Advice needed for ISO 9001:2000 update to 2008

B

blue moon

#1
Dear Friends

really i implement a system for ISO 9001:2008 based on old procedure for ISO 9001:2000

and really i am not take care for some changes like


For quality manual

Objective of QM are
a.To define the scope of Quality Management System including details of and justification for any exclusion.

b.To establish documented procedures for the Quality Management System or reference to them.

c.To define interaction between the processes of the Quality Management System.


where in ISO 9001:2008
define interaction between the processes is changed to determine interaction between

already i make a flow chart to describe the intection but i still using words define instead of determine


is it a problem for me can raise non conformity or observation ? because we have no time to change, can we go for the final audit as it is ?

=====================================================

also if we didn't have outsources process must i mention this at the QM ? or no need ?

attached file for QM if you can revise it with me if i go a good

Regards
 
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SteelMaiden

Super Moderator
Super Moderator
#2
Re: Advise needed for ISO 9001:2000 update to 2008

I think that the easiest thing you can do is go to the bottom of this thread and look at some of the past discussions we have had on this subject. Or try a search for more discussions. There is a wealth of information there, but the basic answer is that there really were no significant changes. Most were minor wording changes that don't do much to affect the intent of the standard.
 
B

blue moon

#3
Re: Advise needed for ISO 9001:2000 update to 2008

Thanks Mr.

Already I read it but I was hoping to get OK from our members.

Another question:

We didn't have any outsourced processes and in old QM we didn't refer to any thing about outsourced process and how we control it because we didn't have any outsourced process.

Is it right ? Or must I explain?

Thanks.
 
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somashekar

Staff member
Super Moderator
#4
Re: Advise needed for ISO 9001:2000 update to 2008

thanks Mr.

already i read it but i was hopping to get ok from our members


another question
we didn't have any outsourced processes and in old QM we didn't refere to any thing about outsourced process and how we control it becuase we didn't have any outsources process

is it right ? or i must explain

thanks
The standard at 4.1 says : " Where an organization chooses to outsource any process .... "
So if you do NOT outsource you are OK. You do not need to say in the Quality manual that you do not outsource anything.
But make sure by a good process review that indeed no process is being outsourced.
 
S

samsung

#5
Re: Advise needed for ISO 9001:2000 update to 2008

thanks Mr.

already i read it but i was hopping to get ok from our members


another question
we didn't have any outsourced processes and in old QM we didn't refere to any thing about outsourced process and how we control it becuase we didn't have any outsources process

is it right ? or i must explain

thanks
IMO, if you don't outsource any process "that affects product conformity to requirements...." you don't need to explain it.

Revisit your system, check with the definition and explanation given in the standard and make sure that your assumption is absolutely OK. There are certain activities which are generally outsourced but go unnoticed when it comes to addressing them within the QMS, e.g. printing/ labeling of packaging material, fabrication work, transportation/ distribution of products, Training, Consultation etc. etc.

Make sure that all such activities are done internally without any external support.
 
B

blue moon

#6
Re: Advise needed for ISO 9001:2000 update to 2008

thanks friends

are calibration and training always treated as outsourced or may be consider them as buy a services and then it will be services purchased " 7.4 purchasing " ?
 
B

blue moon

#7
Re: Advise needed for ISO 9001:2000 update to 2008

and please if you can revise the manual for me
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#9
Re: Advise needed for ISO 9001:2000 update to 2008

<snip> ...also if we didn't have outsources process must i mention this at the QM ? or no need ? <snip>
In the 'old' ISO 9001:1994 days it was expected if not specifically required by verbiage in the standard that the company address every clause in the standard *somewhere* in their QMS documentation (not necessarily in the quality manual its self). If someone knows where it was specifically written, or if I am off track here, please correct me, but I went through years of "Show me where you at least say you do *not* do outsourcing or statistical techniques". One 'stock' statement back in those days was something like "We currently do not outsource any of our processes, but in the future should we do so we shall establish appropriate controls and amend this document".

Since the 2000 version came online the issue of at least addressing clauses or parts of clauses in the standard that you do *not* do went away (once the older auditors were brought up to speed). That was an aspect of the old 1994 (and 1987) times that I thought was pretty stupid. Luckily it has gone away.

Statistical techniques used to be a sticking point in the same way. I worked with a number of small companies back then that were so small, and their processes so simple, that 'statistical techniques' wasn't something they did. Many didn't even have a computer in the early days. Part of the problem was in defining what statistical techniques were. These days even small companies use one or more types of statistical technique(s) (often just spreadsheet analysis of different aspects of the business) so that issue went away.
 
B

blue moon

#10
Re: Advise needed for ISO 9001:2000 update to 2008

thanks for all really i thank you very much

but i have small question becuase you have more experinece than me in audit

i make the objective of competences procedure
1.To determine the necessary competence of personnel performing work affecting product quality.

Personnel performing work affecting conformity to product quality requirements shall be competent on the basis of appropriate education, training, skills and experience.

where i use product quality not conformity to product requirement.


is this may lead the auditor to give NCR becuase i use some words from ISO 9001;2000 not ISO 9001:2008

and if the competence procedure was mandatory? it will be different ?


thanks
 
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