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

The Masters

“You don’t want to overanalyze or make it harder than it is.”

Michael Greller, caddie for 2015 Master’s Golf Champion Jordan Spieth

I came across this quote as I was reading all the great stories of the 2015 Master’s Golf tournament, and it struck me that this is my message in a nutshell to all those wonderful organizations that work so hard at making their facilities better.  You don’t want to overanalyze or make it harder than it is.  As with ISO 9001:2008, the 2015 version of the standard has already begun to cause anxiety among many of our clients.  Not to mention the many frustrations that come with the day to day implementation of an ISO program, such as the bogey of document control, the double bogey of good cause analysis for corrective action or the triple bogey of trying to maintain the internal audit process.  From our beginnings, ICH has strived to be the caddie not only for organizations wanting to shoot “par” as they prepare for accreditation and certification, but also for those organizations wanting to find themselves at the top of the leader board for performance and excellence.

Sometimes it amazes me when organizations find themselves with as many different audit programs as the back nine of any golf course.  And very often, they find themselves struggling just to complete the course of audits they have set in place.  We commonly see Environment of Care Audits, Infection Control Audits, Tracer Audits, Mock Audits, ISO Audits and the list goes on and on.  Is it any wonder that the organization quickly finds itself overwhelmed and 6 over par when the accreditation and certification surveyors arrive on site with their score cards?  As your caddie, ICH is offering you the best “driver” in our bag. 

The Master Surveyor Program

“The Birdie”:  Through the Master Surveyor Program, ICH will endeavor to raise the level of your auditing teams closer to that of a surveyor employed by a registrar or accreditation body, or that would be contracted for a Mock Survey.  ICH will train three clinicians, three generalists and three life safety specialists within your organization.  This provides the organization with three fully trained Mock Survey teams within your own organization to be mobilized at any given time.

“The Eagle”:  In raising the level of your auditing cadre, we anticipate that organizations that complete this course will find themselves to be very comfortable and accreditation ready when the surveyors arrive.            

“Double Eagle”:  Wow, wouldn’t it be great if we could combine all the audit programs within the organization down to one program?  No longer would a hospital have to navigate nine holes in the eleventh hour, just one.  ICH will customize a specific single audit program with your approval that will completely meet all regulatory requirements.  This one system will greatly reduce not only the number of man hours that are spent each and every year to maintain the system and report the results, but also the number of man days required for implementation of organizational audits.           

“Hole in One”:  Here is the best part, return on investment.  It is estimated that the average expenditure of all the audit programs within a healthcare organization is $150,000 dollars per year.  This is not difficult to imagine when you include internal training programs, external training programs, retraining due to attrition, salaries to do something besides primary responsibilities, maintenance of multiple programs, reporting, third party mock surveys and on and on and on.  Just imagine what the cost savings could reach.

If your audit programs have become more of a sand bunker than a putting green, ICH is offering you a sand wedge to help dig you out.

Woody “The Caddie” Conway

P.S. Thanks to my caddie, ICH Team Member Tracey Martin, for his expert assistance with golf references.

For more information, please visit ich-global.com or call 937-569-4134.

"I Love Improvement"

It is our strong recommendation that organizations do not make changes to their quality management systems until the formal standard is released in 2015.  

                           

Do you remember your first computer, your first CD player Walkman, your first boom box, your first cassette player, your first eight track player...should I stop? Change and improvement has a funny way of being quite enjoyable when someone else is doing the work for us, but when it is us that needs to change and improve, it might be a different story. I was giving some guidance to a client just yesterday and from memory rattled of not only the ISO clause down to the letter, but also recited the requirement. Yes, I am an ISO GEEK! I laughed to myself and thought how quickly that is going to change, and I will once again be right back where I was the last time the standard made a major revision. I will be in the same boat with everyone else learning a brand new standard and trying to improve how I communicate the requirements of the standard to my customers. As I think about it though, I am not sure that I would have much respect for a standard that requires continual improvement if the writers did not practice what they preach. Remember when dad would say, "Do as I say, not as I do???" Yeah, that meant a lot. When the ISO 9001:1994 transformed into the ISO 9001:2000, it set the quality management system world on its ear. Everyone was running around as if the sky was falling trying to figure it out. You know what? 15 years later, ISO still stands. I can't really recall what the big deal was, and do you know what else? I don't know how we ever managed without the improvement that the new standard brought. So here we are again, and all I can say is hold on, the ride is going to be fantastic.

Section Ten of the ISO 9001:2015 is all about improvement; improvement from known issues or improvement from potential issues - all in an effort to meet customer requirements and enhance their satisfaction. This improvement can be implemented at the system, process or service line levels.

Section 10.2 Nonconformity and corrective action starts with the known issues. Let's clean house before we try to improve. For the first time, nonconformity has become a single term in the ISO standard. There is no longer segregation between nonconforming product, nonconforming service, customer complaint, internal audit finding, process performance failure or system failures. When bad things happen, we are going to correct them and deal appropriately with the consequences. Next, we are going to ask ourselves if this nonconformity is severe enough that it warrants further investigation to ensure that it does not recur. If it is of a magnitude that could jeopardize the organization, processes or customer then we are going to find out what the true cause of the nonconformity is. We are going to ask ourselves if this same situation has or could occur elsewhere in the organization. We are going to implement applications of control to prevent the nonconformity from recurring anywhere. If need be we might even have to change our quality management system. Never forget that ISO 9001 is okay with making mistakes, but is never okay with repeating them.

Section 10.3, the final chapter or epilogue, brings us to Continual Improvement. It is as if the ISO 9001:2015 standard is saying, "Look we've given you everything you need to make your organization the very best. Now get to it."  

4.1 We understand our Context

                                  Internal and External Risk and Opportunities

4.2 We understand our Interested Parties

                  

                                  External Expectations Risk and Opportunities

5 Leadership is on board

                                        

                                  Supporting, Empowering, and Leading

6.1 We have developed a plan

                                   

                                  Risk and Opportunity is planned

6.2 Actions are taken to address issues                      

                                  Risk & Opportunity is addressed & mitigated

6.3 We plan for change                                              

                                  Change is part of our everyday focus

8.7 Nonconformities are controlled                           

                                  We contain what mistakes we encounter

9.1.2 We know what our customers think                  

                                  We react accordingly to stay ahead

9.1.3 We know what processes are weak                  

                                  We focus our attention there

9.1.3 We know the impact of suppliers

                       

                                  We work together to mitigate risk

9.2 We know where our QMS is weak                       

                                  We change the way we do business

9.3 Management drives us to be better                     

                                  Supplying resources, support, and guidance

10.2 We will make mistakes                                        

                                 Only Once!

All through the standard, the common thread of continual improvement can be identified. Sometimes I wonder if this section should have been the first section of the new revision?

ISO 9001:2015 Geeks Unite!

Woody  

P.S. Watch for "A Deeper Dive into ISO" coming in March!!!

by Woody, the ISO Wizard

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!

ISO 9001 Tips and Advice-Magnitude Level

ISO 9001 Tips and Advice 

Magnitude Level

Twenty years ago when I first started out in ISO the president of the company I worked for made a very insightful evaluation of the ISO 9001 standard. He said, "For years my people have been making stupid mistakes over and over, but with our Corrective Action process now they have to get creative to mess up!" He had captured the essence of corrective action. It's okay to "mess up" it's not okay to repeat it.

The question remains, how do you create a corrective action system that works and not a system that you have to constantly work? The answer is Magnitude Level.

Customer Complaints (required):  
Any customer complaint above “X” dollars to the customer or our organization, any customer complaint resulting in injury to the customer, any complaint that is reoccurs “X” number of time within “X” time frame, any customer complaint that at the discretion of the Management Representative or Management Review team requires formal corrective action.
Magnitude levels can be both Objective and Subjective.
Process Performance (required):
Any goal or objective that falls out of acceptance criteria by less than 5% for less than or equal to two months requires correction.
Any goal or objective that falls out of acceptance criteria by less than 5% for more than two months requires formal corrective action.
Any goal or objective that falls out of acceptance criteria by more than 5% for one month requires formal corrective action.
Now you have a system that my organization can actually live with and will provide return on investment.
Woody
ISO Consultants for Healthcare