Certification: Is It Worth the Hassle?

Certification: Is It Worth the Hassle?
The road to certification can 
be irritating and upsetting
In the life sciences and other regulated industries, obtaining certification in a range of international standards has become a necessity for companies hoping to access and compete in today’s global marketplace. Whether your organization is a laboratory, medical device manufacturer, or automobile maker, becoming certified by an impartial third-party accreditation body assures potential customers that you value quality and your products conform to the highest regulatory standards. This assurance can lead to tremendous marketing and business advantages. But certification can be a long and trying process. 
Which Certification is Right for You?

Undoubtedly the most influential standards body in the world, ISO has established more than 19,500 standards, covering almost every topic or process imaginable, and comprises over 140 national standards bodies. Some of its most popular standards are ISO 10993, ISO 13485, ISO 14155, ISO 14971, ISO 9001, but there are many others.  In addition to ISO, there is a whole strata of national and international standards organizations. Knowing which certification is right for your business, as well as how to obtain it, can be difficult to determine, which is why many companies rely on external quality certification experts  to help them navigate the arduous and time-consuming path to quality certification. 

Why Certify?

Certification has many advantages; one of the biggest is the worldwide recognition your company will gain for its commitment to quality, safety, and sound quality management processes. Demonstrating compliance with an internationally recognized standard also makes it easier to conduct business in foreign markets and overcome many of the technical barriers to trade. Certification also:
  • Enhances your company’s image in the eyes of customers, employees, and other stakeholders;
  • Gives your marketing team a competitive edge;
  • Reduces risk and internal costs through increased efficiency and improved quality of operations;
  • Decreases waste, production lead times, defects, rework, recalls, customer complaints, and the likelihood of regulatory sanctions; 
  • Provides a clear framework for implementing a culture of continuous quality improvement, which can drive innovation and improve employee motivation;
  • Provides consistency in day-to-day business operations;
  • Helps you acquire new business and retain existing customers;
  • Satisfies regulatory or contractual requirements (many companies refuse to do business with companies that are not certified).

 Breaking Down the Barriers to Certification

The benefits of certification are undeniable, so why isn’t every company pursuing it? According to Ken Peterson, director of MasterControl’s quality and compliance consulting division which specializes in quality certification and accreditation services, the roadblocks are time, money, internal know-how, and resources.

“Preparing for a third-party accreditation audit is a long and tedious process. Many companies simply do not have the time, resources, or expertise to assess their entire quality management system and identify and correct the issues and potential barriers to achieving certification success,” said Peterson. “Others simply don’t want to spend the money to hire a consultant to do something they think they can do on their own.”
This rationale reminds me of traveling across the country with my eighteen-month-old twin boys. Rather than spend a bit extra for a direct flight, my husband and I decided to book the more economical flight with stop-overs.  Big mistake! Only one hour into the flight, we both agreed that we’d pay pretty much any price to get there sooner rather than later. My point being: is hiring an external consultant your only route to certification? No. Will it make your life a heck of a lot easier? Absolutely. You’ll enjoy the business and operational benefits of certification without the added stress, disruptions, and yes, perhaps even tears.

There is an excellent Quality Digest articlethat explores the pros and cons of trying to obtain ISO certification on your own. As the author points out, even when the outcome is positive and certification is achieved, it’s a tough row to hoe.

Keep the peace: hire a certification expert.

Tips for Selecting a Certification Consultant

As with all major purchases, it pays to shop around when selecting a quality certification expert. First and foremost, you want to make sure the consultant you choose is experienced in obtaining the certification you are seeking. This seems obvious but, as I’ve mentioned previously, ISO alone has established more than 19,500 standards. If you seek certification in ISO 13485, make sure your consultant is familiar with that particular standard. Also, avoid consultants who use templates.

 “Whether you’re interested in new product certification, quality system certification, or a host of other certifications, it’s important to find a consultant who will sit down with you to assess the scope of your needs and certification goals, and then customize the certification process to suit your business,” said Peterson. “Of course, maintaining your certification is important, too. MasterControl offers post-certification services, such as internal auditing, training, and liaising with accreditation bodies on behalf of our clients. Ideally, you want to find a certification partner who will guide you through every step of the process.”  
For more information about MasterControl's certification and accreditation services, click here.

(1) Ken Peterson, MasterControl’s director of business development, Quality and Compliance Consulting Team, has helped many organizations (including Abbott Laboratories, Johnson & Johnson, and IBM) come up with new quality management solutions that allow them to achieve enhanced and breakthrough results. He frequently speaks at industry events for organizations such as AAMI, PDA, the American Society for Quality Control (ASQ), Barnett International, The Executive Committee (TEC), and other industry forums. To learn more about Ken Peterson and the QCC, click here.

(2) Boudreaux, Miriam, “Do You Need a Consultant to Achieve ISO 9001 Certification?” Quality Digest, August 5, 2009. Available from the Internet: http://www.qualitydigest.com/inside/twitter-ed/do-you-need-consultant-achieve-iso-9001-certification.html
Lisa Weeks, a marketing communications specialist at MasterControl, writes extensively about technology, the life sciences industry, and other regulated environments. Her two decades of marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke Health Care, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med.