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We made a video to help you understand what ISO9001 is. For this we interviewed Tania Schmit, our quality manager.

Hello, I’m Vanessa Montanari, the manager of Pharmaspecific; Hello Tania,

Hello Vanessa

Today we will talk about the ISO9001.

Tania, what is ISO 9001?

It is a set of organizational guidelines for international use that are gathered in a document and used to implement a quality management system. This document is commonly referred to as the international standard ISO 9001.

What is a quality management system?

First, a quality management system is required to represent the entire organizational structure of an organization or a company.

Specifically, this system will show how the activities or processes of an organization will interact with one another.

The purpose of this organization is to facilitate understanding of the dynamics and interactions of these activities or processes.

What is the purpose of this international standard ISO 9001?

As mentioned above, the ISO 9001 standard will help companies to organize their organization through the implementation of a quality management system.

The implementation of this system and ISO 9001 certification are not compulsory.

But it is advisable for any organization to set up a quality management system without necessarily following the path of certification.

What are the principles of ISO 9001?

Currently, ISO 9001 version 2015 is based on the following principles:

  • Customer Satisfaction
  • Management leadership
  • The involvement and motivation of the company’s staff
  • The process approach of activities
  • Improving the performance of the company
  • Decision-making based on evidence
  • Management of Relations with Stakeholders

 What is an ISO 9001 certification?

The ISO 9001 certification is simply the recognition that our quality management system is in line with the requirements of ISO 9001.

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The attribution of the ISO 9001 certification is carried out by a certifying body after carrying out an audit of the company’s management system and not having found any non-conformities which could affect the system.

Why to be certified ISO 9001?

Vanessa, The advantages of being certified ISO 9001 are numerous, among others:

  • Improved customer satisfaction
  • It also gives us access to new markets
  • We can reduce non-quality costs related to potential malfunctions or claims
  • We can lead our organization more effectively
  • The image of the company is positively impacted
  • The company’s sales are increased
  • A valorization of the employees who work for an organization that is ISO certified.

Who can be certified ISO 9001?

Well, any company or any organization can be certified ISO 9001, whatever its size and its sector of activity.

Written by Vanessa Montanari

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