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ISO 9000-2008

 

ISO 9000-2008

ISO 9000-2008 The ISO 9000-2008 family of standards form a coherent set of quality management system standards facilitating mutual understanding in national and international trade.

A quality management systems approach

The International Organization for Standardization (ISO) has the mission of promoting the development of standardization and related world activities to facilitate the international exchange of goods and services. ISO is comprised of 91 member countries. The American National Standards Institute (ANSI) is the member body representing the United States. There are approximately 180 Technical Committees within ISO on a wide range of subjects. Technical Committee 176 was formed in 1979 to harmonize international activity in quality management and quality assurance standards. The ISO 9000-2008 series of standards is the most recent result of the committee. The "2008" identifies the set of standards officially adopted in the year 2008. For more information on the background of the ISO 9000-2008 standards and to purchase your copy please visit the American Society for Quality's website.

The ISO standards provide a framework for fundamental quality management. The standards were developed to effectively document the quality system elements to be implemented in order to maintain an efficient quality system within organizations. Most organizations have obtained registration from an accredited independent third party registering body that certifies the organization complies with the standards. Most organizations obtain registration to ISO 9001. All organizations should be capable of being registered regardless of their decision to actually be registered. The ISO standards describe in many cases the minimal set of processes necessary for delivering quality products and services to customers. You will not win the Baldrige award by simply being registered, but if you are not registered or capable of being registered there is probably no hope that your organization will even get close to winning the Baldrige award.

ISO 9001-2008 has eight sections that auditors use to assess an organization's quality management system. Sections 4 through 8 compose the "Requirements" portion of the standard.

  1. Introduction
  2. Scope
  3. Terms and definitions
  4. Quality management system
  5. Management responsibility
  6. Resource management
  7. Product realization
  8. Measurement, analysis and improvement

So how can TQE help?

TQE's core competence is in the areas of Hoshin Kanri, process management, and process improvement. By using TQE's products and training services your organization can begin to implement processes that address specific requirements of the ISO 9000-2008 standards.

Hoshin Kanri directly addresses the section on Management Responsibility. The standard requires organizations to provide evidence of top management's commitment to the development and implementation of the quality management system. It requires that customer input drive the planning process. It requires that the organization's quality policy be communicated to everyone. It requires that quality improvement objectives be measurable. It requires that responsibilities and authorities be clearly defined. It requires top management to check on progress and take action as necessary.

Any organization that has implemented the Hoshin Kanri planning process will have an easy time providing evidence to an auditor that the requirements of ISO 9000-2008 section 5 are being met. After referencing the Hoshin plan in their Quality Manual, they will only need to open the Hoshin plan to show that the organization's quality policy is clearly defined and communicated to everyone. Management responsibilities will be clearly identified by planning table owners. It will be obvious that all improvement activities link to the organization's quality objectives and that they are measurable. A rigorous set of review tables will clearly show management's commitment and involvement in managing the organization's quality policy. In addition, Hoshin Kanri addresses the Corrective Action clause of section 8 of the standard. Hoshin's Abnormality Tables provides a link between corrective action and specific core processes and helps assure that problems are solved using the systematic PDCA cycle.

TQE can help your organization implement the Hoshin Kanri planning process. TQE's Hoshin Handbook describes the Hoshin Kanri process and provides step by step instructions. The handbook is also used as the text for the on-site workshop. It can help get you and your team up to speed quickly. To complete your Hoshin implementation, TQE provides both web-based and PC-based software to help reduce the paperwork and provide structure for your planning process. The software will help make your Hoshin plan become the way you manage instead of a document collecting dust on the shelf. Implementing Hoshin Kanri can be a giant step toward winning the Baldrige award.

TQE's Process Management and Improvement workshops directly address section 8 of the standard. After completing the training and implementing the concepts people will be able to show that processes are capable of achieving planned results. They will be able to show key performance measures/indicators and how they are used to control and improve processes. They will be able describe how processes are systematically improved and how the improvements are standardized to prevent backsliding.

To help organizations implement the concepts of process management and process improvement, TQE provides an on-site Workshop. It teaches people how to use basic quality tools to manage and improve processes. Once the basic tools are mastered, people are able to determine if their processes are capable of meeting customer requirements. If processes are capable people will know how to standardize the process to assure stable and capable performance. If processes are found to be not capable, then people will know how to use the PDCA model to begin improving the processes so that they will meet customer requirements. If you want to see if you are proficient with the basic quality tools, take this quiz and find out.

Understanding how to use basic quality tools allows people in the organization to take responsibility for the processes they manage. In general, the tools will allow anyone to understand and continuously improve about 80-90% of the processes they manage. For the 10-20% of processes that require more sophisticated tools, TQE also provides training in Design of Experiments. This class teaches engineers and other technical personnel the techniques used by TQM organizations to achieve breakthrough process improvement.

TQE's products and training services can help your organization take steps toward being fully compliant with ISO 9000-2008.