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The changes done in the ISO 9001:2015 revision are considerably more substantial than those produced during the 2008 revision. Few reasons for the changes are:
Risk management becomes a base of the standard
“Risk-based thinking” based approach for risk management has become mandatory in the revised standard: management, risk identification and qualification. Quality results from right management of these risks, which go after the strict scope of the product or service delivered. Quality cannot obtain unless the organization can provide its client a satisfy product or service over the long term.
Risk has its counterpart: possibility. The ISO 9001:2015 standard also grabs this concept of positive uncertainty.
The commitment to quality through visible and strong leadership is strengthened:
• The Ideas of the Management agents disappears completely.
• The stated goals and quality policy must be deeply in keeping with the essentials orientations.
• QMS requirements must be integrate into business processes.
No more quality manual
Once an essential part of the ISO 9001 standard, will the quality manual removes?
Indeed, it is possible, but not in the nearly future, as the concept of the quality manual is deeply fix into the culture of quality.
The revision not requires certified organizations to maintain an up-to-date quality manual. Keep in mind, however, that the documentation requirement is necessary part of the standard. It is still mandatory to document, preserve and maintain relevant information. A quality manual therefore remains one opportunity for fulfilling this requirement, albeit not the sole solution.
Knowledge is a resource like any other
In the 2015 revision, ISO 9001 is once again adapting to its times. Knowledge has become important to successful business development and projects. The new standard considers knowledge like any other resource to be managed:
• Establish the knowledge necessary to carry out the activity in acceptance with the QMS and to achieve the defined goal.
• Knowledge must be protected, maintained and made available where necessary.
• Anticipate changes in knowledge needs and control the risk of failing to acquire knowledge in due time.