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 is divided up into clauses that explain the standard’s individual requirements for device manufacturers:
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.
The device manufacturer must document procedures for timely complaint handling in accordance with applicable regulatory requirements.
States that device manufacturers must ensure that employees have the requisite experience, education, training and skills. Records of training and competence must be kept.
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.
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 International Standards Organization (ISO) creates documents that provide guidelines to ensure that products, processes or services are fit for their manufactured use. Standards ensure the quality we’ve come to expect in goods and services we purchase.
Standards such as ISO 13485 are created by technical committees whose members are experts in their fields. These committees are comprised of ISO members from around the world.Standards may take years to develop and approve and once approved, they may supplant other well-known standards.
For example, FDA is working with the ISO Technical Committee to combine certain parts of 21CFR Part 820 with ISO 13485. Professionals working in quality administration need to stay current on these types of international developments.
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.
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