Getting ISO 13485 Certified-ISO 9001 Fremont CA-ISO PROS #43

Getting ISO 13485 Certified in Fremont, California (CA)

ISO 13485 is a standard created for medical devices. The standard encourages health and safety in the field of medical device equipment. This establishes a benchmark of regulatory standards as the regulations are getting increasingly stringent during each phase of the product’s lifecycle. This standard assists in demonstrating the quality control procedures and upholding professional practice in anything you do to satisfy increasing expectations.

The Differences between ISO 9001 and ISO 13485.

ISO 13485 is a standard that can stand-alone and is similar to ISO 9001:2015 and has its focus on Medical Devices, where ISO 9001 is a general standard and includes various sectors. ISO 9001:2015 followed the latest standard ISO framework of 4-10 range of clauses. ISO 13485 is a stand-alone standard and retains the old ISO 9001:2008 form of 4-8 range of clauses.

Importance of this standard

ISO 13485 helps maintain the trust of customers and staff and is an important prerequisite in the manufacture of medical devices. ISO 13485 has become the internationally recognized standard in the medical device industry and certifies compliance with regulatory requirements. Companies are required to have evidence of the operation of the quality management system over the whole development process. The US Food and Drug Administration ( FDA) declared its decision to use ISO 13485 as the foundation for its consistency framework regulations.

The advantages of ISO 13485

ISO 13485 is the highest quality standard in the medical equipment sector. This is a very effective marketing tool to guarantee the service is taken very seriously by the company’s clients and you have the processes in place to support that. This aligns the business to fulfill the standards of other countries and vendors where enforcement is necessary.

By offering a framework for organizational procedures that can be evaluated and examined, ISO 13485 fundamentally creates a culture of quality improvement internally within the company. It provides a systematic mechanism for resolving issues of concern by corrective action.

It also provides a further commitment to workers when more formalized duties and obligations are established. This will set out simpler roles and result in more satisfied workers and improved outcomes for the business.


Adopting a series of standards in quality control increases customer service. This provides consistency in an environment of quality control, which shows that the company is making every attempt to deliver a product that satisfies rigorous criteria.

ISO Pros also provides training

This course offers you an outline of the intent and specifications of the updated ISO 13485:2016 specification for quality control systems for medical devices. We will give you an introduction to the new standard during this training with an explanation of its details and specifications of ISO 13485:2016. Our coaches can help you recognize the purpose behind the updated, revamped management framework guidelines, and learn how to adapt the quality control concepts of the organization effectively.

This course is conducted by trained professionals and is aimed at those involved with medical devices and liable for creating or collaborating with a quality management system (QMS).

The course consists of lectures as well as laboratory activities.