ISO 13485

Medical Device Regulatory Quality Standards - Importance of ISO 13485

ISO 13485 is an international standard that specifies requirements for medical device manufacturers. The main goal of ISO 13485 is to provide a harmonized model for quality management system requirements in the international market. ISO 13485 compliance is therefore of critical importance. (Note that ISO 13485 2003 has replaced ISO 13485 1996.)

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The MasterControl™ quality management suite is an integrated, configurable, and easy-to-use software solution especially designed to facilitate adherence to the ISO 13485 standard. Here's how MasterControl can help meet key ISO 13485 2003 requirements and at the same time increase efficiency and keep compliance costs down:

ISO 13485 Requirements MasterControl Features to Ensure Compliance with ISO 13485
(ISO 13485 --Clause 4 )

Requires establishment of a quality management system for medical devices. A manufacturer must have quality procedures compliant to ISO 13485 that are documented, controlled, and effectively implemented and maintained.

MasterControl Documents™ helps medical device companies comply with ISO 13485 by automating routing, escalation, approval, and delivery of standard operating procedures SOPs, policies, and other documentation. MasterControl provides automatic revision control to ensure that only the current version of an SOP is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every record), the user must enter a reason for the change. The system tracks these changes and makes them available through reports which ultimately helps in meeting ISO 13485 standards.

( ISO 13485 -- Clause 6 )

A manufacturer must ensure that its personnel have the right experience, education, training, and skills. Acceptable levels of competence must be defined. Training needs must be established and assessed. A record of competence must be maintained.

MasterControl Training™ helps medical device companies comply with ISO 13485 by automating the assignment and monitoring of training tasks and grading of online exams. The software allows sequencing of training courses, so after a prerequisite is completed; the next course is automatically launched. Provides group sign-off feature for verifying training of large groups of employees.

( ISO 13485 -- Clause 8 )

A manufacturer must plan how remedial processes will be used to assure conformity. It must use remedial processes to demonstrate conformance. It must establish a nonconforming products procedure; nonconformances must be corrected and documented.

MasterControl CAPA™ helps medical device manufacturers comply with ISO 13485 by integrating the corrective and preventive action process with other quality processes. The software provides best-practice "8D" process that guides the quality team through every step of CAPA. A CAPA form can be launched directly from another form (i.e., a nonconformance report). Automatically enters relevant data into a CAPA form, reducing data entry and eliminating errors from manual transfer of information. Provides customizable reporting capabilities to help managers monitor entire quality management life cycle.

( ISO 13485 -- Clause 8 )

A manufacturer must plan and perform regular internal audits.

MasterControl Audit™ helps medical device manufactures comply with ISO 13485 by automating, streamlining, and effectively managing the audit process. The audit software provides advanced tracking capability, from scheduling and planning to execution and completion. Offers best practice forms for tracking basic audit information and audit findings. Automates scheduling of all recurring audit-related activities and provides analytics and reporting capability for Increased Management Visibility.

( ISO 13485 -- Clause 8 )

A manufacturer must create a procedure to gather feedback from customers and a feedback system to monitor emerging problems.

MasterControl Customer Complaints™ helps medical device manufacturers comply with ISO 13485 by streamlining the complaint-handling process and reduces the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with processing of a complaint, moving to internal investigation, and culminating with issue resolution.

( ISO 13485 -- Clause 5.6 )

Requires management reviews, including examination of product conformity data.

MasterControl Nonconformance™ is a robust solution designed to help medical device manufacturers comply with ISO 13485 by automating, managing, and streamlining the process for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products. The solution's best-practice form and five-step process connect all responsible personnel for effective and timely disposition of a nonconformance.

Compliant - Sustained ISO 13485 Compliance

MasterControl is compliant, helping you meet ISO 13485 requirements year after year, while keeping compliance costs down.

Connected - Integrated ISO 13485 Compliant Quality Management Suite

MasterControl is connected, giving you the ability to monitor the entire quality system and continuously improve it.

Complete - Enterprise-wide Product Application for ISO 13485 Compliance

MasterControl is complete, meeting every department's needs to ensure that quality initiatives are enforced across the enterprise.

Other ISO 13485 Standards you may be Interested In

Other ISO solutions you may be interested in that MasterControl can help with include: ISO 9001, ISO 9001 2000, ISO 9000 2000, ISO 14000, and ISO 14971, among others.

For More Information on ISO 13485 Standards

To learn more about MasterControl and how MasterControl solutions can streamline compliance with the standards of ISO 13485, please feel free to contact a MasterControl representative.