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

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

Putting all the Pieces Together

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

I love jigsaw puzzles.  Almost every vacation my family takes includes a brand new puzzle, which my family and I will spend the quiet moments assembling.  I have a confession to make; I steal the last piece long before the puzzle is ever done.  There is just something about bringing all the pieces together, that in and of themselves’ has no true image or meaning, but when combined make a beautiful picture.  The reality is that each of my children and my wife contribute to the masterpiece just as much as I, but as the family’s “TOP MANAGEMENT” person I get to put in the last piece. It probably wouldn’t surprise anyone that my children have begun to replicate the process of stealing a piece, so at the end there are six pieces missing and a battle ensues for the placement of that final piece.

In section 7 “Support” of the ISO 9001:2015 standard we see the same puzzle coming together to help present the organization in its best light.  The good news is that, as far as significant changes in implementation, there are few.  Infrastructure and Work Environment remain virtually unchanged.  If you are an ISO geek like me, you may have noticed the note in 7.1.4 that Environment can include physical, social, psychological, environmental and other factor.  Don’t get too excited about trying to maintain and control social and psychological factors at this point.  They tried to put this same language into the 2000 revision of the ISO standard, but it never made the cut.  I suspect that it will quickly disappear in this version as well.  

Calibration remains primarily the same with the exception of the defining characteristics of when an organization implements full and traceable calibration.  In the 2008 standard the deciding factor is, “Where necessary to ensure valid results…..” in the 2015 standard the factor is, “Where measurement traceability is: a statutory, regulatory, customer, interested party, or organizational requirement.”

Training and competency remains the same, although the 2015 standard has extended the language.  The new standard incorporates items such as the quality policy, relevant objects, etc., into this section called Organizational knowledge, Competence and Awareness.  

The very end of section 7 is where one would find the most significant change to the standard.  Document Control and Record Control no longer exist as two separate requirements, but have been combined into what the standard is calling “Documented Information”.  Don’t let this throw you off.  Here are a few clarifying notes, “a peak at the puzzle box” to help you put it all together.

1.      There are only two statements directing the organization as to what documented information needs to be controlled.  (ISO required & Organization Required)

2.      There is no formal requirement for a Quality Manual or the ISO 9001:2008 six required procedures.

3.      The only definitive (called out by name) requirement is for a Quality Policy and Quality Objectives.

4.      The term “documented information” has replaced “documented procedure” as the identifier as to when the requirements for the control of documents and records is to be implemented.

5.      All the requirements in section 7.5 “Documented Information” can be applied to either a Document or a Record, however, as you are reading this section you will see that section 7.5.1,2,&3 most closely resembles the old document control and section 7.5.3.2 most closely resembles the old record control.

As you read through the new standard and begin to turn the pieces over from the blank side to the picture side, I am confident that you will breathe a sigh of relief. Before your eyes the puzzle will begin to show a picture that the intent of the standard has not really changed much.  The box of pieces has been shuffled, but the picture on the box remains the same. 

What we must keep in mind is that there is just something about bringing all the pieces together, that in and of themselves’ has no true image or meaning, but when combined in the right place, makes a beautiful picture. Each member of your team will contribute and hopefully you will not have any “piece thieves” along the way. This puzzle will require all members of the “family” to work together in contributing to the final piece of the puzzle placement! 

Last Piece Thief

Woody

Avoid Titanic Failures with ISO 9001

Titanic Failures

             ISO 9001:2015 standard:ISO 2015 Life Preservers-On Sale Now!

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

White Star Line: Titanic

The story of the Titanic is amazing and great movie. So many things could and do go wrong and have such cataclysmic effects. When you look deeply into the story and history of the Titanic, the question surfaces, "What were they thinking?" Here are just a few of the things that went wrong some you may know, some you may find quite prophetic as you and your organization plan for the ISO 9001:2015 transition.

-Only 20 lifeboats.

-Compliant with code for a 10,000 ton ship, there was no documented code for a ship of 46,000 tons like the Titanic.

-There was only 6 - 7 hours of testing and never at any testing at top speed for maneuvering.

-Life safety training only involved lowering two life boats, giving an inaccurate time of evacuation.

-Binoculars and Searchlights were in short supply.

-State of the art Marconi wireless telegraph system had just a few people trained to operate and/or receive messages.

-There was a fire in the coal bunker that started just prior to the voyage and took several days to extinguish. It is believed the fire may have weakened part of the ship's hull, which aided in the sinking.

-Four cautionary warnings of ice were received between one to six hours prior to the collision.

So why all the statistics and the history lesson? It's in the history that we learn what mistakes not to make.

The ISO 9001:2015 standard has gone to great lengths to encourage an organization to take a long hard look at what the risks and opportunities are and then to proactively respond to them. Section 6 of the ISO standard ties all risk and opportunity assessments together into the planning process for mitigation or continual improvement. We can no longer only look within our organization for threats and opportunities for advancement; we must also look at the empirical data that surrounds our context for avenues of success.

The very first requirement of section 6, requires organizations to include issues (Risks and Opportunities) identified in 4.1, understanding the organization and its context and 4.2 needs and expectations, or interested parties in their quality management system planning. If you had been on the board of directors for the White Star Line, the creators of the Titanic, what would have gone into your planning process?

6.1.1 a) Would 6-7 hours of testing at partial speed given you the assurance that your organization could achieve its intended results? The assurance the ship would safely arrive?

6.1.1 b) Would 20 lifeboats although very much compliant with the "Codes and Standards" of the day, met your criteria to prevent, or reduce, undesired effects?

6.1.1 c) Would the revolutionary Marconi wireless telegraph system have shown evidence of achieving continual improvement?

What would you and your organization have done differently, given the opportunity? What would your strategic plan for success have addressed?

6.1.2 a) Would you have taken actions to address these risks and opportunities, maybe purchased a few more binoculars and search lights?

6.1.2 b) Would you have delayed the launch to integrate, implement and evaluate the effectiveness of the lifesaving protocols?

Any one singular action take to address the known risks would have either decreased the number of lives lost or could have potentially prevented the collision with the iceberg altogether. Section 6.1 closes out the section on Quality Management System Planning with a wonderfully freeing statement. "Actions taken to address risk and opportunities shall be proportionate to the potential impact on the conformity of products and service".

You may feel your organization is just waiting for an iceberg to come floating along and all is lost. However, all is not lost, yet; can you take just one small step today? Start by identifying the biggest risk and begin to address it. Find the easiest risk to correct and address it.

Prior to the voyage, if the Titanic had adequate equipment and supplies, proper testing and training, cautionary warnings heeded and safety plans practiced, many lives could have been saved. If the voyage had been delayed to extinguish the fire in the coal bunker of the Titanic, the great movie may have had a much different ending!

The ISO 9001:2015 standard is only asking you to assess and address those things that could sink you and your organization, to ensure a desired ending.

ISO 2015 Life Preservers-On Sale Now
Woody Conway, ICH Lead Trainer
RABQSA Certified Lead Auditor

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.