• 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
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    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
    Regulatory
    Financial/Business
    Top News
    CareDx, Miromatrix Collaborate on Bioengineered Organs Research

    Capitainer Releases to Market its Fully Automated Sample Handler

    Titan Medical Licenses Most IP to Intuitive; CEO Steps Down

    Nox Medical Secures New Patent for Calculating Respiratory Effort During Sleep Studies

    Concept Medical Earns 4th FDA IDE Nod for MagicTouch PTA
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Checking Up on Surgical Robotics

    Building a Network: How Synchron Is Developing a New Device—and a New Market

    Six Lessons Learned on Developing a Strong Company Culture

    As Hiring Slows, Companies Look Inward to Fulfill Talent Needs

    Artificial Intelligence: Medtech Opportunity or Health Danger?
    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
    Arthur G. Russell Co. Inc., The

    Cirtec Medical

    Providence Enterprise USA Inc.

    NDH Medical Inc.

    Fusion Biotec Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    6 Considerations for Companies on the Cusp of Being Acquired

    3 Key Elements to Consider When Managing a Medtech Sales Force

    Tech-Enabled Virtual Speech Therapy Improves Speech & Communication Skills

    Practical Strategies for Digitization and Integration in Medtech Manufacturing

    Sensors: The Heart of Minimally Invasive Equipment Technology
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Arthur G. Russell Co. Inc., The

    Cirtec Medical

    Providence Enterprise USA Inc.

    NDH Medical Inc.

    Fusion Biotec Inc.
    • 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
    • eBook
    • Resources
    • Podcasts
    • 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
    Online Exclusives

    Six Mistakes to Avoid When Implementing ISO 13485

    Ditching the checkbox mentality and last-minute scrambles.

    Six Mistakes to Avoid When Implementing ISO 13485
    Companies should adopt a quality-first mindset rather than a simple check-the-box mentality.
    Jon Speer, founder and VP of QA/RA at Greenlight Guru01.20.20
    According to a study from MedPAC, there are more than 5,000 medical device companies in the U.S. alone, and each one is required to ensure the production of safe and effective medical devices. To build systems focused on this end, the International Organization for Standardization (ISO) outlined standard 13485 to provide guidelines for medical device quality management systems. The latest version of this standard, ISO 13485:2016, has now been adopted by regulatory agencies on a global scale to build a comprehensive standard that medical device companies can follow.
     
    While this harmonized standard is generally helpful, ISO itself is not a governing regulatory body, unlike traditional government agencies such as the FDA; the organization does not publish audit findings or reports of violations to the general public, making it nearly impossible for device manufacturers to learn from other's mistakes.
     
    During my more than 20 years of experience in the medical device industry, I've seen plenty of mistakes made when companies are implementing processes from ISO 13485. However, there are six that stand out as the most common:
     
    1. The “Checkbox Effect”
    It is common in today's society to treat repeat activities like a to-do list; finish a job task, check the box and move on to the next task. Unfortunately, this checkbox mindset has become commonplace amongst device manufacturers when implementing ISO 13485 processes to achieve compliance. Many contract manufacturers obtain their certification solely to gain a competitive advantage that will help secure more business, rather than earning a certification for their practiced beliefs in the framework for improving quality assurance.
     
    When manufacturers begin implementing ISO 13485, they should take a holistic approach that emphasizes quality from the onset. This plan of attack will help lay a foundation and company culture built on quality standards across the entire business and throughout all future operations and regulatory processes.
     
    Companies that adopt a quality-first mindset when completing ISO 13485 practices will find it to be a significant value-add for their business as a whole, rather than a simple check-the-box activity.
     
    2. Lack of Internal Auditing
    Another process that leads to many mistakes for manufacturers, and just so happens to also be commonly treated as a checkbox activity, is internal auditing.
     
    For example, a company recently reached out to us that was about to lose its ISO 13485 certification. This company had undergone an audit a few months prior to gaining its ISO 13485 certification, and the report uncovered two significant findings. First, this company had not been conducting any internal audits, which is a huge red flag for any auditor. Beyond that, their failure to complete internal audits meant that the company had limited insight into systemic issues with their products. This then led to the second adverse audit finding; no necessary improvements had been made to the device based on customer feedback.
     
    Ask any expert; internal audits should at least be performed on an annual basis. This process allows organizations to dive into their document management, CAPA procedures and other key systems to ensure tasks and functions are operating effectively. Internal audits must be treated as a valuable opportunity to make improvements and updates to the product and processes.
     
    3. Failure to Consider Risk-Based Processes
    The 2016 version of ISO 13485 places a high emphasis on the idea of utilizing risk-based procedures. The standard pushes manufacturers to consider whether or not they thoroughly assessed risk after completing any processes or tasks. However, this often turns into a check-the-box activity, too.
     
    With varying levels of risks in medical device development and quality assurance, manufacturers must document every aspect of a risk assessment and tie it back to its Risk Management File. From here, all files can be managed appropriately and assigned a proper score, which is something that cannot be checked off absentmindedly.
     
    For example, when managing risk with suppliers, there is no “one size fits all” approach. Risk-based processes should be tied to how critical the supplier's role is with the medical device.
     
    You may be wondering how these manufacturers assess the level of risk for suppliers. One way is to carefully evaluate how their component interacts with patients. If the part will come into direct contact with the end-user, it should be assigned a much higher risk score compared to something like labeling.
     
    This risk-based approach is also vital when implementing a complaint handling process. If such a process is not in place, operations can quickly fall victim to a "death by CAPA" scenario.
     
    4. Neglected CAPA Processes
    CAPA refers to the corrective and preventive actions taken by manufacturers to address problematic occurrences, such as systemic issues and quality events. It is critical that manufacturers establish a concrete understanding of these terms to ensure proper implementation. However, the unfortunate reality is that many organizations have poorly defined processes in place or misunderstand these terms, which can lead to additional mistakes and long-term problems. Here are the definitions according to ISO 13485:
     
    • Corrective Action: eliminates the cause of nonconformities to prevent a recurrence.
    • Preventive Action: eliminates the causes of potential nonconformities to prevent their occurrence.
     
    Throughout my many years of hands-on experience, I have come to find that auditors are likely to get in the weeds of the business, namely a company’s CAPA procedures, to ensure full compliance of the methods and tools being used.
     
    That said, don't skip over the process of building effective CAPA procedures within your quality system.
     
    5. No Review of Management
    Management reviews are required under ISO 13485 and FDA 21 CFR Part 820. These reviews are intended to ensure that procedures are executed adequately and followed from the top down. However, the amount of paperwork involved has led many manufacturers to neglect or slip up while implementing this step.
     
    Oftentimes, such reviews can be viewed as another check-the-box activity that is only necessary late in the year. But the extra panic this creates across the organization only compounds the work that needs to be done.
     
    Section 5.6.2 of the ISO 13485 standard offers a list of inputs that medical device companies should consider during management reviews, which includes:
     
    • Results of audits
    • Customer feedback
    • Process performance
    • Product conformance
    • Status of corrective and preventive actions
    • Follow-up to previous reviews
    • Changes that could impact quality systems
    • Improvements
    • New regulatory requirements
     
    Any company with a quality management system that has poor document management will struggle to conduct meaningful management reviews with all nine of these inputs. This is especially true since ineffective methods make it challenging to keep information adequately updated and able to provide traceability of records.
     
    On the other side of the coin, there is a significant opportunity for the executive team to not only take inventory of how well their QMS is functioning, but also find ways to improve company culture and other operations of the business. This process also gives managers the ability to take proactive, preventive actions to identify and correct potential issues early in the process.
     
    6. Failure to Find Value in Customer Feedback
    Many companies struggle to handle and find value in receiving and soliciting customer feedback. This quality process can also become increasingly more difficult when attempting to complete it proactively, which is recommended by ISO 13485:2016.
     
    The area where companies tend to struggle the most is understanding that a complaint is a valuable form of feedback. Despite the situation, both ISO 13485 best practices and the end-users of these devices expect a proactive approach to be taken by companies with regards to managing feedback.
     
    It’s important to note that feedback doesn't have to be critical to be valuable. Feedback can come in many forms, including a letter of commendation, or suggestions for future product improvements. Either way, companies must have systems in place to proactively gather feedback, handle it properly, and ensure quality measures are taken along the way.
     
    Conclusion
    Many of the mistakes associated with the implementation of ISO 13485 processes are standard across the industry and can be avoided relatively easily. By ditching the checkbox mentality and last-minute scrambles, companies can leverage their quality management systems as powerful tools to develop safe and effective medical devices. This, in essence, is the overall intended purpose of the international standard.
     
    While ISO 13485 implementation can be a significant undertaking, many of the mistakes made by companies can be easily avoided. If manufacturers leverage their QMS as a powerful solution for developing safe and effective medical devices, a quality-first culture can be formed. From here, compliance standards are more likely to be met and upheld, and the business will reap the added benefits of valuable insights gained from an effective quality management system.
     

    Jon Speer is the founder and VP of QA/RA at Greenlight Guru, a medical device quality management MDQMS software. A medical device guru with over 20 years of industry experience, Speer knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond baseline compliance to achieve “true quality.”
    Related Searches
    • best medical device
    • ul
    • iso 13485:2016
    • supplier
    Related Knowledge Center
    • Software & IT
      Loading, Please Wait..

      Trending
      • AVS Collects An Additional $8.8 Million In Its Series B Funding Round
      • Philips Names New Supervisory Board Chairman
      • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
      • Medtronic To Buy Wearable Insulin Patch Maker EOFlow For $738M
      • Noah Medical's Galaxy System Achieves First U.S. Robotic Bronchoscopy
      Breaking News
      • CareDx, Miromatrix Collaborate on Bioengineered Organs Research
      • Capitainer Releases to Market its Fully Automated Sample Handler
      • Titan Medical Licenses Most IP to Intuitive; CEO Steps Down
      • Nox Medical Secures New Patent for Calculating Respiratory Effort During Sleep Studies
      • Concept Medical Earns 4th FDA IDE Nod for MagicTouch PTA
      View Breaking News >
      CURRENT ISSUE

      May 2023

      • Computer Concepts for Medical Device Design
      • IVD Manufacturers Are Being Put to the Test
      • The New State of Medtech Outsourcing
      • 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

      Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing
      BGG Receives Patent for Saw Palmetto ID Method
      Premium Label & Packaging Solutions Receives Safe Quality Food (SQF) Certification
      Coatings World

      Latest Breaking News From Coatings World

      Boeing Starts Construction on New St. Louis Facility
      Brand Finance: Post-COVID Recovery Slows for Chemicals Industry Battling Energy Crisis
      BCF Calls for Greater Urgency on REACH Impasse
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      CareDx, Miromatrix Collaborate on Bioengineered Organs Research
      Capitainer Releases to Market its Fully Automated Sample Handler
      Titan Medical Licenses Most IP to Intuitive; CEO Steps Down
      Contract Pharma

      Latest Breaking News From Contract Pharma

      AVROBIO Sells Cystinosis Gene Therapy for $87.5 Million
      Meiji Seika Pharma, Adcock Ingram Pharma Complete Construction of New Manufacturing Facility
      JSR Life Sciences Consolidates KBI Biopharma and Selexis SA
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      Unilever Uses AI for Product Development
      Beautycounter Names New Interim CEO
      Shaz & Kiks Available at Sephora
      Happi

      Latest Breaking News From Happi

      Covergirl Introduces Clean Fresh Yummy Gloss Collection
      Shaz and Kiks Launches at Sephora
      Beautycounter Appoints Board Director Mindy Mackenzie Interim CEO
      Ink World

      Latest Breaking News From Ink World

      ACTEGA, Makro Labelling to Advance Signite Technology
      BCF Requests Greater Urgency on REACH Impasse
      Updated Method Published for Entire BASF Product Portfolio
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      ACTEGA teams with Makro Labelling to advance Signite technology
      Constantia Flexibles and SB Packagings commence joint venture
      Inland donates new VersaStudio printer to local high school
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Mann+Hummel Names President Air Filtration Americas
      KNH Launches Eco-Friendly Menstrual Pads
      Niine Introduces India's First PLA-Based Sanitary Pads
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Enrollment Completed in Anika Therapeutics' Hyalofast Study
      Exactech Releases Next-Gen GPS Shoulder
      Data Shows Favorable Survivorship of MISHA Knee System & Reduction of Arthroplasty Risk in Patients
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      onsemi Presents Path to Accelerate Revenue Growth
      STMicroelectronics Introduces Waterproof MEMS Pressure Sensor
      Graphene Flagship to Join Euro Nano Forum 2023

      Copyright © 2023 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