Risk is not new to the ISO 9001 family of standards. Risk based thinking has been implicit in the language and implementation of the standard. Risk will be explicit in terminology and definition in the 2015 revision.
Formal risk management is addressed in the ISO 31000 standard which is helpful but not necessary to the new revision. As it pertains to the ISO 9001:2015 revision it is termed ‘risk based thinking’ which is not a full management system for risk, but points to awareness of the potential hazards.
Risk Based Thinking
Risk is the balance of the potential inability to obtain what was set out to be done, that is to say, risk is a determinate that can change the ability to finish objectives. In a continuum of potential and actual hazards for risk, risk is a potential. Actual hazards would be the part that corrective action (preventive action is included in DIS) plays towards events. Risk is the preventive action(s) to avoid the event’s occurrence.
Quite frequently risk is regarded as a potential chain of negative events when in reality the opposite is also true. Analysis aids in the prevention of known and unknown hazards increasing customer trust and satisfaction both in the short and long term.
The benefits can outweigh the risks in customer satisfaction, insuring quality assurance, adopting a safety and quality attitude of preventive actions in your company. Approaching the process to put in place risk based thinking can be daunting. The steps necessary (in the “What Can I Do?” Section) can be viewed at this site: QMI Risked Based Thinking.
The draft of the 2015 has been out for a while, but it still can change by the time the full draft is published. The draft has been approved and the final version is on course for 2015.
We at K & S Quality Associates utilize the process approach and risk as a vital component for the implementation and evaluation of processes. If you are coming up for an audit and are needing the ISO 9001:2015 we would be glad to establish risk based thinking for your system, please do not hesitate to email firstname.lastname@example.org.
For further reading on the subject:
- One excellent resource to understand risk, why it is good, and what it means for you is: AS9100 Store.
- Another source for the overall revision process is: Sai Global’s Whitepaper “ISO 9001:2015 Revision Update” which you have to download from their site: SAI Global ISO 9001:2015 Revision.
- Risk based thinking and its pitfall: download the pdf here.
View the whole ISO 9001:2015 article series: here.