Getting ISO 13485 Certified-ISO 9001 San Jose CA-ISO PROS #21

Getting ISO 13485 Certified in San Jose, California (CA)

Getting ISO 13485 Certified-ISO 9001 San Jose CA-ISO PROS #21

Quality control systems can not be compromised in the medical devices sector, which is why the legal standards are so stringent, and why certification is important. At ISO Pros in San Jose, California (CA), we recognize the value of preserving public safety, which is why we have helped you become certified with ISO 13485:2016.

ISO 13485:2016 is primarily intended for suppliers of medical equipment to ensure their quality control program ensures and maintains the consistency and safety of finished goods. Many organizations, such as medical equipment manufacturers, producers, importers, retailers, and installers may also gain from this certification. Although ISO 13485 is focused on ISO 9001, adding much of the same criteria, it includes additional controls that include:

  • Additional data, authentication, evaluation and recognition criteria for regulations
  • Focussing mainly on the management of risk
  • Adaptation of global regulatory standards

When it comes to faulty products, there is no choice, which is why you can trust us at ISO Pros in San Jose, California (CA), offering several years of efficient and creative healthcare certifications.

Why you need to get certified

Companies with an ISO 13485 certification demonstrate a dedication to quality to all customers and regulators in today’s dynamic market place whether working globally or developing locally. It gives better exposure to more customers across the globe. Provides a framework for quality development of how to evaluate activities throughout the enterprise. And will enhance productivity, lower costs, and increase consistency in the supply chain.


ISO 13485 was revised in 2016 to address general issues, the need for consistency within the framework, and to act as a harmonized QMS model for national and regulatory bodies to be adopted. ISO 13485:2016 has expanded emphasis on product realization preparation, “competence” instruction, QMS technical incorporation, harmonization throughout other countries’ regulations, etc., and incorporates “risk” across QMS through supply monitoring, change management, and risk-based decision-making product lifecycles.

ISO 13485:2016 has been the current standard of quality systems for medical instruments. If you haven’t started your gap analysis, now is the time to begin the process. Starting to enforce the requirements of the amended ISO 13485:2016 is crucial for medical product producers and their vendors because the allocated three-year changeover duration does not offer enough implementation time for all organizations. ISO Pros in San Jose, California (CA) will help your business prepare, track, and enhance overall quality control efficiently, as a remedy.

This certification is a recognized level in quality control programs common to companies offering medical equipment and related services. These organizations may be engaged in one or more phases of the life-cycle, including design and creation, manufacturing, storage and delivery, deployment or repair of a medical device, and the design and development or provision of relevant services ( e.g. technical assistance).

The ISO 13485 specification is an appropriate method for fulfilling the detailed specifications for a QMS. Adopting ISO 13485 offers a realistic framework for manufacturers to meet the Medical Product Guidelines, legislation, and obligations as well as show adherence to medical device safety and efficiency.