• Login
    • Join
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Manufacturing
    • Markets
    • Top 10
    • Buyers' Guide
    • Events
    • Microsites
    • More
  • Magazine
  • News
  • Exclusives
  • Manufacturing
  • Markets
  • Top 10
  • Buyers' Guide
  • Events
  • Microsites
  • Current & Past Issues
    Features
    Departments
    Columns
    Editorial
    Digital Edition
    Subscribe Now
    Advertise Now
    Editorial Guidelines
    eNewsletter Archive
    eBook
    Top Features
    Metallic Make Up for Orthopedic Materials

    Infection Control Strategies Offer a Plan of Pathogen Attack

    Multi-Dimensional Approaches to Orthopedic Implant Manufacturing

    Orthopedic Implants Are Fit to Print

    Fitting the Mold of Ortho Device Manufacturing
    Breaking News
    Certifications
    Clinical Trials
    Device Approvals & Patents
    Financial & Deals
    International
    Market Data & Trends
    OEM News
    Orthopedic Innovators
    People
    Product & Service Releases
    Products
    Quality, Recalls & Risk
    Regulatory & Legal
    Supplier & Contract Mfg.
    Live From Shows
    Top News & Features
    Biocomposites Acquires Artoss, Maker of NanoBone Bone Graft Substitute

    Nevro Names Stryker Exec Greg Siller as Chief Commercial Officer

    Mighty Oak Medical Partners with HP for 3D Printing

    John M. Tokish Named Arthroscopy Association of North America President

    Orthonika Receives Grant for Total Meniscus Replacement
    3-D Printing/Additive Mfg.
    Assembly & Automation
    Biocompatibility & Testing
    Clean Room
    Coatings/Surface Modification
    Contract Manufacturing
    Design
    Extrusion
    Finishing
    Forging & Casting
    Instruments, Cases & Trays
    International/Offshoring
    Laser Processing
    Materials
    Machining & Tooling
    Molding
    Packaging & Sterilization
    Prototyping
    Research & Developement
    Software & Quality
    Staffing, Training & Prof. Dev.
    Supply Chain

    Former BD, J&J Executives Join Acuitive Technologies Board

    Augmedics Debuts New Features, Indications for xvision Platform

    Artelon Closes $20M Series B Funding

    Orthofix Unveils Seven-Year Outcome Data for M6-C Artificial Cervical Disc

    The Silicon Valley Bank Collapse and Its Impact on Compliance
    Biologics
    Bracing/Prosthetics
    Extremities
    Imaging
    Instruments
    Large Joint
    MIS/Robotics
    Spine/Neurology
    Trauma/Sports
    Top Markets
    3D Printing Provides Stepping Stones for New Orthopedic Footwear Innovations

    How Honeywell's Spectra Fiber is Used in Orthopedics, TAVR, and More

    All About Reverse Shoulder Devices: Analyzing the Factors Driving Their Popularity

    Evolution of the Global Orthopedic Biomaterials Market

    Industry Innovation: A Look at Regenerative Medicine in Orthopedics
    Companies
    Categories
    Company Capabilities
    White Papers
    Add New Company
    International Buyers Guide Companies
    Braxton Manufacturing

    Life Science Outsourcing Inc.

    AV&R

    Modern Plastics

    Tiodize
    Industry Events
    Webinars
    • Magazine
      • Current & Past Issues
      • Features
      • Editorial
      • Departments
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • eBook
    • Breaking News
    • Buyers' Guide
      • Companies
      • Categories
      • Company Capabilities
      • White Papers
      • Add Your Company
    • Manufacturing
      • 3-D Printing/Additive Mfg.
      • Assembly & Automation
      • Biocompatibility & Testing
      • Clean Room
      • Coatings/Surface Modification
      • Contract Manufacturing
      • Design
      • Extrusion
      • Finishing
      • Forging & Casting
      • Instruments, Cases & Trays
      • International/Offshoring
      • Laser Processing
      • Materials
      • Machining & Tooling
      • Molding
      • Packaging & Sterilization
      • Prototyping
      • Research & Developement
      • Software & Quality
      • Staffing, Training & Prof. Dev.
      • Supply Chain
    • Markets
      • Biologics
      • Bracing/Prosthetics
      • Extremities
      • Imaging
      • Instruments
      • Large Joint
      • MIS/Robotics
      • Spine/Neurology
      • Trauma/Sports
    • Top 10
    • Online Exclusives
    • Slideshows
    • Videos
    • Webinars
    • Events
      • Industry Events
    • Live from Show Event
    • About Us
      • About Us
      • Contact Us
      • Privacy Policy
      • Terms of Use
      • Advertise With Us
    Columns

    A Risk-Based Approach to QMS: ISO 13485:2016 Requirements

    ...

    A Risk-Based Approach to QMS: ISO 13485:2016 Requirements
    Bryan Brosseau, RAC, Vice President, Quality and Regulatory Affairs, Secure BioMed Evaluations11.21.17
    Among numerous major changes contained within the revised ISO 13485:2016 standard, a risk-based approach is perhaps the most notable alteration affecting all areas of the quality system. The 2003 version of the standard addressed risk management in relation to product realization—strictly speaking, risk management was explicitly required by the standard only for design and development activities conducted by the organization. Risk was such a minimal part of the standard, in fact, that a formal definition was not provided. Consequently, regulatory and quality professionals were forced to rely primarily on the referenced ISO 14971 standard for any details regarding risk management.

    Increased Focus on Risk
    ISO 13485:2016 defines risk consistently with ISO 14971. However, the standard further defines risk management as the “systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk,” thereby expanding the practice of risk management to a much broader purpose than simply product realization. The standard further specifies that a risk-based approach must be employed for the “appropriate processes needed for the quality management system.” Diving further into specifics, the standard overtly requires a risk-based approach to outsourced processes, verification of training effectiveness, supplier criteria, and verification of purchased product. In addition, manufacturers must employ a risk-based approach to computer software used in the quality management system, for production or service, and for measuring and monitoring. The standard also requires that one or more processes be employed during design and development, and otherwise expands on the risk requirement for product realization. The general mandate, though, should be given greater consideration than only the specific areas detailed by the standard.

    This increased focus on risk is also evident in areas of the standard where the term “risk” is not specifically used. For example, more detailed requirements are provided for circumstances in which non-conforming material is detected after delivery. This slightly more instructional section is intended to trigger a field action for non-conforming product detected by the manufacturer after it is delivered to a customer or end user. Similar changes peppered throughout the standard lead to lower risks for end users and patients as well as reduced risks within the quality management system, particularly regarding compliance to regulatory requirements.

    Implementation of Risk-Based QMS
    For guidance in implementing a global risk management approach to the quality management system (QMS), look no further than the existing risk processes currently used by medical device organizations. Extrapolating the risk process from design and development to the entire quality system may initially seem like a monumental undertaking but the tools currently used for product realization risk processes are also well suited for assessing and mitigating risk in quality management systems. While the Failure Modes and Effects Analysis (FMEA) may not be used as the sole means of identifying, evaluating, and mitigating device risk, it is an excellent primary tool for managing risk in quality management systems. Analyzing the risks associated with quality processes allows companies to preemptively mitigate them and employ a comprehensive preventive action process. This approach not only ensures compliance to the risk-based ISO 13485:2016 standard, it also eliminates sources of quality system non-conformities. When creating a QMS FMEA, areas that require greater risk focus by the standard (e.g. purchasing and software) may be given greater attention. For example, a general QMS FMEA and a specific QMS FMEA for suppliers might be developed or those areas could be addressed in greater detail in a single FMEA. Outsourced manufacturing processes should specifically be addressed in the Process Failure Modes and Effects Analysis or other risk strategy for processes but risks associated with the general quality system controls should be assessed in the QMS FMEA.

    Obviously, the elaborate details typically used in FMEAs need not be employed for the QMS FMEA. Rather, each process and sub-process should be identified, along with all associated risks. This approach employs the brainstorming process of the FMEA with less of the rigid structure used in design FMEAs. Therefore, marathon risk management meetings would not likely be necessary as they often are for product FMEAs. A representative example for a limited scope is provided in the chart below.


    The prior example is just one of many ways to approach this task in an effective and compliant manner. Listing ISO clauses in the first column and procedures in the second column clearly identifies to the ISO assessor the method used to comply with a risk-based approach to the quality system. This activity may also be combined with a gap assessment to the ISO 13485:2016 standard. Mapping in this way demonstrates line-by-line compliance to the new standard and implementation of the risk-based system. Also, take credit for risk-based additions to the 2016 standard in this activity. For example, the new requirement in 7.4.2 to include notification of changes in purchased product is a risk mitigation measure. As such, organizations should specifically identify this as a method of managing risk in their supplier management programs.


    This activity also can potentially help medtech companies meet the new requirement of identifying the sequence and interaction of QMS processes. Arranging the table in the sequence of operations demonstrates the sequence of events for QMS processes. In choosing this method, companies must ensure they also show how the outputs of one process become the inputs to the next process. This exercise allows them to readily see the outputs of inputs of each process, a required activity for truly assessing the risk of each process.

    Implementation Suggestions
    • In addition to the changes related to risk, ISO 13485:2016 also includes increased focus on management responsibility. Be sure to foster executive management’s participation in this activity. The assignment of appropriate resources is critical to implementing increased regulatory requirements and new processes. Presenting management with a plan for transition and QMS risk management, providing periodic updates on the status, and reporting the completion to management are advisable at a minimum.
    • While applying risk-based strategies at a high level, follow these requirements down through “lower level” procedures as well (procedures, work instructions, forms, etc.) to ensure the principles established in the higher-level documents are being acted upon. Demonstrate this top-down approach in a quality manual documentation diagram.
    • Thorough application of the ISO monitoring and measurement principles to quality management systems is a robust risk mitigation activity. Ensure quality metrics undergo a thorough evaluation for improvement and continued effectiveness. For example, in addition to trending complaint data for product safety, review complaint process metrics (e.g. complaint investigation time) to improve QMS performance. Establish goals in procedures or quality objectives and trend against these goals. If such parameters and trending are already in place, consider expanding the performance criteria of QMS subsystems.
    • Establish a training matrix or other tool to readily identify the risk-based approach to training verification. In the simplified example below, an assessment of the operation technician assembling a device and the quality inspector reviewing carry the greatest risk to product; therefore, a documented assessment of the employees performing these tasks would best demonstrate competency. A sales representative must understand the proper channels and requirements for reporting complaints but otherwise does not need to know the requirements for the actual investigation; therefore, a written competency assessment is adequate. Due to their roles in the process, the operation technician and quality inspector need to be familiar with the other’s roles; however, independent verification of training on one another’s responsibilities is not required.
    • Internal audit planning must account for the status of the process audited, the importance (risk) of the process audited, and results of previous audits of the process audited. The depth and frequency of the audit (e.g. quarterly, semi-annual, annual) must therefore take these factors into account. Furthermore, internal audits conducted after implementation of risk-based changes discussed in this column should evaluate all changes for effectiveness. 


    Bryan Brosseau’s experience has been forged in over 15 years in the medical device and biologics industries. With numerous domestic and international regulatory approvals for medical devices and biologics, his thorough understanding of the regulatory maze means a clear roadmap for regulatory success. Bryan’s creative solutions have been effective in resolving FDA 483s and warning letters, addressing compliance and operations challenges, creating compliant and convincing technical marketing material, and getting medical devices and biologics to market quickly. Bryan received his bachelor’s degree in Biology from the University of Georgia and maintains a Regulatory Affairs Certification from the Regulatory Affairs Professionals Society. Prior to joining SBME in 2015, Bryan served in various operations, quality, and regulatory roles at several medical device and biologics companies.
    Related Searches
    • software
    • regulatory
    • medical devices
    • iso
    Suggested For You
    Autocam Medical Autocam Medical
    Successfully Onboarding Metal-Based Additive Manufacturing Successfully Onboarding Metal-Based Additive Manufacturing
    13 Mistakes to Avoid in a 510k Submission 13 Mistakes to Avoid in a 510k Submission
    Medtech Mettle: A Year in Review Medtech Mettle: A Year in Review
    The Final Four: My Top Headlines for 2017 The Final Four: My Top Headlines for 2017
    Managing Deviations and Adequately Recording Failures Managing Deviations and Adequately Recording Failures
    Advanced Software Offers Metal Artifact Reduction for Extremities Advanced Software Offers Metal Artifact Reduction for Extremities
    FDA Clears Medacta FDA Clears Medacta's 3DMetal Tibial Cones for Knee Revision
    DePuy Synthes Attune Knee Device Lawsuits Mounting DePuy Synthes Attune Knee Device Lawsuits Mounting
    Machining Medicine: Insights into Precision and Laser Machining Demands Machining Medicine: Insights into Precision and Laser Machining Demands
    Comparing CGMP Pharma vs. Device:  Subpart A—General Provisions (Part II) Comparing CGMP Pharma vs. Device: Subpart A—General Provisions (Part II)
    FDA Clears OMNIlife science FDA Clears OMNIlife science's Robotic Tissue Balancing Device
    Perspective (Trends at the Top 2017): Findings of the Top 10 Perspective (Trends at the Top 2017): Findings of the Top 10
    Incorporating Payer Requirements into the Development Process Incorporating Payer Requirements into the Development Process
    An Outsourcing Focus in San Diego An Outsourcing Focus in San Diego

    Related Buyers Guide Companies

    • Autocam Medical

      Autocam Medical

      ...
      Janet Madendorp, Workplace Coordinator 06.01.23

    • 3-D Printing/Additive Mfg.
      Successfully Onboarding Metal-Based Additive Manufacturing

      Successfully Onboarding Metal-Based Additive Manufacturing

      Validating titanium alloy Ti64 for additive manufacturing of orthopedic devices to accelerate technology adoption.
      Jeph Ruppert and Steve Ward, 3D Systems 05.17.21

    • 13 Mistakes to Avoid in a 510k Submission

      13 Mistakes to Avoid in a 510k Submission

      The FDA 510(k) review process can broadly be divided into two steps—acceptance review and substantive review.
      Samradni Patil, Regulatory Consultant and Writer, Kolabtree 11.18.20


    • Medtech Mettle: A Year in Review

      Medtech Mettle: A Year in Review

      Steely resolve and resolutions helped the orthopedic industry survive a politically tumultuous year.
      Michael Barbella, Managing Editor 11.21.17

    • The Final Four: My Top Headlines for 2017

      The Final Four: My Top Headlines for 2017

      ...
      Dawn A. Lissy, President & Founder, Empirical 11.21.17

    Loading, Please Wait..

    Trending
    • Treace To Buy RPM-3D Tech For Up To $30 Million
    • Cementless Hip Implants Are Gradually Losing Their Popularity In Europe
    • FDA Approves Centinel Spine's Two-level Prodisc L Total Disc Replacement
    • Former BD, J&J Executives Join Acuitive Technologies Board
    • Spineart, ECential Robotics Begin Partnership
    Breaking News
    • Biocomposites Acquires Artoss, Maker of NanoBone Bone Graft Substitute
    • Nevro Names Stryker Exec Greg Siller as Chief Commercial Officer
    • Mighty Oak Medical Partners with HP for 3D Printing
    • John M. Tokish Named Arthroscopy Association of North America President
    • Orthonika Receives Grant for Total Meniscus Replacement
    View Breaking News >
    CURRENT ISSUE

    May/June 2023

    • Metallic Make Up for Orthopedic Materials
    • Infection Control Strategies Offer a Plan of Pathogen Attack
    • Multi-Dimensional Approaches to Orthopedic Implant Manufacturing
    • 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

    Nootropic Shown to Support Mental Alertness, Focus, Attention
    SmartyPants Vitamins Launches New Line of Gelatin-Free Multivitamin Gummies at Walmart
    Flavanol Deficiency Linked to Age-Related Memory Decline: COSMOS-Web Study
    Coatings World

    Latest Breaking News From Coatings World

    Axalta Releases Annual Vibes Colour Journal for Architecture and Design Industry
    Beckers Conducts First LCA of UV/EB Coil Coatings
    Evonik Introduces TEGO Rad 2550 Slip and Defoamer Additive
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Fluid Biomed Launches First-in-Human Clinical Trial of ReSolv Stent
    Teleflex's Arrow EZ-IO Needle OK'ed for MRI Environment
    BD Further Expands in Ireland
    Contract Pharma

    Latest Breaking News From Contract Pharma

    MilliporeSigma Announces Proteologix as Winner of North American Biotech Grant
    Veeva Business Consulting Expands with New R&D Services
    Samsung Biologics Accelerates Timeline of New Fifth Plant
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Former Revlon Board Member Launches OurX: A Platform for Textured Hair
    Vegamour Introduces HYDR-8 Leave-In Conditioner
    Medline Redesigns Its Skincare Packaging to be More Intuitive
    Happi

    Latest Breaking News From Happi

    Boka Releases Cinna Mint Toothpaste and Floss
    Flaus Honored in Fast Company's 2023 World Changing Ideas Awards
    BASF To Expand APG Production in Ohio
    Ink World

    Latest Breaking News From Ink World

    Evonik Launches New TEGO Rad 2550 Slip and Defoamer Additive
    HM Document Solutions Acquires Two Xeikon SX30000 Digital Presses
    Tetra Pak Makes Further Progress on Sustainability Transformation
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Global Graphics Software introduces Mako Core 7.0
    Baldwin to exhibit 'Complete Quality Control Solutions' at High Security Printing Latin America
    Label Source acquires division of OMNI Systems
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Cinte Techtextil China Set for September
    Maxcess International Opens New Facility in Mumbai
    emtec Showcases Groundbreaking Achievement in Haptic Measurement
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Biocomposites Acquires Artoss, Maker of NanoBone Bone Graft Substitute
    Nevro Names Stryker Exec Greg Siller as Chief Commercial Officer
    Mighty Oak Medical Partners with HP for 3D Printing
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Sensormatic Solutions Unveils New AM Sheet Labels
    GlobalFoundries, STMicroelectronics Partner on New Facility
    CircEl‐Paper: Recyclable Paper‐Based Electronics

    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