ISO 9001:2015 Quality Management System
What is ISO 9001?
The ISO 9000 standard series was prepared as an International Standard by the International Organization for Standardization (ISO) in 1987 and revised in 1994, 2000 and 2008. The 2015 revision, which was completed with the principle of reviewing the standards every five years and revising them according to the conditions of the day, has entered into force.
ISO 9001:2015 Quality Management System is a management system that can be applied to all organisations without any discrimination. It is an internationally recognised form of management in determining, defining and meeting the customer needs and expectations of the organisation. ISO 9001 Standard reflects all activities of the organisation. It develops with the organisation and responds to changing needs. It sets out the requirements for an effective Quality Management System. The aim of the ISO 9001 System is to reduce, eliminate and, more importantly, prevent errors and defects. The basic assumption here is that if an effective quality management system is established and implemented, quality products and services will be produced to meet customer needs.
The ISO 9001 system provides a suitable environment for organisations to improve themselves and to work systematically in an orderly and disciplined manner. In addition to gaining ISO 9001 advertising and prestige, it provides organisations with the phenomenon of review and continuous improvement.
ISO 9001 Quality Management System is very valuable as it is a standard that many organisations put into practice today and is of great importance in institutionalisation. It has become an indispensable system for companies that are growing or aim to take a step forward by constantly renewing in today’s competitive environment conditions. In order to obtain the ISO 9001 quality certificate, organisations must define their quality management systems and carry out their work as defined. Since the employment of personnel with sufficient knowledge and experience in this field is problematic, many companies find it appropriate to receive consultancy support. As a result of months of work, if the ISO 9001 system established by the enterprises meets the requirements of the standard and is successful as a result of the audits, the companies are entitled to receive ISO 9001 QUALITY CERTIFICATE. Whether the system is functioning properly or not is measured by interim audits every year. Thus, as the fruit of the work done, it is proved that the organisations produce quality products or services with ISO 9001 certificate.
The fact that the difficulties faced by the organizations have changed over the years, the activities in the supply chain have become more complex in parallel with globalisation, the methods of doing business of the organizations have changed, the expectations of the customers and all related parties have increased, the access to information has become easier and the voice of today’s society has become stronger has brought the need for revision. Within this framework, the ISO 9001 Quality Management System standard was published by ISO in September 2015 and published by the Turkish Standards Institute in January 2016 as the Turkish Standard (TS EN 9001:2015).
What are the Main Differences in ISO 9001:2015 Version?
In the new version, particular emphasis is placed on senior leadership, commitment, alignment, purpose, risks and opportunities, legal requirements, competitive market, technology, social – cultural – economic environments, culture, knowledge and performance of the organisation.
The most noticeable change is the new high-level (HLS) structure of the standard. This structure enables organisations using multiple management systems to facilitate the integration of management systems.
Another change is the standard’s focus on a risk-based approach. Although this approach has always been part of the standard, it has been made more explicit in the new version.
ISO 9001:2015 Version Differences:
- Adoption of a high-level structure (HLS),
- Include an explicit requirement for a risk-based approach to support better understanding and application of the process approach,
- Fewer prescribed conditions,
- Less emphasis on documents,
- Increased applicability for services,
- Including a requirement for defining the boundaries of the quality management system,
- Emphasis on institutional structure,
- Increased emphasis on leadership
- More emphasis on achieving the desired outputs to increase customer satisfaction
What are the Benefits of ISO 9001:2015 Version?
- Leadership engagement,
- Address organisational risks and opportunities in a structured way,
- It uses simplified language, a familiar structure and terms that will be particularly useful for organisations using multiple management systems, such as environmental, occupational health and safety or business continuity,
- Implementation of practices for more effective use of the supply chain,
- More user-friendly for service and knowledge-based organisations.
Who Can Use / Apply ISO 9001 Standard?
All requirements of the ISO 9001 Quality Management System Standard are general and are intended to be applicable to all organisations regardless of their type, size and the products or services they provide. For this reason, it can be applied by all organisations that aim continuous improvement and want to establish an effective Quality Management System. There is no restriction in terms of sector or scale in this regard.