Pengendalian Rekaman

 Perubahan redaksi tanpa merubah persyaratan apapun terkait dengan
persyaratan pengendalian rekaman
The organization shall establish a documented procedure to define the controls

needed for the identification, storage, protection, retrieval, retention and
disposition of records.”
Records shall be remain legible, readily identifiable and retrievable.

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 Clause 5.5.2 Management Representative

 Penambahan statement bahwa MR yang ditunjuk harus anggota dari
management organisasi
Top management shall appoint a member of the organization's management who,
irrespective of other responsibilities, shall have responsibility and authority that includes…
 Clause 6.2.1 Sumber daya manusia

 Perubahan redaksional dari “affecting product quality” menjadi “affecting
conformity to product requirement..”
 Penambahan catatan terkait conformity to product requirement
Personnel performing work affecting conformity to product ~requirements shall be

competent on the basis of appropriate education, training. skills and experience.
NOTE Conformity to product requirements can be affected directly or indirectly by

personnel performing any task within the quality management system.

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 Clause 6.2.2 Kompetensi, Pelatihan dan Kesadaran

 Penggantian redaksional judul klausul menjadi “Competence, Training
and Awareness”
 Perubahan redaksional pada point a) dan point b)
a} determine the necessary competence for personnel performing work affecting
conformity to product quality requirements,
b) where applicable provide training or take other actions to satisfy these needs
achieve the necessary competence.
 Clause 6.3 Infrastruktur

 Penambahan “Information Systems” sebagai bagian dari supporting
services
c) supporting services (such as transport, communication or information systems).

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 Clause 6.4 Lingkungan Kerja

 Tambahan catatan untuk memberikan klarifikasi apa saja yang tercakup
didalam parameter lingkungan kerja.
NOTE The term "work environment" relates to conditions under which work is
performed including physical environmental and other factors (such as noise,
temperature, humidity, lighting or weather)
 Clause 7.1 Rencana Realisasi Produk

 Penambahan kata “measurement” pada klausul 7.1 c)
c} required verification, validation, monitoring, measurement inspection and test
activities specific to the product and the criteria for product acceptance;

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 Clause 7.2.1 Penetapan Persyaratan Produk

 Perubahan redaksional pada point c) dan point d)
 Tambahan catatan untuk memberikan klarifikasi tentang “Post-delivery
Activities”
c) statutory and regulatory requirements applicable to the product, and

d) any additional requirements considered necessary by the organization.
NOTE post-delivery activities include for example actions under warranty provisions,
contractual obligations such as maintenance services and supplementary services
such as recycling or final disposal.

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 Clause 7.3.1 Rencana Desain dan Pengembangan

 Penambahan catatan guna memberikan klarifikasi bahwa design review,
verification dan validation adalah aktivitas yang berbeda, walaupun dapat
dilaksanakan secara terpisah atau gabungan. Contoh: kegiatan verifikasi
dan validasi dapat dilakukan bersamaan.
NOTE Design and development review verification and validation have distinct
purposes. They can be conducted and recorded separately or in any combination as
suitable for the product and the organization
 Clause 7.3.3 Keluaran Desain

 Catatan baru terkait informasi untuk “preservation of product”
NOTE Information for production and service provision can include details for the
preservation of products

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 Cluase 7.5.1
 Perubahan pada point d) – kata devices diganti dengan kata equipment
 Clause 7.5.2 Validasi Proses
 Perubahan redaksional tapi tidak merubah persyaratan
 Contoh process yang perlu validasi, welding, sterilization, training, heat
treatment, call center service, or emergency response
 Clause 7.5.3 Identifikasi dan Mampu Telusur

 Penambahan redaksi guna menjelaskan bahwa identifikasi status hasil
test dan inspeksi produk berlaku pada seluruh tahapan realisasi produk
The organization shall identity the product status with respect to monitoring and
measurement requirements throughout product realization

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 Clause 7.5.4 Properti Pelanggan

 Perubahan redaksional tapi tidak merubah persyaratan dan penambahan
“personal data” sebagai bagian dari customer property
If any customer property is lost, damaged or otherwise found to be unsuitable for use,
organization shall report this to the customer and maintain records (see 4.2.4).
NOTE Customer property can include intellectual property and personal data
 Clause 7.5.5 Pengawetan Produk

 Hanya perubahan redaksional tanpa merubah persyaratan
The organization shall preserve the product during internal processing and delivery to the
intended destination in order to maintain conformity to requirements, As applicable
preservation shall include identification, handling, packaging, storage and protection.
Preservation shall also apply to the constituent parts of a product.

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 Clause 7.6 Control of monitoring and measuring equipment

 Kata-kata “devices” di versi sebelumnya diganti dengan “equipments”
 Penambahan kata “both” pada point a) guna menjelaskan bahwa kalibrasi
atau verifikasi atau kedua-duannya bisa saja diperlukan dalam
pengendalian alat / peralatan ukur
 Perubahan redaksional pada point c) agar lebih jelas terkait identifikasi
status kalibrasi alat
 Tambahan catatan baru terkait verifikasi terhadap software yang
digunakan untuk monitoring and measurement.
NOTE Confirmation of the ability of computer software to satisfy the intended

application would typically include its verification and configuration management
to maintain its suitability for use.

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 Clause 8.2.1 Kepuasan Pelanggan

 Tambahan catatan baru terkait beberapa metode yang bisa diterapkan
dalam upaya pemantauan persepsi pelanggan.
NOTE Monitoring customer perception can include obtaining input from
sources such as customer satisfaction surveys, customer data on
delivered product quality, user opinion surveys, Lost business analysis,
compliments, warranty claims, dealer reports
 Clause 8.2.2 Internal Audit

 Perubahan redaksional tapi tidak merubah persyaratan terkait dengan
prosedur terdokumentasi
 Tambahan bahwa rekaman audit dan hasilnya harus disimpan sesuai
dengan klausul 4.2.4
 Tambahan keterangan terkait tanggung jawab manajemen dalam
memastikan koreksi dan tindakan korektif dilakukan tanpa penundaan.

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 Clause 8.2.3 Pemantauan dan Pengukuran Proses

 Tambahan catatan baru dimana organisasi sebaiknya
mempertimbangkan type dan cakupan dari aktivitas pemantauan dan
pengukuran terhadap setiap proses terkait dengan dampaknya terhadap
persyaratan produk dan efektivitas sistem.
NOTE When determining suitable methods jt is advisable that the organization
consider the type and extent of monitoring or measurement appropriate to each
of each processes in relation to their impact on the conformity to product
requirements and on the effectiveness of the quality management system.
 Clause 8.2.4 Pemantauan dan Pengukuran Produk

 Persyaratan untuk menyimpan “evidence of conformity with acceptance
criteria” tetap ada
 Klarifikasi bahwa yang dimaksud dengan produk release adalah
penyerahan kepada pelanggan (“to the customer”)

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 Clause 8.3 Pengendalian Produk tidak sesuai

 Persyaratan tentang “persyaratan dokumentasi” di klausul ini dirubah
redaksinya tapi tidak merubah persyaratannya.
 Persyaratan untuk mengendalikan produk yang tidak sesuai yang
ditemukan setelah produk tersebut terkirim, sekarang di pindah menjadi
point d)
“A documented procedure shall be established to define the controls and

related responsibilities and authorities for dealing with nonconforming
product.”
“d) by taking action appropriate to the effects or potential effects of the nonconformity
when nonconforming product is detected after delivery or use has started.”

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 Clause 8.4 Analisa Data

 Tambahan referensi klausul pada point b), c) dan d)
b) conformity to product requirements (see 8.2.4),
c) characteristics and trends of processes and products, including opportunities for
preventive action (see 8.2.3 and 8.2.4), and
d) suppliers (see 7.4).
 Clause 8.5.2 dan 8.5.3 Corrective & Preventive Action

 Penekanan pada review efektivitas dari tindakan koreksi dan pencegahan
 8.5.2 Bullet f) reviewing the effectiveness of the corrective action taken.
 8.5.3 Bullet e) reviewing the effectiveness of the preventive action taken.

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Akhir Masa Transisi
Schedule Transisi (Transition Phase) As per Nov-2010, semua
certificate ISO 9001 versi 2000
sudah tidak berlaku lagi
(invalid certificate)
Nov 2008 Nov 2009 Nov 2010
Masa Persiapan Transisi Masa Implementasi

Kedua standard (ISO 9001:2000 dan ISO Hanya standard ISO 9001:2008 yang
9001:2008) dapat digunakan sebagai kriteria dapat digunakan sebagai kriteria audit
audit baik untuk klien baru (Certification Audit) baik untuk Certification maupun re-
dan existing clients (Follow-up atau Repeat certification audit
Audit).
Kriteria audit yang disepakati oleh Badan
Sertifikasi dan Klien, harus diidentifikasi
dengan jelas di Audit Plan

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Rekomendasi untuk Transisi – scenario 1
 Scenario 1 – Untuk organisasi yang masa validitas sertifikat ISO 9001:2000

berakhir SEBELUM November 2010
 Upgrade ke standard ISO 9001 versi baru 2008 bisa dilakukan pada saat
Repeat Audit
Contoh:
 PT.XYZ certificate ISO 9001:2000 valid s/d 2009-June-06
 Repeat Audit is due 2009-March-06
 Standard Audit ISO 9001:2008 sebaiknya digunakan sebagai audit kriteria
pada saat Repeat Audit

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Rekomendasi untuk Transisi – scenario 2
 Scenario 2 – Untuk organisasi yang masa validitas sertifikat ISO 9001:2000

berakhir SESUDAH November 2010
 Upgrade ke standard ISO 9001 versi baru 2008 bisa dilakukan pada saat
Surveillance / Follow-up Audit
Contoh:
 PT.ABC certificate ISO 9001:2000 valid s/d 2010-Dec-12
 Follow-up II Audit is due 2009-Dec-03
 Standard Audit ISO 9001:2008 bisa digunakan sebagai audit kriteria pada
saat surveillance audit II.

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Questions & Answers
Thank You

12/28/2018

Awareness & Transition To ISO 9001 - 2008 - Rev02-2

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Awareness & Transition To ISO 9001 - 2008 - Rev02-2

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Awareness and Transition to

ISO 9001:2008* New version

1 PT TUV International Indonesia

Latar belakang Perubahan Standard

2 PT TUV International Indonesia

 Proses Peninjauan (Process Review) dari Komite Teknis TC 176

3 PT TUV International Indonesia

4 PT TUV International Indonesia

 Untuk meningkatkan persyaratan standard yang ada

Kriteria Perubahan yang diadopsi “High Benefit / Low Impact”

5 PT TUV International Indonesia

6 PT TUV International Indonesia

Additional or reduced requirement significantly affecting many users

MEDIUM Minor additional or reduced requirements for some users

7 PT TUV International Indonesia

8 PT TUV International Indonesia

 “Most Commented Areas of Confusion”

9 PT TUV International Indonesia

10 PT TUV International Indonesia

a) needs to demonstrate its ability to consistently provide product that

 Penambahan kata statutory selain regulatory requirement

 NOTE 1 In this International Standard the term "product only applied to

11 PT TUV International Indonesia

 Clause 2 and 3 Terms and Definition (Terminologi dan definisi)

 Clause 4.1 General Requirement (Persyaratan umum)

12 PT TUV International Indonesia

b) The degree to which the control of the process is shared

13 PT TUV International Indonesia

 Clause 4.2.1 Persyaratan Dokumentasi

c) documented procedures and records required by this International Standard, and

 Tambahan note terkait dengan “Documented Procedure”

NOTE 1 Where the term "documented procedure" appears within this

14 PT TUV International Indonesia

 Clause 4.2.3 Pengendalian dokumen

 Clause 4.2.4 Pengendalian Rekaman

The organization shall establish a documented procedure to define the controls

15 PT TUV International Indonesia

 Clause 5.5.2 Management Representative

 Clause 6.2.1 Sumber daya manusia

Personnel performing work affecting conformity to product ~requirements shall be

NOTE Conformity to product requirements can be affected directly or indirectly by

16 PT TUV International Indonesia

 Clause 6.2.2 Kompetensi, Pelatihan dan Kesadaran

 Clause 6.3 Infrastruktur

17 PT TUV International Indonesia

 Clause 6.4 Lingkungan Kerja

 Clause 7.1 Rencana Realisasi Produk

18 PT TUV International Indonesia

 Clause 7.2.1 Penetapan Persyaratan Produk

c) statutory and regulatory requirements applicable to the product, and

19 PT TUV International Indonesia

 Clause 7.3.1 Rencana Desain dan Pengembangan

 Clause 7.3.3 Keluaran Desain

20 PT TUV International Indonesia

 Clause 7.5.3 Identifikasi dan Mampu Telusur

21 PT TUV International Indonesia

 Clause 7.5.4 Properti Pelanggan

 Clause 7.5.5 Pengawetan Produk

22 PT TUV International Indonesia

 Clause 7.6 Control of monitoring and measuring equipment

NOTE Confirmation of the ability of computer software to satisfy the intended

23 PT TUV International Indonesia

 Clause 8.2.1 Kepuasan Pelanggan