The Updated ISO 9001:2015

Introduced in September 2015, the updated ISO 9001:2015 represents a significant change to ISO 9001:2008 requirements. The new standard is scheduled to take effect on September 14, 2018. This gives organizations three years to prepare from the date of release, and more than half that time is now passed. Only 15 months remain for you to comply. If you aren’t already on the path to compliance, now is the time to begin.

The new updated ISO 9001:2015 standard includes fewer clauses (eight instead of ten), a revised high-level structure that forms a new common core for all quality standards (Annex SL), and several terminology differences. It also includes the following six new major requirements that you’ll need to incorporate into your quality management system (QMS).

Updated ISO 9001:2015 – New Major Requirements

1. Context (Clause 4.1)
   You must now take into consideration and be able to discuss with your assessor all factors and situations that affect your organization’s operation. This includes industry regulations, governance, and interested party issues. To prepare for this requirement, conduct a self-evaluation to determine how various internal and external factors relate to your QMS and overall company objectives, strategies, products, and services.
2. Needs and Expectations (Clause 4.2)
   This builds off the “context” requirement and mandates that you have a comprehensive understanding of the needs and expectations of your stakeholders – both internal and external. This includes anything that might affect your ability to produce and deliver the expected products and services. To comply you must show that this information is gathered and monitored, and regularly reviewed in a formal process such as your management review meetings.
3. Risks and Opportunities (Clause 6.1)
   This new requirement mandates that you incorporate a risk-based approach to your business into your quality management system. The process starts with identifying and documenting potential risks and opportunities and developing an action plan to address them. You must incorporate these actions into your QMS and then monitor and evaluate the results of those actions. The key is that the actions you take need to be in proportion to the level of risk faced in each situation.
4. Organizational Knowledge (Clause 7.1.6)
   This mandates the ways in which you must handle the knowledge your organization requires for successful execution and delivery of your products and services. You need to maintain a knowledge base and make it readily available to all relevant parties in your organization. You must also continuously evaluate your organizational knowledge to ensure it is keeping up with changing needs and trends. If not, you need to have a plan to acquire and integrate the necessary new knowledge.
5. Design and Development (Clause 8.3.1)
   This new requirement only impacts organizations that conduct formal design and development as part of their business. You must formally document a process to plan and control the design and development function. You need to identify appropriate inputs and establish the controls that ensure you achieve your desired outcomes. You also must be able to demonstrate controls over any changes to your design and development process.
6. Proactive Improvement (Clause 10.1)
   This formalizes what has been simply mentioned in previous ISO 9001 standards. It mandates that you have a documented continuous improvement process in place for your existing products and services. This includes addressing the future needs and expectations of your customers. You must also take action to correct, prevent, or reduce undesirable outcomes and improve the overall performance of your quality management system.

If you are currently certified to ISO 9001:2008, you already have a solid QMS base. Moving to the new standard will take some work, but now is the time to make sure you have a plan in place to meet the looming deadline.

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