What is ISO 13485?

ISO 13485 is an international management standard developed specifically for medical device manufacturers. It provides a harmonized model for creating and maintaining an effective quality management system (QMS) for the design and manufacture of medical devices.

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Understanding ISO 13485: 2016 — A Brief, Yet Comprehensive, Overview

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What is the History of ISO 13485

ISO13485 was first published by the International Organization for Standardization (ISO) in 1996. In 2016, ISO 13485 manufacturing standards were revised to address suppliers and incorporate risk. ISO 13485:2016 explicitly requires device makers to apply a risk-based approach to all quality phases, including outsourced processes, as well as more structure for validation, verification and design transfer.

What are ISO 13485 Clauses?

ISO 13485 is divided up into clauses that explain the standard’s individual requirements for device manufacturers:

  • Clause 4: Requires establishment of a quality management system (QMS) for medical devices so that procedures are documented, controlled and effectively implemented and maintained. It also requires written supplier agreements and risk-based control of outsourced products.
  • Clause 5: The device manufacturer must document procedures for timely complaint handling in accordance with applicable regulatory requirements.
  • Clause 6: States that device manufacturers must ensure that employees have the requisite experience, education, training and skills. Records of training and competence must be kept.
  • Clause 8: Manufacturers must plan how remedial processes will be used to assure conformity and create a procedure to correct and document nonconformances. The manufacturer must also plan and perform regular audits and have a procedure to gather customer feedback to monitor emerging problems.

What is an ISO 13485 Template?

ISO 13485 templates are designed by third-party vendors to help medical device manufacturers navigate the individual steps of building a quality management system (QMS). They provide practical guidance and how-to instructions for manufacturers to set up a QMS with the aim of saving companies precious time in initiating manufacturing operations.

How Do I Get ISO 13485 Certification?

There is a hierarchy of requirements that a device manufacturer must fulfill in order to gain ISO 13485 certification to develop and maintain a company’s quality management system (QMS). They include the following:

  • Create a plan for your QMS
  • Make sure your plan meets regulatory requirements
  • Build and implement design control processes
  • Establish procedures for documents, records and training
  • Conduct a review of audit, corrective action and preventative action (CAPA) and management processes
  • Complete an initial certification in a phased approach

MasterControl’s ISO 13485 Solution

The MasterControl quality control management suite is an integrated, configurable and easy-to-use software solution designed to help device manufacturers facilitate compliance to the latest ISO 13485 standard. It provides automated routing, escalation, approval and delivery of standard operating procedures (SOPs) for effective ISO 13485 document control. The MasterControl solution also offers supplier management features for tracking supplier agreements and risk-based control of outsourced products as well as automating the assignment and monitoring of training tasks and course completions.

MasterControl’s digital ISO 13485 toolkit provides users with a simple and effective method for participating in risk assessment and mitigation activities and sets triggers to perform risk analysis. It also tracks and monitors open corrective and preventative actions (CAPA) while improving the overall ISO 13485 CAPA process and streamlining and automating audit procedures. Finally, the software simplifies the collection of customer complaints and aids the identification, evaluation, review and handling of nonconformances, from materials to finished products.

MasterControl and the FDA

MasterControl and its partner, i4DM, have served as the quality management system (QMS) providers for the FDA’s Office of Regulatory Affairs since 2009. They also serve as QMS providers for the Division of Pharmaceutical Analysis, part of the FDA’s Center for Drug Evaluation and Research (CDER).