The Success of a Quality Management System
Jun 14
Believe it or not you can now add value to your business by gaining % LINK3%. With the new 2008 issue of the ISO9001 standard being even more practical and user friendly than the improved 2000 issue and a metamorphosis from the original bureaucratic standard, it is at last receiving the recognition it deserves as a useful quality management system tool. It is now a requirement for ISO 9001 certification that the quality management system closely monitors process activities and implements actions for improvement.The ISO9001:2008 quality management system standard has changed so much from the original which was completely focused on documentation.
ISO 9001 quality management system certification is intended for any organization regardless of size, type or product including service.The standard requires you to aim to achieve Customer Satisfaction through implementation of your Quality Management System.The ISO 9001:2008 standard includes elements that require you to monitor and measure your processes and seek continual improvement.
In order to achieve ISO 9001 certification an organization should have a “Documented quality management system”, and not a “system of documents”.Your quality management system documentation should be used for communication, demonstrating due diligence and sharing experience or information. Quality management system documents may be in any form or type of medium, and the definition of “document” in ISO 9000:2005 clause 3.7.2 gives paper, magnetic, electronic or optical computer disc, photograph and master sample as examples.
In order to achieve ISO 9001 certification of it’s quality management system an organization needs to address key elements of the standard.Quality Management System, Management Responsibility, Resource Management, Product Realization, and Measurement, analysis and improvement are key elements of the standardThe Quality Management System section 4 requires that you have a documented % LINK2% and have procedures in place to control documents and records.
The Management Responsibility elements of the standard include the requirements for management commitment and review, a Quality Policy, and defined levels of responsibility and authority within the organisation.
The ISO 9001 Resource Management Section includes clauses for resources, human resources and training, infrastructure and work environment.The ISO 9001 Product Realisation Section includes clauses for control of customer property, design and development, identification and traceability, calibration, planning, product preservation, production and purchasing.
Section 8 defines the quality management system requirements for Measurement, Monitoring and Improvement and includes sub-clauses internal audit, control of non-conforming product, corrective action and preventative action, all of which are compulsory procedures as defined by the standard.
The extent of the quality management system documentation may differ due to the size of organization and type of activities, the complexity of processes, and the competence of personnel.There are also number of compulsory quality management system records required to meet the requirements of the standard . Process flow charts, organization charts, specifications, work instructions, approved supplier lists quality plans and inspection plans can add value to an organization’s quality management system although they are not specifically required by the standard there is an indication they could be useful in demonstrating compliance.
The quality management system documents required to achieve ISO 9001 certification are considered much less demanding than the first versions.The value of ISO 9001 certification for your quality management system has never been higher and it sends a clear message to all interested parties that a certified organization is committed to high standards and continual improvement.