Total number of Requirements for ISO 9001:2008 vs. ISO 9001:2015

M

Matrix45

#1
Trying to ascertain the workload required to change to the new standard.
Please advise the total number of requirements for ISO 9001:2008 and the total for ISO 9001: 2015.
Also ,AS 9100D-2016 has 106 more requirements than the ISO 9001:2015 standard - Please advise
 
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Randy

Super Moderator
#2
This is a useless exercise mainly because "requirement's" are different between different organizations and the value they place on their QMS

Don't waste time ($) doing this, just compare what you have to what you need and fill in the holes....You may have to change nothing at all
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#3
This is a useless exercise mainly because "requirement's" are different between different organizations and the value they place on their QMS

Don't waste time ($) doing this, just compare what you have to what you need and fill in the holes....You may have to change nothing at all
LOL - I remember going through and highlighting all the "shall"s in yellow back in the late 90's in an internal auditor class.
 
M

Matrix45

#4
Thanks Randy. There are many changes to the new standards and although the transition is simple I need somehow to convince the stakeholders of the organisation the work that is involved. It's no use just identifying the requirements that we are currently working to against the new changes. There are huge changes and even more so in AS 9100 such as the aligning the QMS with the business strategy. Risk assessment throughout, product safety, counterfeit, knowledge management etc . I need at least be a bit more specific....
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#5
Thanks Randy. There are many changes to the new standards and although the transition is simple I need somehow to convince the stakeholders of the organisation the work that is involved. It's no use just identifying the requirements that we are currently working to against the new changes. There are huge changes and even more so in AS 9100 such as the aligning the QMS with the business strategy. Risk assessment throughout, product safety, counterfeit, knowledge management etc . I need at least be a bit more specific....
I would hope that the prospect of aligning the QMS with the business strategy would not require a lot of work or convincing. What have you been doing in your QMS that does not support business strategy (which I am guessing is to supply good and affordable product/service, and make a profit in doing so)?

Chances are good you are already doing most of the things that are different. I find most people just need to learn to take credit for the good things they already do - risk has been a part of our lives in business for a long time.

Does your top management have a business plan? If so, you may not have seen it yet but it probably identifies interested parties.

Does your organization have a business contingency plan for disruptions? If so, you have probably already considered internal and external issues, risks and taken steps to address them.

Randy is right - so much of the rest really has not changed. The language has changed.
 
M

Matrix45

#6
Folks- I don't need expert advice about implementing standards or what needs to be done. I am merely trying to ascertain the total number of requirements (irrespective if they vary between organisations or whether they are "shall" etc.). Surely there must be a number out there :)
 

howste

Thaumaturge
Super Moderator
#8
To me the answer to the question is "what do you want it to be?" There are too many different ways to count the requirements. For example, look at ISO 9001:2015 clause 8.5.5:
8.5.5 Post-delivery activities
The organization shall meet requirements for post-delivery activities associated with the products and services.
In determining the extent of post-delivery activities that are required, the organization shall consider:
a) statutory and regulatory requirements;
b) the potential undesired consequences associated with its products and services;
c) the nature, use and intended lifetime of its products and services;
d) customer requirements;
e) customer feedback.
I count two shalls. Does that mean there are two requirements? Or do I expand it out and count one shall for each of the letters below the second shall because there are five things to consider and call it six requirements in the clause? But a) and c) each have multiple items, so is it nine requirements? :confused:
 
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