The requirements of ISO 9001:2015 are viewed and implemented very differently by organizations, depending upon such variables as their size, resources, business sector, maturity, and external requirements.

In 2017, much of the ISO standards user community, as well as the supporting third party certification industry, was left with the same question. What standards/specifications aren’t changing right now?

Manufacturing professionals in quality assurance and process improvement are not new to understanding the importance of quality. However, do they know the difference to be made in creating a culture of quality with regards to driving the policies, practices, and processes needed to accomplish an organization’s work?

Cost of quality is often misunderstood, improperly measured, and underutilized.

Quality management systems enable organizations to implement a structured approach to their activities. This allows for continuous improvement enhancing the organization’s efficiency. 

Have you noticed that your orange juice may not just be orange juice anymore? While tasty and nutritious, simple orange juice may not always be enough for our increasingly competitive world. Maybe it has added calcium, or extra vitamins; it may even have an optimized amount of pulp for your individual needs. 

Last month, we examined the supply chain. The management of this complex system is a daunting task. That’s why, with this month’s column, we will move the discussion from the system to the standard—specifically, the quality management standard, ISO 9001:2015.

ISO 9001:2015 was created as a High Level System (HLS). By virtue of being a HLS, the design of the new standard is for other standards to align themselves accordingly by integrating the elements and changes within the context of the principles required in the elements for 9001.

New changes to ISO 13485, published this spring as EN ISO 13485:2016, mean U.S. medical device companies that sell in Europe will need to integrate risk-based approaches throughout their quality management systems. The emphasis on risk management is the biggest of several changes in the third version  of ISO 13485.

For many organizations the countdown to complying with the newest ISO 9001 standard has begun.