1.0 AN INTRODUCTION TO ISO 9001:2015
With this new International Standard, some of the clause structure and terminology in ISO 9001:2008, have been changed to improve alignment with other management systems standards.
Basic Changes
•The adoption of the HLS ( standardized High Level Structure)
•An explicit requirement for risk-based thinking to support and improve the understanding and application of the process approach.
•Fewer prescribed requirements.
•Less emphasis on documents.
•Improved applicability for services.
•A requirement to define the boundaries of the QMS.
•Increased emphasis on organizational context. (Link between customer expectations, organizational objectives, the Quality Policy, process objectives and process measurement)
•Increased leadership requirements. (Active Participation)
•Greater emphasis on achieving desired outcomes to improve customer satisfaction. (Performance Measurement)
Major differences in terminology between ISO 9001:2008 and ISO 9001:2015
Products from 2008 has become Products and services. Exclusions are No longer used in 2015. Documentation, Records is now Documented Information. Work Environment has morphed into Environment for the operation of processes. Purchased Product is now externally provided products or services. Suppliers are now External Providers and Preventive Action is gone.
It is important to recognize that the changes in the structure and terminology do not need to be reflected in the documentation of an organization’s quality management system. As in the 2008 version of the ISO 9001 standard, the structure of clauses is intended to provide a coherent presentation of requirements rather than a model for documenting an organization’s QMS (Quality Management System). There is no requirement and no intention for the structure of an organization's quality management system documentation to mirror that of this International Standard.
There is also no requirement for the terms used in an organization’s QMS to be replaced by the terms used in this International Standard. Organizations can choose to use terms which suit their operations. For example:
ISO 9001; 2015 could be
‘external provider’‘supplier’, 'partner’ or ‘vendor’
‘Management Review’ Monthly Operations Meeting
‘Nonconformance’ITBF – Issue To Be Fixed
In fact unique terms adopted for your organization can enhance the effectiveness of the system by eliminating old biases, and criticisms born from misapplications and misunderstandings of the intent of terms used in the past.
The basic concept of a process based system has not changed with the 2015 standard and is if anything enhanced. Stressed in 2015 is the requirement to consider and analyze risk. While understanding risk was implied in the 2008 version of the standard it is much more explicit in this new standard.