MOST FREQUENTLY ASKED QMS QUESTIONS

If your organization is in the exploratory stage of implementing a quality management system (QMS), here are some commonly asked questions and answers to guide you in establishing a system that accommodates the needs of your business and helps you achieve your compliance goals.

What is a quality management system (QMS) and why is it important?

A QMS is a set of policies, processes, and procedures that serve as the framework for helping organizations produce high-quality products that meet customer expectations and comply with industry regulations and standards.

A QMS provides organizations with a systematic approach to identify and resolve nonconformance issues and gain better control of business processes. In turn, this can improve efficiencies, drive continuous improvement, and reduce compliance risks.

Who at a company uses QMS?

Quality, operations, and engineering teams can all benefit from using QMS.

  • Quality teams benefit from QMS by having a single source of truth for quality and product records creates a closed-loop system that reduces compliance and audit risks and helps develop accurate product tests. QMS can also help manage quality training to prove employee competency.
  • Engineering teams benefit from QMS by gaining visibility into product and quality records from a QMS platform can help engineers ensure a product is designed and manufactured with quality and compliance in mind.
  • Operations teams benefit from QMS because it keeps suppliers, partners, and in-house teams on the same page when quality issues arise, ensuring delivery timelines can be met.

What companies/industries benefit from using QMS?

Highly regulated companies, such as medical device companies, benefit the most from a QMS. This includes companies that need to comply with certain quality standards to commercialize their products, such as:

  • ISO standards
  • FDA regulations
  • Other quality system standards

What are the main benefits of QMS?

The main benefits of using QMS include:

  • Management of quality processes throughout the product lifecycle
  • Single source of truth for critical quality and compliance records
  • Reduced risk of noncompliance by unifying quality processes
  • Encourages continuous improvement

Why does a company need QMS?

Companies need a QMS to ensure their product complies with regulatory standards they need to meet to bring their product to market

What is the difference between QMS and QMP?

A quality management system (QMS) stores information on all the responsibilities, procedures, and processes needed to ensure a product remains compliant while a quality management plan (QMP) outlines the actionable items needed to ensure a product is compliant and defines a plan to ensure compliance.

What is the difference between QMS and QA?

A quality management system (QMS) manages the processes, procedures, and responsibilities required for regulatory compliance while quality assurance (QA) refers to the process of ensuring a product meets quality standards, including compliance with regulatory standards.

What is the difference between ISO 9001 and other quality standards?

Unlike other quality standards which are industry specific (i.e., ISO 13485, AS9100, IATF 16949), ISO 9001 is a globally recognized standard that can be applied to any business. It provides the framework for establishing and maintaining a QMS which includes a quality policy, quality manual, and supporting processes and procedures.

What are the seven quality management principles?

The seven quality management principles according to ISO 9001 are engagement of people, customer focus, leadership, process approach, improvement, evidence-based decision-making, and relationship management. Together, these principles help guide companies on how to put quality at the center of their organization.

What are the different quality management systems?

Quality management systems have evolved over the years from traditional paper-based approaches that managed quality records in physical binders and file folders, to stand-alone document-centric software systems to help automate the management of traditional paper processes, to today’s product-centric QMS that connects product record and quality processes in a centralized cloud system.

What should I consider when choosing QMS software?

When choosing a QMS software, consider:

  • Whether or not it helps enable you to better meet ISO standards, FDA regulations, and other regulatory requirements
  • The benefits of a cloud-native solution vs. on-premises, including cost savings and reduced IT maintenance
  • Whether or not it can enable collaboration across all stakeholders and systems
  • How difficult implementation may be
  • How secure the solution is
  • If the solution is scalable

What are the main features of QMS software?

A QMS software platform will usually have:

  • A quality policy that serves as a framework for QMS and SMART objectives that outline measurable goals to strive for based on the quality policy
  • A quality manual that lays out the scope of the QMS
  • A method for gathering customer satisfaction information regularly
  • A framework to plan, do, check, and act for continuous improvement
  • Document control capabilities

How do PLM and QMS work together?

PLM and QMS can work together to provide a single source of truth for all product and quality information. PLM stores information on the design, development, and manufacturing of products while QMS has data on how to ensure products meet quality and regulatory standards. Together, they help reduce the risk of product issues, make review and revision processes more efficient, and overall speed bringing products to market.

What are the benefits of Cloud QMS over paper-based QMS?

Cloud QMS provides more flexibility and is more scalable, has automatic updates, is more affordable with lower upfront costs, and is faster to implement compared to paper-based QMS.

When is a 510(k) submission required?

A 510(k) submission is required when a company wants to sell a medical device in the United States or when a change or modification that could affect safety or effectiveness is made to a device already on the market.

Can a quality management system for medical device companies help with regulatory compliance and audits?

Yes, a quality management system (QMS) can help with regulatory compliance and audits. A QMS creates a framework for companies to consistently comply with regulatory standards while centralizing product and quality records for easier access in the event of an audit.

Is there a specific quality management system recommended for medical device companies by regulatory bodies such as FDA or ISO?

Medical device companies often choose QMS solutions that align with the requirements of FDA regulations and ISO standards. These solutions typically include features such as document control, risk management, closed-loop CAPAs (corrective and preventive actions), supplier management, audit management, training record management, and validation.

Are there any case studies or success stories of medical device companies that have implemented a quality management system?

Yes, there are numerous success stories available to showcase the implementation of quality management systems in medical device companies. These case studies highlight the benefits, challenges, and outcomes experienced by different organizations. Some examples include:

  • Success Story: Potrero – This customer story outlines how a medical device company implemented Arena to achieve regulatory compliance, streamlined processes, and enhanced product quality. It discusses the challenges encountered and the positive impact on the company’s operations.
  • Success Story: RefleXion Medical – This customer story focuses on a medical device manufacturer that implemented Arena to address quality compliance and improve efficiency. It highlights the key criteria needed in a QMS and the positive outcomes achieved in terms of design control, increased team collaboration, and productivity.
  • Success Story: Pulse Biosciences – This customer story showcases how a scaling medical device company successfully implemented Arena after an inefficient manual process. It discusses the benefits of having a robust QMS in place as the company scaled, including streamlined processes, effective risk management, and improved compliance and scalability.

How much does a quality management system for medical device companies typically cost?

The cost of a QMS system for medical device companies can vary widely depending on various factors such as the size of the company, complexity of operations, complexity of products, specific requirements, and the solution provider.

There are some cost considerations to keep in mind:

  • Licensing or Subscription Fees: The cost can vary based on users, modules, functionalities needed, and the duration of the subscription.
  • Implementation and Customization: The cost of implementing a QMS can include expenses related to system setup, configuration, data migration, and customization to align with the company’s specific processes and requirements. Implementation costs can vary based on the complexity of the company’s operations and the extent of customization required.
  • Training and Support: Training employees on the QMS and providing ongoing technical support may involve additional costs. Some QMS providers include training and support as part of their package, while others may charge separately for these services.
  • Integration and IT Infrastructure: If the QMS needs to integrate with existing systems or requires specific IT infrastructure, there may be additional costs associated with integration, software development, hardware upgrades, or cloud hosting.
  • Maintenance and Upgrades: QMS solutions often require regular maintenance and updates to ensure continued compliance and functionality. Consider the costs of maintenance, upgrades, and keeping up with regulatory changes.
  • Validation: Medical device companies need to comply with FDA 21 CFR Part 820 and Part 11. Software validation can be costly and time-consuming, but it’s required by U.S. law. Be sure to understand you QMS system requirements and how you will meet them.

What are the considerations for integrating a quality management system with other systems used in a medical device company, such as ERP or CRM?

There are some key considerations for integrating a QMS with an ERP (enterprise resource planning) or CRM (customer relationship management) system:

  • Compatibility – Assess the compatibility of the QMS with existing systems such as ERP or CRM to ensure you can communicate and exchange data effectively. Compatibility may depend on factors like system architecture, data formats, and communication protocols.
  • Data Mapping and Synchronization – Define and map the data elements between the QMS and other systems. Determine which data fields need to be synchronized, how they should be mapped, and how often data should be updated or synchronized between the systems.
  • Data Security and Privacy – Consider data security and privacy requirements when integrating systems. Ensure that sensitive data, such as intellectual property, is protected during data exchange between systems. Implement appropriate security measures, such as encryption or access controls, to safeguard data integrity and confidentiality.
  • Workflow and Process Alignment – Analyze the workflows and processes in the QMS and other systems to identify points of integration and alignment. Determine how data and information flow between systems to support streamlined processes and efficient collaboration across departments.
  • System Customization and Configuration – Evaluate the flexibility and configurability of the QMS and other systems to meet integration requirements. Determine if any system customization or configuration is necessary to ensure seamless data exchange and proper alignment of processes.

What are the challenges of implementing a QMS?

Some of the key challenges of implementing a QMS include:

  • Lack of planning; no clear direction
    Without a clear plan and vision for what you want to accomplish, your QMS will not be effective. Before implementation, establish and document a plan that includes policies, processes, and performance metrics to support your QMS. The plan should align with your corporate goals and objectives as well as applicable regulations and standards. Employee roles and responsibilities should be clearly defined and communicated across the organization. Additionally, the proper resources should be allocated to help implement and maintain the QMS.
  • Lack of technology; reliance on manual, disconnected systems
    As part of their QMS, manufacturers must maintain a large volume of records regarding product design, development, and quality processes to comply with FDA, ISO, EU MDR, and other regulatory requirements. Teams cannot quickly locate files and track revisions if documentation is physically stored in multiple locations or electronically maintained using spreadsheets, Microsoft Word, and other ad-hoc solutions. Ultimately, organizations lack the control and traceability that is necessary to demonstrate compliance when using these manual processes and disconnected systems.
  • Resistance to change; lack of engagement
    Oftentimes, organizations establish a comfort level with doing things a certain way and are not receptive to change. The introduction of new processes or technology to support a QMS may seem daunting if employees do not have a complete understanding of the benefits or how these changes will impact their daily workload.
  • Lack of training
    If employees are not fully trained on the policies, processes, and functionality of the QMS, they will not embrace it. Training and engaging your teams will make them feel more confident about how the new QMS can help them drive continuous improvement and meet company goals to deliver high-quality products that meet customer expectations.

How long does it take to implement a quality management system in a medical device company?

The time to implement a quality management system (QMS) in a medical device company can vary depending on various factors, including the size and complexity of the organization, the scope of the QMS, and the level of readiness and resources available. Generally, the implementation process can take several months. It involves tasks such as assessing existing processes, developing and documenting procedures, training employees, conducting audits, and ensuring compliance with regulatory requirements. The timeline also includes factors such as system selection, configuration, and integration with other systems. Implementing a QMS is an ongoing process that requires continuous improvement and maintenance even after the initial implementation phase.

How do you implement a QMS in an organization?

Implementing a QMS requires careful planning and involvement from all employees across an organization.

To ensure a successful implementation, follow these steps:

  1. Conduct a Gap Analysis – Perform a thorough gap analysis to identify the current state of quality management practices and processes within the organization. This will help identify areas of improvement and define the scope of the QMS implementation.
  2. Involve Stakeholders – Involve key stakeholders, including employees, quality teams, and other relevant departments throughout the implementation processes. Encourage active participation, engagement, and input to ensure a comprehensive and collaborative approach.
  3. Work Cross-Functionally – Assign a cross-functional team (e.g., engineering, quality, operations, IT) to oversee the implementation. Team members will be responsible for handling quality processes and records. In the case of an enterprise QMS solution, they will oversee user administration, system configuration, access policies, integrations, and other key functions.
  4. Customize to Fit the Organization – Tailor the QMS to fit the specific needs and requirements of the organization. While it is important to adhere to quality standards, the QMS should be flexible and adaptable to the unique processes and workflows of the medical device company.
  5. Establish a Deployment Schedule – Consider data transfers, employee training, and other essential action items that need to occur before the actual deployment. Also consider any major business initiatives that will be impacted by the implementation (e.g., upcoming regulatory audit).
  6. Identify Risks – Assess potential risks that may create bottlenecks in the implementation. Identify ways to avoid or mitigate all risks prior to go-live.
  7. Provide Adequate Training – Provide comprehensive training to employees on the QMS, including its purpose, processes, and documentation requirements. Training should be ongoing and cover both new hires and existing employees to ensure a common understanding and consistent application of the QMS.
  8. Deploy the System – Deploy the system using an all-at-once or phased approach. A phased approach is best suited for an enterprise QMS, as it enables organizations to prioritize quality data and processes that are most critical to meeting their business objectives while getting acclimated to the new system.
  9. Document and Communicate Procedures – Develop clear and concise procedures for all relevant processes and ensure they are documented and easily accessible to employees. Effective communication and awareness of the QMS requirements will help ensure compliance and consistent practices.
  10. Establish Performance Metrics – Define key performance indicators (KPIs) to measure the effectiveness of the QMS implementation. Establish metrics to align with the organization’s objectives, such as product quality metrics, customer satisfaction, and compliance indicators.
  11. Measure Success – After a set period, measure the effectiveness of the QMS to ensure that your organization is meeting its defined targets.
  12. Conduct Regular Audits and Reviews – Regularly audit and review the QMS to ensure its effectiveness and identify areas for improvement. Internal audits, management reviews, and external assessments can provide valuable insights and help drive continuous improvement.
  13. Foster a Culture of Quality – Cultivate a culture of quality throughout the organization by promoting accountability, continuous improvement, and a focus on customer satisfaction. Encourage employees to actively participate in quality initiatives and provide feedback for process enhancements.

How do you measure the effectiveness of a QMS?

Several tools can measure and monitor the effectiveness of a QMS and drive continuous improvement. Some of the commonly used methodologies include:

  • Control charts
  • Six Sigma

  • Cause and effect (fishbone) diagram

  • Pareto charts
  • Customer surveys
  • Customer complaint reports
  • Nonconformance reports (NCRs)
  • Internal audits

Manufacturing companies typically use these tools to monitor processes associated with product development, operational efficiency, product safety, delivery, and customer service.

What is validation?

Software validation is the process of checking if a software system meets the requirements to execute its intended purpose. The FDA requires software validation when using software to manage product development and quality processes of a medical device.

How do you validate a cloud-native application?

Because all Arena QMS customers use the same infrastructure and software, we can continuously maintain the system in a validated state against predefined intended uses.

Arena Validate covers installation qualification (IQ) and operational qualification (OQ) requirements of core Arena functionality.

What are key components of validation in quality management systems?

  • Comprehensive validation documentation package shared with every major update release
  • Advanced-release notifications containing risk assessment and impact analysis
  • Ongoing support from senior validation experts

What are the challenges and pitfalls to watch out for during validation of a quality management system?

Validating software is difficult for traditional on-premises software solutions and often prevents customers from upgrading to the latest release.

Validating paper-based QMS or older on-premises and document-centric QMS software solutions is labor-intensive, inefficient, and difficult. All this expense pulls valuable team members and resources away from product work.

How do I ensure that my quality management system validation meets industry standards and guidelines?

Regardless of the type of QMS solution used, companies must demonstrate and provide evidence, or validate that it meets the requirements to consistently deliver safe, high-quality devices to market.

Our team validates the Arena application against predefined requirements (intended uses as defined by Arena), allowing your team to review our validation scope and supplement your validation with additional unique intended uses.

How do you maintain and improve a QMS?

Today many companies are leveraging electronic quality management systems to maintain the high volume of records that are essential to meeting regulatory requirements. Housing standard operating procedures (SOPs), design history files (DHFs), training records, and other QMS documentation in an electronic repository enables organizations to gain better control over their quality processes and easily compile files in the event of a regulatory audit or inspection.

Whether it’s an enterprise system or a more conventional document-based system, organizations should periodically analyze the performance of their QMS to identify gaps and make the necessary adjustments. Analyzing product development processes (e.g., ECO cycle time), customer complaints, product nonconformances, corrective and preventive action (CAPA) resolutions, and other critical areas will help organizations drive continuous improvement and meet their compliance goals.

How can technology be used to support a QMS?

Advanced digital technologies like the Cloud can be used to eliminate data silos and communication gaps to help companies quickly resolve product nonconformances and other quality issues. Cloud-based QMS solutions aggregate quality records in a single source of truth, providing dispersed teams with convenient access to the latest information. By automating the management of quality information, organizations can apply best practices in document control, training management, design controls, and other critical areas.

To get the most value from a QMS and meet your business objectives, it is important to maintain a tight connection between product and quality information. Product-centric QMS solutions manage linked relationships between quality processes (e.g., engineering changes, CAPAs) and the product bill of materials (BOM) for greater control, traceability, and visibility. With everything connected in a single cloud-based system, teams can easily identify, track, and resolve quality and manufacturing issues throughout the product development process and avoid audit risks.

What are the benefits of using automated tools for validation in quality management systems?

  • Reduces time and costs associated with developing and executing test cases
  • A comprehensive set of validation documentation including requirements, impact analysis, test plan, protocols, execution records, traceability, and reports for use as objective evidence of software validation
  • Provides customers time to evaluate the scope of upcoming releases to assess the impact—no surprises on Arena releases
  • Continuing benefits of validation documentation for ongoing Arena releases
  • Ensures ongoing validation support

What are the risks of not validating a quality management system?

Companies may reach a state of inertia, avoiding updating processes to improve product quality, delivery, or costs due to the burden of manual updates, validation work, and training.

What are the best practices for implementing a quality management system in a medical device company?

It takes careful planning and execution to implement a quality management system (QMS) in a medical device company. Here are a few recommendations:

  • Regulatory Requirements: Become familiar with the regulations that apply to your industry, such as the FDA’s Quality System Regulation (QSR) or the ISO 13485 standard. Check your understanding with your quality and compliance leadership.
  • Purpose: Decide the “Why?” of your QMS implementation by defining clear objectives. Objectives should be in line with higher-level business, regulatory, and other objectives. QMS examples: Reduce CAPA cycle time by 25% (to reduce scrap and rework rates); reduce the complaint backlog by 50% (to improve customer satisfaction); achieve 95% training compliance (increase yields, comply with regulations); improve access to quality information to 100% (to promote a culture of quality).
  • Leadership Involvement: Link your implementation objectives to business objectives to get the support of top management. Once they understand how a QMS supports their initiatives and objectives, get an executive sponsor who can ensure sufficient funding and help you face challenges or unforeseen changes.
  • Employee Engagement: Make staff members aware of the value, goals, and targets of the QMS with help from your executive sponsor. Schedule both formal training and open office hours where you can hand-hold people through new processes and answer specific questions. Ask users for feedback on the process, software, and documentation. Leverage guided help in the application.
  • Documented Procedures: Keep records of all procedures that are easy to read, brief, and clear. This covers nonconformity procedures as well as corrective and preventative measures. Put these procedures under change management to ensure that they are current, accurate, and incorporate user feedback.
  • Continuous Improvement: Schedule regular QMS reviews and updates in response to performance against objectives, internal audits, client feedback, software updates, and legislative changes. Stay in touch with your executive sponsor so they can see your progress.
  • Systems Validation: Make sure any software your QMS uses has been verified for documented, intended uses.
  • Prepare for Audits: Performing regular internal audits can help you get ready for regulatory audits from outside sources. They point up instances of noncompliance as well as chances for development.
  • Patient First: Remember that producing consistently safe and effective devices is the main objective of a QMS in a medical device company.

What are the different quality management systems?

Quality management systems (QMS) are plans that help companies ensure their goods and services always meet customer needs and make customers happier. Some of the different QMS methods are:

  • Total Quality Management (TQM): Emphasizes long-term success through customer satisfaction. Everyone in a TQM organization is responsible to improve processes, products, services, and the company’s culture to be successful.
  • ISO 9001: Defines standard global QMS requirements. ISO 9001 certification tells the world that your processes consistently deliver quality products that comply with regulations.
  • Six Sigma: Defines tools and methods that eliminate mistakes in any process. Six Sigma means only 3.4 defects per million opportunities (basically zero). Fewer errors reduces costs and therefore improves profits.
  • Lean Management: Focuses on continuous improvement. The goal of Lean is to give customers value by incremental changes for better efficiency and quality.

Each QMS has its strengths and commonalities. The right one for you depends on your requirements, goals, and culture.

What role do employees play in a QMS?

From entry level to upper management positions—employees at all levels play a vital role in maintaining a QMS and driving a culture of continuous improvement.

Senior management is responsible for developing policies and objectives around the QMS and communicating them to the organization. They also designate roles and responsibilities for carrying out core QMS processes and allocate the necessary tools and resources.

All employees should be empowered to identify areas for process improvement. Additionally, they should take part in key decisions that help the organization deliver better products and services and enhance customer satisfaction.

READY TO LEARN MORE?

To learn even more about QMS software, check out our Ultimate QMS Guide.

READY TO LEARN MORE?

To learn even more about QMS software, check out our Ultimate QMS Guide.