Perbedaan ISO9001:2000 dengan ISO9001:2008
4.1 Persyaratan Umum
ISO9001:2000:
Apabila organisasi men-subkontraktorkan (outsourcing) berbagai proses yang mempengaruhi kesesuaian persyaratan produk, organisasi harus memastikan adanya pengendalian proses itu. Pengendalian proses yang di-subkontraktorkan harus dinyatakan dalam sistem manajemen mutu.
ISO9001:2008:
Proses outsourcing lebih diperjelas. Apabila terdapat proses yang disubkontraktorkan, organisasi
bertanggung jawab penuh atas pemenuhan persyaratan pelanggan, perundang-undangan dan peraturan yang berlaku.
NOTE 2 An ‘’outsourced process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party.
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’s capability to provide product that conforms to requirements,
b) the degree to which the control for the process is shared,
c) the capability of achieving the necessary control through the application of 7.4.
Remarks:
The NOTE 3 has been added to clarify the meaning.
It also identifies factors that may influence the type and extent of control over outsourced processes.
4.2.1 Persyaratan Dokumentasi
ISO9001:2000:
Bila dijumpai istilah ”prosedur terdokumentasi” dalam standar, hal ini berarti prosedur ditetapkan, didokumentasikan, diterapkan dan dipelihara.
ISO9001:2008:
Sebuah prosedur boleh memuat beberapa proses atau beberapa proses boleh tercakup dalam satu prosedur. Fleksibel dalam pembuatan prosedur.
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.
4.2.3 (f) Pengendalian Dokumen
ISO9001:2000:
Dokumen eksternal harus dikendalikan, tetapi definisi dokumen eksternal terlalu luas.
ISO9001:2008:
Dokumen eksternal adalah dokumen yang diterima dari pihak luar yang diperlukan untuk perencanaan dan operasional sistem manajemen mutu.
Remarks:
Clarity has been provided on which external documents organizations need to control.
4.2.4 Pengendalian Rekaman
ISO9001:2000:
Records shall be established and maintained to provide evidence of conformity to requirements and…
ISO9001:2008:
Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.
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 remain legible, readily identifiable and retrievable.
5.5.2 Wakil Manajemen
ISO9001:2000:
Wakil Manajemen dapat dijabat oleh personil dari luar organisasi.
ISO9001:2008:
Wakil Manajemen harus berasal dari jajaran manajemen dan bukan dari luar perusahaan.
Remarks:
The Management Representative must be a part of the organization’s management. The organization may not outsource this responsibility. However this does not prevent the delegation of day to day responsibilities to other individuals (including sub contractors) reporting to the Management Representative.
6.2.1 Umum – Sumber Daya Manusia
ISO9001:2000:
Personel yang melaksanakan pekerjaan yang mempengaruhi mutu produk harus berkompeten atas dasar pendidikan, pelatihan, keterampilan dan pengalaman yang sesuai.
ISO9001:2008:
Personil yang harus berkompeten bukan hanya personil yang pekerjaan berhubungan langsung dengan produk, melainkan juga yang tidak berhubungan langsung dengan produk, (marketing, sales,dll).
NOTE Conformity to product requirements may be affected directly or indirectly by personnel performing any task within the quality management system.
Remarks:
A new note has been added to further explain that personnel performing any task which may directly (e.g. in production) or indirectly (e.g. processing relevant information) affect conformity to product requirements shall be competent.
6.2.2 Kompetensi, Pelatihan dan Kesadaran
ISO9001:2000:
a) determine the necessary competence for personnel performing work affecting product quality,
ISO9001:2008:
The organization shall
a) determine the necessary competence for personnel performing work affecting conformity to product requirements,
Remarks:
This clause is linked to clause 6.2.1 (Please refer to NOTE in 6.2.1).
The Organization shall determine the necessary competence for all personnel working within the management system who may directly or indirectly affect conformity to product requirements.
ISO9001:2000:
b) provide training or take other actions to satisfy these needs,
ISO9001:2008:
The organization shall
where applicable, provide training or take other actions to achieve necessary competence,
Remarks:
The phrase ‘where applicable’ allows organizations to determine their own approach.
6.3c Infrastruktur
ISO9001:2000:
Organisasi harus memelihara peralatan pendukung (seperti transportasi atau peralatan komunikasi)
ISO9001:2008:
Peralatan pendukung ditambah: sistem informasi.
Information systems have been added to the list of supporting services that are needed to be determined and maintained by organizations.
6.4 Lingkungan Kerja
ISO9001:2000:
Organisasi harus menetapkan dan mengelola lingkungan kerja yang diperlukan untuk mencapai kesesuaian pada persyaratan produk.
ISO9001:2008:
Definisi lingkungan kerja sekarang lebih luas meliputi fisik, lingkungan dan faktor lainnya seperti cuaca, pencahayaan, bunyi dan temperatur untuk memastikan persyaratan produk terpenuhi.
7.1 Perencanaan Realisasi Produk
ISO9001:2000:
c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product
ISO9001:2008:
c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance;
Remarks:
The word ‘measurement’ has been added to the previous statement.
7.2.1a Penetapan Persyaratan yang berkaitan dengan produk
ISO9001:2000:
persyaratan yang ditentukan oleh pelanggan, termasuk persyaratan untuk penyerahan dan kegiatan pasca penyerahan,
ISO9001:2008:
Standar baru memberikan contoh-¬contoh kegiatan pasca pengiriman antara lain warranty, mantainance services, recycling atau final disposal.
Remarks:
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.
7.3.1 Perencanaan Perancangan dan Pengembangan
ISO9001:2000:
Organisasi harus mengelola bidang temu antara kelompok berbeda terkait dalam perancangan dan pengembangan untuk memastikan komunikasi efektif dan kejelasan penugasan tanggung jawab. Hasil perencanaan harus diupdate, jika sesuai, selagi perancangan dan pengembangan berlangsung
ISO9001:2008:
Tambahan pada catatan: review, verifikasi dan validasi desain
mempunyai tujuan yang berbeda. Ketiga kegiatan ini dapat dilaksanakan dan direkam secara terpisah atau merupakan gabungan yang sesuai bagi produk.
Remarks:
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.
7.3.3 Output Perancangan dan Pengembangan
ISO9001:2000:
Output desain dan pengembangan harus disajikan dalam bentuk yang memungkinkan dilakukan verifikasi terhadap input desain dan pengembangan dan harus disetujui sebelum dikeluarkan.
Output desain dan pengembangan harus
a) memenuhi persyaratan masukan bagi perancangan dan pengembangan,
b) memberi informasi yang sesuai untuk pembelian, produksi dan penyediaan jasa,
c) berisi atau mengacu pada kriteria keberterimaan produk, dan menentukan karakteristik produk yang penting untuk pemakaian yang aman dan benar.
ISO9001:2008:
Tambahan keterangan pada poin b) Informasi untuk pembelian, produksi dan penyediaan jasa, bisa juga termasuk rincian informasi untuk preservasi produk.
Remarks:
This NOTE gives an example as to how the clause could be used.
7.5.1 Pengendalian Produksi dan Penyedian jasa
ISO9001:2000:
d) the availability and use of monitoring and measuring devices,
f) the implementation of release, delivery and post delivery activities.
ISO9001:2008:
d) the availability and use of monitoring and measuring equipment,
f) the implementation of product release, delivery and post delivery activities.
Remarks:
This clause has been re-worded to clarify the meaning.
7.5.2 Validasi Proses untuk produksi dan penyediaan
ISO9001:2000:
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.
ISO9001:2008:
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.
Remarks:
This clause has been re-worded to clarify the meaning.
7.5.3 Identifikasi dan Mampu Telusur
ISO9001:2000:
Organisasi harus mengidentifikasi status produk berdasarkan persyaratan pemantauan dan pengukuran
ISO9001:2008:
Identifikasi status produk diseluruh realisasi produk
Remarks:
Clarification has been provided that the product status shall be identified throughout the whole product realization process.
ISO9001:2000:
Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).
ISO9001:2008:
Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records (see 4.2.4).
Remarks:
This clause has been re-worded to emphasise maintenance of records related to identification and traceability of product.
7.5.4 Hak milik pelanggan
ISO9001:2000:
otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4).
NOTE Customer property can include intellectual property.
ISO9001:2008:
otherwise found to be unsuitable for use, the
organization shall report this to the customer and maintain records (see 4.2.4).
NOTE Customer property can include intellectual property and personal data.
Remarks:
This clause has been re-worded to clarify the meaning and ‘Personal data’ has been added to the NOTE.
7.5.5 Pemeliharaan Produk
ISO9001:2000:
The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling....
ISO9001:2008:
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....
Remarks:
This clause has been re-worded to clarify the meaning.
7.6 Pengendalian sarana pemantauan dan pengukuran
ISO9001:2000:
Jika software digunakan, harus dipastikan kapabilitas software tersebut pada saat penggunaan awal (initial use)
ISO9001:2008:
Tambahan catatan: Pada umumnya pemeriksaan (confirmation) kapabilitas software computer mencakup kegiatan verifikasi dan manajemen konfigurasi (configuration management).
8.2.1 Kepuasan Pelanggan
ISO9001:2000:
Sebagai salah satu pengukuran kinerja sistem manajemen mutu, organisasi harus
memantau informasi berkaitan dengan persepsi pelanggan apakah organisasi telah memenuhi persyaratan pelanggan. Metode untuk memperoleh dan memakai informasi ini harus ditetapkan.
ISO9001:2008:
Standar baru memberikan contoh metode pengukuran dan pemantauan kepuasan pelanggan yaitu melalui :survei kepuasan pelanggan, data pelanggan tentang kualitas produk, survey opini konsumen, analisa kerugian perusahaan, compliments, warranty claims, laporan dealer
Remarks:
A NOTE introduced which should help organizations to understand the different ways in which customer perception could be captured.
8.2.2 Audi Internal
ISO9001:2000:
Standard lama yang tidak menyatakan internal audit rekamannya harus dipelihara
ISO9001:2008:
Standard baru menetapkan rekaman internal audit harus dipelihara.
Remarks:
Please refer to ISO 19011 Guidelines for quality and environmental management systems auditing
8.2.3 Pemantauan dan Pengukuran Proses
ISO9001:2000:
Organisasi harus menerapkan metode sesuai untuk pemantauan dan, jika dapat, pengukuran proses-proses sistem manajemen mutu. Metode-metode ini harus memperagakan kemampuan proses untuk mencapai hasil yang direncanakan. Bila hasil yang direncanakan tidak tercapai, harus dilakukan koreksi dan tindakan koreksi, seperlunya, untuk memastikan kesesuaian produk.
ISO9001:2008:
Tambahan Catatan: Dalam menentukan metode pemantauan atau pengukuran proses, hendaknya dipertimbangkan jenis dan cakupan pemantauan atau pengukuran yang sesuai bagi tiap-tiap proses.
Remarks:
NOTE When determining suitable methods, it is advisable that the organization should consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the management system.
A new NOTE has been introduced explaining the factors that should be considered when determining suitable methods for monitoring and measurement.
8.2.4 Pemantauan dan Pengukuran Produk
ISO9001:2000:
Release produk atau penyerahan jasa tidak boleh dilanjutkan sampai semua pengaturan terencana (lihat 7.1) diselesaikan secara memuaskan, kecuali kalau disetujui oleh kewenangan yang relevan, dan bila dapat oleh pelanggan.
ISO9001:2008:
Personil yang berwenang me-release produk ke customer harus ditetapkan dan rekaman harus tersedia.
8.3 Pengendalian produk tidak sesuai
ISO9001:2000:
When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.
ISO9001:2008:
Where applicable, the organization shall deal with nonconforming product by one or more of the following ways:
e) by taking action appropriate to the effects, or potential effects, of nonconformity when nonconforming product is detected after delivery or use has started.
Remarks:
The words ‘where applicable’ have been added.
This clauses has been re-worded and re-numbered. The intent remains the same.
8.4 Analisis data
ISO9001:2000:
Analysis of data shall provide information relating to
a) customer satisfaction (see 8.2.1),
b) conformity to product requirements (see 7.2.1),
c) characteristics and trends of processes and products including opportunities for preventive action, and
d) suppliers.
ISO9001:2008:
a) customer satisfaction (see 8.2.1),
b) conformity to product requirements (see 8.2.4),
c) characteristics and trends of processes and products including opportunities for preventive action (see 8.2.3 and 8.2.4), and
d) suppliers (see 7.4).
Remarks:
The clause numbers now provide clear reference with respect to the kind of data to be analysed.
8.5.2 Tindakan Koreksi
ISO9001:2000:
Tindakan koreksi yang dilakukan harus di- review
ISO9001:2008:
Efektivitas tindakan koreksi yang dilakukan juga harus direview
8.5.2 Tindakan Pencegahan
ISO9001:2000:
Tindakan pencegahan yang dilakukan harus di- review
ISO9001:2008:
Efektivitas tindakan pencegahan yang dilakukan juga harus di-review
