ISO 9001: 2015 Quality Management System

What is ISO 9001 ?

    The ISO 9000 standard series was prepared as the International Standard in 1987 by the International Organization for Standardization (ISO) and was 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 current conditions, came into force.

    ISO 9001: 2015 Quality Management System is a management system that can be applied to all organizations without any discrimination. It is an internationally accepted management style in determining, defining and meeting customer needs and expectations of the organization. ISO 9001 Standard reflects all activities of the organization. It responds to changing needs by developing with the organization. It sets out the conditions of an effective Quality Management System. The purpose 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 prepares a suitable environment for organizations to develop themselves and to work systematically in an order and discipline. In addition to providing ISO 9001 advertising and prestige, it brings the phenomenon of review and continuous improvement to organizations.

    The ISO 9001 Quality Management System is very valuable as it is a standard that many organizations put into practice today and is of great importance in institutionalization. It has become an indispensable system for companies that are growing or aiming to move one step forward by constantly being renewed in today's competitive environment. In order to obtain the ISO 9001 quality certificate, organizations must define their quality management systems and carry out the works as defined. Since the employment of personnel with sufficient knowledge and experience in this matter is difficult, many companies find it appropriate to receive consultancy support. The ISO 9001 system established by the enterprises as a result of the work that lasted for months results in the companies being entitled to receive the ISO 9001 QUALITY CERTIFICATE if it meets the requirements of the standard and is successful as a result of the audits. The healthy functioning of the system is also measured by interim audits conducted every year. Thus, as the fruit of the work done, it is proven with the ISO 9001 certificate that the organizations produce quality products or services.

    The differences in the difficulties faced by the organizations over the years, the complexity of the activities in the supply chain in parallel with globalization, the change in the business methods of the organizations, the increase in the expectations of customers and all related parties, the easier access to information and the stronger voice of today's society have brought the need for revision. In this context, ISO 9001 Quality Management System standard was published by ISO in September 2015; It was published as the Turkish Standard (TS EN 9001: 2015) by the Turkish Standards Institute in January 2016.

WHAT ARE THE MAIN DIFFERENCES IN TS EN ISO 9001: 2015 VERSION ?

   In the new version, special emphasis is placed on high-level leadership, commitment, compliance, purpose, risks and opportunities, legal requirements, competitive market, technology, social - cultural - economic environments, organization's culture, knowledge and performance play a role in understanding the context of the organization. 

    The most noticeable change is the new high level (HLS) structure of the standard. This structure enables organizations using multiple management systems to facilitate the integration of management systems.

    Another change is that the standard focuses on a risk-based approach. Although this approach has always been part of the standard, it has been made more prominent in the new version.

TS EN ISO 9001: 2015 version differences:

• Adoption of high level structure (HLS),
• Include a specific requirement for risk-based approach to support better understanding and implementation of the process approach,
• Having less set conditions,
• Less emphasis on documents,
• Increased applicability for services,
• Include a requirement for defining the boundaries of the quality management system,
• Emphasis on the institutional structure,
• Increased emphasis on leadership
• More emphasis on achieving desired outcomes to increase customer satisfaction

WHAT ARE THE BENEFITS OF TS EN ISO 9001: 2015 VERSION ?

• Leadership participation,
• Addressing organizational risks and opportunities in a structured way,
• Using a simplified language, a familiar structure and terms that will be useful especially for organizations using multiple management systems, such as environment, occupational health and safety or business continuity,
• There are practices for more efficient use of the supply chain,
• More user-friendly for service and knowledge-based organizations.

Who Can Use / Apply the ISO 9001 Standard ?

    All requirements of the ISO 9001 Quality Management System Standard are general and it is intended to be applicable to all organizations regardless of their type, size and the products or services they provide. For this reason, it can be applied by all organizations that aim at continuous improvement and want to create an effective Quality Management System. There is no restriction in terms of sector or scale in this regard.