Has anyone had a chance to review the FDIS?

Andy I'm just starting to take my training on it from my former employer. I'll let you know

 

Can you help with a copy of the standard please? Did is what I have for now and I have read and read but waiting for the GPS to see the final amendments.

 

I have been able to draft the ISO 9001:2015 QMS outlined chart for implementation with the DIS ready for modification based on FDIS.

 

I don't have it but I'm beginning to sit through BSI's webinars. I'll wait until the final version to buy the standard. My only real point of interest at this time is how it's going to impact companies like mine that carry both ISO-9001 and ISO-13485.

 

I didn't read the changes to internal audit as watering down at all. Rather the reverse. For example, it calls for the audit criteria and scope for each audit to be defined. Importance of processes concerned, changes affecting the organization and results of previous audits are all to be 'taken into consideration' for planning, establishing, implementing and maintaining the program...

 

I did go through the FDIS last week. I will read it again a few times. The main thing that strikes me at most places is about the Internal audit and third party audit. Training about this as I feel must be loaded with case studies. Certainly a challenge to the fair and impartial audit proceedings. The FDIS does make a meaningful impact and looks to give a further push to the TOP MANAGEMENT to understand themselves, and play a progressive part in the management system. (Hope they can see it too)
The context of the organization should be an eye opener to the leadership. This must make them see what can work for them rather than copy styles of different organization and culture. Consultants must come out of prescribing common solutions and formats and assist clients to recognize their context better.

 

I've gone through it. I can see some real problems ahead. If a company wants to use it as a business management tool, it provides a sound foundation. However, if a company is looking for registration due to a mandate and is only interested in obtaining the flag, it is going to cause a lot of pain. There can be a lot of interpretations. As it is, I see too many auditors saying the current 9001 "implies" this or that. It is going to take a while for the dust to settle.

 

I've been going through it with the TAG meetings. By itself, it is shaping up to not be too bad. Being the next version of the 9001....there is some pain. Like Somashekar says, there is a lot more Top Management involvement required. Also, the Preventive Action, since no one seemed to really understand it, was taken out as its own clause, and sprinkled throughout the standard as risk based thinking.

One of the requirements I find peculiar is the Knowledge base sharing. What that clause essentially says is that you can no longer have that Old Joe on 3rd shift who never shares what he knows because he thinks it is his job security. So, now either he shares what he knows or there is risk for a nonconformity.

I've said the following before, and I will say this again: I personally think that those who will find the new version easy will be the companies with a mature 9001 QMS in place already. They will just have to perform a gap analysis of where they need to revise some areas in their own QMS, where to add certain parts, relieved that they can shave off something they hated. They can keep what was working for them and get rid of things they considered bulky and that they were only doing it as a requirement of the standard. The new standard answers the complaint "there are too many documented procedures required" and "this standard has me do things I don't want to do or I never do". A very important thing is that everyone is going to also buy the 9000 update because there are MANY new wordings and phrases and the 9000 is where they are going to be addressed.

New comers will find it a lot harder, especially if they just want the certificate for customer purposes. The 9001:2008 has all of this rigid framework you can build a template off of for doing good business, but the 9001:2015 is trying to be a whole lot more flexible for both manufacturing and service-based businesses. So, there are parts that are not crystal clear on what they should do, and that can lead to getting dinged on requirements they didn't realize they should have had better in place. This flexibility and emphasis on risk based thinking encourages top management to really know their business and help them make decisions based on all interested parties. It should be easier for smaller businesses who know what they do and how they do it and helps to keep everything lean (with their own ideas of how to do it those ways).

Also who will find it a lot harder, possibly the hardest, are going to be the auditors, because they are going to have to really know the system more, the processes more, have to look at fewer checkboxes to tick (do you have 6 documented procedures, do you have a quality manual, etc) and have to look at more process flows and effectiveness of the business itself.

People are chomping at the bit for the FDIS, but I would wait for its actual release. Especially if you have a mature QMS in place. There already have been several changes made from the DIS, and I project we (the US) are going to have a few last comments after the TAG meeting in August that may get addressed with appropriate rationale.

 

I have read the FDIS using various methods. The standard is much more readable through my ISO 9001:2008 eyes, as I understand change from the present framework. The more ambiguous clauses in my view are 4.1 Understanding the organization and its context, and 4.2 Understanding tube needs and expectations of interested parties. I am tempted to ignore the notes in 4.1, as they are TMI without really providing any helpful guidance. Once past that mind-warping area, the FDIS reads pretty well if you already have a mature QMS. The published correlation matrix for ISO 9001:2008 to the DIS still works pretty well for the FDIS.

 

The details in the Planning (clause 6) with the use of direct words is appealing. The use of direct words across the standard is making it simple and effective.

 

Sorry, I meant wait for the official release of the standard, not the release of the FDIS.