"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

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

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