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

“On the Eighth Day of ISO….”

“On the Eighth Day of ISO….”

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

My Management Rep. gave to me . . . . No significant changes!  This fact alone will make many people, primarily those in that actual patient care processes, very excited!  Currently, remember the Standard is not final, in the ISO 9001:2015 Standard in Section eight; Operations, there are limited changes to what is asked of an organization.  So rest at ease and enjoy the holiday season knowing that the Eight Maids a Milking will continue to Milk just as they always have.

However, there are the “Five Golden Rings” for operations that you may want to take a peek at before the holiday rush.

The planning of service provision will have precise requirements for implementation. The intent is to resolve the risks to an organization defined in section six of the Standard.  What we do as we implement our processes must now be inclusive of planning, and carrying out our processes to deter issues within the organization. (8.1) 

One unique change in determining the requirements related to patient service provision is a distinct call out for the organization to ensure they meet the defined requirement, and substantiate any claims they make for service provision.  I am not sure how this will shake out in the healthcare world, but organizations should begin to think about what they promise patients, in regards to the services they provide. (8.2.2)

The materials or purchasing process in the new standard is now inclusive of outsourced processes, just as if they were a supplier of any other stock item.  This means that the criteria for evaluation, selection, performance monitoring and re-evaluation apply to all product or service providers.  This goes even one step further in including suppliers that provide product or service directly to your patients on your behalf.  This is where those six geese might lay an egg that we are not fully prepared for.  So how do we deal with these six geese?  Here are the six eggs the ISO standard is asking you to communicate to “ANY” supplier: (8.4)

·         Product or Service we are purchasing

·         How said product or service is approved

·         Any qualification service providers need

·         Any interaction with the QMS that the vendor may need to control

·         How their performance is going to be monitored

·         Any onsite inspections/surveys the organization intends to perform at the vendors premise

Customer Property has now been expanded to include property of external providers.  Simply put, if we damage customer or vendor product we are responsible to let them know.  I would hold off on setting up any kind of processes to notify vendors of damaged product due to the fact that this may be one of those areas that may fall off in the final draft of the standard. (8.5.3)

I told you that there were no significant changes to operations, however, if you will recall in the 2008 Standard, Nonconforming Product was not a part of operations. It was included in the measuring, monitoring and improvement section of the Standard.  It has moved into the operations section and with one significant change.  Let me caution you as you read this next section not to get too scared, overwhelmed, excited or exacerbated.  This is a section that is going to cause a lot of discussion as to the intent and the expectations and implementation for the Standard is in a certified organization.  Let the dust settle and wait, wait, wait, for the final version to be released. Remember a bird in the hand is better than two in a pear tree.

Let me outline this for you so as to present clear understanding:

·         ISO 9001:2008            NCP required identification and segregation of bad product and                                        product means product.

·         ISO 9001:2008            NCP requires a record of the actions taken for nonconforming                                           product to be maintained but that was for product only.

                                   (1 Record)

·         ISO 9001:2008            Process failure was governed by 8.2.3 Measuring and Monitoring                                     of Processes and subsequently 8.5.2 Corrective Action.

                                   System failure was governed by 8.2.2 Internal Audits and                                                   subsequently 8.5.2 Corrective Action.

                                   Service failure was governed by customer complaints and                                                 subsequently 8.5.2 Corrective Action.

                                   These last three only required a record if the magnitude level                                      was such that formal and complete corrective action was                                                         determined to be necessary by the organization.

·         ISO 9001:2015            Is not only inclusive of all the requirements for nonconforming                                          “product” but is also inclusive of Nonconforming process                                                   outputs and Nonconforming services.

Here is where the new Standard is going to get all the ISO lords a leaping.  Question? “So does that mean that I have to have both a NCP records and a corrective action record for every nonconforming product?  Process Failure?  Process Performance Failure? Customer Complaint?  System Failure?   

The Answer is simple, but requires patience.  The answer; wait until the dust settles. Most likely there will be some significant changes and/or clarification to this portion.  If it were my QMS, I would not touch NCP or Corrective Action until I had the final “Gospel” version-gave to me. (8.7)