ISO 9001:2015 Quality Management

ISO 9001:2015 was published in September 2015 and is the internationally recognised standard for Quality Management Systems (QMS). It is the most popular standard in the ISO 9000 series and the only standard in the series to which any organisation, regardless of size or industry, can certify. 

The standard is used by millions of organisations across the world to demonstrate their commitment to quality and continuous improvement through demonstrating their ability to consistently provide products and services that meet and exceed customer and regulatory requirements. 

ISO 9001:2015 uses a systematic, risk based, process driven approach to managing your business and maintaining the effectiveness of a quality management system. 

The standard provides a framework and set of principles that ensure a common-sense approach to the management of your organisation to consistently satisfy customers and other stakeholders. In doing this it provides the basis for effective processes and effective people to deliver an effective product or service time after time.

Context of the organisation - This relates to the internal and external factors that could affect, influence and impact an organisation and its ability to provide products and services to customer requirements. Organisations are required to review, analyse and understand these factors allowing them to implement mitigation and reduce the risk of severe impacts on the business. 

Leadership - Organisations are required to demonstrate leadership and commitment directly with the QMS. Senior management are required to be actively involved.

Planning – How organisations use planning to address organisational risks, opportunities, changes and quality objectives. "Risk-based thinking" what brought in as a new element in 2015. Taking a risk-based approach requires an organisation to determine the risks and opportunities, plan actions to address them, implement them in a quality management system and Evaluate their effectiveness. 

Support -  This focuses on resources needed for the QMS: providing resources, ensures employees are competent and aware, and includes documented information to support your quality management system.

Operation – This covers plan and control processes needed to meet the requirements for products and services (design and development, external providers, production and service provision, release of products and services, nonconforming outputs).

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Performance Evaluation – This requires your organisation's QMS to monitor, measure, analyse, and evaluate your quality management system.

Improvement - Based around continual improvement. Select opportunities for improvement, take action against nonconformity, implement corrective actions as necessary, and continually improve your quality management system.