ISO9001 Quality Management System Certification

What is ISO 9001 standard

The ISO 9001 standard provides a Quality Management System (QMS) model for obtaining and meeting customer requirements and improving their satisfaction. It is universal and applicable to all types of organizations. Therefore, both public and private sector enterprises, including non-governmental organizations, can benefit from the ISO 9001 quality management system model; Although it is a small, medium, or large company. The immediate benefit that implementing ISO 9001 can bring is the integration of internal process activities focused on improving customer satisfaction, which will lead to many other internal or external reimbursements. The size of these benefits depends on the efficiency of the process in achieving these goals.

Changes to ISO 9001:2015

By meeting the requirements of the new standards, companies can meet customer expectations with consistent and high-quality products or services, while establishing sustainable relationships with all relevant stakeholders.

Why revise?

In a world of constantly changing economic, technological, and environmental challenges, companies need to constantly transform to maintain their leading position. Therefore, a review of all ISO standards is conducted every five years to determine if revisions are needed to keep them up-to-date and relevant to the market.

The changes made in the revised version of ISO 9001:2015 are much more significant than those made in the 2008 revised version. ISO 9001:2015 aims to respond to the latest trends and be compatible with other management systems, such as ISO 14001:2005.

ISO 9001:2015 Objective

The ISO 9001:2015 standard has been restructured: the titles of chapters and sub chapters, as well as the order of clauses and paragraphs, have been thoroughly revised. These changes reflect a strategic choice that will gradually be applied to all management system standards (MSS) to be published by ISO.

Enhance the organization's ability to meet customer needs

The quality management system is placed at the core of corporate governance.

Senior management should be responsible for the effectiveness of the management system, not just for it

From being merely 'promised' to demonstrating 'leadership'

With advanced architecture, ISO 9001:2015 can be easily integrated with other management systems (ISO 14001:2015, ISO 45001)

Proactively identify and manage risks

Properly consider the needs and expectations of all relevant stakeholders

Due to simplified language and fewer directive requirements, ISO 9001:2015 will be more suitable for all types of companies.

The creation of a knowledge database will ensure effective internal exchange of knowledge owned by the company.

main changes

1. Rewrite standards according to HLS

Overall, this restructuring will not affect the content or requirements of the standards. However, when examining the text in detail, the structure has been changed to comply with the new writing guidelines and topic sequence. This change reflects a strategic choice that will gradually be applied to all ISO standards of the management system. Starting from ISO 55001 (Asset Management Systems), the new structure is consistent with Annex SL.

With this new universal structure, ISO aims to help businesses and organizations integrate all or part of their various management systems more easily, and ultimately achieve a truly unified management system. This consistent universal structure makes it easier for companies to incorporate the components of other standards they include. Related to environmental standards such as ISO 14001:2015, ISO 27001:2013, and even the future ISO 45001 standard for occupational health and safety management.

2. Risk management becomes the foundation of standards

Each major revision of this standard introduces a concept that enables certified companies to achieve higher levels of maturity. Risk management based on the 'risk-based thinking' approach has become the fundamental content of the revised standards: risk identification, qualification, and management. Proper management of these risks leads to an improvement in quality, which goes beyond the strict scope of the delivered products or services. Quality does not exist unless an organization can provide qualified products or services to its customers in the long term. Risk has its counterpart: opportunity. The ISO 9001:2015 standard also includes the concept of positive uncertainty. Of course, risk is an additional concept and cannot replace the existing concepts in the standards. Risk is incorporated into the fundamental principles and these concepts are refined. Therefore, the process approach and PDCA remain the two fundamental pillars. Managing risk also means continuous improvement. Corrective measures correspond to uncertain, erroneous quality or poorly managed risks; Preventive measures can address potential but non occurring risks of violations.

3. Leadership

The commitment to quality has been strengthened through strong and visible leadership. The idea of 'management representatives' has completely disappeared. Quality policies and established goals must be aligned with strategic direction. QMS requires integration into business processes.

4. Standards open to the service industry

The environment for organizational development has changed, and the revision of standards takes into account the development of the way organizations conduct business or activities. ISO 9001 was originally designed for the manufacturing and industrial sectors, and it has always been a sacrifice for its own success. Many organizations in other fields have also become its own achievers. The revised version of ISO 9001:2015 has taken these changes into consideration. Its vocabulary selection and abstraction level simplify the implementation of all industries, including services.

5. There are no more quality manuals available

Once it becomes a part of ISO standards, will the quality manual disappear? Indeed, it is possible, but it will not be possible in the near future because the ideas of the quality manual are deeply rooted in the quality culture.

This revision no longer requires certification organizations to maintain the latest quality manual. However, please note that document requirements are still part of the standard. It is still necessary to record, maintain, and preserve relevant information. Therefore, although not the only solution, a quality manual is still a possibility to meet this requirement. The purpose of this standard is to consider technological and social changes. Information is no longer created, organized, managed, maintained, disseminated, and accessed as it was 20 years ago when paper was the primary medium. This change also gives the company's organization greater flexibility. Now, as long as the basic principles are followed, the standard can be adhered to without compromising management agility.

6. The importance of the context surrounding certification organizations and their stakeholders

The two new clauses (4.1 and 4.2) require more consideration of the surrounding environment of the organization. They need to conduct background analysis, identify stakeholders, and understand their expectations.

Knowledge is any other resource

In the 2015 revised version, ISO9001 once again adapted to the times. Knowledge has become the key to successful projects and business development. The new standard regards knowledge as any other resource to be managed:

Identify necessary knowledge to carry out activities and achieve established goals in accordance with the quality management system.

Knowledge must be maintained, protected, and provided when necessary. Predict changes in knowledge demand and manage the risk of not being able to acquire knowledge at the appropriate time.