Introduction to ISO 9001:2015 Quality Management Standard
The International Organisation for Standardisation (ISO) has published a major revision of its ISO 9001 standard that applied 15 September 2018.
ISO 9001:2015 quality management standard is internationally recognised and defines the principles for Quality Management System.
What is a Quality Management System (QMS)?
- Describes how an organisation can meet the requirements of its customers
- Based on the idea of continual improvement
The choice of a quality management system is a strategic decision for an organisation that can help to improve its overall performance and ensuring to consistently meet customer needs and improve their satisfaction. This can lead to repeat custom, new clients and increased business.
The potential benefits to an organisation of implementing a quality management system based on this International Standard are:
- Opportunities to improve customer satisfaction
- Easily identify risks and opportunities
- Demonstrate conformity to specified quality management system requirements
- Opportunities to expand into new markets, as some sectors including governments and public bodies require suppliers being certified to ISO 9001 before doing business
ISO 9001:2015 is suitable for organisations of all types, sizes and sectors, and is accessible to all types of enterprises, including smaller companies as ISO provides support to assist them with certification.
What is ISO 9001:2015
Customers First
Ensuring you consistently meet customer needs, and enhancing their satisfaction, can lead to repeat business from existing customers, new clients, and having a great reputation for your organisation.
This standard sets out the requirements for a quality management system. It is intended to help businesses and organisations of all sizes to be more efficient and improve customer satisfaction.
Why was ISO 9001 revised?
ISO 9001 has been updated to take into account the different challenges that businesses face in today’s digital age, and major advancement in technology.
Increased globalisation has also changed the way we do business with organisations often operate more complex supply chains.
Along with increased expectations from customers ISO 9001 needed to reflect these changes in order to remain relevant.
Organisations certified to the ISO 9001:2008 standard were granted 3 years to migrate their quality management system to the new edition with the transition period ending
15 September 2018. Failure to have done so by this date meant your organisation will no longer be certified for this standard.
All ISO standards are reviewed every five years to establish if a revision is required to keep it current and relevant for the marketplace. ISO 9001:2015 is designed to respond to the latest trends, and be compatible with other management systems such as ISO14001.
ISO 9001 developed from British Standard BS 5750 a long line of mainly defence related standards going back to the 1950’s on “Quality Systems”. Its equivalent in European Standards was EN29000 and in the International Standards Organisation ISO9000.
The improvement was to help organisations ensure they meet the needs of customers and other stakeholders while meeting any statutory and regulatory requirements related to a product or service.
The key changes in the standards:
- There is no longer a requirement for a quality manual
- The focus is on context and risk-based thinking
- There is no longer a requirement of a management representative
- There is no specific clause for “Preventive Actions”. The following ISO 9001:2015 terms have been revised:
“document” and “records” have been replaced with the term “documented information”
“documented procedure” has been replaced by maintained documented information”
“documented record has been replaced by “retained documented information”
The new version follows a new, higher level structure to make it easier to use in conjunction with other management system standards, with increased importance given to risk, and to provide confidence in the organisation’s ability to consistently provide customers with conforming goods and services and to enhance customer satisfaction.
By taking a risk-based approach, an organisation becomes proactive rather than reactive, preventing or reducing undesired effects and encouraging continual improvement.
Plan-Do-Check-Act (PDCA) Model
This is a model for improvement that is sustained, rather than just a one-time quick fix, and it is for this reason that it is applied to the ISO 9001 standard. The ISO 9001 standard has, as a main goal, the continual improvement of the Quality Management System.
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