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Awareness and Transition to ISO 9001:2008* New version

PT TUV International Indonesia 5/19/2012

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

PT TUV International Indonesia 5/19/2012

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

PT TUV International Indonesia 5/19/2012

Proses Pengembangan standard ISO

PT TUV International Indonesia 5/19/2012

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

PT TUV International Indonesia 5/19/2012

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

PT TUV International Indonesia 5/19/2012

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
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 No increased or reduced requirement

MEDIUM

LOW

No change in intent of requirement No impact on most users Need only minimum or marginal changes in organization documentation

PT TUV International Indonesia 5/19/2012

Matrix kriteria manfaat / dampak perubahan ISO 9001


BENEFIT CATEGORY CRITERIA
Address a widely expressed specific users by improving clarity and eliminating 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

HIGH

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

PT TUV International Indonesia 5/19/2012

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

PT TUV International Indonesia 5/19/2012

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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PT TUV International Indonesia 5/19/2012

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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PT TUV International Indonesia 5/19/2012

Scope Perubahan pada ISO 9001:2008


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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PT TUV International Indonesia 5/19/2012

Scope Perubahan pada ISO 9001:2008


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 The degree to which the control of the process is shared The capability of achieving the necessary controls through the application of 7.4

b) c)

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PT TUV International Indonesia 5/19/2012

Scope Perubahan pada ISO 9001:2008


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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PT TUV International Indonesia 5/19/2012

Scope Perubahan pada ISO 9001:2008


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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Scope Perubahan pada ISO 9001:2008


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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PT TUV International Indonesia 5/19/2012

Scope Perubahan pada ISO 9001:2008


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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PT TUV International Indonesia 5/19/2012

Scope Perubahan pada ISO 9001:2008


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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PT TUV International Indonesia 5/19/2012

Scope Perubahan pada ISO 9001:2008


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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PT TUV International Indonesia 5/19/2012

Scope Perubahan pada ISO 9001:2008


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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Scope Perubahan pada ISO 9001:2008


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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Scope Perubahan pada ISO 9001:2008


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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Scope Perubahan pada ISO 9001:2008


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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Scope Perubahan pada ISO 9001:2008


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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Scope Perubahan pada ISO 9001:2008


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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Scope Perubahan pada ISO 9001:2008


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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Scope Perubahan pada ISO 9001:2008


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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Schedule Transisi (Transition Phase)

Akhir Masa Transisi


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


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

Masa Implementasi
Hanya standard ISO 9001:2008 yang dapat digunakan sebagai kriteria audit baik untuk Certification maupun recertification audit

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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

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