Future ISO 9001 Variations: "Lighter" and "Higher Level" Versions?

Sidney Vianna

Post Responsibly
Staff member
Super Moderator
#1
From http://isotc.iso.org/livelink/livel...5883/Activities.html?nodeid=3554104&vernum=-2

That consensus had not yet been reached on how best to position a future ISO 9001. A number of options had been put forward, including for a 3 part series of standards, to include a “lighter” version of ISO 9001, a “current level” version of ISO 9001, and a “higher level” version of the standard. Other options included allowing for a wider ranging version of the standard, with more extensive “exclusions” being permitted. There did seem to be a general feeling that a “lighter” version of ISO 9001 was not a favourable option, but that other options should be considered for the incorporation of “higher” level requirements.
 

12stones

Inactive Registered Visitor
#2
I don't know that this differentiation of levels is necessary for ISO. Where it's been determined necessary to increase the impact of a quality system, new standards have been created by inserting the additional requirements such as ISO 13485. The initial purpose of ISO 9001 was to create a base level of standardization. If it's determined that ISO 9001 isn't effective in its current state due to not having strict enough guidance or requirements, then the standard should be revised so that it will be deemed more effective in its implementation and practice. If ISO 9001 is sufficient in meeting its intent, then let the industries that require stricter or higher level controls state them in their current standards or create new ones that are based on ISO 9001 as has been done in the past. Just my $0.02.
 

treesei

Inactive Registered Visitor
#5
This is interesting. For couple of years I have been building something similar but of course not official. I am a supplier quality engineer in the medical device industry. From my experience I believe that it is almost necessary to allow deviations of 9001 to both "higher" and "lighter" directions to build a practically usable and effective supplier base. I have put my thoughts into an article which is under review for publicaion.
 

somashekar

Super Moderator
Staff member
Super Moderator
#7
:agree1:
Standard should not be played to the gallary unlike movies or stage shows. Standard must be just one right standard, which the industry or enterprise must map suitably and according to their business requirements. It is then the duty of the CB to assess and do the bit to provide directions to improve it from the assessed situation.
With one standard now, we have seen so much dilution that good industries just do not recognize the certification from any CB. They make their own choice and when it comes to supplier's status, they even resort to customer audit in spite of supplier being certified.
 
G

George Weiss

Guest
#8
Just a view/opinion, obviously:
A super-light version would get my vote so that a great deal of fence sitting organizations might consider the move into this ISO controlled world. It would be like a McDonalds dollar menu. I am sure that some form of involvement might be better than complete rejection of certifying the ISO methods and ways. I know a very effective defense supply company whom to this day is not ISO, and operates with one set of calibrated gage blocks. They know their business, and customer’s shaking their heads come back due to the good work done.
 

howste

Thaumaturge
Moderator
#9
Countless unofficial light versions already exist. They're called self-declaration of conformity. In this scheme, a company gets the full version of the standard, they implement some of the requirements (that they choose), then they claim they are conforming to the requirements of the standard (with no independent verification).
 
G

George Weiss

Guest
#10
As I walked the dog this morning a good profiling thought lit up. I can see the sole proprietor of a small business sometimes not wanting to jump to ISO 9000 because he is fine with the way things are without outside review. I am guessing that ISO is a good thing and works within organizations which are operating not for the owner, but for the representatives of the owner, who might want metrics, (or your word), for their jobs and conventional methods to govern their processes. So an ISO 9000 light method as just mentioned is a good current route. I would put such a tag on the quality wall of my small business to get a foot in the door. :agree1:
 
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