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
