• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread

    Endoscopic Hemostasis Devices Market Valued at $730 Million

    Henry Schein Buys Majority Interest in Prism Medical Products

    Boston Scientific's Vercise Genus DBS Earns FDA Approval

    Biotech Team Develops ELISA Protocol for COVID-19 Antibody Detection
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    K-Tube Technologies

    Medbio LLC

    Spectrum Plastics Group

    Unicep

    Qosina Corp.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Spectrum Plastics Group

    FUTEK Advanced Sensor Technology Inc.

    Element

    Unicep

    K-Tube Technologies
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Columns

    Quality Systems: It’s All Greek to Us

    ...

    Quality Systems: It’s All Greek to Us
    Related CONTENT
    • Empirical Technologies Corp.
    • Transformative Testing: Addressing Patient Safety and Cybersecurity
    • Why Big Companies With Internal Labs Should Outsource Testing
    • The Gawky Teenage Phase: 3D Printing Enters Adolescence
    • MPO Summit: The View from the Top
    Dawn A. Lissy, President & Founder, Empirical04.03.19
    I admire people who love what they do. There’s a lot of truth to the oft-quoted Mark Twain observation: “Find a job you enjoy doing, and you will never have to work a day in your life.”

    For the most part, that applies to me. But my friend Mike Gentry, VP and principal consultant of Quality Consulting, is truly living the dream. He doesn’t just assess quality for his day job, he looks forward to weekend opportunities to ply his craft.

    “When I go into companies and I talk to them, I’m kinda weird because I get excited about quality,” he said. “When I walk in and I’m like, ‘Are you ready to have some fun?’ They’re like, ‘Uh, no, you’re auditing me.’”

    But Gentry is undaunted and his enthusiasm is unflagging—maybe even contagious.

    “I understand quality is a dry subject. A lot of people really don’t find it fascinating. I do,” he said. “One of my jobs, when I consult with somebody about their quality management systems, is to try to get them to understand it and the importance of it enough to also get excited about it, at least to the point they also want to get something out of their quality management system.”

    Gentry was more than happy—excited, even—to teach a quick history lesson on quality systems and ISO certifications. The concept of quality control really took root in 1926 with the International Federation of National Standardizing Associations, the forerunner of modern ISO. In 1946, that organization met with delegates from the United Nations Standards Coordinating Committee to form a new global standards body, the International Organization for Standardization, and the new organization began official operations in 1947.

    “Initially, ISO standards were much more prescriptive,” Gentry said. “A lot of companies felt that ISO was basically telling them how to run their companies, or how to conduct their business, through telling them the specifics of how to perform the associated processes. As time has progressed, however, the ISOs have transitioned into becoming less prescriptive and less invasive on the specifics of how a company functions via its quality management system.”

    Gentry also told me ISO is not short for International Standards Organization or any other group. It’s from the Greek word “isos,” which means “equal.” The ISO standards on everything from orthopedic implants to office furniture are there to reassure that item is crafted to meet specific standards of quality associated with that product, no matter where it comes from.

    “It doesn’t mean their systems are all set up the same, it means they’re following a standard when they’re doing the manufacturing or testing and that quality checks are in place,” Gentry said. “Hopefully, I get the same quality of product in Denmark as in the U.S. or China. It’s [the idea that] it’s equal product, equal quality.”

    Quality systems are fundamentally about mindset, Gentry said. Processes are important, but the goal is to provide the best possible product. Linda Braddon, CEO of Secure BioMed Evaluations, believes the best quality systems are simple.

    “We have a very minimalist approach,” she said. “What we have found over the years is when we go in and [a client is] messy or has 483s, warning letters, or are under consent decree for FDA or have a warning letter, it is almost always because their quality system is so complicated their staff shuts down. When you make the rules so hard to obey, people don’t try harder to obey, they stop paying attention.”

    It’s easy to add complexity, she said. But if you keep a quality system simple, people are more likely to understand and follow it. She also encourages her customers to see audits and even warning letters as opportunities. It’s all a work in progress, she said.

    “The point [of a quality system] is that it’s about continuous improvement,” she said. “We’re going to try very hard [to pass audits], but sometimes they bring up a great point. Sometimes you get a nonconformance and you fix it and you learn something.”

    Braddon’s company is unique. It’s the only outsourcing option for quality systems that she or I know of. Thanks to an increasingly paperless world, she’s able to get documents signed electronically and stay in close contact with clients. She said it’s a practical option for smaller companies without the budget or depth of expertise to develop and maintain quality systems in-house.

    “Good quality and regulatory people are a nightmare to find and keep,” she said. “We become our client’s outsourced quality staff because they couldn’t do it more cost effectively. At some point, they’ll integrate. Usually at that point, it’s because they’re either selling or hiring staff for maintenance. But there’s probably a good two to five years where we’re a really highly seasoned, cost-effective solution.”

    Regardless of how or where you maintain your quality system, the best ones engage employees across ranks and job functions, Gentry said.

    “You do want everybody to understand why they have the quality system,” he said. “The quality manager absolutely knows the quality system. But that’s not the intention. The intention is that those policies flow from the top down.”

    Gentry said he often finds smaller companies are much more engaged in regulatory processes and much more likely to eventually join him in his excitement about audits.

    “A percentage of the larger companies—not all of them, of course—seem to engage their quality system more in order to sell product, which, of course, is the goal of any company,” he said. “I get more questions about how to meet the minimum requirements from larger companies.”

    And those smaller companies also tend to have simpler systems, he said.

    “It’s been my experience that the smaller companies really engage their quality system to be as simple as possible, but they also expect that system to provide maximum value to both their company and to their customer,” Gentry said. “I normally see good excitement and lots of ‘a-ha moments’ from smaller companies that realize what putting that quality system in place means for their customers, and for their company as well, as we create that quality system and as we ‘tweak’ and customize it.”

    Braddon agreed. Larger companies are more likely to build in more complex quality systems that can in some cases create compliance hurdles, she said.

    “I think the large companies with very burdensome quality systems are what people find very hard to execute,” she said. “I think the level of engagement is different from the small startup with very passionate people, the ones where your CEO has every cent of his savings sunk into it is going to care more about the end product more than the person drawing a salary from a job.”

    For Braddon, building a strong partnership is key to creating that top-down flow. Frequent, open communication is key to managing multiple systems for a range of clients, she said.

    “We don’t act like consultants, we act like staff, like trusted partners,” she said. “It’s important to hire people that you like and have confidence in. Sometimes the decisions are hard. There are times I say, ‘You just have to trust me. I can’t defend this in an audit.’ If you’re going to work with us and partner with us, you need to be doing so because you believe we have your best interest at heart, we understand the rules, and we’re always considering the patient.” 


    Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting, LLC, and Empirical Machine, LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio. 
    Related Searches
    • patient
    • contact
    • development
    • compliance
    Related Knowledge Center
    • Software & IT
    Suggested For You
    Empirical Technologies Corp. Empirical Technologies Corp.
    Transformative Testing: Addressing Patient Safety and Cybersecurity Transformative Testing: Addressing Patient Safety and Cybersecurity
    Why Big Companies With Internal Labs Should Outsource Testing Why Big Companies With Internal Labs Should Outsource Testing
    The Gawky Teenage Phase: 3D Printing Enters Adolescence The Gawky Teenage Phase: 3D Printing Enters Adolescence
    MPO Summit: The View from the Top MPO Summit: The View from the Top
    Biocompatibility Pulse Check: How FDA’s New Requirements Affect Our Industry Biocompatibility Pulse Check: How FDA’s New Requirements Affect Our Industry

    Related Columns

    • Software & IT
      The Five Steps Toward Machine Learning

      The Five Steps Toward Machine Learning

      When talking about AI and ML, we’re no longer discussing the theoretical scenarios science fiction is made of. We’re talking about what’s possible.
      Sue Marchant, Machine Learning and Artificial Intelligence, MasterControl 05.01.20

    • Software & IT
      Expanding Quality Beyond the Four Walls of Your Organization

      Expanding Quality Beyond the Four Walls of Your Organization

      As suppliers can impact product quality, device manufacturers must oversee them as though they were an extension of the company and not an outside entity.
      Seth Goldenberg, Ph.D., and Carl Ning, Veeva Systems 03.04.20

    • Software & IT
      Unlocking Market Doors with Real-World Evidence

      Unlocking Market Doors with Real-World Evidence

      Real-world evidence is becoming increasingly important for manufacturers to demonstrate value beyond efficacy and safety standards.
      Seth Goldenberg, Ph.D., Vice President, Vault Medical Device & Diagnostics, Veeva Systems 11.04.19


    • Contract Manufacturing | Software & IT
      Five Ways Quality 4.0 Is Changing the Face of Medical Device Manufacturing

      Five Ways Quality 4.0 Is Changing the Face of Medical Device Manufacturing

      Industry 4.0 represents the dawn of the digital transformation that began with the third revolution, connecting the physical and natural worlds.
      Scott Reedy, Senior Director of Marketing, Arena Solutions 10.08.19

    • Contract Manufacturing | Digital Health | Software & IT
      Connecting the Dots in Medical Device Outsourcing

      Connecting the Dots in Medical Device Outsourcing

      ...
      MPO Staff 07.30.19

    • Software & IT
      Five Strategies to Navigate Regulatory Challenges in Medical Device Development

      Five Strategies to Navigate Regulatory Challenges in Medical Device Development

      ...
      Seth J. Goldenberg, Ph.D., Vice President, Vault Medical Device & Diagnostics, Veeva Systems 07.30.19


    • Software & IT
      Connected Quality Systems Reduce Risks

      Connected Quality Systems Reduce Risks

      ...
      Scott Reedy, Senior Director of Marketing, Arena Solutions 06.13.19

    • Software & IT
      Using Digitization to Get Ahead in Medtech

      Using Digitization to Get Ahead in Medtech

      ...
      Bryant Headley, Customer Success Executive, MasterControl 05.01.19

    • Software & IT
      Five Questions to Improve Your Requirements Management

      Five Questions to Improve Your Requirements Management

      ...
      Kevin Steigerwald, VP of Product & UX, Jama Software 04.03.19


    • Software & IT
      Digital Transformation: Seven Considerations for Your QMS

      Digital Transformation: Seven Considerations for Your QMS

      ...
      Tony Parise, Product Strategist—Life Sciences, ETQ 04.03.19

    • Software & IT
      Three Questions to Master Continual MDSAP Conformity

      Three Questions to Master Continual MDSAP Conformity

      ...
      Tony Parise, Product Strategist—Life Sciences, ETQ 03.07.19

    • R&D & Design | Software & IT
      Disrupting the Outsourcing Model

      Disrupting the Outsourcing Model

      ...
      Steve Maylish and Shannon White, Fusion Biotec 01.31.19


    • Software & IT
      4 Ways to Prepare for the European Medical Device Regulation (MDR)

      4 Ways to Prepare for the European Medical Device Regulation (MDR)

      ...
      Melonie Warfel, Vice President, Medical Device & Diagnostics, Veeva Systems 01.30.19

    • Software & IT
      Organizational and Regulatory Influences on Creating and Sustaining an Effective QMS

      Organizational and Regulatory Influences on Creating and Sustaining an Effective QMS

      ...
      Annette Schaps, Schaps Consulting, and Chuck Cimalore, Arena Solutions 11.26.18

    • Software & IT
      How to Choose the Right Quality Management System

      How to Choose the Right Quality Management System

      ...
      Chuck Cimalore and Rasean Hamilton, Omnify Software and EarLens 09.07.18


    Trending
    • Telemedicine, Regulatory Changes To Characterize Medtech Industry In 2021
    • Masimo Earns CE Mark For New Fingertip Pulse Oximeter
    • Philips Buys Capsule Technologies In $635M Deal
    • Understanding Food-Grade Vs. Biocompatibility For Medical Device Materials
    • Medtech Matters: Surgeons Scrubbing In Virtually
    Breaking News
    • Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread
    • Endoscopic Hemostasis Devices Market Valued at $730 Million
    • Henry Schein Buys Majority Interest in Prism Medical Products
    • Boston Scientific's Vercise Genus DBS Earns FDA Approval
    • Biotech Team Develops ELISA Protocol for COVID-19 Antibody Detection
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    NIH Study Compares Low-Fat, Plant-based to Low-Carb, Animal-Based Diet
    Gadot Positions Mineral Line for Vegan Market
    Nutritfy India to Launch Global Broadcast Channel Covering Nutrition
    Coatings World

    Latest Breaking News From Coatings World

    PPG Reports Q4, Full-year 2020 Financial Results
    BASF Begins Implementing Ralignment of Global Business Services Unit
    Nouryon Appoints Curtis Espeland to Board of Directors
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread
    Endoscopic Hemostasis Devices Market Valued at $730 Million
    Henry Schein Buys Majority Interest in Prism Medical Products
    Contract Pharma

    Latest Breaking News From Contract Pharma

    CONTINUUS Awarded $69.3M DoD Grant
    AbbVie Licenses ProBioGen’s GlymaxX Technology
    WDSrx Expands Warehouse Network
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Coty Appoints Chief Procurement Officer
    Lageen Tubes Launches Mono-Material PE Tube Solutions
    Jason Jones Loses Battle with Covid-19
    Happi

    Latest Breaking News From Happi

    Coty Appoints Chief Procurement Officer
    Amyris To Enter Cannabinoid Beauty
    RB Buys Queen V
    Ink World

    Latest Breaking News From Ink World

    Morancé Soudure France Adds Comexi F2 MC 10-color Flexo Press
    THIMM Group Installs 1st Koenig & Bauer CorruFLEX
    Cowan Graphics Adds Fujifilm Inca OnsetX3 HS
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Gallus planning virtual event for March
    Lemu Group engineers mask-making machine
    Niagara Label upgrades with Nilpeter flexo press
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Freudenberg to Establish Apparel Interlining Competence Centers
    Minet Adds Spunlace Line in Romania
    Lemu Group Engineers Mask-Making Machine
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Conformis Enters Development & Supply Agreement with SITES Medical
    Sectra, RSA Biomedical Sign Distribution Agreement for Implant Stability Tool
    Siemens Healthineers’ DR Systems Cleared by FDA
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    UDC Subsidiary Adesis' Website Wins 2020 MarCom Platinum Award
    Ynvisible Names Michael Robinson CEO, Jani-Mikael Kuusisto SVP Ventures
    IHSMarkit Reports Top Clean-Tech Trends for 2021

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login