What is ISO 9001:2015?

ISO 9001: 2015 is defined as the international standard that specifies requirements for a Quality Management System (QMS).  It provides a framework and set of principles that ensure a common approach to the management of the organization.

Organizations use this standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. The ISO 9000 family is the world's most known quality management standard for companies and organizations of any size.

Adoption of QMS

The adoption of a Quality Management System (QMS) is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives.

The potential benefits to an organization of implementing a quality management system based on this International Standard are:

• The ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;

• Facilitating opportunities to enhance customer satisfaction;

• Addressing risks and opportunities associated with its context and objectives;

• The ability to demonstrate conformity to specified quality management system requirements

Risk-Based Thinking

Risk-Based Thinking is the identification of internal and external risks, both positive and negative, and deciding how they should be addressed when developing processes to improve outputs and mitigate against undesirable outcomes.

The PDCA Cycle

ISO 9001 promotes the adoption of a process approach when developing, implementing and improving the effectiveness of the quality management system, to enhance customer satisfaction by meeting requirements. Specific requirements considered essential to the adoption of a process approach are included in clause 4.4...

The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle with an overall focus on risk-based thinking aimed at taking advantage of opportunities and preventing undesirable results.

The PDCA cycle can be briefly described as follows:

Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers’ requirements and the organization’s policies, and identify and address risks and opportunities;

Do: implement what was planned;

Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results;

Act: take actions to improve performance, as necessary.