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The Impact of ISO 9001:2008 on your Quality Management System
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The release of ISO 9001:2008 in December 2000 brings a significant impact to your organization's quality management system. Understanding the changes and registration implications early will be the key in successfully implementing the new requirements.
What are some of the key issues your organization needs to consider in order to get a jump-start on your ISO 9001:2008 implementation or transition process?
- The structure, emphasis, and terminology of ISO 9001:2008 reflect a significant change from the 1994 version. ISO 9001:2008 is based on a "Process Model" with a strong emphasis on customer satisfaction and continual improvement - addressed only passively by the 1994 version. In addition, the Standard has been changed from twenty main requirement clauses to five. Note that you are not required to re-write the entirety of your documentation to "match" the new Standard. However, in addition to addressing the additional requirements imposed by ISO 9001:2008, you should restructure your Quality Manual to reflect the structure of the new Standard, describing at the policy level how the elements of your Quality Management System interact within the construct of the Process Model and describing the sequence and interaction of the processes included in the Quality Management System.
- ISO 9001:2008 places an increased emphasis on the role of top management, including consideration of regulatory and statutory requirements within your quality management system and the establishment of measurable quality objectives throughout the organization. In many organizations this will mean that management will need to take a more active role in promoting and supporting the quality management system and will need to give more attention to establishing, tracking, and updating quality objectives.
- ISO 9001:2008 places an increased emphasis on Resource Management, including human resources, infrastructure, and the work environment. Your organization's training system may need to be enhanced to address the new requirement to determine training effectiveness. In addition, infrastructure and work environment planning and maintenance must be included in the scope of your quality management system.
- ISO 9001:2008 places an increased emphasis on measurement and data analysis related to the effectiveness of your quality management system, organizational processes, and resulting products. Measurements and resulting data analysis must assure conformity and drive continuous improvement efforts. Some organizations may need to develop the systems to obtain and analyze applicable data; others may be able to simply document what they are doing today. In either case, there is a need to demonstrate how your organization's quality policy, quality objectives, audit results, data analysis, corrective and preventive actions, and management reviews work together to facilitate continual improvement.
- ISO 9002 and ISO 9003 have been eliminated. Organizations registered to ISO 9002 or ISO 9003 in the past must become registered to ISO 9001 by limiting the scope of application or by tailoring the requirements. If your organization performs product design to meet customer or regulatory requirements, you no longer have the option to arbitrarily exclude the design control requirements; they must be addressed by your quality management system.
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