Getting ISO 13485 Certified-ISO 9001 Miami FL-ISO PROS #19

Getting ISO 13485 Certified in Miami, Florida (FL)

The medical devices industry has many non-negotiable policies particularly with regard to the health and quality of goods. Especially as regulatory standards are becoming more strict at any phase of a medicinal product’s life cycle, from production to distribution. Business organizations are constantly expected to demonstrate their quality assurance processes to promote best practices for everything they do.

What is ISO 13485 certified?

ISO 9001:2015 is structured to define the requirements of the quality assurance system where an organization wants to:

  • To demonstrate the capacity to supply medical equipment and facilities that can meet patient needs reliably when complying with relevant legislative and regulatory guidance.
  • Concentrating on patient safety and ensuring that the products they manufacture meet the standard requirements while retaining conformity with the norm, based on what the function is, that it is meant to perform.

All are specific requirements set out in ISO 13485:2016. This certification may be used by manufacturers or third parties interested in the medical equipment industry, even those providing services that relate to the QMS.

Why it’s good to have certified QMS software

Cer QMS Technology provides all of the advantages ISO 13485:2016 provides:

Brand awareness and credibility is increased

With QMS applications introduced in your company for ISO 13485 Medical Devices, you will reflect the trust of your customers and clients when doing business with you. A good ISO 13485 QMS software offers a great promotional tool, and it has become a must for medical device manufacturers in several countries to illustrate compliance. This helps you to take on further opportunities.

Improving decision making

One essential quality control concept under ISO 13485 is that it relies on the facts when it comes to decision-making. When you make educated choices using the evidence and information, you could easily match them with your company objectives. Everything your intuition says to you, is not always going to be right; it sometimes puts you in serious trouble for the company. The added benefit here is an insight into your company’s health since you can monitor any changes that you create and their effects.


The structure of ISO 13485

ISO 13485 is structured into 8 sections, the first 3 of which are general (scope, standard references, and terms/definitions) and sections 4 to 8 set out the actual QMS requirements:

QMS – Section 4:

The aims and requirements of a QMS are typically described within the documentation. It includes specifications for the Standard Guideline, Register of Medical Equipment, and managing paper and records.

Executive Accountability – Section 5:

Management responsibilities requirements include top management commitment to implementing and maintaining the QMS, focusing on the client and regulatory requirements. In addition, the section includes quality assurance, QMS planning, and annual performance reviews, as well as responsibilities and jurisdiction (including the performance representative’s position), and internal communication.

Resource control – Section 6:

Management of resources involves supplying and managing sufficient services for the planned operations, including staff, equipment, and work climate.

Product realization – Section 7:

Brand awareness involves all facets of the supply chain or related operation of a medical product, as relevant to the company. The QMS can remove any subchapters which correspond to non-applicable activities. The comprehensive section covers specifications for planning, inventory standards, design & growth, ordering, assembling, service distribution, and management of all testing and measurement devices.

Measuring, analysis, and improvement – Section 8:

These practices are required to ensure that the QMS stays effective. In this section, it covers input from manufacturing and post-production, complaint management (including any mandatory reporting to regulatory authorities), internal assessments, amongst others.