Regulatory
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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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.
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.
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
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.
Businesses desiring to be competitive in today’s international markets find implementing and maintain a quality management system imperative for product differentiation. Conforming to ISO 13485 can deliver a number of benefits:
When company processes correspond to the ISO 13485 standard, it means they are transparent. Transparency saves money. Unclear or vague documentation, which is often what keeps company processes and ISO 13485 compliance at odds, is avoided.
ISO 13485 certification establishes a company’s credibility and dedication to quality. Prospects recognize the value the certification and understand the investment in quality a company makes to earn it.
Companies deemed ISO 13485 compliant receive a certificate which can be displayed on corporate advertising and marketing materials, leading to increased credibility with customers, employees and stakeholders. Increased credibility ultimately leads to increased brand equity, a desirable competitive advantage.
ISO 13485 compliance promotes harmonization, e.g., a standardized quality vocabulary. When device makers are using the same language to communicate, there is less chance of miscommunication and misunderstandings that can lead to deviations and other quality events than cause patient harm and regulatory sanctions.
To learn more about MasterControl's software systems, please contact a MasterControl representative.
