Getting ISO 13485 Certified-ISO 9001 Philadelphia PA-ISO PROS #17

Getting ISO 13485 Certified in Philadelphia, Pennsylvania (PA)

ISO Pros is one of the leading ISO 13485: 2016-Medical devices providing certification and quality assurance systems. ISO Pros has worked with leading pharmaceutical companies for many years. As an ISO 13485 specialist, we offer advice on QMS for the medical device industry to ensure our customers are mindful of the advantages of their organization’s MDD ISO 13485 designation.

ISO 13485:2016 is a quality control framework that is appropriate for the purposes of regulation. It fits the requirements of a suitable quality assurance system. ISO 13485:2016 lays out criteria for a robust quality control program for design & growth, manufacturing, storage, shipment, deployment, maintenance of medical devices where a company wants to demonstrate the capacity to provide medical devices and related facilities that reliably satisfy the relevant consumer and regulatory specifications.

ISO 13485 framework includes a fitting method for working with the precise requirements of a quality assurance system for medical instruments. It is created for both manufacturers and service providers who both meet and demonstrate compliance with the regulatory requirements. ISO 13485 specifications are used by suppliers or other external parties that provide the medical device producers with goods or services.


Benefits of ISO 13485

  • Exposure is increased to more certified markets around the world.
  • Define how to test and improve corporate processes.
  • Strengthen efficiency, lower costs, and monitor the performance of the supply chain.
  • Proof that you are creating safer and more efficient medical devices.
  • Comply with market expectations and regulatory guidelines.

What is ISO 13485

This rule represents the quality and system requirements that medical device producers will integrate into their systems of management. Unlike some ISO codes, manufacturers of medical devices requiring 13485 certifications must first learn the requirements of customers and their regulatory agencies and how to implement ISO 13485 quality assurance system.

The latest edition of ISO 13485 does not comply with ISO 9001:2015 and maintains the ISO 9001:2008 framework with a stronger emphasis on threats and regulatory criteria. The standard includes similar annexes to ISO 13485:2003 and ISO 9001:2015 respectively.

In 2003 the second edition of ISO 13485, which harmonizes regulatory quality assurance systems across the world, was published. While ISO 13485 is a stand-alone ISO 9001 standard, it exempts other ISO 9001 requirements which are not exclusive to the medical device industry.

As part of a quality management system according to ISO 13485, companies must address the issue of risk management during product development. ISO 14971 serves as a hazard management guidance document.

Compliance with ISO 13485 standards guarantees precision, security, and durability in the design and manufacture of medical equipment and appliances, in conjunction with FDA 21 CFR Part 820 and CFR Section 210/211. For some countries, the standard for doing business is ISO 13485.

ISO 13485 was updated and published with effect from 1 March 2016. The change to this standard’s new revision will occur over a three-year cycle that ended on March 1, 2019. It means that, after their usual audit cycle (recertification or oversight), all organizations certified to ISO 13485:2003 will be expected to perform an upgrade audit by that time. As ISO Pros in Philadelphia, Pennsylvania (PA) schedules the audits for 2020 and 2021, we will ask regarding the planning and timing of the upgrade.