Thursday, July 24, 2014

SO NOW THAT YOU FINALLY UNDERSTAND THE 9001:2008 STANDARD…“WHY CHANGE EVERYTHING?”



It is our strong recommendation that organizations do not make changes to their quality management systems until the formal standard is released in 2015.
“Just when you thought it was safe to go back into the water…”  It wouldn’t surprise me that many of you are feeling this way as the new ISO 9001:2015 standard looms on the not so distant horizon. 
When you think about it, isn’t that what ISO has been preaching for years, Continuous Improvement?  It is refreshing to know the International Organization for Standardization practices what they preach.
When people ask my goal as a consultant, teacher and auditor, I reply that my job is to ensure the organization sees Return on Investment, Litigation Security and most importantly, Patient Safety or Customer Satisfaction.  When you look at the new standard you can’t help but notice the heightened awareness to RISK.  Risk that an organization might face can come in the form of a thousand different possibilities like little piranhas that can swiftly eat away at the success of an organization or it can come in the form of a great white shark that can immediately devastate an organization. 
What the new standard is attempting to accomplish is to set up a series of life guard stands for an organization whereby the threat can be identified far off in the distance before it can do any real harm.  In section 4 of the ISO 9001:2015 standard the organization is asked to take a good hard look at itself, its customer and any other interested parties that play a relevant role in the success of the organization.
           

                                                 
As the organization begins to evaluate their context, “the pool of water that they are swimming in” they very quickly discover that they themselves may be the cause of some of their greatest risks.  Maybe due to resource constraints, equipment constraints, facility constraints, etc., they may have reached their capacity to fulfill customer needs.  The ISO standard simply asks us to identify and then, in a controlled fashion, mitigate those risks.  Maybe we take swimming lessons and develop a stronger stroke so that we can stay ahead of the competition.
In our current culture customers demand higher levels of quality without additional expense. As an organization clearly identifies these needs and expectations, the risk to the organization will be revealed.
If we identify what it is that our customers truly want and expect, we can now begin to address these issues, not only for the good of the customer, but also for the financial strength of the organization. An organization can maintain cost and see a nice profit, if they change their culture.  To begin to change this culture, an organization needs to improve processes and build quality into the process, instead of inspecting it into their processes. They must work to reduce the number of process failures to consistently and reliably reproduce the product. By doing this, we can feed the sharks what they want instead of letting them eat away at our success.
“Interested party” is the name the ISO standard has given to all others who hold a relevant role in the success of an organization.  This category can be large; however they are not very difficult to manage.  Regulatory bodies want their codes to be complied with; investors want their money; suppliers want their invoices paid.  The smart organization will identify, assess and mitigate the threat that each interested party plays in their success.  If my supplier, my “swim coach”, isn’t helping me stay ahead of the competition, I have to get a new swim coach/supplier.  If I ignore the “Do not swim in shark infested waters” sign I may need to get a bigger sign or put up larger barricades.  Identifying risk from interested parties can keep our organization healthy and safe.
When you believe in your organization strongly enough you will see that Identifying, Assessing and Mitigating the RISKS to your organization is something that you will grow to appreciate.
See You in 2015 and enjoy your safe swim.

Thursday, July 17, 2014

ISO 9001:2015

SO NOW THAT YOU FINALLY UNDERSTAND THE
9001:2008 STANDARD,
"LET'S CHANGE EVERYTHING"
As you have probably heard, the ISO 9001:2008 standard is being revised to the ISO 9001:2015 version. Now don't get too nervous! Although the changes are significant, when you see the modifications and improvements to the standard, I think you will be genuinely excited! Currently the new ISO standard is in Draft mode. The Final Draft will be published in September of 2015. It is our strong recommendation that organizations do not make changes to their quality management systems until the formal standard is released in 2015.

Over the coming months, ICH will be spotlighting one clause of the new standard each month, providing a sample of what we anticipate in the new standard. We will be highlighting not only the significant changes but also what your organization can do to be prepared and ensure a smooth transition. ICH will be on the front lines with you to offer support for you in the trenches.

Along with these monthly articles, ICH will be offering, tools, whitepapers, webinars, seminars, training material and courses. Many of these will be available at no cost. So make it a point to follow our newsletters and  Visit our website for more information!  
See you in 2015!