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ISO 13485 Audit Checklist

ISO 13485 QMS software and Audit Checklist

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CQ ISO 13485 QMS software

What is ISO 13485 QMS software and Audit Checklist?

An ISO 13485:2016 supported quality management system is applicable to the medical device industry and follows the ISO 9001 process model of Plan, Do, Check, Act designed for regulatory compliance. It is more prescriptive, requiring a demanding quality management system and documentation

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Benefits of ISO 13485 software

The medical devices industry must focus on the quality and safety of the products due to its implications for patient health and safety. Having an ISO 13485 certified QMS software has many benefits. Some of them are —

  • Improves brand recognition and credibility
  • Helps with better decision making
  • Reduces errors through improved processes
  • Enhances customer satisfaction
  • Encourages employee engagement
ISO 13485 Audit Checklist

What are the features of CQ's ISO 13485 supported EQMS Software?

ComplianceQuest Modern Cloud Enterprise Quality Management System (EQMS) supports the latest edition of ISO 13485 by automating the entire QMS requirements while maintaining full traceability. 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:

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    Monitoring operational and performance key trends through reports and dashboards
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    Gaining insight into the availability of employee resources based on their training competency and equipment resources to ensure the sustainability of equipment
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    Enabling collaboration/communication through tools such as Chatter and Social Median

Some of CQ’s ISO 13485 software features are listed below —

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    Risk assessments to determine the actions necessary for mitigation or to initiate changes to QMS processes
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    Dashboards and reports to provide insight into overall performance and efficacy
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    CQ Complaints Management solution to capture customer inquiries, cases, product quality issues, and adverse events
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    CQ Change Control and management software to 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
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    CQ Equipment Management software allows an organization to manage the schedule for equipment maintenance. It will enable the capture of equipment calibration output to determine their status and overall lifecycle performance
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    CQ Audit Management software allows an organization to perform internal safety audits for the work environment and contamination control
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    CQ Non-conformance solution enables organizations to streamline recording and manage all quality events from single or multiple sites in one centralized system
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    ComplianceQuest provides reports and dashboards to fully monitor quality processes across the organization based on key company metrics/goals, regulatory requirements, and customer satisfaction
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    All documents associated with production and service provisioning can be controlled and maintained in the CQ Document Management solution
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    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
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    ComplianceQuest provides training management for job function and compliance through classroom sessions, online/SCORM content, or documents
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    CAPA allows the organization to identify and track correcting, preventing, or reducing issues while implementing continuous improvement and effectiveness checks

What is an ISO 13485 Audit Checklist?

Quality managers use ISO 13485:2016 audit checklist to determine if the QMS aligns with the ISO 13485 software standard requirements. The ISO 13485 audit checklist is used for internal audit while preparing the system for a third-party ISO 13485 certification audit. The ISO 13485 audit checklist allows quality managers to document evidence of compliance based on processes, standard requirements, and process characteristics

What are the Uses of the ISO 13485 Audit Checklist?

CQ’s Audit Checklist feature helps quality leaders “know their gaps”, take preventive action and, overall, stay compliant with all regulations. The checklist also has other uses, such as

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    Simplifies audit planning
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    Helps to identify process gaps
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    Acts as a comprehensive document for third-party evaluation
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    Includes corrective actions deadlines
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    Reduces audit preparation time
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    Aids with data consolidation

Benefits of Using ComplianceQuest ISO 13485 Software

ComplianceQuest offers cloud-based Quality Management Software (QMS) to plan, monitor, and improve its overall quality management. ComplianceQuest helps organize a company’s ISO 13485:2016 needs while efficiently helping auditors and notified bodies to find what they need quickly and effortlessly. The robust EQMS platform helps organizations meet their ISO 13485:2016 requirement in various criteria, including –

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    Quality management system
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    Management responsibility
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    Resource management
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    Product realization
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    Measurement, analysis, and improvement

What are the various focus areas where ISO 13485 Software is applicable?

ISO 13485 software is useful to organizations focusing on the design, production, installation, and servicing of medical devices and their related services. By definition, a medical device is any product, such as a machine, instrument, implant, or in-vitro reagent, that is manufactured for its use in the diagnosis, prevention, or treatment of diseases and other medical conditions. The standard is also applicable to certification bodies that help these organizations with their auditing processes

Frequently Asked Questions

Why should medical device manufacturers focus on implementing quality practices?
  • Helps to reduce manufacturing costs
  • Improves productivity and efficiency
  • Enhances customer satisfaction
  • Increase profitability
  • Provides competitive advantages
  • Protects organization’s reputation and builds on relationships
What is the Importance of Medical Device QMS?

The QMS helps medical device manufacturers with:

  • Enterprise-wide data visibility of both quality and safety parameters
  • Seamless workflows and business processes
  • Easy setup for multiple standards like ISO 9001, ISO 45001, OHSAS 18001
  • Predictive insights for quality; proactive approach to safety
  • Aligning people and processes
  • Reducing the cost due to inefficient safety or quality process
  • Better manage risk across two misaligned systems

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