Quality Management System

Quality Management System

Written by Ana Canteli on 11 March 2022

The interest in quality management can be found in the middle ages with the birth of the manufacturing sector in trade associations. At the dawn of the Industrial Revolution, the first quality management plans were born, which were created to control the production processes and their results systematically. Because the greater the number of people involved in the production of expected results and the greater the number of resulting products and services, the development of good practices became necessary to guarantee qualitative minimums.

Quality management became crucial during World War II when war artifacts created in different factories had to be assembled or used together, without any errors, such as weapons and ammunition.

The importance given to quality management systems did not stop growing after the war. The one who benefited the most was Japan, which incorporated into its industry the improvements implemented in the quality systems of the US, focusing not so much on inspection, but on the advancement of production processes, in collaboration with the people involved in them.

In response to this qualitative leap, the concept of total quality management - The Total Quality Management system (TQM) - emerged. The most important thing is the metrics and any approach that improves the entire organization in your set. But, we are getting ahead of ourselves. The ideal would be to define the Quality Management System QMS is today.

What is a quality management system?

A quality management system plans, controls, and improves the components of an organization related to customer satisfaction and the achievement of the entity’s objectives.

The quality system arises when the production context is repetitive, measurable, and susceptible to continuous improvement. And it is specified in the documentation that defines the processes, procedures, and responsibilities to achieve the quality policies and the goals they pursue.

There are many definitions of quality systems; however, we will follow the guidelines set forth by the International Organization for Standardization (ISO) in this article. The family of quality standards is the most widely accepted in many sectors, and some of the criteria are more applicable to specific industries.

The most notable are:

• ISO 9000 series - standards in quality management

• ISO 4000 series - environmental management systems

• ISO 13485 - quality management system for medical devices

• ISO 19001 - guidelines for auditing management systems

Principles of quality management

• Customer satisfaction: it would be of little use to create an entire system that involves the whole company if, ultimately, its results do not improve customer experience and satisfaction. Keep in mind that new products and services appear every day, capturing customers’ attention; on the other hand, they become more demanding and with higher expectations. Therefore, all the steps of the quality system must not lose sight of the client’s figure as a fundamental objective.

• Leadership: for the quality system to bear fruit, it is essential to have the support and commitment of the management, who is responsible for aligning the company’s strategy with the quality system to be implemented. The command will have to coordinate the techniques used by all the teams and distribute and manage the assigned resources in a harmonized way.

• Relationship management: it is necessary to take responsibility for the company’s links with customers, but also with suppliers, public administrations, shareholders, and other interest groups, to work towards balance and mutual benefit.

• Personnel’s commitment: it may be challenging to implement the quality system if the employees disagree or do not collaborate. Motivating and encouraging the organization’s members is essential for achieving the quality management system QMS.

• The process-based approach is ideal for implementing the quality system indicated by the ISO 9000 series. It is necessary to analyze and determine the tasks, activities, resources, and personnel focused on obtaining the products or services offered to the client. They also include the monitoring and control phases of said processes.

• Evidence-based decision-making: when things start to go wrong in a company, wrong conclusions are usually drawn, or far from the factors that have motivated those poor results. In this sense, quality systems, thanks to the design, construction, implementation, control, review, and improvement phases, contribute to detecting and measuring deviations, thus cooperating in making informed and data-based decisions.

• Continuous improvement: the audit provided by a quality system following ISO 9000 will help us detect the points of improvement and how and with what resources to implement them. And this includes innovation. Quality management is essential since it provides us with an understanding of the changes that will be made, the cooperation and collaboration required, and the necessary documentation to ensure the planned improvement plan.

The importance of document management in quality systems

In the same way that quality management has a long history, document management and its role in quality management systems can be said.

Documenting the best practices to control production and improve production processes created the standards of quality management systems. Therefore, to the extent possible, it is recommended to keep the information documented to support the operation of the processes. The definition of documentation in a quality-oriented organization is extensive: communications, metrics, forms of compliance with quality standards, shared knowledge, etc. This may not include all the documents required for comprehensive quality control. In that case, we would have to include:

• Quality manual, which includes the quality policy and objectives

• Process map with its interactions

• Documentation on procedures of the quality management system

• Work instructions

• Registry maintenance

• Other documentation (internal, local, sector regulations, etc.)

For an organization to successfully implement a quality system, it needs document management software that contains all the evidence necessary to demonstrate the performance of the QMS objectively.

The effective maintenance of documentation is vital to the success of the quality system. During the design phase of the quality management system QMS, the organization should detail the types and series of documents and the creation, retention, and document editing policies. Quality management standards do not usually prescribe a method for document management. However, the ability to capture and retain all supporting evidence helps to implement the company’s quality management system successfully.

Implementation is best executed in a granular manner by breaking each process into threads and educating staff on documentation, training, tools, and metrics.

The OpenKM document management system has been successfully implemented in organizations that have obtained the certification of their quality management system.

The document and electronic records management software includes access to online training courses available at OpenKM Academy. This OpenKM e-learning platform seeks to facilitate the training, acceptance, and use of the quality system chosen by the company.