ISO 9001:2015

It was published in September 2015, updating the earlier ISO 9001: 2008 and it provides a set of standardised requirements for a Quality Management System (QMS). With over 1,000,000 organisations currently certified to the standard globally. Organisations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.

Who should use the ISO 9001:2015?

ISO 9001:2015 applies to any organisation, regardless of size or industry.

Organisations of all types and sizes find that using the ISO 9001 standard helps them: 

• Organise processes
• Improve the efficiency of processes
• Continually improve

All organisations that use ISO 9001 are encouraged to transition to ISO 9001:2015 as soon as possible. This includes not only organisations that are certified to ISO 9001:2008.

The most noticeable change to the standard is its new structure. ISO 9001:2015 follows the same overall structure as other ISO management system standards, making it easier for anyone using multiple management systems. Another major difference is the focus on risk-based thinking. While this has always been part of the standard, this new version gives it increased prominence.

Key elements of ISO 9001:2015

ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organization. Specific sections of the standard contain information on topics such as:

• Requirements for a quality management system, including documented information, planning and determining process interactions
• Responsibilities of management
• Management of resources, including human resources and an organization’s work environment  
• Product realisation, including the steps from design to delivery
• Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action

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