ISO 9001:2015

▷ Reasons for Use

The global adoption of ISO 9001 may be attributable to a number of factors. A number of major purchasers require their suppliers to hold ISO 9001 certification. In addition to several stakeholders’ benefits, a number of studies have identified significant financial benefits for organizations certified to ISO 9001, with a 2011 survey from the British Assessment Bureau showing 44% of their certified clients had won new business. Corbett et al (2005) showed that certified organizations achieved superior return on assets compared to otherwise similar organizations without certification. Heras et al (2002) found similarly superior performance and demonstrated that this was statistically significant and not a function of organization size. Naveh and Marcus (2007) showed that implementing ISO 9001 led to superior operational performance. Sharma (2005) identified similar improvements in operating performance and linked this to superior financial performance. Chow-Chua et al (2002) showed better overall financial performance was achieved for companies in Denmark. Rajan and Tamimi (2003) showed that ISO 9001 certification resulted in superior stock market performance and suggested that shareholders were richly rewarded for the investment in an ISO 9001 system.
While the connection between superior financial performance and ISO 9001 may be seen from the above, there remains no proof of direct causation, though longitudinal studies, such as those of Corbett et al (2005) may suggest it. Other writers such as Heras et al (2002) have suggested that while there is some evidence of this, the improvement is partly driven by the fact that there is a tendency for better performing companies to seek ISO 9001 certification.
The mechanism for improving results has also been the subject of much research. Lo et al (2007) identified operational improvements (cycle time reduction, inventory reductions, etc.) as following from certification. Buttle (1997) and Santos (2002) both indicated internal process improvements in organizations leading to externally observable improvements. Hendricks and Singhal (2001) results indicate that firms outperform their control group during the post implementation period and effective implementation of total quality management principles and philosophies leads to significant wealth creation. The benefit of increased international trade and domestic market share, in addition to the internal benefits such as customer satisfaction, interdepartmental communications, work processes, and customer/supplier partnerships derived, far exceeds any and all initial investment according to Alcorn.

▷ Background

ISO 9000 was first published in 1987. It was based on the BS 5750 series of standards from BSI that were proposed to ISO in 1979. Its history can however be traced back some twenty years before that when the Department of Defense published its MIL-Q-9858 standard in 1959. MIL-Q-9858 was revised into the NATO AQAP series of standards in 1969, which in turn were revised into the BS 5179 series of guidance standards published in 1974, and finally revised into being the BS 5750 series of requirements standards in 1979, before being submitted to ISO.
BSI has been certifying organizations for their quality management systems since 1978. Its first certification (FM 00001) is still extant and held by the Tarmac company, a successor to the original company which held this certificate. Today BSI claims to certify organizations at nearly 70,000 sites globally. The development of the ISO 9000 series is shown in the diagram to the right.

▷ Quality Management System Process Approach

This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. Specific requirements considered essential to the adoption of a process approach are included in 4.4.

Understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its intended results. This approach enables the organization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the organization can be enhanced.

The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results.

The application of the process approach in a quality management system enables:

1. understanding and consistency in meeting requirements;
2. the consideration of processes in terms of added value;
3. the achievement of effective process performance;
4. improvement of processes based on evaluation of data and information.

Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks.