ISO 9000 quality management (QM) standards are based on a long term international cooperation and broad consensus, and they have achieved a wide recognition in organizations all over the world. They have been the major references for the development of quality approaches in all kinds of organizations during more than a quarter of century. All quality experts and many business people have very likely some awareness or experience of those standards. Hence, we also have broad continuous discussions how to get a maximized benefit of the standards.

When considering the international standardization we should understand both standards creating process and the use of standards. Both of these are based on voluntary approach and action. Standards creating and standards applying are two very different and often separate worlds. Standards creating is a consensus process of independent experts and national standardization organizations but in standards applications business leaders have responsibility and innovation is core of the process.

ISO 9000 standardization process is slow and ineffectively managed and cannot flexibly follow the general development and trends of business environments and society at large. The standards have flaws and problems, and also lack of clarity from the business point of view, mainly due to the general standardization process. The organizations implementing the standards must be aware of this matter of fact, and they are responsible to make the necessary improvements in their standards realizations. Also in these cases the standards have a strong and good reference value.

One can refer to a multitude of success stories pertaining to systematically implemented QM development projects. However, at the same time recognized experts have indicated that even the majority of development initiatives, which have been undertaken under the name of quality have not been successful or even have failed. We cannot be pleased with the majority of the current practices of applying the ISO 9000 standards in these projects. There is much criticism and even cynicism against the standards implementation and the achieved results. This is mainly due to intentional or accidental misunderstanding of the objectives, nature, structure, and substance of the standards.

ISO 9000 standards do not aim at striving for similar QM solutions. All organizations and their stakeholders have unique needs and business environments. Standards should be applied with integration, responsiveness, collaboration, and innovation.

The basic standards of the ISO 9000 family are ISO 9004 and ISO 9001 that form a complementary pair of standards for QM and quality assurance (QA). ISO 9004 represents the organizational QM broadly, and ISO 9001 is its part for providing QA and satisfaction to organizations’ customers. Very often organizations applying the ISO 9000 standards have not clearly recognized the differences and relationship of the ISO 9001 and ISO 9004 standards in their implementations. ISO 9001 cannot operate effectively or efficiently without taking into account the foundation of ISO 9004 and understanding clearly the key concepts and principles of the whole standards family. The commercialized certification is in a credibility crisis, and we need new innovations for the QA in particular in applying the ISO 9001 standard.

The drafting of the fifth revision of the ISO 9000 standards has started in 2012 with the work for the new ISO 9001. A big challenge for this revision is to provide a stable core set of ISO 9001 requirements for the next 10 years or more, and to ensure that this standard will reflect the changes in the increasingly complex, demanding, and dynamic environments in which organizations operate. ISO 9004 was revised quite extensively already in 2009.

The “Quality management principles” (QMPs), which have been drawn up as a basis for the entire ISO 9000 standards family, have also been revised for next revision of the standards. QMPs are a set of fundamental belief, norms, rules and values that are accepted as true and that can be used as a basis for QM. QMPs emphasize what we should take into account in all contexts of ISO 9000 standards. QMP's provide the profound knowledge for understanding all the standard clauses. ISO 9000 QMPs should be utilized together with the general management principles that have been articulated by many recognized business management teachers.

Successful business management requires knowledge and practices of many different specialized disciplines. QM is one of those disciplines. In addition to the ISO 9000 standards, a lot of other standards have been created also for the other specialized disciplines including environmental management, social responsibility management, risk management, occupational health and safety management, information systems/service management, information security management, dependability management, etc. For these areas there are general standards but also sector specific standards, e.g. those for automobile industry, software industry, aviation industry, military applications, health care, etc. There are needs to apply these standards simultaneously in organizations.

In order to help organizations to integrate the aspects of different managerial disciplines, ISO/IEC Directives have defined a high level structure and identical core text, and common terms and core definitions to be used in all discipline specific management standards. The high level structure consists of key issues of the business management that is significant for promoting the business integration in applying the standards. The new harmonized approach will be applied in the fifth revision of the ISO 9001 standard.

It is very typical that organizations use simultaneously with the ISO 9000 standards also other well-known reference models of business management, e.g. performance excellence models (quality award criteria), Kaizen, SixSigma, lean, Balanced Scorecard (BSC), etc. practices. Often organizations have not made clear the relationships between them that may cause confusion and inefficiency. They may even compete with each other. All these different methodologies may, however, be seen as sub-domains of a comprehensive business-integrated QM approach according to the ISO 9000 standards. ISO 9000 standards also promote world-widely referred TQM (Total Quality Management) movement within organizations. Factually the concept QM of ISO 9000 equals the concept TQM.

The QM is applied in a multidimensional business environment. All organizations operate in complex business and social communities, and hence in the QM realizations we should take into account phenomena related to the business networks and ecosystems of these communities. The prevalent practices are weak to meet the needs of these changed circumstances. Innovations are needed at the organizational level when the standards are applied in these environments.

ISO 9000 standards are often said to place stress on quality documentation. However, serious requirements for documentation come only from business needs, not from standards, which present only guidance or general models. Different members of the organization have different needs of documentation contents and form. Business documentation also fulfills the needs of QM and QA, and thus no distinct quality documents, e.g. quality manuals or procedure documents, are needed. In today's dynamic process environments stable and stiff documentation structures are no more adequate but instead flexible and collaborative information and communication arrangements are required. Mobility is a crucial requirement for business process activities today, and that should be taken into account in documenting and using information. Effective use of advanced information and communication technology, e.g. social media (Web 2.0), gives new possibilities especially by strengthening applications in the area of tacit knowledge that covers the most important and biggest part of business knowledge.

Evaluating the performance of QM is a problematic issue. QM aims at results or outputs of business activities or processes to fulfill needs and expectations of all stakeholders and through that ensure sustained success of an organization. QM is an essential part of the management of an organization. All its activities are seamlessly embedded within the business system and business processes of an organization, and their management. QM covers the whole area of the management of an organization from top management to management of operational activities (business processes) and individual self-management of employees. It is impossible say where is the border between business management and QM. Hence, instead of QM evaluations we carry out comprehensive evaluations of the performance of business processes and results.

Strategic performance evaluations cover business units and their businesses as a whole. They are primarily made as self-assessments. We have available two major models for these evaluations: (a)  Performance excellence models (quality award criteria), (b) Maturity models. We prefer the first one but in general organizations are not well aware of the differences of these models in order to make their own selection.

Audits are more operational evaluation practices. One should make clear distinction between internal and external audits. They are very different activities with the different purposes and processes. Internal audits aim at business performance improvements and external audits for QA, i.e. for providing confidence among an organization’s customers. ISO 9001 can also be used as general requirements for the conformity assessment by 1st, 2nd and 3rd parties. 3rd party audits and certifications have been overly emphasized. Business excellence and sustained success cannot be achieved only by striving for ISO 9001 certificates, a broader ISO 9000 approach is needed.

We have two approaches to the improvements. Reactive development is achieved through problem solving. However, more can be achieved when opportunities, challenges and innovations are the basis of performance development, and the organization takes proactively into account the existing strengths, competitive advantages, and  opportunities. The improvement is carried out through utilizing well established methods including e.g. performance analyses, corrective and preventive actions, innovations, and benchmarking.

Every organization has always its own existing realization of QM and way to use ISO 9000 standards that can be gradually improved according to the organization's business development strategies and practices. Methodology to be applied depends a lot on the organization’s business situation and development targets. Worth and value that may be expected from the development contributions include:

• Improved fulfilling of the customers’ needs and expectations and increased satisfaction
• Solved problems in the business processes and their interfaces and responsibilities
• Reinforced awareness of the business integrated quality among the leaders and employees
• "Real option” benefits by building new business opportunities on QM innovations, operations and results

Epilogue

The title of this paper, “ISO 9000 for the Creative Leader” was used in 2001 when we wrote a small pocket book with that name for the help and orientation of business leaders in a big Finnish service company (Sonera Corporation). At that time the third version of the ISO 9000 standards was just published. That book become a real “bestseller” within the company and its business community. Now in 2013 we are in the advent of the fifth revision of the standards, and we have new challenges for both the new standards creation, and their understanding and applying in the changed business environments. We also have a lot of new means for the QM realization according to the ISO 9000 standards. We hope that this workshop paper and related slides could again serve as a contribution for ideas, discussions, and considerations when looking for challenging QM implementation solutions. The aim of this paper is to broaden the horizon for critical discussion on important QM issues to the organizational, national, and international levels.

References

1. Anttila, J. and Vakkuri, J. (2001), ISO 9000 for the creative leader, Sonera Corporation, Helsinki, Finland
   
   
   
   
2. Anttila, J. (2012), “ISO 9000 standards series, a continuous subject to wide international interest and application. How to apply standards in an innovative way for organizational performance excellence and sustained success?”

[This text has been presented at a conference workshop in Hail, Saudi Arabia in 2013]