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Perubahan ISO 9001:2008 ke ISO 9001:2015 (DIS)
ISO 9001:2008 di tahun ini 2014 akan mengalami perubahan, perubahan ini karena memang setiap 5 tahun seharusnya standard ISO 9001 ini di update dan disesuaikan dengan perubahan Qulity Management, Perubahan Bisnis, Perubahan Tuntutan customer dll,  
 
untuk ISO 9001:2015 (DIS) ini akan menggunakan HLS (High Level Structure) yang terdiri dari 10 klausal, structure ini juga akan dipakai untuk Sistem Manajemen yang lain (ISO 14001:2014,dll).
dan struktur HLS tersebut adalah sbb:
Sertifikasi ISO 9001:2015
Struktur yang baru ini nantinya akan memudahkan organisasi/ perusahaan dalam melakukan integrasi sisitem manajemen (mutu, Lingkungan, K3, dsb)
aspek Term and Devinition akan lebih lengkap, karena berbeda dengan versi pendahulunya yang memisahkan term and definistion di ISO 9000, untuk versi ISO 9001:2015 (DIS) ini semua definisi akan dimasukan dalam standard ISO 9001:205, hal ini untuk lebih memudahkan organisasi dalam memahami standard.
 
ada 8 point perubahan utama dari ISO 9001:2008 ke ISO 9001:2015 (DIS) yaitu sbb:
 
 
 
 
 
 

1. Structure dan Terminology, beberapa perubahan terminology di ISO 9001:2015 (DIS ) ini adalah sbb:
·         Product à Product and Services
·         Exlusion à Tidak digunakan (Lihat annex A.4 untuk klarifikasi)
·         Documentation, record à Documented Information
·         Work Environment à Environment for the operation of process
·         Purchase Product à Externally provided product and services
·         Supplier à external Provider
 
2. Product à Product and Services
setiap kata product di dalam ISO 9001:205 (DIS) akan selalu diikuti dengan kata-kata services, hal ini semakin menegaskan bahwa ISO 9001 bukan hanya untuk perusahaan manufacture tapi juga jasa, sekaligus melihat perkembangan bisnis dewasa ini yang menunjukan bahwa produk tetap harus didukung oleh jasa pendukung yang baik.
3. Context of The Organisation
Organisasi bukan tidak hanya memperhatikan kebutuhan dan persyaratan customer tapi juga harus memperhatikan kebutuhan dan keinginan “interest party”, dan ini sebagai salah satu landasan dalam membangun sisitem manajemen mutu di dalam organisasi.
 
4. Documented  Information ( Documentation, record à Documented Information)
Istilah Dokumentasi dan record /catatan berubah menjadi informasi yang terdokumentasi, tidak ada prosedur wajib seperti yang diminta oleh ISO 9001:2008, standard ini lebih menekankan kepada  informasi yang terdokumentasi (baik berupa IK, STD, Video, Foto, catatan, dsb)
5. Risk Based  Approach
yang sangat baru di sisitem manajemen mutu ISO 9001:2015 (DIS)  ini adalah pendekatan Resiko  terhadap  kegiatan di dalam organisasi, setiap proses di dalam organisasi harus mempertimbangkan aspek resiko, walaupun ketentuan atau metode untuk penghitungan resiko diserahkan kepada organisasi masing masing.
 6. SCOPE and Aplicability
 Tidak ada spesifik klausal yang bisa di exclude, apabila proses tidak dilakukan oleh organisasi maka proses tersebut boleh tidak dilakukan dengan catatan bahwa tidak akan mempengaruhi kualitas produk/jasa yang diberikan.
 
7. Organization Knowledge
Organisasi harus membuat “knowledge management” yang menjamin bahwa “knowledge” yang dipunyai oleh organisasi tetap di manage dengan baik, sehingga bisa dimanfaatkan sampai kapanpun, hal ini tentu tetap harus disesuaikan dengan besar/kecilnya dan resiko di dalam organisasi
8. Control of externally provided product & services
·         Purchase Product à Externally provided product and services
Pembelian product di ISO 9001:2008 bisa dikecualikan namun pada ISO 9001:2015 (DIS) ini tidak dapat dikecualikan karena pergantian istilah dari barang yang dibeli menjadi barang / jasa yang disediakan oleh pihak luar (HO, Group,dll)
·         Supplier à external Provider
Istilah Supplier diganti dengan Provider Eksternal seperti yang dijelaskan terkait dengan pembelian produk diatas bahwa penyedia barang/jasa tidak harus supplier tapi bisa juga group atau kantor pusat, dll.
 
demikian sekilas penjelasan mengenai perubahan ISO 9001:2008 ke ISO 9001:2015 (DIS), untuk seminar mengenai perubahan ISO 9001:2008 ke ISO 9001:2015, dapat menghubungi kami di www.konsultant-iso.com, HP : 0812 10 9 10 329, email budi_wibowo_bb@yahoo.com
semoga bermanfaat..
 
 
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