ARTICLE

Linking ISO 9001:2015 to Business Leadership, Strategy and Performance

by: Smith and Howard

February 1, 2016

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The updated ISO 9001:2015 requirements, more specifically “Leadership”, “Risk Based Thinking” and “Context of the Organization”, have many components linking QMS standards to business management systems, leadership involvement, and strategic planning that were not previously required. The newly required alignment involves the entire organization, a more comprehensive approach to improved performance, process, and quality.

Many manufacturing organizations are unaware of the problems, and the root causes, of misalignment, inefficiency, and dysfunction that create operating risk. Minimizing and eliminating these problems goes a long way toward driving organizational success. The opportunity for companies, therefore, is to identify, understand, prioritize, and address the risks in their businesses that would create the most value by their mitigation. In other words, to develop an internal roadmap for methodically strengthening their businesses by reducing the risks that are obstructing sustainable profitable growth and depressing enterprise value.

These new ISO 9001:2015 components, outside of the conventional QMS box, compel an added assessment of the entire organization, more holistically than what has been used previously. The favorable benefit of this additional assessment will identify specific operations and processes necessitating support in coupling new ISO requirements, as well as generating roadmaps to strengthen and better align the business.

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