5 FAQs About ISO 13485 Answered
For medical device manufacturers, ISO 13485 is the most reliable, internationally recognized standard of quality management. The ISO 13485 standard mentions all the requirements that an effective quality management system in the medical device industry should meet. Some of the most common questions about ISO 13485 are discussed below: 1. What’s Difference About ISO 13485:2016? Several changes […]
4 ISO 13485 Changes That Can Help You Gain A Competitive Edge
The 2016 update to the ISO 13485 standard brought about some notable changes for companies to focus on. If your company has been underperforming, it might be time to lean into the requirements of the standards and capitalize on these changes. Not only will you ensure that the medical devices you’re manufacturing are of the […]
The Importance of Audits for Companies
Auditing is a way of evaluating the internal controls of a company. Audits help in revealing systematic errors that occur throughout the year, and a year-end audit is essential to an organization’s decision-making. For ISO audits, there are two main categories: internal and external. In order to become ISO certified, you need to have internal auditors and […]
3 Key Benefits of ISO 13485 Certification
Getting an ISO certification is essential for any company to ensure consistent quality and create a legitimate brand that can be trusted. However, the number of companies that are ISO certified in the United States is quite low, especially within the health services industry. ISO 13485 standard was developed to ensure quality and safety within the […]
ISO 9001 Vs. ISO 13485 For Medical Devices: Understanding The Differences And Similarities
Both ISO 9001 and ISO 13485 are international standard requirements that address different aspects of quality management systems (QMS).
How to Gain ISO 13485 Certification for your Medical Device Company.
If your company makes medical devices, then you need to know how ISO 13485 can help you to develop a comprehensive management system for designing and making all medical devices. How does ISO 13485 help with Quality control for your manufacturing business? ISO 13485 requires that a business show that they have a quality management […]