The process of implementing ISO 9001 depends the sophistication of your existing quality program, the size of your organization and the complexity of your processes. The 14 steps are implementing an ISO 9001 quality management system successfully.
Top Management Commitment: The top management (managing director or chief executive) should demonstrate a commitment and a determination to implement an ISO 9001 quality management system in the organization. Top management must be convinced that registration and certification will enable the organization to demonstrate to its customers a visible commitment to quality. It should realize that a quality management system would improve overall business efficiency by elimination of wasteful duplication in management system.
Establish Implementation Team: ISO 9001 is implemented by people. The first phase of implementation calls for the commitment of top management - the CEO and perhaps a handful of other key people. The next step is to establish implementation team and appoint a Management Representative (MR) as its coordinator to plan and oversee implementation. The members of the implementation team should also be trained on ISO 9001 quality management systems by a professional training organization.
Start ISO 9001 Awareness Programs: ISO 9001 awareness programs should be conducted to communicate to the employees the aim of the ISO 9001 quality management system; the advantage it offers to employees, customers and the organization; how it will work; and their roles and responsibilities within the system. The awareness program should emphasize the benefits that the organization expects to realize through its ISO 9001 quality management system.
Provide Training: the ISO 9001 quality management system affects all the areas and all personnel in the organization, training programs should be structured for different categories of employees - senior managers, middle-level managers, supervisors and workers. The ISO 9001 implementation plan should make provision for this training. In addition, initial training may also be necessary on writing quality manuals, procedures and work instruction; auditing principles; techniques of laboratory management; calibration; testing procedures, etc.
Conduct Initial Status Survey: ISO 9001 does not require duplication of effort or redundant system. The goal of ISO 9001 is to create a quality management system that conforms to the standard. This requires organizational arrangements, the drawing up of additional documents and possible removal of existing documentation (procedures, inspection/test plans, inspection/test instructions) and records (inspection/test reports, inspection/test certificates).
Create a Documented Implementation Plan: The organization has obtained a clear picture of how its quality management system compares with the ISO 9001 standard. All non-conformances must be addressed with a documented implementation plan.
Develop Quality Management System Documentation: Documentation is the most common area of non-conformance among organizations wishing to implement ISO 9001 quality management systems.
Document Control: The quality management system documentation has been generated. A documented system must be created to control it. Control is simply a means of managing the creation, approval, distribution, revision, storage, and disposal of the various types of documentation.
Implementation: It is good practice to implement the quality management system being documented as the documentation is developed, although this may be more effective in larger firms. In smaller companies, the quality management system is often implemented all at once throughout the organization.
Internal Quality Audit: As the system is being installed, its effectiveness should be checked by regular internal quality audits. Internal quality audits are conducted to verify that the installed quality management system. Conform to the planned arrangements, to the requirements of the standard ISO 9001 and to the quality management system requirements established by your organization.
Management Review: When the installed quality management system has been operating for three to six months, an internal audit and management review should be conducted and corrective actions implemented. The management reviews are conducted to ensure the continuing suitability, adequacy and effectiveness of the quality management system.
Pre-assessment Audit: When system deficiencies are no longer visible, it is normally time to apply for certification. However, before doing so, a pre-assessment audit should be arranged with an independent and qualified auditor.
Certification and Registration: Once the quality management system has been in operation for a few months and has stabilized, a formal application for certification could be made to a selected certification agency.
Continual Improvement: Certification to ISO 9001 should not be an end. You should continually seek to improve the effectiveness and suitability of the quality management system through the use of: Quality policy, Quality objectives, Audit results, Analysis of data, Corrective and preventive actions, Management review, ISO 9001 provides a methodology for continual improvement.
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