ISO 9001

What is ISO 9001?

ISO 9001 is the international standard for Quality Management Systems (QMS) published by the International Organization for Standardization (ISO). This internationally recognized standard has more than 1 million certificates issued in more than 178 countries. It is designed for companies in any sector and of any size. 

This regulation establishes a framework and a series of principles for carrying out processes and organizational management that seek to ensure that customer needs are met. They also certify the quality of products and services per user requirements. ISO 9001 also aims to improve processes, especially those with systematic failures, to reduce their impact, improve response capacity, and reduce costs. 

What is the ISO 9001 structure?

The current version of ISO 9001 was published in September 2015; it is currently in its fifth edition, which replaced ISO 9001:2008. Here, the quality management requirements for internal application are specified; furthermore, it is based on a cycle of planning, implementation, review, and constant maintenance.

The structure is divided into ten sections. The first three are introductory (objective and field of application, standard references, and terms and conditions). The remaining seven include the requirements for the Quality Management System (QMS):

• Organization’s context: includes the requirements to identify the organization’s internal and external problems, as well as the scope of the QMS, its processes, and how they interact.
  
• Leadership: refers to senior management’s participation in the execution of the quality management system, which is oriented around decision-making.
  
• Planning: to ensure the success of implementing the quality management system, identifying strengths and weaknesses.
  
• Support: the list of requirements, competence, decision-making, communication, and documentation.
  
• Operation: brings together the requirements for planning, control, and production of products or services from projection to delivery.
  
• Performance evaluation: depending on the requirements for monitoring, measurement, analysis, and evaluation.
  
• Improvement: brings together the guidelines for improving the company’s plan and operation with corrective actions to achieve consumer satisfaction. 

What are the stages of the certification process?

The ISO 9001 standard sets some requirements to achieve certification, and each company must find the optimal way to achieve it:

1. Documenting the procedures carried out at the company, with the goals pursued and the steps planned to be implemented to achieve them.
2. Periodic review of the ISO 9001 standard documentation through internal audits. This step is essential for maintaining ISO 9001. 

What elements are considered for the ISO 9001 certification? 

• Company infrastructure: it must have adequate facilities for carrying out its activity. In addition, this infrastructure must be maintained, preserving the equipment and other assets that ensure the quality of the product or service offered by the company.
• Working environment: refers to the conditions of the workspace: facility temperature, humidity, protection systems, hygienic conditions, etc.
• Relationship with suppliers: having ISO 9001 certification also entails having a quality guarantee for the products and services from the suppliers the company works with. 
• Process measurement: in order to know how they work and improve their quality, it is necessary to analyze the results generated based on these measurements.

Why is the ISO 9001 standard important? 

Companies that achieve ISO 9001 certification gain a series of benefits:

• Improved institutional image: they gain prestige in the market and generate trust among consumers.
• Increase in sales and better results: as a result of the increase in credibility, there is improvement in the company’s financial situation.
• Increased productivity: efficient resource management, both technological and human, means greater productivity.
• Growth in the level of satisfaction: among both customers and workers at the companies themselves, given the value gained in the market. 
• Process integration: this allows for fewer errors thanks to automation, increasing efficiency and reducing reworking. 
• More participation from senior managers and employees: all company personnel are committed to identifying the aspects that require improvements.