ISO 9001 Quality Management System
What is a Quality Management System?
A quality management system (QMS) is a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization. (i.e. areas that can impact the organization’s ability to meet customer requirements.) ISO 9001:2008 is an example of a Quality Management System.
Some people generically refer to the group of documents as a QMS, but specifically it refers to the entire system – the documents just describe it. A QMS is nothing more than good business sense.
This demo will show you what a documented ISO 9001 Quality Management System (QMS) looks like and how the documents all flow together.
A QMS integrates the various internal processes within the organization and intends to provide a process approach for project execution. A Process Based QMS enables the organizations to identify, measure, control and improve the various core business processes that will ultimately lead to improved business performance.
A complete ISO 9001 Quality Management System must address all the requirements of ISO 9001, and more specifically must meet the ISO 9001 Documentation Requirements.
The Concept of Quality Management
- A Quality Management System in its basic concept is quite simple. It seeks to: Recognize the external quality related requirements specified in Licenses to Trade, guidelines, specified customer requirements, and the chosen management system standard(s)
- Ensure that all requirements have been documented within the management system in the appropriate location in terms of defined specific system requirements
- Confirm that employees receive applicable training in the quality system requirements
- Outline performance processes, where applicable, to the quality system requirements
- Produce records or evidence that system requirements have been met
- Measure, monitor and report the extent of compliance with these performance procedures
- Continually monitor and analyze changes to the requirements and confirm that all changes are reflected in changes to the specific requirements when necessary
- Execute the audit and analyze the system processes and correct them when necessary
- Include processes that will help continually improve the quality system.
Products to help You create a Quality Management System
- Our Complete ISO 9001 QMS includes the ISO 9001 Quality Manual, Procedures & Forms
- Our ISO 9001 Workbook shows you step-by-step how to create a QMS
- ISO 9001 Implementation Training shows you how to implement ISO 9001
What A Quality Management System Is Not
There are many definitions for general quality management systems. Most of them emphasize the use of some type of system that is repeatable, measurable and constantly improving. In an ISO 9001 (or other ISO standards) quality system, this structured way of delivering a better service or product is supported by detailed procedures such as work instructions, quality manuals, written quality policies and more. The key is to provide all those who must execute the quality system with detailed, understandable and workable instructions which define both expectations and actions to achieve the stated quality goals. Most of the systems include some type of internal and external oversight (auditing) process which ensures that the system is being executed properly.
At its core a quality management system is an integrative element, uniting diverse aspects of a company into a unified purpose of delivering products/services in their best form. Rather than be seen as a cost burden, an effective quality management system is viewed as key element of success. Quality management sytems have key elements such as:
- Being centered on the customer or consumer of the good or service, actively providing that customer with the best value possible
- Some type of continuous improvement profile, which implies that there is not “perfect” state of action, that all processes and approaches can always be improved upon
- An efficiency imperative that says waste must be reduced and all resources maximized
- It also requires top management support and the provision of adequate resources to achieve
- It aids or facilitates clear understanding between all participants
- Measurement and accurate data collection are incorporated within it
- As noted above, documentation of the current, correct approaches (procedures, processes) are at its core