| Cart Total:
Menu
Standard Issues: A Risky Mistake
  • Healthcare, Manufacturing, Quality, Sales

Standard Issues: A Risky Mistake

What went wrong with the risk-based approach in ISO 9001:215?

Publication:
Quality Progress
Date:
May 2022
Issue:
Volume 55 Issue 5
Pages:
pp. 50-52
Author(s):
Cianfrani, Charles A., Sheps, Isaac, West, John E. (Jack)
Organization(s):
Green Lane Quality Management Services LLC, Green Lane, PA, Israeli Standard Institute Central Committee for MS Standards, Silver Fox Advisors, Houston, TX

Abstract

ISO 9001:2015 was a major revision that included aligning the standard to the high-level structure (HLS) for management systems standards. When the HLS was revised last year, it was renamed the harmonized approach (HA) and the preventive action requirement was replaced with the risk-based thinking approach. The HA’s definition of risk was adopted in ISO 9000:2015. This column explains what went wrong with the way “risk” and “risk-based thinking” are defined in the HA, ISO 9000 and ISO 9001.

ALREADY A MEMBER?    REGISTER