Risks and Opportunities are managed on a daily basis at every company.
Everyone evaluates risks and opportunities every time they make a decision. It is all about weighing the probability of a positive outcome versus the impact or cost of a negative outcome from an action taken.
An addition to the ISO 9001:2015 requirements, compared to previous versions of ISO 9001, is to understand and take action to address the risks and opportunities for your QMS. This can be done however you want, and many companies will perform a SWOT analysis as a way to identify business strengths and weaknesses, but the important factor in realizing profit is deciding what actions you will take. A SWOT or Strengths, Weaknesses,
By identifying the risks and opportunities that are applicable to your company, and deciding what actions you will take, if any, to address these, you will be able to find ways to limit the negative impacts of potential problems and also capitalize on the opportunities that can lead you into new sales markets or product lines. Properly acting on risks and opportunities can realize great profit for your company and help resolve a fundamental requirement in ISO 9001:2015 for “risk based thinking”.
Risks and Opportunities play a role in continual improvement and should be “plugged in” to your regular improvement processes where specifically enumerated in the ISO 9001:2015 standard. Prior to approving and implementing a quality plan, corrective action, non-conformance, design and development plan are all areas that require “risk based thinking”. These quality processes (and more) are required and used by most companies who apply a formal and organized risks and opportunities procedure.
CVG Strategy Experts
Our Exemplar Global Lead Auditor Consultants can help you with implementing a quality management system, which will include a risks and opportunities procedure. CVG Strategy has prepared, trained and implemented quality management systems for manufacturing companies in the past 10 years.
CVG Strategy is a consultancy offering coaching, mentoring, training and program development focused on areas including Business Process Improvement, ITAR and Export Compliance, Cyber Security and Product Test and Evaluation. For any additional questions, please contact us now!