BENGKEL PEMIKIRAN BERASASKAN RISIKO ISO 9001:2015

BENGKEL PEMIKIRAN BERASASKAN RISIKO ISO 9001:2015

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PEMIKIRAN BERASASKAN RISIKO (RISK BASED THINKING) ISO 9001:2015

RBT memungkinkan suatu organisasi untuk menentukan faktor-faktor yang boleh menyebabkan proses dan sistem pengurusan kualiti (quality management system, QMS) tidak mengikut standard yang ditetapkan. Dari pengenalan RBT ini, organisasi juga dapat menerapkan pengendalian preventif (pencegahan) dengan meminimakan kesan negatif dan memaksimakan peluang. Pengenalan konsep RBT ini menggambarkan integrasi antara pengurusan kualiti dengan pengurusan risiko.

Konsep RBT secara tersirat telah disertakan pada edisi-edisi ISO 9001 yang lepas, sebagai contoh melalui persyaratan untuk perancangan, peninjauan, serta perbaikan. ISO 9001:2015 juga menggabungkan persyaratan bagi organisasi untuk memahami kandungannya (klausa 4.1) dan menentukan risiko sebagai dasar perancangan (klausa 6.1). Hal ini menunjukkan penerapan konsep RBT dalam perancangan dan penerapan proses QMS (klausa 4.4) serta akan membantu menentukan maklumat di dalam dokumen adalah tepat (documented information).

Salah satu tujuan utama Sistem Pengurusan Kualiti (Quality Management System) adalah sebagai alat pencegahan. Oleh itu, ISO 9001:2015 tidak memiliki klausa atau subklausa berasingan berkaitan tindakan pencegahan. Konsep tindakan pencegahan dinyatakan melalui penggunaan RBT di dalam penyusunan persyaratan QMS.

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