31. May 2016

Practical Experience made with ISO 9001:2015

Eight months after ISO 9001:2015 has appeared, things have calmed down again. Have the hurdles when it comes to successfully changing over to this Standard already been taken? What are the facts and practical experience, in this respect? Quality Austria has made a survey among 200 customers in order to collect the first experiences made with the new Standard.

It is true that the number of publications about the new Standard has decreased. Nevertheless, we still are at the beginning of implementation. By mid-May 2016, i.e. eight months after the publication of the Standard, fewer than two per cent of qualityaustria’s customers have carried out the changeover and are proud holders of Certificates acc. to ISO 9001:2015. The eight months correspond to approx. 20 per cent of the transition period of three years. However, approx. 40% of our customers plan to have successfully completed the changeover as early as 2016 (cf. Figure 1). This means that this topic will be a hotly contested issue as early as this year.

Nobody intends to lay back the Certificate because of the ISO 9001 Revision. Prior doubts, according to which the requirements might be too high, have strongly been relativized in practice. The audits acc. to ISO 9001:2015 that have been conducted by Quality Austria have also confirmed that companies are prepared to the changes well and that the requirements of the Standard reflect trends from practice.

Figure 1: Answers to the question: Are you planning your audit for the changeover to ISO 9001:2015 (or have already carried out this changeover)?

Challenges of the new Standard

The new Standard has a new structure and includes altogether seven clauses. At our survey, we have asked the companies how challenging implementation of the new requirements placed by these clauses is. The diagram below shows the answers on two poles, namely the mentions according to which the Revision does not lead to any need for change, on the one hand, and the mentions according to which it is “very challenging” to implement the relevant changes.

Figure 2: Answers to the question: “How challenging is implementation of the single clauses for you?”
The answers reflect the focal contents of the new ISO 9001.

The clause “Planning” includes the key requirements relating to risk-based thinking. This is a topic that creates a lot of value to organizations but also means a new approach for many organizations. Thus this topic is correspondingly challenging for companies. Concrete challenges named by companies are the following: “How can risk-based thinking be implemented at all levels of the organization?”; or “In what depth should we make risk assessment?” Thus the challenge does not consist in choosing a method but in establishing a consistent, lean and well-aimed procedure, which will help to identify and assess risks and to take actions without generating bureaucracy or delaying decisions. Thus the challenge consists in acting systematically and consistently.

The requirements placed on the organization’s top management have been enlarged just as well. In this respect, many see the challenge of “convincing top management” or “succeeding in involving the leaders and managers.”

In some organizations, the management system is controlled and steered by top management even now. In other organizations, top management thinks that certified management systems will rather lead to documentation expenditure and bureaucracy. These pictures, which are based on wrong interpretations of the past, will prevent companies from fully utilizing the value that may be created by their systems.

Significant challenges are also seen in Clause 7 of the Standard, Support. These challenges are primarily focussed on the topics of knowledge and competence. The requirements relating to the topic of “Organizational knowledge” are new. Those in the field of competence are closely linked with these requirements and have seen a slight further development as compared to the predecessor edition of the Standard. Challenges stated by organizations include “the necessity to manage the required organizational knowledge and competencies” or “implementation of effective knowledge management at all organizational levels.” This feedback points to the same direction as feedback relating to risk-based thinking. The organizations are not striving for creating rapid and presentable solutions but for achieving continuity and effectiveness in the sense of value creation.

At the qualityaustria survey, people were also asked for the biggest value created by the changeover. In this respect, the “fact that the requirements have become more flexible”, the “stronger emphasis on the process approach” and, above all, “the fact that the topics of risks and opportunities are systematically dealt with” were given as examples.

 

Suggestions from practice for practice

Finally we have asked organizations that have already set out on the journey to make some suggestions to others. The suggestions formulated do not only refer to design as far as the contents are concerned but also to the changeover process. Examples: “Do not invent new things, most things already exist anyway.” hints at the fact that the new topics should not be tackled by thinking about a new method right away but by, first of all, checking what approaches there already are in relation to this topic. “Lean and streamlined documentation, simple structure, no doctoral thesis” is aimed at emphasizing that value created by an organization’s activities is to be optimized while reducing the requirements and documentation to what is necessary. The two suggestions “Start soon enough” and “Involve your employees” are directed towards the fact that good solutions will, in most cases, not be developed in the privacy of one’s own home but by involving the persons concerned by way of the processes and having a look at the impacts on interacting processes. For this purpose, things should be started soon enough. Then it won’t be necessary to wait for the last moment to come up with provisional solutions that can, in the long run, prove to be time-consuming and costly.

Author and Contact Person

Team

Ms. Dr. Anni Koubek

Executive Vice President Sector Management Medical Devices

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