Understanding ISO 9001 Risk Based Thinking

Risk has been always implicit and addressed in ISO 9001. Many of its requirements, are aimed to prevent risks, therefore risk and ISO 9001 is not a new combination. Previous editions of ISO 9001 included a clause on preventive action, which aimed to prevent the occurrence of nonconformities.

ISO 9001 specifies requirements for the organisation to understand its context and determine risks as a basis for planning. Risk based thinking considers both risks and opportunities.

The Introduction and Annex A of ISO 9001:2015 provide an explanation on risk-based thinking, including clarification on risk and opportunity concepts. More comprehensive information can be found in Risk based thinking paper at iso.org/tc176/sc02/public.

An audit of risk-based thinking in an organisation cannot be performed as a stand-alone activity. It should be implicit during the entire audit of a QMS, including when interviewing top management. An auditor should act in accordance with the following steps and collect objective evidence as follows:

• What inputs are used by the organisation for risk and opportunity determination? These inputs should include the following:

1. Analysis of external and internal issues.
2. The strategic direction of the organisation.
3. Interested parties, related to its QMS, and their requirements, also related to the QMS.
4. The scope of QMS of the organisation.
5. The processes of the organisation.

• The auditor should note that the organisation has to determine the extent of documented information needed to provide objective evidence of the application of risk-based thinking. There is no specific requirement in ISO 9001:2015 on how to document the results of determinations of risks and opportunities.

• An organisation’s needs for, and the extent and type of, documented information will vary greatly due to the context of the organisation, its size, culture, nature of products and services, applicable statutory and regulatory requirements, or customer requirements regarding the risks on products, etc.

• How can an organisation determine its risks and opportunities, while considering the above? Objective evidence could be in various forms, for example:

1. Meeting minutes
2. SWOT analysis
3. Reports on customer feedback
4. Brain-storming activities
5. Competitor analysis
6. Planning, analysis and evaluation activities related to several processes, e.g. strategic planning, design and development, marketing, production and service provision, corrective actions
7. Management review
8. Risk determination or evaluation records, if determined applicable or needed by the organisation, etc.

• How can an organisation address its determined risks and opportunities? The actions needed to be taken can be in different forms, for example:

1. The revision of old, or the setting of new, objectives
2. Action plans
3. On the job training
4.  Work instructions
5. Improvement targets and projects, etc

• Does the organisation evaluate the effectiveness of above-mentioned actions? The auditor should confirm if internal audits and performance evaluation activities take into account the effective application of risk-based thinking.

Attribute to original publisher/ publishing organization: The International Organization for Standardization (ISO) and the International Accreditation Forum (IAF), https://www.quality.org/knowledge/risk-based-thinking