“A Deeper Dive: ISO 9001:2015”

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

As a certified diver, there is probably nothing more satisfying and thrilling than seeing all of your training and preparation pay off as you gently glide through the water with harbor seals and sea lion pups frolicking and dancing around you, begging you to play.  As a father of three certified divers and being obsessively compulsive about their safety, getting to the play portion can only come after the safety portion.  I have personally sat through the training program three times when each of my sons became old enough to enter this whole new world of adventure, and therefore I feel that I have earned the right to be in charge of all the rules.  As we in the ISO family begin this brand new adventure into an uncharted world, I can’t help but make some simple connections between ISO and SCUBA.

Before each and every dive there are some safety protocols that each and every “good” diver should go through.  As a diver, you Begin With Review and Friends (BWRF).  This acronym stands for each of the safety checks that you and your buddy check out on each other’s equipment before each dive to ensure a successful dive.  “B” stands for BCD, or your Buoyancy Control Device. Does your flotation device work?  “W” stands for weights. Can you and your buddy easily remove the weights in the event of an emergency and get to the surface?  “R” stands for regulator. Does your breathing device work? No explanation needed.  “F” stands for a final once over for all the gear that will be going down with you to make sure that nothing is tangled, loose, missing, or defective.  You don’t want to get to the bottom and find out something isn’t right.

For our adventure into the deeper and uncharted waters of the ISO 9001:2015 Standard, I want to encourage you to use the same acronym but with a little twist on Begin With Review and Friends, “BWRF”.    “B” stands for Base.  What you have already put in place with your ISO 9001:2008 standard will become the base of your 2015 program.  Do not think that you have to go and start all over again.  You do not have to recreate the wheel.  You would think that this is common knowledge; however, I have already been approached by organizations to help them redo what has already been determined to be effective, efficient and compliant with both the 2008 & 2015 Standard.  In each of the coming months as we discuss how to actually begin to implement the new standard, we will always start with what 2008 has given you as a base before we begin building what 2015 is asking for.

“W” stands for “Woody is right!” Just Kidding?

“W” stands for What.  What does the new ISO 9001:2015 standard actually require?  Already, we have received questions from clients that indicate that people and organizations are beginning to read into the standard requirements that simply are not stated in the standard, but are being drawn out by interpretations.  This can result in far more complex, restrictive and overbearing management systems that in time may prove to be so cumbersome that the organization fails to realize the return on investment for their efforts.  As we journey through the ISO standard, we will take just a few statements to clarify exactly what the standard is saying and what it is not saying.  Hopefully this will keep organizations from getting too deep without enough air to support themselves.

“R” stands for Reason.  Reason will have a twofold purpose in our coming articles.  The first purpose will be an explanation as to some of the reasons why the ISO 2015 standard is requiring what they are requiring. The second and most important purpose will be a clear, concise and logical approach to achieving the requirement.  Many times organization will put in place multiple control features to ensure compliance in every possible scenario at the expense of time, resources, money and much frustration and anxiety.  ICH hopes to bring to the table implementation ideas and concepts that will help your organization fulfill the new requirements without overtaxing the organization and its resources.

“F” stands for Final.  When we say final, we want to ensure that organizations do not put anything in place that is not a good business practice...that if implemented and not a final requirement of the ISO 9001:2015 Standard, would not in any way negatively impact the organization.   With that being said, the final sections of each of the following news articles will focus on where organizations can begin to implement the new standard and not be at risk of putting an unnecessary activity or process in place that is not beneficial to the organization.  We will offer suggestions for user friendly methodologies for compliance.  We will suggest multiple possibilities as to where the organization can use systems that are already in place for compliance.  We will recommend best practices that have been identified across the country in the healthcare industry.  We will do our very best to make this transition to the new standard as painless as possible. And as always, we will be there to lend a helping hand or be a sounding board for any of your questions.

Who’s ready to Dive Deeper?  Next month we cover Management Review and Risk Control.

In over my head and loving it,

“W”

   

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

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