The quality management system (QMS) standard ISO 9001:2008 is currently under review. Like all ISO standards, which go through a revision every 5 years, ISO 9001 is being updated to reflect new technological advancements in the workplace and a to give a higher focus on the quality of outputs to customers.
The review process is currently at the Final Draft International Stage (FDIS), the fifth stage of a six stage process and the final revised ISO 9001:2015 is due to be published by September 2015. Some of the upcoming changes to ISO 9001:2008 are:
- The new ISO 9001 standard aligns with high-level organizational structure established on the ISO Guide 83 (“Annex SL”), requiring all new ISO management system standards to be aligned on a high-level structure with a set of common requirements. This structure aims to facilitate the implementation process and the integration of several management systems in a harmonized, structured and efficient manner. Such structure is as follow:
- Normative References
- Terms and Definitions
- Context of the Organization
- Performance Evaluation
- Some concepts are replaced, such as the term “product” is replaced by “goods & services” and “continual” by “continual improvement.” “Purchasing” and “outsourcing” will be replaced by “external provision of goods and services”
- The new standard puts a greater emphasis on the “context of the organization” which implies a broader measurement, planning and implementation view.
- The new standard will take a risk-based approach to determine the type and extent of controls appropriate to each external provider and all external provision of goods and services. The proposed standard addresses risks which can affect conformity of goods and services as well as customer satisfaction.
- Senior management will be required to take a more active involvement in the quality management system.
- There will be general requirements for documentation, with no reference to documented quality manual, documented procedures or to quality records. The DIS refers to “Documented Information.”
- The need for exclusions may not be considered to be necessary in the new version of the standard but feedback on this is being sought as part of the revision process.
Regardless of the upcoming changes, ISO 9001 will continue to be a generic standard, relevant to all sizes and types of organizations in any sector and it will continue to deliver “confidence in the organization’s ability to consistently provide product or services that meets customer and applicable statutory and regulatory requirements”.