ISO 9000 9001 Standards: Quality Management Systems
IQA – Portland, Oregon ISO 9000 / 9001 Standards Training & Consultant Company
Worth noting is that for ISO conformance,documentation is not the objective, it is a means to an end. Proof: read ISO 9001: 2008 and notice it requires only 8 documented procedures, which by the way are not related to the design, manufacturing and testing of products or services.
To focus onfor ISO and to be a lot more effective than most organizations:
- Demonstration of process control at all levels of the organization:
- Use of key performance indicators (KPIs) can be helpful here. Include KPIs for processes such as corrective and preventive action, internal and external audits etc,
- If your process is under control you have the right mix of competency, documentation, instrumentation, materials etc. You should however remain vigilant for identification of opportunities for improvement.
- Team work instead of well intended solo activities:
- Corrective and preventive actions shall be addressed by a team rather than by a quality manager. These actions bring the largest opportunity for improvement and should be taken seriously. A brief weekly meeting between managers from the various departments can greatly improve root cause analysis and this enhance the effectiveness of the solutions provided.
- For any problem, devise a solution and an alternative solution
Committees wrote these ISO standards, and although common-sense and non-bureaucratic in nature, they are not easy to understand without some guidance.
We will be happy to put you on the right track. Contact IQA by phone: 503 522 9456, or you can Email Us.
More About ISO 9000 / 9001 (Source: Wikipedia)
A good source of information is the ISO website:
High level information regarding these standards is available through Wikipedia:
ISO 9001 standard
The ISO 9000 family of standards relate to quality management systems and are designed to help organizations ensure they meet the needs of customers and other stakeholders (Poksinska et al, 2002). The standards are published by ISO, the International Organization for Standardization and available through National standards bodies. ISO 9000 deals with the fundamentals of quality management systems (Tsim et al, 2002), including the eight management principles (Beattie and Sohal, 1999; Tsim et al, 2002) on which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill.
Third party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over a million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today.
Reasons for use
The ISO family of standards is the only international standard that addresses systemic change, the idea of system change is best summarized by W.E. Deming, the holistic transformation of the organization is the single most important factor and is often overlooked. 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.
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.