Designing a QMS
Designing a Quality Management System (QMS) for a medical device manufacturer involves several key considerations to ensure compliance with regulatory requirements and achieve high product quality and safety standards that are appropriate for the individual business.
The QMS design and implementation process should take a risk-based approach with the following aims in mind:
- Tailored: The QMS should be specific to the organisation’s needs and cover all relevant business activities and processes. It should also be compliant with relevant regulations and standards. The quality policy and objectives should be aligned with the organisation’s strategic goals and reflect the organisation’s commitment to quality and compliance.
- Balanced: The size and structure of the QMS should be appropriate to the organisation’s size and complexity. This approach ensures that the QMS is not overly complex or too simplistic, but just right for the organization. Consideration should be given to how a QMS can be implemented and updated. The aim should be to design a QMS that is compact, structured, proportional, risk-based and understandable by employees and regulatory authorities.
- Living: A QMS is not a static set of documents but a collection of living documents that need regular updating and maintenance. This is essential to ensure that the QMS remains relevant and effective, reflecting the changing company processes and regulatory changes.
QMS structure
In a QMS, documents are often organised into a hierarchy or levels to ensure clarity, control, and ease of use. Organising the QMS in this structured manner enables a medical device manufacturer to ensure comprehensive coverage of all regulatory requirements, facilitate efficient process management, and promote continuous product quality and safety improvement.
Level 1 documents: High-level documentation that provides an overview and framework for the entire QMS. Level 1 documents can include:
- Quality Manual: the highest-level document in the QMS hierarchy, containing the QMS scope, structure, and process map
- Quality Policy: a formal statement of the organisation’s commitment to quality, regulatory compliance, and continuous improvement.
- Quality Objectives: specific, measurable goals aligned with the quality policy. Objectives help drive improvement and ensure alignment with organisational goals.
- Organisational Purpose and Structure
Level 2 documents: Processes defined by Standard Operating Procedures (SOPs). Any activity that receives and converts input to output can be considered a process. The output from one process can be the input of another process. An SOP documents a process including:
- Depicts a sequence of process steps
- Defines the responsibilities for each step
- Identifies applicable documents and records
- May detail some process steps, or may refer to a level 3 document
Level 3 documents: Detailed instructions or resources for conducting specific tasks or processes, including a range of different document types and formats:
- Work Instructions
- Forms
- Templates
- Logs
Records: Documents that provide evidence of activities performed, decisions made, and results achieved. They are essential for demonstrating compliance with regulatory requirements, internal policies, and standards and facilitating audits and continuous improvement efforts.
Designing processes: The Deming Cycle (PDCA)
The Deming Cycle, also known as the PDCA (Plan-Do-Check-Act) cycle, is a continuous quality improvement model with four repetitive steps. This cycle is fundamental in designing and maintaining effective processes within a quality management system (QMS) for medical devices.
Plan: Planning is the first stage of any medical device development and production activity.
- Identify Goals and Objectives: Define what needs to be achieved in the process or activity, including quality and compliance aspects.
- Develop Action Plans: Create detailed plans for the activity, including processes to follow, resources required, and responsibilities, as well as setting measurable targets and timelines.
In the QMS, planning is covered by resource management components (ISO 13485: Chapter 6 Resource Management)
- Implement the Plan: Execute the action plans developed in the planning phase. This may involve procedures, staff training, or the implementation of infrastructure.
- Collect Data: Gather data during implementation to monitor the progress and effectiveness of the plan. Monitor performance metrics and quality indicators to evaluate the effectiveness of the implemented processes. Maintain comprehensive documentation of all processes, changes, and outcomes as required by the QMS.
In the QMS, the “Do” activities are covered by product realisation components (ISO 13485: Chapter 7 Product Realisation)
- Evaluate Results: Compare the collected data against the expected outcomes to determine whether the plan was followed and achieved the desired outcomes. Conduct regular internal audits to ensure compliance with QMS procedures and regulatory requirements. Conduct reviews and gather feedback from stakeholders at critical. points in the process
- Analyse Deviations: Identify any deviations from the plan and analyse the reasons behind these discrepancies.
In the QMS, “Checking” is covered by measurement, analysis and improvement components (ISO 13485: Chapter 8 Measurement, analysis and improvement)
- Standardise Successful Processes: If the plan succeeds, proceed with the next activities in the medical device lifecycle and standardise the processes to maintain standards.
- Adjust and Improve: If the results are unexpected, identify what went wrong and make the necessary adjustments. This may involve revising the plan and going through the cycle again.
- Continuous Improvement: Foster a culture of continuous improvement by regularly reviewing and updating the QMS to incorporate new standards, technologies, and best practices.
- Regulatory Updates: Stay updated with changes in regulatory requirements and ensure that the processes adapt accordingly.
In the QMS, “Act” is covered by management responsibilities components which ensure that the QMS adapts to feedback (ISO 13485: Chapter 5 Management Responsibilities)
By applying the Deming Cycle to a medical device QMS, organisations can systematically and continuously improve their processes, ensuring that their medical devices are safe, effective, and compliant with regulatory standards. This approach enhances product quality and helps manage risks and maintain regulatory compliance throughout the product lifecycle.
Resources
MedDev Central Academy:
MedDev Central Knowledge Hub:
International Medical Device Regulators Forum (IMDRF):
United States of America (USA):
Food and Drug Administration (FDA) guidance on the status and transition to Quality System (QS) regulation (21 CFR Part 820):
International Standards:
ISO 13485:2016: Medical devices - Quality management systems - Requirements for regulatory purposes
European Union (EU):
Medical Devices Regulation (MDR) 2017/745:
- QMS Requirements: Chapter I, Article 10(9)
- Conformity Assessment based on QMS and TD: ANNEX IX, Chapter 1
In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746
- QMS Requirements: Chapter I, Article 10(8)
United States of America (USA):
Food and Drug Administration (FDA), Federal Food, Drug, and Cosmetic Act (FD&C Act):
ISO 13485: An international standard that specifies requirements for a quality management system (QMS) specific to the medical devices industry.
Manufacturer: A legal entity that designs, produces, assembles, or labels a medical device with the intention of placing it on the market.
Quality: The degree to which a device consistently meets regulatory requirements and user expectations for safety, efficacy, reliability, and performance.
Quality Management System (QMS): A formalised system that documents the structure, responsibilities, and procedures required to achieve effective quality management.
Quality Manual (QM): The highest-level document in the QMS hierarchy, containing the QMS scope, structure, and process map. This document may be a single document or a series of related documents. The Quality Manual may also be known as the Quality Management Manual (QMM).
Quality Policy: a formal statement of the organisation’s commitment to quality, regulatory compliance, and continuous improvement.
Quality Objectives: specific, measurable goals aligned with the quality policy. Objectives help drive improvement and ensure alignment with organisational goals.
Record: A documented piece of evidence detailing activities, decisions, or results, created and maintained to demonstrate compliance with regulatory requirements and quality management standards.
Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.
Risk Management (RM): The systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, controlling, and monitoring risk.
Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.
Standard Operating Procedures (SOPs): Detailed, written instructions to achieve uniformity in the performance of a specific function.