• October 3, 2018

What Is a Quality Management System (QMS)? — ISO 9001 & Other Quality Management Systems

Quality management systems (QMS) are formalized systems documenting the processes, procedures, and responsibilities needed to achieve quality policies and objectives. An effective QMS coordinates and directs an organization’s activities in meeting both customer and regulatory requirements, continually improving effectiveness and efficiency.  

ISO 9001:2015 is the international standard specifying requirements for quality management systems. It is the most widely accepted approach to quality management systems.

Although the term QMS is sometimes used to describe the ISO 9001 standard or the group of documents detailing the QMS, in practice it literally refers to the entirety of the system. Documentations only serve to describe the system.

Quality management systems serve many purposes, including:

1. Reducing waste
2. Lowering costs
3. Engaging staff
4. Improving processes
5. Setting organization-wide direction
6. Facilitating and identifying training opportunities

Standardization

Quality became increasingly important during World War II. To expedite production processes without sacrificing safety, the United States military began to use quality techniques of sampling for inspection, aided by the publication of military-specification standards and training courses.

In the post-war economy, the importance of quality only increased. Japanese Industry embraced a quality revolution, reversing their reputation for poor quality exports by embracing philosophies of American leaders like W. Edwards Deming and/or Joseph M. Juran, effectively shifting focus from inspection to improving all organization processes. By the 1970s the U.S. industrial sectors such as steel, electronics and automobiles had been decimated by Japan’s high-quality competition. Years later the Japanese would fall victim to the Koreans, a result of the same approach.

Benefits of quality management systems

Effective design and deployment of a quality management system will impact affects every aspect of an organization.

The major benefits include:

1. Meeting and or exceeding Customer Requirements
2. Meeting the organization’s requirements.  

Additional benefits include the ability to produce consistent results, preventing mistakes, reducing costs, and continually improving the organization’s offerings.

ISO 9001:2015 and other quality management standards

While other standards related to quality management systems include industry specific super sets of the ISO 9000 family (including ISO 9000 and ISO 9004, ISO 14000 environmental management systems, ISO 13485 quality management systems for medical devices, ISO 19011 auditing management systems, and IATF 16949 for automotive-related products, and AS9100D for aerospace management systems), ISO 9001:2015 is by far the most implemented quality management system standard in the world.

Elements and requirements of a quality management system

1. Quality policy and quality objectives
2. Internal processes and their interactions
3. Quality manual
4. Procedures, instructions, and records
5. Data management
6. Customer satisfaction from product quality
7. Improvement opportunities
8. Quality analysis

Each element serves a purpose toward the overall goals of meeting the customers’ and organization’s requirements.

Establishing and Deploying a QMS

The Plan-Do-Check-Act (PDCA) allows for continuous improvement to both the product and the QMS. The basic steps to implementing a quality management system are as follows:

1. Design
2. Create
3. Deploy
4. Control
5. Measure
6. Analyze
7. Improve

Design and Construction

The design and construction activities serve to develop the structure of a QMS, its processes, and plans for deployment. Top management must oversee this portion to ensure that their vision, the needs of the organization, and the needs of its customers are a driving force behind the systems development.

Deployment

Deployment is best achieved in a systematic manner, stratifying each process into subprocesses, and educating staff on documentation, tools, and metrics.

Control and Measurement

Control and measurement are accomplished through routine, systematic audits of the quality management system.

Review and Improve

1. Review and improvement deal with how the results of an audit are handled.
2. Determine the effectiveness and efficiency of each process toward its objectives
3. Communicate these findings to the employees,
4. Develop new best practices and processes based on the data collected during the audit.

The design and deployment of an effective QMS is a major organizational commitment and should not be taken lightly. Organization’s great increase the effectiveness and efficiency of their QMS by retaining industry experts like the Quality Resource Center www.TheQualityResourceCenter.com. With over a quarter century of service, the Quality Resource Center remains the gold standard in ISO based quality management consulting. The Quality Resource Center – Experience the Difference.

• October 3, 2018
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• ISO 9001