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ISO 9001 2015 Update and Risk Based Thinking

por Eddy Klinger (02/07/2020)


One of the most important changes made during the revision of ISO 9001 to its 2015 edition is the establishment of a systematic approach to risk, rather than treating it as just one component of a quality management system.
It replaces the necessity of preventive action with Risk-Based Thinking (RBT). This update was intended to avoid unnecessary confusion; however, it actually seems to have created more confusion as the terminology introduced was not very widely used elsewhere.

For ISO, the objective behind taking a risk-based approach was to make an organization proactive rather than being purely reactive. It was aimed at reducing or tour shangrila preventing undesired effects and promoting steady progress. In a risk-based management system, preventive action is instinctive.

Adopting "Risk-Based Thinking"

There is no harm in organizations adopting risk-based thinking, where "thinking" refers to proper assessment of risk, so that planning and avoiding it can be done.

This could reap very positive results as properly avoiding major risks would improve customer satisfaction and confidence, assure consistent quality of goods and services and bring about a proactive culture of improvement and prevention. It is firmly believed that successful companies have always taken a risk-based approach and ISO 9001:2015 is working to put that into the structure of the world's most important QMS guideline.

ISO 9001:2015 is, tour shangrila at the root of it, about managing change processes in your business by taking a future-facing approach, understanding the challenges and risks that could affect your organization's capability to comply with customer needs, and taking a preventive approach supported by properly documented information. The important factors for obtaining a successful ISO 9001:2015 certification are to have an effective plan and to consider opportunities and risks.

Upper-tier management should be able to ensure that they understand risks and opportunities facing the business as a whole. They need to make sure that the management system will be able to achieve their desired results, reduce or prevent negative effects, obtain steady improvement and that steps to address opportunities and risks are incorporated into processes and their effectiveness evaluated.
Risk-based thinking in terms of how it relates to but is different from a formal risk management program.

For detailed information on ISO:2015, attend webinar by our expert speaker, Duke Okes, who has conducted hundreds of workshops on ISO 9001.

The webinar will discuss in terms of how it relates to but is different from a formal risk management program, and provide examples of its application within a quality management system.