DIS ISO 9001:2015 Quality Management System Requirements

This revision is due to be published later this year.

By 2018, the current ISO 9001:2008 version shall cease and all QMS shall be certified to the 2015 version. Check with your certification body for actual timeline. 

This 2015 version has been re-structured with new requirements & Clauses revised.

Here are the KEY Changes :

• Retained ISO9001:2008 requirements have been moved into Clause 8 (Operation)
• "Exclusion" is no longer in use. Organization shall review "Applicability" in their QMS & which requirements could not be applied (with justifications).  
• No specific requirement for a quality manual.
• No specific requirements for procedures.
• Maintain documented information could mean procedure, work instructions, method statement, documents, records, etc.
• No specific requirements for records.
• Retain documented information could mean records or evidence to demonstrate conformity or something has been carried out....
• No specific requirements to appoint a Management Representative (MR) as many responsibilities have now been moved to Top Management. But someone has to be the guardian / contact person to maintain Organizations' QMS.
• New concept : Context of Organization (internal & external factors)
• New concept : risk-based thinking (identify, monitor, measure, analyse, improve)
• Emphasize on Process Approach in QMS

Our BESH Recommended Actions for Organizations :

For Organizations who are already certified to ISO 9001:2008 :

• Understand the requirements in DIS ISO 9001:2015,
• Identify Context of Organization,
• Understand the needs & expectation of interested parties,
• Identify potential risks & opportunities in your processes, determine extend of controls,
• Engage Top Management & Key management staff to make them understand their added roles & responsibilities, authorities, etc.
• Document your business / operational processes as inter-connected process flow with Plan-Do-Check-Act (PDCA) elements.
• There is no requirement to re-number your QMS documentations to be inline with the new standard's clause numbers. Identify gaps in your QMS & document how you would close these gaps (add actions, processes, etc).    
• Wait for the new standard to be published & review all your QMS documentation & processes. 
• Implement & monitor effectiveness of QMS.  

For Organizations who have implemented QMS but are not yet certified to ISO 9001 :

• Understand the requirements in DIS ISO 9001:2015,
• Identify gaps in your QMS & document how you would close these gaps (add actions, processes, etc). 
• Wait for the new standard to be published & review all your QMS documentation & processes before going for certification.   

For Organizations who have not embarked on the ISO 9001 journey :

• Understand the requirements in DIS ISO 9001:2015,
• Nominate management staff (Preferable managerial position) for training to understand the standard's requirements,
• Contact a reliable consultant to kick-start for your Organization.