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October 2018

ISO 9001 – A Great Idea!

The benefits of ISO 9001 should not be underestimated. Organizations of all sizes benefit greatly by leveraging this standard, realizing cost and efficiency savings, and resulting improvements in the bottom line. Here are six good reasons to embrace the ISO 9001 –

  1. Optimization of Process Integration – Viewing the overall processes and how they interact using the process approach of ISO 9001 enables the Organization to more readily identify improvements in efficiency, resulting in cost savings. Optimizing process flows can also drive efficiencies, reduce errors, reduce rework, and eliminating waste that can occur when processes are not maintained with consideration of inefficiencies.
  2. Employee Engagement – involving employees in improving the processes they work with results in happier and more engaged employees, enabling greater productivity. Engaged employees are especially more productive when they understand the process and how they contribute to the result. No one is more valuable than the people working on the process in identifying areas that need improvement and helping design and implement real improvements.
  3. A Culture of Continual Improvement – Continual improvement is a cornerstone management principle of ISO 9001. Embracing the commitment to improve your processes and organizational outputs will identify inefficiencies by design and deployment use of systematic methodologies.  This is especially evident when problems occur and effective in reducing the impacts of problems by eliminating their root causes. Embedding this in your organization’s DNA results in tangible, continual year over year improvements greatly benefiting the Organization.
  4. Enhancing the Image of the Organization – ISO 9001 is the gold standard of internationally recognized quality management systems and has become the de facto method for creating world class quality management systems. It is often a requirement when an organization is considering a supplier. This is particularly the case when competing for public sector jobs in many countries. Holding ISO 9001 certification is a powerful marketing tool.
  5. Customer Satisfaction – A foundational principle of the ISO 9001 is measuring and improving customer satisfaction.  Improving customer satisfaction results in retaining customers. This means more repeat business, better customer testimonials, and more customer referrals. And more revenue!
  6. Fact based Decision Making – Another key principle of ISO 9001 is the evidence-based decision making. Decisions based on evidence, rather than “gut feeling” focuses on applying resources to the areas that will improve efficiencies and increase cost savings with less trial and error. Monitoring the processes you are improving allows you to see how much improvement has occurred – based on the data.

 

ISO 9001 Is Foundational

ISO 9001 is a solid foundation for implementing many other Annex SL based management standards, such as ISO 14001 for environmental management and ISO 27000 for IT service management, which follow much of the same structure and organization

The international nature of ISO 9001 has already been identified and is, in fact, such a basic and influential standard that it has been used as the basis when industry groups want to add specific industry requirements, thus creating their own industry standard. Among these are IATF 16949 (Automotive), AS9100 (Aerospace), and ISO 13485 (Medical Devices).

 

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.