About ISO 9001
The International Organization for Standardization, an organization founded in 1947 in London UK, brings together entities from over 170 countries, whose main activity is the standardization of working methods in many areas of society.
ISO 9001 Standard
Set of “rules” (requirements) that a company should follow to demonstrate that it has the ability to meet the needs and requirements of its customers (stakeholders).
This document provides guidelines for the development of a management model, capable of providing the customer with the confidence that the organization can offer consistently, goods and services.
Document that attests the company’s ability to meet the needs and requirements of its customers (stakeholders) or, in other words, the company can provide goods and services according to the expectation of its customers.
Term used to show that a company has implemented consistently the ISO 9001 requirements and obtained as a result of the certification audit, the approval of its quality management system. In other words, the ISO 9001 certification is the formal and international recognition that the company or organization has a management system in accordance with a recognized standard. Note: the ISO 9001 certification is not related to product or company. It is related to the quality management system of the company.
Methodology or systematic work that aims at the continuous improvement of the company’s processes an the customer satisfaction. The quality management system is based on continuous improvement cycle, or PDCA.
Created in the 20 by the American physicist Shewhart, the PDCA came to prominence in the 50 through the work of w. Edwards Deming, American statistician. The PDCA serves as the foundation for any organization that wants to manage its operations through quality management. Consisting of four steps, the continuous improvement cycle is explained below:
(P) Plan: companies that work in an organized way since the beginning, invest their time in planning activities that will be develop over time. The planning of future activities depends on the information obtained from different sources. This information serve as subsidy for taking actions, the next step of the PDCA cycle. Planning stage inputs: mission, vision, values, SWOT analysis, objectives, results, etc. Planning stage outputs: action plans. (D) Execute: this step consists in the implementation of the action plans established during the previous step (planning). Execution stage input: action plans. Execute stege outputs: actions implemented in accordance with the action plans. (C) Check: this step is the evaluation of the results obtained after implementation of the actions. Check stage inputs: the results od the actions implemented in accordance with the action plans. Check stage outputs: standardization of activities, preventive and/or corrective actions according to the results obtained. (A) Act: this step consists in the implementation of actions from the results obtained. Act step inputs: the results of actions executed according to the action plans. Act step outputs: Standardization of activities, corrective and preventive actions. As described earlier, the PDCA is critical to any organization that wishes to manage its operations on the basis of quality.
The concept of quality is subjective. Although each person has your perception of value, it becomes easier to talk about quality when we associate the concept to a product or service. It’s easy to talk about quality when we use something “tangible” as the object of analysis. Quality is a characteristic related to a product or service that has an influence (positive or negative) on the individual or steakholder.
The quality has evolved through time as well as its comprehensiveness. Today it is very common to hear the terms “quality control”, “quality assurance” and “quality management”. Quality Control: systematic of evaluation focused on the product or service. Quality Assurance: systematic of evaluation focused on the process that produces the good or service. Quality Management: systematic of evaluation which focuses on the set of processes of the company that generate the goods and/or services of an organization.
The certification process of the quality management system of a company is based on three steps:
A). Implantation of the QMS
The company structures its internal processes (maps the processes, standardizes activities and sets performance indicators) the company structures its internal processes (maps the processes, standardizes activities and sets performance indicators) and implements the management of results, also known as routine management (monitors and manages the results of indicators and implements actions to promote continuous improvement of all the processes).
B). Certification Audit
The company hires a certifying body that, through an audit, assesses the degree of adherence of the company’s management system to the requirements of ISO 9001. If consistency (high degree of adherence/meets the ISO 9001 requirements) the company has its management system recommended (certified) by the audit team.
C). Certificate Issue
The ISO 9001 certificate is issued by the certification body contracted by the company.
They perform audits and grant certification based on ISO 9001 standard.
Usually three reasons lead a company to implement the quality management system: Perception of value: the organization’s management awareness on the benefits achieved with the quality management system; Market needs: based on the strategy of corporate positioning against the competition and/or need to provide products and/or services to other countries, agencies and/or government organizations that require a higher level of qualification, warranty and safety. Fad: in this case it is not enough to achieve the objective which is the development of a culture based on quality. Normally, in this case, the process is abandoned midway.
In a process of change there are always difficulties. The implementation of a quality management system is no different and the three main difficulties are presented in the table below, along with some causes:
Difficulty Main causes
Lack of senior management commitment
- Lack of top management understanding
- Failure in conducting the process by the consultant
- Expectation of< short-term results
Lack of commitment of the company’s employees
- Lack of follow-up of the top management
- Failure in conducting the process by the consultant • Excess of other priority
- Lack of understanding of leadership
- Insecurity with its own results
- Fear of change
Lack of financial resources
- Retraction of the economy
- Investment in more important projects
- Organization of processes
- Optimization of existing resources
- Integration between the company’s departments
- Improvement in internal processes of evaluation and control
- Identifying deviations
- Greater credibility of the company towards the market
- Identification of risks and opportunities
- Greater compliance and meeting the requirements of customers • Waste rate reduction
- Improvement of internal organizational climate
- Reduction of customer complaint rate
- Increased competitiveness
Currently, more than one million companies are certified annually in ISO 9001. China, Italy and Germany lead the ranking of countries with the highest number of certificates issued.
Give a help to your company QMS. Start a free trial.
Sign up for a free 14-day trial. No credit card required.