Managing a Quality System

Before anyone can manage a great quality system, they need to make sure it is developed the correct way. Developing a QMS is the foundation for ensuring the organization’s products or services are safe, effective and controlled to deliver customer satisfaction. Throughout the organization’s life cycle, from startup through maturity, the quality needs are continually evolving. Maintaining compliance with regulations while controlling costs represents a challenging balancing act that everyone in the industry encounters.
The most successful companies do critical assessments of their needs and gaps in the present and in the future, and then deploy a risk-based approach to their quality system to achieve their goals. Below is a breakdown of the 5 essentials to incorporate to effectively manage a quality system.

#1 Identify Your Needs


It’s critical to identify the quality standards, regulations and/or requirements surrounding the company’s products, service and business needs. Think about these major points when developing and/or assessing a quality system and how they apply within the company.


  • Geography – In which countries does the company manufacture, distribute or conduct business?
  • Industry – The type of product or service sector such as medical device, pharmaceutical, biologic, combination product, cosmetic, nutraceutical, service, or other?
  • Use Setting – Is the product used at home and/or institutional settings?
  • Regulatory Agencies – Is registration with the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), etc.?
  • Standards – Certify to an international standard (i.e., ISO 9001, ISO 13485 or other) Is there a competitive advantage/or requirement to be registered
  • Manufacture – Are you manufacturing in-house or outsource to another manufacturer?


#2 Create Milestones to Analyze and Implement Upgrades


quality system

Creating milestones is one of the most important parts of having a great quality system, and it is the focal point of any phased approach to managing quality systems. The phased approach ensures that companies are meeting basic requirements in a timely manner with the expectation that there will be continuous improvement through periodic assessments and modifications with the existing quality system.


Main Elements of a Quality System

Management responsibility and commitment to the quality management system (QMS), ensuring ongoing communication with and support from the organization to follow the quality system.


  • Resource management – Ensuring the right people are doing the right things.
  • Employee competence against their job requirements.
  • Product realization – How is the product or service developed, transferred to manufacturing, and delivered to the customer while providing safety and efficacy.
  • Evaluation – What quality system metrics are used to assure compliant product and customer satisfaction, and drive continuous improvement.


#3 Use an Electronic QMS That Is Right for Your Company


When deciding how the quality system will be controlled it is important to understand different electronic QMS options based on the company’s needs. With electronic systems, there are ones that are controlled manually, electronically, or with the hybrid combination of the two. All these approaches can increase compliance, but their effectiveness depends on the scale, complexity, and needs of the quality system that’s in place. Typically, startup or early stage organizations can benefit from basic manual systems or hybrid systems that automate some of the more labor-intensive quality functions such as document control.


While midmarket organizations can benefit from increased automation through hybrid or enterprise QMS systems that address multiple quality needs such as document control, deviation control, nonconformance, equipment calibration, equipment maintenance orders, audits, corrective and preventive action (CAPA), change control, training, and functions that control product outputs. And large organizations can benefit from integrating enterprise QMS systems with their enterprise resource planning (ERP) and related systems for even greater interoperability.



Quality System Types
Type  Pros  Cons

 Manual, Paper-based

  • Low cost.
  • Easily changeable.
  • Time consuming.
  • Cumbersome as data grows.

 Stand-alone systems typically one or a few functions such as CAPA or document control.

  • Relatively low cost.
  • Effective for key single systems.
  • Generally requires minimal.
  • configuration, works right out of the box.
  • Minimal adaptability.
  • No integration with other quality functions.

 Enterprise QMS

  • Automates the entire quality function.
  • Modules are integrated.
  • Some systems integrate with the company’s ERP system.
  • Costly.
  • More resources/expertise to implement and maintain.


#4 Ensure Staff Is Properly Trained in Quality


With any position at any company, it is imperative that staff is properly trained, and part of that training must include how to utilize the quality system properly. No one wants to get flagged in an audit for something that could have been avoided by proper training. Companies require a competent and knowledgeable individual to be the quality system leader. They will oversee implementation, keeping the system compliant and pushing forward improvements.


It is also a part of the quality system leader’s job to ensure that either current staff is or can be trained on maintaining the quality system and if not, that the gaps are filled temporarily with contractors until the training is complete or the positions are filled. QMS leaders can perform a skills assessment to analyze the skills of in-house quality personnel against the company’s needs. Temporary gaps are common and can be closed by hiring consultants that can provide specialized knowledge without paying for a full-time employee. These include aren’t limited to:


  • Internal and external audits.
  • Regulatory training on key topics.
  • Medical liaison for complaints, clinical, etc.
  • Other complaint handling.


#5 Quality System Risk-Based Approach


When it is time to evaluate and start implementing changes in a quality system, the focus during the evaluation should be on risk and how to mitigate as much of it as possible. First, evaluate the areas of risk throughout the product lifecycle and identify what the greatest risks are. Once the major risks have been identified, find the areas in the quality system that are related to these risks and develop improvements to the prosses that mitigate the risk while still staying compliant. This approach ties in with No. 2 on the list, create milestones to analyze and implement upgrades. The milestones and upgrades created should be a part of this risked based approach.




Choosing the appropriate QMS and making sure it is managed the right way is crucial in any business’s success. When the quality system is not functioning in line with the companies needs it will have a ripple effect throughout the quality and compliance of the product and it is the Quality Manager’s job to make sure that the system operates smoothly. By using the 5 Essentials to Effectively Manage a Quality System above, leaders will know what to look for when evaluating their current system for improvements or will have a guide to creating a new, successful, system that is right for the company.


About Regulatory Compliance Associates


quality systemRegulatory Compliance Associates® (RCA) provides life science consultants & healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:




We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. Our life science consultants are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.


As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.


  • Founded in 2000
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021


About Sotera Health


The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.


Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.


We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.


RCA’s Pharmaceutical Consulting Services


Regulatory Compliance Associates (RCA)® has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, RCA offers leading pharmaceutical consultants that can help you navigate through the challenges associated with evolving industry regulations.


Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and the unique inner workings of the regulatory process. 


Client Solutions


Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, RCA® Inc. will guide you through every step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:


  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking expertise in the remediation of warning letters, consent decrees, 483’s or import bans


Regulatory Affairs


Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.


As your partner, we can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.


  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services


Compliance Assurance


The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At RCA® Inc., we offer the experience and resources necessary to guide you in quality compliance.


  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness


Quality Assurance


Regulatory Compliance Associates® Inc.’s Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality life science consultants with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.


  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support


Remediation Services 


Regulatory Compliance Associates® Inc. has significant experience and a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that the regulatory agency will accept and be realistic to execute.


We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.


  • Regulatory Action
  • Warning Letter
  • 483 Observation
  • Oversight Services


RCA’s Medical Device Consulting Services


The regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA’s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.


Our team of over 500 life science consultants — including former FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. We offer expertise in a variety of medical fields, such




For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if we do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance Associates Inc.®, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks.


With a well-planned design, along with full visibility of product development and the supply chain, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.


Regulatory Affairs


Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.


As a trusted regulatory affairs consultant, our FDA veterans and industry experts are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support. 


  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR


Compliance Assurance


Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® Inc. can help.


Our network of over 500 FDA veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry.


  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response


Quality Assurance


Regulatory Compliance Associates® Inc.’s Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our life science consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.


In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At RCA, we offer you the assistance you need to monitor these processes and ensure quality compliance every step of the way.


With more than 15 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry experts and FDA veterans is fully equipped to handle your unique QA needs.


  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • Facility Validation
  • Equipment Validation


Remediation Services


Regulatory Compliance Associates® Inc. is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex remediation services & challenges. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.


Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our unique expertise and experience that makes partnering with RCA® Inc. a competitive differentiator in the remediation space.


  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP 


Strategic Consulting


Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® life science consultants can help ensure a successful mix of people and product so your project is on time, on budget, and you’re never embroiled in a costly mistake.


Our 500 industry and FDA experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.


  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Product Complaints
  • Medical Information


To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 


Our website uses cookies to give you the best possible experience.

By continuing to use this site, you agree to the use of cookies.
Privacy Policy