The authors of ISO 9001 recognize that dealing with risk is part of management, including quality management. The 2015 standard will require risk-based thinking (RBT) as part of systemic quality management, just as the process approach is part of systemic quality management. Good news: application of RBT, like that of the process approach, comes naturally to successful management personnel. Continue reading
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
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
An organization’s context and existing plans for operating are important to consider when defining a management system and its associated internal processing requirements. An organization’s context depends on its product, industry, competence levels of personnel, complexity of operations, size, etc. All of these are important considerations when defining a management system and deciding what documentation is appropriate. Continue reading