What is ISO 9001?

ISO 9001 is the requirement standard of the ISO 9000 family of standards. It outlines the guidelines that an organization must follow in order to implement and maintain a Quality Management System.

The latest version of the standard was introduced on September 15th, 2015, it is referred to as ISO 9001:2015, and organizations had until September 28th, 2018 to implement the new standard.

Key Content of ISO 9001:2015

ISO 9001:2015 is constructed around 7 quality management principles:

customer focus;
leadership;
engagement of people;
process approach;
improvement;
evidence-based decision making;
relationship management.

The following are the main changes from the ISO 9001:2008 standard:

A same High Level Structure (HLS) as ISO 14001, ISO 22000, ISO 45001, etc. This means that it is simpler to integrate numerous management systems
There is greater emphasis on the measurement of inputs into processes and their outputs. Examples of inputs would be labor, raw materials, data, specifications, etc. The output must be checked that it is of good quality
The emphasis is on “Risk Based Thinking” which effectively replaces “Preventive Actions” as it is no longer mentioned
The Context of the Organization is used and includes all Interested Parties whose expectations and requirements must be considered in an organization’s products and services
The Management Representative is no longer required and Quality is now the responsibility of the entire organization
The Interested Party is now extended beyond customers to include suppliers, employees, shareholders, the community, etc.
The terms “document” and “records” have been replaced with the term “documented information” which is defined as the “information that the organization has to control and maintain”. The information can therefore be in any format from paper to electronic. There is also no longer a need for a quality manual

Changes from ISO 9001:2000 to ISO 9001:2008

ISO 9001:2008 was a minor upgrade and provided clarifications to the requirements of ISO 9001:2000, together with some changes to make it more consistent with ISO 14001:2004. There were no new requirements.

Changes from ISO 9001:1994 to ISO 9001:2000

This was a major upgrade to the standard. Prior to that it was made up of three standards:

ISO 9001:1994 – Manufacturing with Design & Development
ISO 9002:1994 – Production and Installation (No Design)
ISO 9003:1994 – Final inspection and test

These were all merged into a single standard, ISO 9001:2000.

For ISO 9001:2000 the 20-clause structure was abandoned and replaced with the following 5 sections:

Quality Management System: An organization needed to establish their processes, determine how the processes interact, what resources were required to maintain them and how they were measured and improved. When this had been done then a system for controlling the documentation and the quality manual had to be developed
Management Responsibility: Senior management in an organization needed to be familiar with this section as it is they who were responsible for setting policy, objectives, reviewing the systems and promoting the effectiveness of the systems within their organization
Resource Management: The organization needed to allocate the necessary resources to ensure that the customer received what they expected to receive. It covered people, equipment, premises and support services
Product Realization: These were the required processes to produce and deliver the products and/or services. Activities such as receiving instructions from customers, designing and developing the products, purchasing the materials and services and, finally, the delivery were included.
Measurement Analysis and Improvement: This covered the process of measuring product performance against the quality standards, customer satisfaction, the effectiveness of the management systems and ensuring continual improvement of the systems

It is process orientated and follows the operating principle of the Plan-Do-Check-Act (PDCA) methodology. The new standard became more customer-oriented and expects organizations to communicate with customers and to measure and monitor customer satisfaction.

It also emphasized the need to make improvements and specifies that an organization must evaluate the effectiveness and suitability of its quality management system, and to identify and implement systemic improvements. The evidence that training has taken place was no longer sufficient and instead the effectiveness of the training has to be evaluated.

Finally, documentation requirements became less prescriptive and permitted greater flexibility.