ISO 9001 is an international standard that applies to quality management systems (QMS) which focuses on all elements of quality management that an organization must have to effectively manage and improve the quality of their products or services.
The ISO 9001 was created by the International Organization for Standardization (ISO), an international network of national standards institutes working in partnership with governments, industry and consumer representatives, whose mission is to promote the development of global standardization for the purpose of facilitating the international exchange of goods and services.
This standard is part of the ISO 9000 family, which are a set of standards and guidelines for quality management that since its initial publication in 1987, have gained a global reputation as the basis for the establishment of quality management systems. From the ISO 9000 series, ISO 9001 is the only standard that requires certification, the other standards are supplementary and contain deeper information on how to sustain and improve quality management systems.
For decades, the process of globalization has led companies to redefine their strategies and processes in order to compete successfully in today’s market. With the implementation of ISO 9001, an organization demonstrates its ability to consistently provide products or services that meet the demands of its customers and compliance with applicable law. Any organization, regardless of the type of products or services they offer, can use ISO 9001 as their guideline to implement, maintain and improve a successful QMS. This International Standard provides a process approach for its execution, which enables the QMS to connect with other organizational processes and focus on continuous improvement and customer satisfaction will lead to an improved business performance.
Many believe that the implementation of a QMS based on ISO 9001 is only for large companies because it requires strict quality controls. This, however, is not true. ISO 9001 specifies what an organization “should” do, but not “how” they should do it, giving great flexibility for any company, large or small, to use this standard. Additionally, ISO 9001 does not establish specific quality requirements; this is a decision taken by each organization; the standard is only a guide to achieve the goals and objectives set by each organization.
More and more small and medium size organizations are deciding to adopt the ISO 9001 standard, often because they want to continuously improve their QMS, satisfy their customer’s expectations, and because ISO 9001 is becoming a symbol of quality in both the industrial and services industries.
What is ISO 9001:2015?
ISO 9001:2015 is the most recent edition of the ISO 9000 series of quality management system (QMS) standards. ISO 9001:2015 is a comprehensive management system standard designed to provide all types of organizations with the tools necessary to improve performance and customer satisfaction. ISO 9001:2015 emphasizes the following areas:
- Continual improvement throughout the organization
- Customer satisfaction, of both internal and external customers
- Regulatory requirements applicable to the organization
ISO 9001:2015 has also been improved to be more compatible with ISO 14000, the environmental management standard. Organizations that choose to adopt this version of the standard will benefit in the following ways:
- Increased productivity and performance
- Increased market share
- Increased customer satisfaction
- Reduced operating costs
- Reduced waste
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- Risk Management in ISO 9001
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To the novice quality manager, ISO jargon can be extremely overwhelming. What is an NCR? What do you mean by OFI? Are we certified or accredited? But before you go and pull out your hair, let’s take a moment to go over some of the most frequently used terms and their definitions with regards to ISO and Management System Certification.