The ISO 9001:2015 Champion

“The credit belongs to the man who is actually in the arena…”

Theodore Roosevelt

My heart goes out to those in the Management Representative roles within healthcare organizations.  Many of you have literally spent years getting your organizations to the point where they are just now comfortable with the ISO 9001:2008 standard, and wouldn’t you know it, someone kicks sand in your eyes. When you open your eyes again, you are confronted with a brand new standard.  You’ve paid your dues, trained your leadership staff, educated your management staff, communicated to employees and trained auditors. Now you can look back and finally say, “I’ve come through it!”  You’ve committed no crime and yet now that September 2015 is upon us and the inevitable release of ISO 9001:2015 looms on the horizon, I know what you’re thinking.  “I’ve served my sentence.” 

 I truly do feel your pain and am living through it with you, only a few months ahead of schedule.  I can imagine some of the questions that must be going through your mind.  “How do I get trained on this new standard?” “How do I train leadership, managers, employees and my auditors on this new standard?”  “How do I make this fit into my budget for 2016?”  “Where do I find the time not only for myself, but all of the other staff?”  “Where can I even get my hands on the new standard?”  If you are hyperventilating, take a deep breath and allow me to put a little perspective on what’s to come. 

Although the new standard has raised the bar on organizations wanting to set themselves above and beyond the competition, not everything has changed.  So what has stayed the same?  Many of the day to day operations of patient care and support processes have remained relatively unchanged.  Many of the performance requirements, for monitoring, measurement, analysis and improvement (although increased slightly at the foundation) remain true to the previous standard.  Internal audits are still required.  So in a nutshell, you don’t have to start from ground zero and go through the whole process again, and you don’t have to spend a fortune.

ICH has developed the ISO 9001:2015 Standard Overview Champion Course for those organizations who have already gone through the process of developing a quality management system to the requirements of the ISO 9001:2008 standard.  This course is designed to train the participants to a complete knowledge of the new and existing requirements of the new standard.  It is an excellent course for those Internal Auditors who are now very familiar with auditing and need to know what the new requirements bring to the organization and how to audit to the new requirements.  Are you looking to train yourself as the management representative/”ISO Champion”?  Do you need to bring your department managers up to speed on their role in the organization?  At ICH, we have specifically designed this course to be a compliment to what your organization already has in place.  The Champion Class is a very concise course over two days to give you and your entire organization the knowledge base they need to move forward in the development of their management system. 

I know that ISO 9001:2008 has not been a bed of roses or a pleasure cruise, but the good news is that you are not starting from scratch when you implement the revised version.  Consider the new standard a challenge and get started today.  If you don’t know where to start, give us a call. It is our passion and privilege to support hospitals on this journey.

Woody Conway

RISKY BUSINESS

ICH achieves ISO 31000 Risk Management Certification

“It isn’t the Risk that scares me, it’s the uncertainty that comes with it.” Anonymous

“Healthcare”

You don’t need to google that word very long to come to the clear understanding that this industry has to deal with an incredible amount of “risk”.  Just looking at some of the terms that healthcare professionals use on a daily basis will give you some insight; risk manager, adverse event, sentinel event, near miss, high risk drugs, wrong site/wrong patient/wrong procedure, infection prevention and control, unanticipated death, patient safety system, physician rehabilitation, infectious blood, radiation protection, nuclear medicine, informed consent, restraints and seclusion, hazardous materials, emergency management…all this from page one.  As I have developed newsletters, webinars and class materials on the ISO 9001:2015 Standard, I can’t help but become overwhelmed by the stated and implied requirements for the identification, analysis and mitigation of risk and opportunities.  So it shouldn’t come as any great surprise when I began to realize that this new standard is significantly raising the bar and work load on healthcare organizations when it comes to dealing with risk and opportunity.  Here at ICH, we need to change the way we do business if we expect to assist those who have chosen to be our clients in changing the way they do business.  How will we help organizations who encounter risk on a daily basis control, mitigate and eradicate all the risks they encounter? 

That question led us to ask ourselves another, “How do we propose to help organizations navigate their way through all the current risks that they encounter, especially in light of the ever looming prospect of a new revision to the ISO 9001 Standard?  The answer was to do that which we would encourage our clients to do: seek out and learn from the best of the best.  Enter the ISO 31000 Risk Management Standard.  We realized very quickly how integral this standard can be for an organization when coupled with the understructure of a strong and sustainable business management system.  We saw how the 31000 standard fits hand in glove with the 9001 standard’s latest revision.  We came to grips with the fact that organizations who truly understand risk management need not be concerned with the changes in the new standard, but should embrace it as a wonderful tool to stop the madness that healthcare risk imposes on each and every person in the organization.  As healthcare organizations travel through their journey from compliance, to performance, to risk mitigation and finally to opportunity, this standard walks by their side, providing the guidance needed to see hope become reality… the hope that “we truly can make a difference on the face of healthcare in America”. 

It is with this thought in mind that I am very proud to announce that ICH has become the first healthcare organization to achieve certification to the ISO 31000 Standard in the United States.

We look forward to bringing all that we have learned to your organization at your request.  Healthcare has always been a “Risky Business”.  However, at ICH we hope to remove a little of the pressure from your shoulders. 

Woody Conway

For more information on the 31000 standard or 31000 consulting services contact:  Rebecca Detling

937-569-4134  

rdetling@ich-global.com

High Performance

It is our strong recommendation that organizations do not make changes to their quality management systems until the formal standard is released in 2015.  
                           
My son just bought his first vehicle at the age of 15. His pride and joy is a 1995 Jeep Wrangler. No, he doesn't have a license but at the age of 15 ½ he has a learners permit and has graced the streets and sidewalks of our fair city with his presence. Performance Evaluation, section nine, is one section of the new ISO standard that I can truly say I am living out each and every time my son takes me for a training drive. I failed to mention that the Jeep Wrangler is a stick shift. On our way home from purchasing the vehicle my son was insistent and resolute that he knew how to drive a stick shift. After all, how hard could it be? You just Clutch, Shift, Gas and away you go..... so he proclaimed and I, being the good father, tried to inform him that it was a lot harder than he thought. If you have a child you will know that sometimes they just have to learn for themselves. So after thirty minutes of nagging, I pulled down an old farm road, parked the Jeep in some poor soul's driveway, and allowed my son to give it shot just to shut him up. After seven times stalling the Jeep and creating a crater in the farmer's driveway my son turns to me and says, "Dad maybe you better drive the rest of the way home." He had evaluated his performance and the empirical evidence led him to some immediate correction, corrective action, and preventive action all under the watchful eye of Top Management, Me.

Section Nine of the ISO 9001:2015 standard simply stated is, how we as a healthcare organization evaluate our performance as we traverse the highways and bi-ways of patient care, organizational advancement and continuous improvement. Just like my son driving a stick shift, section nine gives us four areas where an organization needs to focus: 1. The Clutch, Customer Satisfaction; 2. The Shift, Data Analysis; 3. The Gas, Internal Audits; 4. The License, Management Review.   
 
In the new standard Customer satisfaction primarily remains the same and once again maintains precedence for the organization to evaluate its quality management system. Here is a very interesting change in the verbiage. The organization shall monitor customer perceptions "of the degree"to which requirements have been met. Did my son get the Jeep into first gear? Yes, but the white padded whiplash collar might indicate that my requirements for a safe trip were not met to the degree that I had anticipated. Our patients may leave the hospital healthy but did they hate the experience? To what level or degree of excellence have we met our customer's requirements? Anticipate this change to necessitate value data. Another interesting change is that the organization shall obtain information relating to customer Views and Opinions of the organization and its products and services. You can anticipate a change to the wording of this requirement but not the intent. This requirement is very objective in its nature but the information "Real to our Patients" is very subjective to the success of our organization. My son's opinion of his driving as you might imagine is far greater than mine, however it is I his customer, whose opinion must grant permission for him to drive. So it is with hospitals. We may think that we are doing a great job and have the data to prove it but the objective opinion becomes subjective reality as our patients venture on to the hospital down the street. Now that we have the clutch in, let's shift gears.
It is in the analysis of data; the factual based decision making that allows any organization to shift from one level of excellence to another. This requirement is reflective of the ISO 9001:2008 requirement but now the requirements have been expanded. We have seven gears that we can use to propel us to the next level. The Analysis and Evaluation section states that the outputs of Analysis and evaluation shall be used to:   a) Demonstrate that our services provided to our customers are conforming b) Enhance customer satisfaction c) Ensure our QMS is effective          d) Achieve the objective of our business planning e) Determine the level of performance of our processes f) Determine the level of performance of our suppliers, vendors, contractors g) Find opportunities for improvement. It is my opinion that the accreditation and certification bodies will expect to see some evidence presented for each of these requirements. So now we have it in gear let's release the Clutch and Give it some Gas.

You will be happy to hear that for the most part the Internal Audit process remains the same with negligible changes to terminology, so we will move on to the last portion of section nine, the Management Review.
Just like that gas pedal that my son seems to be so fond of, Management Review is truly what is designed to propel the organization to success. While many of the requirements are verbatim from the 2008 version we want to highlight the most significant changes or the high octane requirements. In section 9.3, Management Review, it is now required to provide objective evidence in the minutes that changes in external and internal issues that are relevant to the QMS, including its strategic direction, are included. What does that mean, Woody? If you will recall when we first started this journey together in section 4. 1 and 4.2, we identified our own hospital context (what on the inside of our hospital are our strengths and weaknesses) and the needs and expectations of our outside interested parties were. Now it is time to see where we are succeeding, at risk, or have opportunity to excel as it pertains to those items identified. For our relevant interested parties if our performance, trends or indicators show that we are not meeting their needs, then these issues need to be brought to the attention of top management and action taken, as appropriate. Brand new to the management process is the inclusion of information or issues concerning external suppliers. The last and most intriguing requirement for me is the inclusion of the effectiveness of actions taken to address risks and opportunities. If you will recall back in section six, we were to identify and react to risks and opportunities within the organization. Now is the time for top management to see how we did and how effective our actions were. Now that top management has a plethora of information as to the status of the QMS, if can effectively allocate the resources needed, the gas if you will, to move the organization forward.

If you walk through section nine of the ISO standard step by step coordinating your activities and processes you will find that clutch, shift, gas might be tricky at first, but over time and with practice, you will find that you stall out less and less frequently.

Hope this helps.

White Knuckles on the Roll Bar

Woody