“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)

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