The Global Standard in Quality Management Systems

By Gene Russell, President & CEO of Manex Consulting

What is ISO?

According to Wikipedia, “The International Organization for Standardization (ISO) is an independent, non-governmental organization, the members of which are the standards organizations of the 162-member countries. It is the world’s largest developer of voluntary international standards and facilitates world trade by providing common standards between nations. Over twenty thousand quality management standards have been set covering everything from manufactured products and technology to food safety, agriculture and healthcare.

The vast majority of the 1.2 million ISO certificates issued are for ISO 9001 at 71% and 20% for ISO 14001.

ISO 9001 provides the best baseline for an organization’s Quality Management System or QMS.

Use of the standards aids in the creation of products and services that are safe, reliable and of good quality. The standards help businesses increase productivity while minimizing errors and waste. By enabling products from different markets to be directly compared, they facilitate companies in entering new markets and assist in the development of global trade on a fair basis. The standards also serve to safeguard consumers and the end-users of products and services, ensuring that certified products conform to the minimum standards set internationally.”

Certifications include ISO 9001, ISO 13485, ISO 10001, ISO 50001, ISO/TS 16949 and AS 9100.

Benefits of ISO Certification

ISO certification provides various benefits to the company, its employees and its customers. Investing in ISO certification will allow your business to:

  • Increase customer satisfaction and retention with consistency of service and product performance and on-time delivery.
  • Improve your customers’ perception of your organization’s image, culture and performance.
  • Reduce costs with improved productivity and efficiency.
  • Reduce defects and cycle time.
  • Gain global recognition as an organization committed to quality.
  • Facilitate trade in international markets.
  • Improve communications, morale and job satisfaction.

Your customers need to know that your organization’s products and services will consistently meet their specific requirements and needs. With this increased quality-consciousness, a certified quality management system demonstrates your commitment to quality and customer satisfaction. ISO certification is widely used in corporate collateral, websites and at tradeshows. It solves major operational and quality issues, while at the same time generating much needed client growth and new revenue.

A robust quality management system based on the ISO Quality Management Standard ensures your customers receive a universal level of quality using the most effective, reliable and efficient best practices. In addition, they gain international certification, businesses report reduced waste, more efficient labor utilization, and increased customer satisfaction.

Revisions & Requirements

The most recent ISO 9001:2015 revision makes the most significant revisions since 2000. Generally speaking, the adoption of a QMS is a strategic move rather than tactical. Under some of the new changes, there are clauses relating to “context” and associated internal and external issues, which have an impact on the organization and its QMS and with the needs and expectations of those “interested parties” who can be affected by the organization’s activities. These changes require the move away from a purely inward focusing approach to QMS development and implementation to one where external factors have a greater influence on the way QMS is focused and prioritized; to be as effective as possible in meeting key internal and external objectives.

There are also new requirements to identify potential risks and opportunities, which may have an impact on its ability to consistently meet customer requirements.

Although ISO 9001:2015 no longer has any requirements relating to “Preventative Action,” the identification of potential errors and taking action remains in the new requirements under risks and opportunities. In addition, the requirement to determine whether any identified non- conformity could also potentially exist or occur elsewhere is similar to the current “Preventative Action” requirements. An interesting change in the ISO 9001:2015 is the requirement for direct involvement by senior leadership, not just “management.” Top management must demonstrate that they maintain a focus on providing products and services that conform to customer requirements, meet applicable statutory and regulatory requirements, and enhance customer satisfaction. Top management will now have to demonstrate that they were involved in the preparation of the policy as well. Continuing on the topic of personnel, everyone must be advised of their QMS roles, responsibilities and authority.

The new standard also places a higher degree of emphasis on the planning a business does, which is integral to their business. A business is now required to consider both “context” and “interested parties” when planning and implementing ISO 9001:2015. Relative to that plan, the senior leadership needs to determine if its management system can:

  • Achieve intended outcomes.
  • Prevent or reduce undesired effects.
  • Achieve improvements.

ISO 9001:2015 requires proportional actions. In other words, not all risks are the same. The risk impact and associated opportunity must be considered when planning and implementing a QMS. There needs to be evidence of this planning and implementation and that any actions subsequently reviewed confirm effectiveness or not.

In addition, a new requirement in the new standard is organizational knowledge. The maintenance of competent fully trained personnel on various hardware, software, technical manuals, intellectual property and so forth to operate the business must be fully demonstrated.

The new requirement also addresses the competency of personnel, reviews and action plans. It also requires both internal and external resources be fully aware of its quality policy and quality objectives. They must understand their contribution to the effectiveness of the QMS including the benefits of improved performance and the implications of not confirming with QMS requirements.

There are also new requirements in the following areas:

  • Communication
  • Documented Information
  • Operational Planning and Control
  • Customer Communication
  • Determination of Requirements and Services
  • Design and Development of Products and Services
  • Control of Externally Provided Processes, Products and Services
  • Performance Evaluation
  • Improvement

ISO 9001:2015 has a goal to specify the requirements for a QMS that can be used by businesses that want to:

  • Demonstrate their ability to consistently provide products or services that meet customer and applicable statutory and regulatory requirements.
  • Enhance client satisfaction through the application of such a system, including processes for improvement, and the assurance of conformity to those customer and applicable requirements.

Manex has an experienced ISO implementation team comprised of fully-trained, highly-skilled professionals who are qualified to support and evaluate companies pursuing ISO certification. Learn more about ISO certification at

About the Author:

Gene Russell is President and CEO of Manex and has over 30 years of senior executive strategic planning, operational management, and consulting experience in the manufacturing and technology sectors. With his extensive knowledge of manufacturing operations, he has developed and implemented key strategic initiatives for companies, allowing them to improve performance and achieve profitable growth. He can be reached at