The management by objective (MBO) mindset was very popular in the years leading up to the release of ISO 9001, a mindset W. Edwards Deming lived to rebuke personally (see Out of the Crisis, p. 75-76). While MBO is not a nonconformity per ISO 9001, it is not required by ISO 9001 and auditors should not expect MBO-type objectives in order for organizations to demonstrate measurable objectives or improvement. Continue reading
Evidence of risk-based thinking can be found all over a good quality management system (QMS). From definition of the system itself, to the processing controls in place, to each action taken to improve the system and its processes. Therefore, no additional documentation should be needed to comply with upcoming ISO 9001 requirements demanding risk-based thinking. While no additional procedures or forms will be needed, though a mention of risk-based thinking somewhere in QMS documentation seems appropriate. Continue reading
The long awaited revision of ISO 9001:2008 is upon us and it comes accompanied by much angst. Over 1.3 million organizations have successfully implemented the international quality management system standard and achieved this expensive, hard-earned certification. But now that is all about to change. Painful decisions will need to be made in the coming years on whether to embrace the changes needed for recertification after 2018, or to drop the ISO 9001 certification altogether. Continue reading
Using ISO parlance, a management system is designed to achieve objectives. In the case of a quality management system (QMS) the most basic objective is to succeed by satisfying customers. A QMS is a system designed to satisfy customers by providing them with timely, quality products and services. Continue reading
INTRODUCTION
Standards provide crucial communication, alignment and compatibility at an international, national, industry and individual organizational level. These standards, accessible to everyone from global powers to developing countries, from international corporations to the Mom and Pop small business, provide guidance and infrastructure, state of the art technical knowledge and management best practices. Continue reading