ISO 9001, the world's leading quality management standard, is under revision, with an updated version due by the last quarter of 2015. Each major revision of the standard introduces a concept that allows certified companies to reach a new level of maturity.
ISO 9001:1987 – Procedures
ISO 9001:1994 – Preventive action
ISO 9001:2000 – Process Approach & PDCA
ISO 9001:2008 – Process Approach & PDCA
ISO 9001:2015 – Risks & Opportunities
Risk Management Approach (risk identification, qualification and management) has become fundamental in the revised standard. Quality results from proper management of associated risks, which go beyond the strict scope of the product or service delivered. Quality cannot exist unless the organization can provide its client a conforming product or service over the long term.
Risk has its counterpart: opportunity. The ISO9001:2015 standard also embraces this concept of positive uncertainty. Of course, risk is an additional concept that in no way supersedes the concept already present in the standard. Risk is incorporated into the fundamentals and rounds out these notions. As such, the process approach and PDCA remain two essential pillars.
Managing risk also means working towards continuous improvement. Corrective action corresponds to an unidentified, wrongly qualified or mismanaged risk; preventive action addresses a risk of possible but un-occurred noncompliance.
The commitment to quality through strong and visible leadership is strengthened: The idea of a “management representative” disappears completely. The quality policy and stated goals must be deeply in keeping with the strategic orientations. QMS requirements must be merged into business processes.
The purpose of the standard is to take account of technological and societal changes. Information is no longer created, organized, managed, maintained, disseminated and accessed as it was 20 years ago when paper was the primary medium. This change also allows for greater flexibility in companies’ organization. It is now possible to comply with the standard without jeopardizing managerial agility, as long as the fundamental principles are respected.
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