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 […]

ISO 9001 for the Transportation Industry: What You Need to Know

In the transportation and logistics industry, the business environment is challenging and the competition can be quite tough. Companies need to constantly find new ways to improve their operations. This helps them focus not just on survival, but on growth and success as well. The activities and business models of companies in the logistics industry demand […]

ISO 9001 In Hospitals

For years, ISO 9001 has been maintaining a standard system of quality management in many industries all over the world. By entering the healthcare world, it guarantees an improved level of care and safety.

Creating a High-Quality Clinical Environment with ISO Standards for Healthcare

From initial diagnosis and the development of a treatment plan to medical interventions and record keeping, every part of the healthcare industry operates under standardized guidelines, regulations and best practices. These are outlined by various medical associations, governing bodies and national as well as state-level laws. Major responsibilities for the management and administration of hospitals include […]

Small Businesses and ISO 9001: How It Can Help

Whether you run a large organization or run a small business, implementing ISO 9001, Quality Management System (QMS) standard has countless benefits. As the world’s most recognized standard, ISO 9001 aims to provide a workable framework that is suitable for monitoring and improving a business. It increases productivity and safety of the employees, reduces costs and […]

4 Mistakes You Should Avoid While Implementing ISO 13485

For organizations aiming to implement a smooth implementation of ISO 13485, the process is somewhat complicated because the ISO, unlike many other regulatory bodies, does not disclose a lot of data to learn from. Based on our many years of experience as ISO 13485 certification consultants, we often come across mistakes repeated by many companies […]

Why Companies Should Consider Hiring External Consultants

An ISO Certification is a significant achievement; however, it can be frustratingly lengthy and tiring process without the help of an experienced ISO Consultant. Here are the various benefits of hiring an ISO Consultant:    

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 […]

4 Ways of Creating an Efficient Production and Service Provision with ISO 9001

In the 2015 update to ISO 9001, clause 8.5.1 requires your company to implement control measures on your production and service provision processes. The idea behind this is to create a ‘controlled environment’ that enables monitoring, evaluation and corrective actions as needed. Below, we share some ways how you can create a strong production and […]