ISO 9001:2015 Addresses Risk. Is Your Organization Ready? Tracks ISO 9001:2015 Addresses Risk.
Is Your Organization Ready? By Sandford Liebesman
Originally Published in Quality Progress Magazine, September 2014. Reprinted here with permission.
The global economy has provided organizations with many opportunities that didn’t exist even 10 years ago, but it also presents organizations with many risks due to changes, including the internet and extensive outsourcing to countries such as China and Mexico.
To handle these changes, organizations must employ risk- based thinking, an approach that includes tools for identifying, managing and mitigating risks. One method consists of defi ning the organization’s objectives, specifying the risk categories, identifying risks to the objectives and developing methods for managing the risks.
Risk in ISO/DIS 9001:2015
There are many elements of risk-based thinking in the draft international standard (DIS) of ISO 9001:2015 (ISO/DIS 9001:2015) that may affect organizations as they work toward compliance to the revised standard. The following excerpts and summaries describe references to risk in ISO/DIS 9001:2015.2
Defi nition. ISO/DIS 9001:2015 defi nes risk as the “effect of uncertainty on an expected result.” The DIS does not include requirements for preventive action.
Process approach. An important element discussed in clause 4.4 of the DIS is the process approach, which requires an organization to “determine the processes needed for the quality management system (QMS)” and its application of those processes throughout the organization. This includes identifying:
• Inputs, outputs and resources. • Sequence and interaction. • Effective operation. • Responsibilities and opportunities for improvement.
• Risks and the opportunities and actions needed to address them.
Customer focus. Clause 5.1.2 says top management must “demonstrate leadership and commitment with respect to customer focus by ensuring ... the risks and opportunities that can affect products, services and the ability to enhance customer satisfaction are determined and addressed.”
Actions to address risks and opportunities. Clauses 6.1.1 and 6.1.2 say organizations must “determine the risks and opportunities” that must be addressed to ensure the QMS can:
• “Achieve its intended results. • Prevent or reduce undesired effects. • Achieve continual improvement.”
Actions taken to address risks and opportunities must be proportionate to the potential effects on conformity of goods and services, and customer satisfaction. Furthermore, the organization should implement changes in a “planned and systematic manner,” identifying risks and opportunities, and reviewing the potential consequences of changes. Options for addressing risk can include avoidance, eliminating the source, sharing the risk, and deciding whether to take the risk.
Post-delivery activities. According to clause 8.5.5, when applicable, an organization must determine and meet requirements for post-delivery activities associated with the nature and intended lifetime of the goods and services, accounting for:
• Risks associated with the goods and services. • Use and lifetime. • Customer feedback. • Statutory and regulatory requirements.
Management review. Clause 9.3 says an organization must consider the effectiveness of the actions taken to address risks and opportunities (also see clause 6.1). This includes:
• Determining what needs to be monitored and measured so the organization can demonstrate conformity of goods and services to requirements.
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