The ISO 9001:2008 on Quality Management Systems was replaced by the ISO 9001:2015 in September 2015. With considerable changes to the layout, structure, wording and focus of the standard, organisations have three years to make the transition to the new version. However, considering the changes, ISO 9001:2015 training is recommended to ensure correct implementation and ongoing compliance with the requirements of the standard.
It forms part of the ISO 9000 series of standards related directly to quality management. The aim of the standard is to improve consistency in quality across the globe. By implementing the standard, companies follow a standardised approach to quality management. This helps to eliminate confusion which emanates from following standards relevant only in one country. With such, companies have the assurance that their trading partners follow a standardised approach to quality management, and they can thus have more confidence in their ability to consistently deliver high-quality products and services.
Why the Changes?
The original ISO 9000 series was written for the manufacturing industry. However, the positive effects of compliance quickly became known. And because companies were looking for one standardised approach to quality, the standard became widely adopted across all industries around the world. Indeed, it became the most popular series of the ISO standards, with ISO 9001 implemented in over 168 countries and more than a million companies certified as compliant in their quality management systems.
Although the standard was meant for the manufacturing industry, it was still generic enough to be implemented in any type of industry. The standard was applicable to any organisation, regardless of its size. This enabled smaller firms to also train their employees accordingly and to implement the standard. In effect, it allowed smaller firms to compete favourably with other larger firms because of their approach to quality management.
The above said, terms used in the standard reflected the terms normally encountered in the manufacturing industry. ISO 9001:2015 has successfully addressed the problem with universal terminology, applicable to all types of industries. Words used in the standard also make the standard more applicable to companies delivering services instead of products, whereas in the past, wording still lacked the universal character to ensure easy application for service-oriented companies.
Although no training is required to understand the structure changes of the standard, in order to successfully implement ISO 9001:2015, the said changes reflect a standardised approach to the layout of the new ISO standards. With such, the new version is compiled according to High Level Structure format reflected in the changes in layout regarding chapter and sub-chapter titles. The order of the paragraphs has been changed alongside some of the clauses. These structural changes came about to ensure compliance with the new way that the standards are written.
The changes form part of the new approach to structure, which is reflected in all the new ISO standards. The aim is to create a uniform look and feel to the standards, which facilitates easier integration of ISO 9001 with other standards from the ISO product stable.
Although the quality manual featured prominently in earlier versions of ISO 9001, it is no longer a requirement for certification. However, companies are still required to meet the requirements of documentation. The change in this regard doesn’t mean that the quality manual isn’t important. What it does mean is that the standard has been adapted to reflect technological changes.
ISO 9001:2015 training on the implementation in this regard is recommended, since the new version is more flexible in terms of how the quality manual or documentation is stored, presented, made available and distributed. In the past, companies stored their quality documentation in paper format.
Advances in technology over the past 20 years have made it possible to make the quality policies available electronically. Such quality policies are also more available to customers. Instead of having to read a single manual to get insight into the quality policies and procedures, customers and employees alike, can access relevant information electronically.
The standard is thus more flexible in terms of the organisation and distribution of the information, as long as the key principles are followed.
Knowledge as a Resource
Knowledge management plays an important role in the new version. Training of employees and implementation of ISO 9001:2015 must be done in compliance with the requirement that knowledge is a manageable resource. The same principles regarding quality for product or service delivery must be followed in the collection, maintenance, retrieval, distribution and protection of knowledge.
It is important to expect and predict changes in the knowledge needs, and to manage the risk of not obtaining the knowledge in the required time. Another requirement in this regard is the identification of knowledge needed to complete activities in compliance with the quality management system, in order to reach the stated goals.
Leadership is the other focus point of ISO 9001:2015. The standard focuses on visible and definite leadership with the management representative concept done away with. Quality policies must form part of the company’s strategic plans and the implementation of the quality management system must ensure full integration with the firm’s business processes.
New clauses regarding the context of the enterprise have been introduced, thus requiring analysis of the context and identification of the stakeholders. It also requires understanding of stakeholder requirements and expectations.
Importance of Risk Management
Risk management forms the base of the new version. Companies will find that with ISO 9001:2015 training/implementation, a risk-oriented approach is followed throughout the standard with focus on identification, management and qualification of the risks. With a long-term approach to quality and risk management, the standard still follows the process approach of the 2008 version, in addition to PDCA.
Corrective steps relate to mismanaged risks and risks not identified. Preventative actions help to address risks of non-compliance.
Companies that have not yet complied with the 2015 version should take the necessary training and implementation steps to ensure full compliance for certification purposes. At WWISE, we provide GAP analysis services to determine shortcomings, training of employees in quality management, the transition to ISO 9001:2015, and internal and external auditing. We furthermore provide full preparation for certification assistance, in addition to the development of integrated management systems.