Overview of the ISO 9001:2015 Requirements

As planners and implementers of quality management systems based on the ISO 9001:2015 Standard, you must have a big picture understanding of what your organization must do and why. Here is a list of 10 things you need to know about ISO 9001:2015 in terms of its purpose and requirements: 

1 Scope  The ISO 9001:2015 standard is to be used as a means to demonstrate your organization's ability to consistently provide products or services that meet customer and regulatory requirements, and for enhancing customer satisfaction.
 
2 Normative references  The standard refers to the ISO 9000:2015 in whole. Your organization needs to understand this document. It talks about the process approach and risk-based thinking which are the central themes of the standard.

3 Terms and definitions The terms and definitions used within ISO 9001:2015 are based on the ISO 9000:2015 document, where risk is defined as the effect of uncertainty. Risks should either be eliminated or their adverse impacts be reduced to manageable levels. When your organization takes upon a given risk, it should link that risk to a certain opportunity of gainful benefit. 

4 Context of the organization As an organization, you must define the issues, whether positive or negative, within the context of your organization in terms of its external and internal environment, needs and expectations of interested parties, scope and operation of the quality management system, including its documentation system.
5 Leadership Top management is at the core of the quality management system as it must demonstrate its leadership and commitment by taking full accountability for the quality management system, ensuring that customer and regulatory requirements are met, addressing all risks and opportunities, maintaining customer focus, establishing the quality policy and ensuring that organizational roles, responsibilities and authorities are assigned, communicated and understood within the organization.
6 Planning  Your organization must take actions to address risks and opportunities arising from its external and internal environment, and needs and expectations of interested parties. It must also establish quality objectives including their action plans and control all planned changes so as to preserve the integrity of the quality management system.
7 Support  Your organization must provide necessary resources to support the quality management system, ensure that staff is competent and aware of the quality management system requirements, determine its internal and external communication requirements and manage its documented information of documents and records.
8 Operation  Your organization must plan and control its operations in terms of processes, resources and documented information, including determining and confirming customer requirements, controlling the design and development process, controlling external products and services, releasing of products and services, and controlling of nonconforming outputs.
9 Performance evaluation Your organization must evaluate its quality management system's performance by monitoring, measuring and analyzing its processes including customer satisfaction levels. Audits must also be carried out to check on conformance to the planned arrangements of the quality management system. And top management must review overall performance of the quality management system based on these evaluation results.
10 Improvement  Based on the management review of the quality management system's performance, your organization must identify opportunities for improvement that can be actioned upon, including correcting any undesirable output via the corrective action process.


    Graphical representation of the ISO 9001:2015





Ismail Latiff  helps his corporate clients implement the ISO 9001, ISO 14001 and OHSAS 18001 International Standards via training, documentation development, audit and advisory services. Check out his presentations on Slideshare.