World Quality Week Q&A With Quality Management Expert Janet Book

World Quality Week is celebrated annually by the Chartered Quality Institute (CQI) and the quality management profession globally to raise awareness of this important subject. This year’s focus is on quality conscience — doing the right thing — which is also a core NSF value. To join the celebrations around the world, we have interviewed our very own expert in quality management, Janet Book, Principal Consultant for Medical Device Consulting.

A: Hi, my name is Janet Book. I am one of the Principal Consultants at NSF. I have been with NSF for a little over a year; however, I have more than 35 years’ experience in the medical device field. My undergraduate degree is in biology. I started my career in blood banking, moved to a hematology equipment manufacturer and have been in the medical device industry ever since. I have extensive experience in performing audits, establishing and improving quality management systems, and developing and providing quality-related training.

A: Quality management plays an important role in the medical device industry because ensuring that a device works consistently and effectively each and every time is imperative for the well-being of patients. A robust quality management system helps companies establish processes to ensure that their devices are designed with the patient in mind, are safe and effective (cause no harm), and are manufactured in a consistent manner.

A: First, ISO is an abbreviation for the International Standards Organization. This organization publishes standards for many different industries as well as specification documents, technical documents, etc., in order to standardize ways of working. The ISO 13485 standard (Medical devices – Quality management systems – Requirements for regulatory purposes) details the obligations of a medical device manufacturer. In other words, this standard provides direction to manufacturers of medical devices as to what requirements must be met in order to have a compliant quality management system.

A: For medical device manufacturers to achieve their ISO 13485 certification, they must develop, implement and maintain a quality management system that meets the requirements within the ISO 13485 standard. Once a manufacturer has established a compliant quality management system, they can contract with a notified body (an independent third party) to assess their quality management system against the ISO 13485 criteria. One of the keys to successful certification is the ability to demonstrate compliance through the establishment of procedures, processes, and documented evidence of implementation and maintenance.

A: Although the ISO 13485 standard has been adopted throughout the European Union, it has also been adopted as the de facto standard in other countries around the world. Health Canada has adopted ISO 13485, as has the Japanese Ministry of Health. However, many countries have established their own requirements for a quality management system for medical devices. One such regulation is 21 CFR Part 820 – Quality System Regulation, which is overseen by the U.S. FDA. Other countries, such as China, Brazil and South Korea, to name just a few, have also established their own medical device regulations.

The ISO 13485 standard serves as the foundation for the Medical Device Single Audit Program, or MDSAP. A consortium of five countries (Australia, Brazil, Canada, Japan and the United States) has established this program in order to reduce the number of audits any participating manufacturer has to “host” by the regulators of these countries. The concept is that if the manufacturer undergoes an MDSAP audit, the regulators of these five countries will accept these audit findings as substantially equivalent and accept these results in lieu of performing their own regulatory audit. The MDSAP audit does not cover “for cause” audits, however.

A: A medical device manufacturer should have a quality management system in place that is easy for everyone to follow/work in, so that when it’s time for an audit or inspection, there is no preparation to be done! A quality management system should be everyday best practices, and when you find a better way of doing something, change the way you work.

As for what to expect during an audit/inspection, the manufacturer should expect their quality management system to meet the intent of the standard/regulation and withstand scrutiny. There should be enough evidence showing that the quality management system is working effectively and everyone knows what to do.

A: A manufacturer that has combination products may need to incorporate other requirements into their quality management system to cover a given combination product. For example, a medical device manufacturer that incorporates blood or blood components into their devices might need to include additional requirements for handling blood, or the manufacturer of a pharmaceutical delivery device may need to incorporate certain aspects of the applicable drug laws.

A: “Doing the right thing” to me means acting with integrity ALL the time. The American author and philosopher Aldo Leopold is credited with saying, “Ethical behavior is doing the right thing when no one else is watching — even when doing the wrong thing is legal.” It is a matter of sticking to your values. One piece of advice that I give to anyone in the quality management area is this: “Think about this device being used on your mom.” If you know you have done all you can to ensure that this device will work safely and effectively, then you won’t worry about it being used on your mom.

A: I live and breathe quality, so for me, every week is World Quality Week!

A: NSF can help manufacturers develop their quality management system, we can assess their QMS to see if it is robust and meets all of the requirements of the standard/regulation, and we can provide training to ensure that all of your employees understand the requirements of the standard/regulation. Email us at medicaldevices@nsf.org to find out more.