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