ISO 13485 Quality Management System for Medical Devices

What is ISO 13485 Quality Management System?

ISO 13485 is the internationally recognized standard for Quality Management System (QMS) in the medical device industry. It provides a framework for companies to ensure product safety, regulatory compliance, and quality. Based on the ISO 9001 process model (Plan, Do, Check, Act), ISO 13485 requires a more detailed and prescriptive approach, focusing on stringent documentation and regulatory adherence.

iso 13485 qms for medical device industry

In today’s competitive business environment operating internationally or expanding locally, companies with an ISO 13485 certification communicate a quality commitment to both customers and regulators. It allows increasing access to more markets worldwide, provides a mechanism on how to review processes across your organization for continuous improvement, and can increase efficiency, cut costs and improve your supply chain performance.

In 2016, ISO 13485 was updated to reflect general concerns, the need for clarity within the standard and to serve as a harmonized QMS model to be used by national and regulatory bodies. ISO 13485:2016 has increased focus on product realization planning, training “competency,” integration of QMS software, harmonization across other country laws, etc. and integrates “risk” throughout the QMS including supplier controls, change management, and product lifecycle for risk-based decision-making.

An internationally accepted standard by the FDA and other countries, ISO 13485:2016 is increasingly being required or at least beneficial in supporting regulations around the world, including Health Canada Canadian Medical Device Regulations CMDCAS program. In the absence of another update specific to the EU, CEN/TR 17223:2018 was introduced to provide the guidance on the relationship between EN ISO 13485:2016 and the new MDR (EU 2017/745) and IVDR (EU 2017/746) regulations which entered into force in May 2018. In addition, ISO 13485:2016 has become the backbone of the MDSAP (Medical Device Single Audit Program) with its integration in 2019.

ISO 13485:2016 has become the new foundation for medical device quality systems. If you haven’t started your gap analysis, the time to start that transition is now. It is critical for medical device manufacturers and suppliers to begin implementing the standards of the revised ISO 13485:2016, as the allotted three-year changeover period may not provide adequate time for all organizations to transition. ComplianceQuest can help as a solution for companies to effectively plan, monitor and improve overall quality management.

ComplianceQuest Modern Cloud Enterprise Quality Management System (EQMS) supports the latest edition of ISO 13485:2016 by automating your entire quality management system requirements while maintaining full traceability. CQ’s EQMS Suite was designed from the ground-up to be not only extremely user-friendly at all levels but also provide a very powerful platform to scale from small companies to large global enterprises. ComplianceQuest helps you organize your company’s ISO 13485:2016 requirements improving productivity while easily helping auditors and notified bodies to find what they need quickly and effortlessly.

ComplianceQuest - ISO 13485:2016 Compliance Chart

Section	Sub-Section	ComplianceQuest Solution(s)	Description
4. Quality Management System	4.1 General Requirements	⦁ CQ EQMS Suite ⦁ Validation Package ⦁ Dashboards, Reports, Analytics	ComplianceQuest provides a complete suite of applications to manage and maintain the applicable regulatory requirements for quality. Key solutions include risk assessments to determine the impact of actions necessary for mitigation or to initiate changes to QMS processes while dashboards and reports provide insight into overall performance and efficacy. ComplianceQuest provides a Validation Package for each solution including OQ scripts and supporting validation documentation for its GAMP5 configured software.
4. Quality Management System	4.2 Documentation Requirements	⦁ Document Management	ComplianceQuest provides document management solution that enables an organization to create, collaborate, revise and maintain all controlled documents and medical device files and can provide the latest version to appropriate permission users on any device anywhere, anytime.
5. Management Responsibility	5.1 Management Commitment	⦁ CQ EQMS Suite	ComplianceQuest provides solutions that help top management with the oversight of their quality management system embedded in their organization and maintenance of its effectiveness by: – monitoring operational and performance key trends through reports and dashboards; – gaining insight into the availability of employee resources based on their training competency and equipment resources to ensure the sustainability of equipment; – and general collaboration / communication tools, such as Chatter and Social Media, used throughout the organization.
	5.2 Customer Focus	⦁ Audit ⦁ Complaints ⦁ Document Management ⦁ Dashboards, Reports, Analytics	ComplianceQuest provides internal audit capabilities to review applicable regulations and requirements to the organization processes and determine whether those processes are being met. CQ Complaints Management solution can capture customer inquiries, cases, product quality issues, and adverse events. Results of the complaints investigation review can initiate Changes or CAPA actions to help resolve issues and to improve the process for the future to meet the necessary requirements. All relevant documentation concerning customer and product requirements can be controlled and maintained in the CQ Document Management solution. Trends can be easily monitored through Reports and Dashboards on any aspects of the quality system status and customer complaints.
	5.3 Quality Policy	⦁ Document Management ⦁ Training	ComplianceQuest helps an organization document and maintain the latest information about a company’s product specifications and design controls. Any issues identified during management reviews, verification, or validation activities can be escalated to a CAPA to take necessary action on the problem identified.

	5.4 Planning	⦁ Change ⦁ Document Management	All documents can be controlled and maintained in the CQ Document Management solution. CQ Change Control and management software can capture all the information for any change to product, services or the quality management system including the relevant tasks to meet quality requirements and objectives.
	5.5 Responsibility, Authority and Communication	⦁ Chatter ⦁ Document Management ⦁ Training ⦁ Dashboards, Reports, Analytics	ComplianceQuest provides the ability to use latest technology in communication and collaboration through Salesforce “Chatter” for discussions and Social Media to easily follow certain records and chat and receive notifications when changes occur. All processes needed for the quality management system can be controlled and maintained in the CQ Document Management solution.
	5.6 Management Review	⦁ Change ⦁ Document Management ⦁ Dashboards, Reports, Analytics	All procedures for management reviews can be controlled and maintained in the CQ Document Management solution. Reports can be run to identify key trends from audit, changes, complaints, CAPAs, non-conformances, etc. and can easily be exported into spreadsheets for further analysis. The output from the review meeting can initiate a change for improvement or to meet any new or revised customer or regulatory requirements.
6.Resource Management	6.1 Provision of Resources	⦁ Not Applicable
	6.2 Human Resources	⦁ Training	ComplianceQuest provides training management for both job function and compliance through classroom sessions, online/SCORM content or documents. All training is captured providing insight into an employee’s compliance for their role(s). Assessments/exams can be taken by the employee to determine the level of competency on the specific subject and the effectiveness of the training. Through tight integration with CQ Document Management, training can include SOPs whereby employees can easily read and sign off that they understand the document without or with Manager approval.
	6.3 Infrastructure	⦁ Document Management ⦁ Equipment ⦁ Dashboards, Reports, Analytics	CQ Equipment management software allows an organization to manage the schedule for equipment maintenance and allow the capture of equipment calibration output to determine their status and overall lifecycle performance. All information about equipment lifecycle and SOPs can be maintained within the CQ Document Management solution.
	6.4 Work Environment and Contamination Control	⦁ Audit ⦁ Document Management ⦁ Training	CQ Audit Management software allows an organization to perform internal safety audits for the work environment and for contamination control. Audit schedules are easy to setup. Actions can be assigned based on findings. Audit report summary generated and finally escalation to CAPA as needed. All documents and SOPs concerning work environment and contamination control can be maintained within the CQ Document Management solution. CQ Training Management system shows the trained personnel to perform the work.
7. Product Realization	7.1 Planning of Product Realization	⦁ Document Management ⦁ Inspections ⦁ Dashboards, Reports, Analytics	All documents, SOPs, Validation documents, and Risk Files can be controlled and maintained in CQ Document Management solution. Monitoring of incoming parts or in-process testing can be managed through CQ Inspection Management providing detail data on test results and can trigger a non-conformance should any test fail.
	7.2 Customer-Related Processes	⦁ Complaints ⦁ Change ⦁ Document Management	ComplianceQuest provides a Customer complaint management system to intake, process and investigates customer issues. Once a problem has been identified, a change request can be triggered to start the process for correcting or improving product quality or changing applicable product and process requirements. All documents concerning customer-related processes can be controlled and maintained in CQ Document Management solution.
	7.3 Design and Development	⦁ Change ⦁ Document Management ⦁ Training	ComplianceQuest helps an organization document and maintain the latest information about a company’s product planning, specifications and design, and development controls. Any issues identified during reviews, verification, or validation activities can be escalated to a CAPA to take necessary action on the problem identified. Any changes identified during the design and development process can be managed through CQ Change. Management has the ability to capture all the information for the change, perform a risk impact assessment, identify the relevant tasks to be completed and assign the tasks to appropriate resources. All documents, SOPs or relevant files to the design and development planning and the process can be controlled and maintained in CQ Document Management solution.
	7.4 Purchasing	⦁ Audit ⦁ CAPA (SCAR) ⦁ Document Management ⦁ Inspections ⦁ Supplier On-boarding ⦁ Supplier Portal ⦁ Dashboards, Reports, Analytics	ComplianceQuest provides an organization with a complete set of solutions for managing Suppliers including supplier on-boarding, supplier audit, approved supplier list, receiving inspections, supplier corrective action (SCAR), supplier portal for document and data exchange and supplier ratings/scorecard for monitoring a supplier’s quality performance.
	7.5 Production and Service Provision	⦁ Document Management ⦁ Inspections ⦁ Training ⦁ CAPA Software ⦁ Complaints ⦁ Change Control ⦁ Reports and Dashboards	ComplianceQuest helps an organization document and maintain the latest information about a company’s product specification/characteristics. Inspections can be performed at appropriate stages to verify that the criteria for the product have been met. Training management will ensure that only qualified operators are performing the operation of processes. On-going monitoring can be performed, and any problems identified in the reports about production can be escalated to a CAPA to prevent a recurrence. Complaints can enable organizations to quickly respond to a customer and help escalate any customer disposition to applicable ERP system. Change Control enables any identified problem from CAPA and Complaints to go through a formal review and control of any changes for production. All documents associated with production and service provisioning can be controlled and maintained in CQ Document Management solution.
	7.6 Control of Monitoring and Measuring Equipment	⦁ Document Management ⦁ Equipment ⦁ Validation Package	CQ Equipment Management allows an organization to manage the schedule for equipment maintenance and the capture of equipment calibration output to determine their status and overall lifecycle performance. All information about equipment lifecycle and SOPs can be maintained within the CQ Document Management solution. Results from internal audits or non-conformances and CAPAs can be easily shared to provide documented evidence on organizational knowledge. ComplianceQuest provides the ability for an organization to create reports for its key metrics/measurements and provide on-going monitoring to give insight on whether the organization is controlling its equipment.
8. Measurement, Analysis and Improvement	8.1 General	⦁ CQ EQMS Suite
	8.2 Monitoring and Measurement	⦁ Dashboards, Reports, Analytics	ComplianceQuest provides reports and dashboards for a company to fully monitor quality processes across its organization based on key company metrics/goals, regulatory requirements and customer satisfaction.
	8.3 Control of Nonconforming Product	⦁ CAPA ⦁ Document Management ⦁ Inspections ⦁ Non-conformance	CQ Non-conformance solution enables organizations to streamline recording and management of all types of quality events from single or multiple sites in one centralized system. Organizations can quickly triage and perform risk assessment impact of all quality events and instances of non-conformance. When a quality event or a non-conformance is determined to impact production, organizations can document and enforce containment activities related to lots, units and batches. Enforcement of containment activities ensures that nonconforming material is controlled and prevented from improper usage.
	8.4 Analysis of Data	⦁ CQ EQMS Suite ⦁ Document Management ⦁ Dashboards, Reports, Analytics	ComplianceQuest provides reports and dashboards for a company to fully monitor quality processes across its organization based on key company metrics/goals, regulatory requirements and customer satisfaction.
	8.5 Improvement	⦁ CQ EQMS Suite ⦁ CAPA ⦁ Change ⦁ Document Management ⦁ Dashboards, Reports, Analytics	ComplianceQuest provides a comprehensive suite of quality and compliance solutions along with reports to help companies determine opportunities for improvement. Both CAPA and Change Control provides the organization to identify and track correcting, preventing or reducing issues while implementing plans for continuous improvement and effectiveness checks.