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From error to experience: the first 5 steps to start a Quality Management System

Technology development is a cold, cruel, and merciless path, especially in the world of medical devices. A technical or quality error can be the root cause of an accident or the end of your company.

Today Quality Systems still represent a necessity to stay in the market, especially, they went from being a competitive advantage to being a commodity in the industry, so entering the market becomes a major challenge.

It is not only a matter of identifying the problem, proposing and validating the solution, but also of guaranteeing its quality.

But where do we start? We are a company with limited resources doing a little bit of everything and looking to change the world.

Here we leave you with the lessons learned from the first 5 steps to starting your Quality Management System.

1. Identify your applicable regulations.

Identify the reasons and motives why you need the QMS, it could be from a process of growth and maturation to the need for the sale of the product.

It is important that you identify if it is an ISO ( 9001; 13485), a NOM ( 241, 240), etc. If you are not familiar, look for experienced people to help you in the process.

2. Make your organization chart

The business organization chart is the graphic representation of the functioning and hierarchies of your organization and allows among other things:

  • It seeks to delimit the jobs and orders the hierarchies, vertical and horizontal.

  • It makes known who is responsible for each area, delimiting responsibilities, scope, and tasks,

  • Describes the basis for budget distribution and business growth.

It is very important to integrate it as your work team grows.

3. Map the processes and documents that your QMS will have

The elements that will contain the Quality Management System depend on the current regulations of the country where you manufacture or market your products. Here you will find the minimum and most common for compliance in NOM-241-SSA1-2012 Good Manufacturing Practices for establishments dedicated to the manufacture of medical devices:

  • Quality Manual.

  • Audit System.

  • Complaint management.

  • Handling of out-of-specification or non-conforming products.

  • Deviation management and CAPA system.

  • Recall of the product from the market.

  • Change Control.

  • PMV (Master Validation Plan).

  • Product monitoring and measurement.

  • Technology Transfer.

  • Risk Management.

  • Document control.

  • Returns management.

4. Create the identity of your documents (Good Documentation Practices):

Set out in a document your Good Documentation Practices Policy and a mechanism to keep the name, version, passwords of your documents, or other information that you consider relevant for the traceability of your documents.

Whatever allows you to identify and trace your documents and not confuse them.

There are no perfect solutions when you start, as you integrate documents to your QMS you will understand the necessary data for the identification of your documents.

Select the preferred language: In the case of NOM-241-SSA1-2012, QMS documents must be written in Spanish. Tip: When documents are in two or more languages, they should always include the Spanish version. Some documents may exist in hybrid form, for example, part in electronic format and others in paper.

Data should be recorded by the person who performed the activity and at the time the activity was performed.

5. Set out the process for the Creation, Modification, and Deletion of a document of your QMS.

It consists of a Procedure that you will follow where you mention step by step what you need to create, modify, delete or update your formats.

Tips: Mention who requests it, who authorizes it, and the result of the request.

It is time to create and document your work, remember that if you have any doubts, our team specialized in Quality and Regulatory Affairs can help you.

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