Creating and Auditing a Global Quality System

For Medical Devices


Medical device and drug firms with multi-national facilities have many challenges. They need to comply with numerous regulatory requirements. To increase the efficiency of their operations, many firms are creating a globally harmonized quality system for their entire organization, and they are using internal and supplier audits to maintain compliance with regulatory requirements.

The reason that many firms built their quality systems using 21 CFR 820 is that these requirements are more prescriptive.

To find out about what companies are actually doing in this area, my firm, Compliance-Alliance, conducted a survey of the techniques that worked and the techniques that failed. To disseminate this and other information, Compliance-Alliance, in cooperation with the University of Southern California, Underwriters Laboratories and Emergo Group, will be sponsoring a series of seminars on this topic on March 9 -11 at the Westin Casuarina Hotel in Las Vegas. Although Las Vegas is a city of chance where it takes luck rather than skill to succeed, these seminars will discuss the practices that companies use so they don't have to rely on luck.

The survey was conducted in October of 2008. Approximately 238 representatives of large, medium and small firms completed the survey. The results revealed that most firms:

  • Have one quality system for the entire multi-national organization
  • Rate themselves, in regard to their effectiveness in maintaining a globally harmonized quality system, with a 4 or a 5 on a scale of 6
  • Do not use a global quality council to oversee quality activities
  • Use one quality manual
  • Share metrics across the organization on CAPA, audit reports, recalls and adverse events
  • Disseminate information and use posters (among other small items) to remind employees about the importance of quality within the organizations
  • Have or are moving toward using a single notified body for all of their facilities
  • Employ TUV RH, BSI or TUV BS as their notified body
  • Comply with ISO 13485, 21 CFR 820, and Canadian Medical Device Regulations
  • Built their quality system on 21 CFR 820 and then implemented the requirements of ISO 13485

Many of these results were expected; however, some were surprising. Below are my comments about selected findings.

Have One Quality System for the Entire Organization
In general, most medical device manufacturers are now in the process of creating and refining their globally harmonized systems. The fact that most of the firms answering the survey rated themselves with a 4 or 5 on a scale of 6 shows that more work needs to be done in this area.

Failure to Use a Global Quality Council to Oversee Quality Activities
It is unfortunate that most firms are not using global quality councils to oversee quality activities. Firms using such entities report that these groups aid attempts to design common procedures and get cooperation for compliance. Firms who have quality councils often arrange quarterly conference calls to discuss challenges and new initiatives. It is not surprising that firms have encountered problems with time differences, language barriers and getting the appropriate people to be on the calls. As time goes on, it is likely that more organizations will use similar entities. In setting them up, firms need to be mindful to include senior level officials who are able to speak with authority and implement initiatives agreed upon during the council meetings.

Use One Quality Manual throughout the Organization
Most firms use one quality manual throughout the organization. Some of the characteristics of the quality manual include:

  • Presidential sign-off on the manual
  • Translation to appropriate languages
  • Numerous graphics used to aid interest and clarity
  • Employees receive hard copies of the manual

If firms want their employees to read and adhere to their quality manuals, these handbooks should be written in a clear manner and provide specific guidance that is easy to understand and follow.

Share Metrics across the Organization on CAPA, Audit Reports, Recalls and Adverse Events
Although most firms were sharing metrics on these issues, all companies should be doing this. Other types of quality data that should be shared include out-of-box-failures, cost of poor quality, and first time release data.

Use Posters and Other Small Items to Emphasize the Importance of Quality
Dale Carnegie, in suggesting ways to change behavior said, "Act enthusiastic and you'll be enthusiastic." In a similar mindset, firms who value quality and, on a continual basis, communicate its importance in different ways are more likely to have their employees accept and act according to the firm's values. Although the survey did not ask about how often the CEO or top management express their support for quality, firms whose CEOs talk and write about this in emails, memos, webinars, or the company newsletters, appear to get more adherence to quality initiatives.

Employ One Notified Body for All of Their Locations
Multi-national organizations that use one notified body for all locations report that this makes it easier to maintain common practices. Despite this advantage, some firms do not use the same notified body for all of their facilities as they believe this serves as a check to motivate the notified body to provide better service.

Use TUV RH, BSI, or TUV BS as the Notified Body
Although the notified bodies listed above were the most commonly used, survey respondents to a lesser extent used KEMA, Underwriters Laboratories, NSAI and Intertek. Compliance-Alliance conducted a customer satisfaction survey on current notified bodies. To learn about the results from that survey, see it on the Compliance-Alliance Website.

Build Their Quality System Based on 21 CFR 820 before Implementing the Requirements of ISO 13485
The reason that many firms built their quality systems using 21 CFR 820 is that these requirements are more prescriptive. Additionally, for firms located in the United States, FDA can use a host of regulatory sanctions for noncompliance including criminal prosecution against the company and officials within the company. An FDA inspection is an evaluative process in which the FDA is looking to record discrepancies, and, if necessary, take regulatory action. During notified body audits, auditors sometimes see themselves as an aid to the firm to help them achieve compliance.

Las Vegas March 9-11 Seminars
The seminars feature a distinguished faculty consisting of current and former FDA officials, seasoned regulatory professionals from large, medium and small multi-national device firms, and representatives from notified bodies. The seminars will also feature a networking reception in the evening, and the opportunity to enjoy the city.

March 9-10 seminar, "Creating a Globally Harmonized Quality System" will cover how to:

  • Overcome the major challenges firms have in complying with FDA's Quality System Regulation
  • Use ISO 13485 as a framework for regulatory approvals
  • Synchronize a quality system that complies with the US and Japanese requirements
  • Create a single quality system throughout an international corporation
  • Develop a globally harmonized quality system using limited resources
  • Implement an effective postmarket surveillance system
  • Harmonize a complaint and adverse event reporting systems
  • Improve a firm's relationship with its notified body
  • Optimize medical device translations and accelerate time to market

The March 10-11 seminar, Internal and Supplier Auditing in a Global Quality System, will cover:

  • FDA's expectations for device firms with international facilities
  • Tips for conducting internal audits in international facilities
  • An action plan for what to do after the audit
  • Similarities and differences in handling an FDA inspection versus a notified body audit
  • Tips from an auditor on multi-site audits under the Pharmaceutical Affairs Law in Japan
  • Lessons learned from a former Boston Scientific official on a quality system audit by the Pharmaceutical Medical Device Agency in Japan
  • GHTF Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers
  • How to coordinate quality compliance for multiple international locations and suppliers

The distinguished faculty includes:

  • Al Taylor, FDA's CDRH
  • Javad Seyedzadeh, Senior Vice President RA/QA, Gambro
  • Cheryl Johnson, Sr Manager, International Quality, Boston Scientific
  • Jaap Laufer, PhD, VP Public & Regulatory Affairs, Emergo Group Inc.
  • Robie Aridi, Vice President Operations, Lansinoh Laboratories
  • Denise Dion, Eduquest, formerly of FDA's Office of Regulatory Affairs
  • Bonnie Norman, Director RA/QA, Intel Digital Health
  • Kris Ann Bolt, QA Supervisor, Harmac Medical Products
  • Robert Klepinski, Fredrikson & Byron (formerly with Medtronic)
  • Emi Zychlinsky, PhD, Vice President, R & D, Hitachi Chemical Diagnostics
  • Harvey Rudolph, PhD, HRRM LLC, formerly Deputy Director, FDA Office of Science and Technology
  • Marlene Bobka, VP, FOI Services
  • Virginia Perry, Partner, Perry-D'Amico & Associates
  • Keisuke Suzuki, Former Director for Guidant Japan K.K.
  • Steve McRoberts, Principal Engineer Regulatory Systems, UL
  • C. Seiko Ohyama, RCB Lead Auditor for PAL 3rd Party Certification, UL Japan Inc.
  • Frances Richmond, Ph.D, Director Regulatory Science Program, USC School of Pharmacy
  • Tara Kambeitz, Global Marketing Manager, UL
  • Evangeline Loh, PhD, Director, Regulatory Affairs, Emergo Group
  • William I. White, Ph. D, Quality System Strategies LLC, former Manager, Quality System Strategy, Bayer HealthCare LLC
  • Jim Moore, Executive Vice President, Merrill Brink International
  • Nancy Singer, President, Compliance-Alliance

The cost for each seminar $1195. When registering for both seminars together, the cost is $1995. Go to the website for more information or contact Nancy Singer at 703-525-4159 or

Nancy Singer founded Compliance-Alliance to specialize in professional development for those employed in the drug and medical device industries. Previously she served as AdvaMed's Special Counsel for FDA compliance and enforcement matters. In her role as Special Counsel, Nancy was a member of the FDA/industry working group that evaluated and suggested reforms to the FDA inspectional process. She then represented the industry on the working group that conceived and validated the procedures for the Quality System Inspection Technique (QSIT). Her career began as an attorney with the United States Department of Justice where she did litigation for the Food and Drug Administration. Subsequently she was a partner at the law firm of Kleinfeld, Kaplan and Becker. Nancy received her B.S. from Cornell University, and J.D. and L.L.M. degrees from New York University Law School. During her career, she taught food and drug law at Catholic University Law School and George Washington University Law School. She chaired the Food and Drug Law Section of the Federal Bar Association, and retired as a Commander in the United States Naval Reserve. While working on QSIT and the FDA/Industry Grass-Roots Task Force, Nancy received Vice President Gore's Reinventing Government Hammer Award, FDA Commissioner's Special Citation and the Food and Drug Law Institute's Distinguished Service and Leadership Award. Nancy's email address is

Learn More about Regulatory Compliance

FDA LinkMedical Device Quality Systems Manual: A Small Entity Compliance Guide Article
Baluss, Jane. "Assessing FDA Regulation of Diagnostic Tests and Services." June 2008, Accessed 1-20-09.