The ISO 9001:2015 International Standard was published in September 2015. Certified organizations will have three years to transition to the new standard.
The Standard encourages more internal and external stakeholder focus as part of a risk-based approach to quality management. It also emphasizes that adopting a Quality Management System (QMS) is a strategic decision for the organization.
It is important to note that this revision is compliant with the new clause structure specified in Annex SL (10 Clauses). This is key for organizations already registered to ISO 9001:2008, because there is no requirement to change their existing QMS procedure and document structures.
The ISO 9001:2015 International Standard includes significant new requirements that expand on the existing ISO 9001:2008 Standard, including:
“Context of the Organization” is a new concept; it refers to the combination of internal and external factors and conditions that can have an effect on the organization’s approach to its products and/or services.
Risks and Opportunities:
The organization is now required to identify risks and opportunities that can potentially impact the operation and performance of the QMS. This is an element in the planning and implementation of the QMS that also requires the organization to implement actions to address risks and opportunities.
Top management must now demonstrate a greater degree of direct involvement in the organization’s QMS.
The terms “documented procedure” and “record” from ISO 9001:2008 have been replaced by “documented information” throughout the ISO/FDIS 9001.
A detailed description of the organization’s processes – with inputs, outputs, and measures, as well as risk and opportunities – is required to define the organization’s QMS.
QSG’s ISO 9001:2015 training workshops and courses are available at our training facilities or on-site at your organization:
ISO 9001:2015 Overview
ISO 9001:2015 Leadership
ISO 9001:2015 Lead Auditor-PECB Certified
ISO 9001:2015 Internal Auditing
ISO 9001:2015 Implementation
ISO 9001: 2015 Risk Based Thinking
ISO 31000 – Risk Management