New issue of ISO 9001 standard


The fifth version of ISO 9001 standard has been published on 22 September 2015. Since its first issue in 1987 the use of international standard for quality management system ISO 9001 widely spread all over the world and is used today in private sector, public administration and other organizations. The number of users continues to increase. Today, more than 1.1 million management systems in organizations around the world are certified in accordance with the requirements of ISO 9001 standard.

With 9001, a standard was introduced in the international business environment, which became a basic proof of organization's ability to meet expected requirements of clients in many fields. It is also a tool for effective and efficient operation of organization, which was put in force at users, and if it is properly applied, ensures the continuous improvement of organizations operation. It is a standard, which facilitates or in some cases even enables the access to different markets and contributes to organizations success on these markets.

ISO 9001 standard has been renewed several times, namely in 1994, 2000 and 2008. The beginning of renewing the ISO 9001 standard goes in 2012. The renewal lasted three years.


  • Quality management principles are renewed. Now there are seven of them, therefore one principle less. Among the principles, the system approach is no longer explicitly stated and it is included in the process approach. The principle of mutual relationship with suppliers has been expended to all interested parties.
  • New structure of the standard ("high-level structure"), which was introduced by ISO in 2012 for all system standards. This will enable greater synergy, when ISO 9001 is used with other management system standards.

o Scope
o Normative references
o Terms and definitions
o Context of the organization
o Leadership
o Planning
o Support
o Operation
o Performance evaluation
o Improvement

  • Terminology: Due to use of requirements of the standard in service organizations and in order to facilitate its understanding and acceptance of requirements, once of the key changes is the replacement of the term "product" with the term "products and services".
  • Content changes:
    o Context of the organization. The requirements in this chapter mostly represent novelties. What is expected from organizations? Identifying issues from external and internal environment in relation to its mission and strategic direction. Understanding the needs and expectations of interested parties. Also, requirement for process approach is explicitly stated in this chapter.
    o Leadership. Several details are given regarding the proofs for compliance with the requirements stated in this chapter. The quality policy has to be available for all interested parties.
    o Planning. A brief summary of this chapter is that there are no preventive actions, since the organizations will assess and manage risks. The organization will prevent key risks or reduce unwanted effects and ensure that the quality management system will achieve expected results and implement recognized opportunities for improvements. Requirements for quality objectives and plan for their achievement are explicitly set in this chapter. In addition, planning and control of changes is expected from the organizations.
    o Support. Requirements in this chapter are updated, the request for knowledge management is added, i.e. knowledge needed for functioning of quality management system; requirements regarding employees awareness are extended, requirements for internal and external communication are defined. This chapter also deals with documentation, i.e. with the term: "documented information", which includes current terms: documentation (also from external sources), documents and records.
    o Operation. In this chapter requirements are collected from Chapter 7 of previously valid issue of the standard and additional request for the management of nonconformity.
    o Performance evaluation. The chapter includes monitoring, measurement, analysis and evaluation, internal audit and management review.
    Improvement. The chapter discusses nonconformities, corrective actions and improvements, however does not say anything about preventive actions, which are now included among the requirements in the chapter
    o Planning (risk management). At measurement it is important to take the risks and opportunities into consideration.

The new issue gives the standard a new strategic orientation. It takes into account the fact that more and more management systems are used together and are integrated with business processes of the organization; that the priorities are efficiency and quality management system result and that the requirements of the system have to be adapted to current and future business conditions and requirements. Management of risks and opportunities are coming forefront, taking into consideration the requirements of interested parties. Quality management system is expected to become a tool for realization of strategic choices and fulfilment of organization's mission.

Preparation of organization to the new version of standard
Organizations, that already have a certified quality management system in compliance with the requirements of ISO 9001:2008, will have time for transition to the new version of the standard till September 2018. Therefore, the organizations have plenty of time, which shall not put them asleep. All our clients have been acquainted with the way of transition. Those more curious are invited to attend our trainings, which will be lectured by MSc Peter Kunc, the member of technical committee ISO/TC 176, which will prepare a new issue of the standard (more about the lecture can be found here)
SIQ offers the following help at the transition to the new version of the standard:

  • Implementation of info-lectures about the basic changes and key benefits of the new version
  • Implementation of pre-audit according to the new version of ISO 9001:2015 standard
  • Implementation of Gap analysis, which more specifically and systematically displays the differences between the current situation in the organization and the new requirements of ISO 9001:2015 standard
  • Implementation of transition audit in one or two steps, regarding the wishes of organization
  • Training on new version of ISO 9001:2015 standard (for internal auditors, novelties...)
  • Providing technical information regarding the transition process