Newsgroup: it.discussioni.iso9000
Titolo: integrazione alle risposte alle domade sulla ISO:DIS 9001

Riporto le risposte (un po' lunghette)  avute da un altro newsgroup
(l'unico dal quale ho avito risposte) in merito alle mie domande sulla
ISO:DIS 9001 inviate il 15/05, ad integrare quelle avute da Giuseppe Bove e
Gianni Burani.
Ciao, Paolo.
1) Posted by Bryce E. Carson, Sr. on May 27, 2000 at 21:17:14:
2) Posted by Ray on May 26, 2000 at 11:45:58:
1) In Reply to: 8 questions about ISO/DIS 9001:2000 posted by paolo on May
26, 2000 at 09:34:21:
Paolo;
You have asked good questions. I currently am a member of the ANSI Z1.11
Technical Review Committee. We are currently revising and reviewing the
Z1.11 guideline document so that the 1994 guideline standard will meet the
new ISO 9001:2000 requirements. I will attempt to answer you questions as
best as I can. 
I have been following the new Standard since the first issue of CD1
(Committee Draft) through to the now DIS (Draft International Standard) I
disagree with Rays assertion that it is too early. He stated that your
inconsistency concerns are probably best addressed to your nation's
representative body, who will probably be glad to have them. As I have
stated it is to late. Voting terminated April 25, 2000.
Several registrars in the USA have issued dual ISO 9001:1994 (accredited)
certificates and ISO 9001:2000 (unaccredited) certificates. For your
information, voting on the DIS ISO 9001: 2000 document terminated on April
25, 2000. This means that we are nearing the end of the process. Having
lived through the transition of the ISO 9001:1987 to the ISO 9001:1994 as a
Vice President for a registrar, the same questions about when to apply the
new standard surfaced. 
Our consulting firm is currently implementing the draft standard at several
of our healthcare and manufacturing clients. One of our clients will
undergo registration in September and the registrar has agreed to assess to
the ISO 9001:1994 and ISO 9001:2000. Therefore, I feel that I am qualified
to answer (or attempt to) answer your questions.
Your Question 1) Why is chapter 7.1 (Planning of the realization processes)
ahead of all the others (from the 7.2 to the 7.6), leading to believe that
the planning refers to all these processes if in the appendix B.2 the
equivalence does not include also chapter 4,3, 4.4, 4.6 of the 9001:94? 
Clause 7.1 becomes the foundation for the remainder of Element 7, which is,
the planning of the organizations process management. The title Product
Realization is the term used to cover the delivery of a service or the
manufacture of a product or a combination of the two. 
In the first sentence we find the key to the entire Element 7: Product
realization is that sequence of processes and sub processes required to
achieve the product (service). You are correct in that the remainder of the
items in Element 7 may be processes that need to be planned within your
quality management system. Remember when you are planning you will need to
identify what your objectives are for your product or service, how the
resources will be provided, what processes are to be used, how these
processes will interact with each other, what monitoring and verification
methods will be used and how the results will be recorded. Contrary to your
posting, Appendix B2 in fact does address 4.3, 4.4 and 4.6 of ISO 9001:1994.
Your Question 2) If the planning relates to all the processes (and not only
the 7.5), how do you validate the supplying process (for example?) 
Good question. Clause 7.5.5 Validation of Processes refers to “Special
Processes”. In laymen’s terms, this Clause identifies what you do when you
cannot measure the results of your process. 
As you are aware there may be some processes and associated product and/or
service where a measurement (inspection) to confirm that the product and/or
service meets specified requirements cannot be carried out unless we
destroy the product (i.e. welded product) or disrupt the service (i.e.
surgery).
To overcome this problem that standard allows us to use trained and/or
qualified operators or “qualified processes”. You asked how one would
validate the supply process. That is a pretty broad question. For many
service industries, the service provided is instantaneous. This does not
readily allow inspection or monitoring before delivery of the service.
Therefore, a validation (qualification) would need to take place.
If your company is supplying products, then you probably have the
opportunity to monitor the process and inspect the product prior to
delivery, therefore you PROBABLY (and I am assuming that you supply
product) would NOT need to validate the supply process. 
Another Example: one of my consultants is providing consulting services to
a client and provides advice. Failure by the consultant to assess and
interpret information received from the client correctly or to take into
account potential negative outcomes is likely to be discovered only after
the client has attempted to use the information supplied by the consultant.
Therefore, my firm must validate a process of giving advice and qualify and
train consultants. 
Common processes where validation (qualification) may be necessary;
welding, soldering, heat treatment, brazing, pathology lab, x-ray,
nondestructive examination, etc.
Your Question 3) What it is a device of measurement and monitoring, or
which is the difference between a measurement device and a monitoring one? 
Clause 7.6 – Measurement device – i.e. gauge, micrometer, thermometer,
oscilloscope, multimeter, caliper etc.. Monitoring Devices – fetal monitor,
heart monitor, blood glucose monitor etc. There is no difference here
between the two. They both follow the same requirements for calibration.
The word monitoring equipment will assist organizations such as hospitals
and clinics better identify which equipment may require calibration.
Your Question 4) How can I tare a monitoring device? 
The same way you would a measuring device. They may be required to be
calibrated as well.
5) Why the citation, in several chapters, to point 5.5.7 is made in way non
consistent (there is reference to the 7.5.2, but not to paragraph 8.2.2, is
to the 8.2.4, but not to the 8.2.3 or the 8.5.2)?
I am not sure I understand your question. The Clause 5.5.7, Control of
Quality Records, is referenced throughout the new Standard the same way
that it was in the ISO 9001:1994 Standard. In the 1994 Standard many
references are made to (See 4.16) implying that a record of that activity
is required to be maintained. 
Likewise in the new Standard we see (See 5.5.7); this also indicates that a
record is required to be maintained for that activity. A real concern of
mine is that the DIS ISO 9001:2000 Standard does not require the
organization (in other words it does not say See 5.5.7) to maintain records
of Nonconformity or Internal Audits! This is scary.
6) What is the difference between a deficiency please see 8.2.2), a
nonconformity (8.3) and a problem (8.5.2)? 
Clause 8.2.2 is Internal Audit – Deficiency – This is the same as the 1994
Standard. Wording is the same so I assume this will not change in the
upcoming Final Draft. 
Clause 8.3 is Control of Nonconformity – Nonconformity - This is simply the
nonfulfillment of a requirement 
Clause 8.5.2 is Corrective Action – Problem – The same words used in the
1994 Standard. My spin? They are the same! 
No difference in theory. 
7) Why after much emphasis on the necessity of monitoring of customer
satisfaction, chapter 8,2,1 recites "... to monitor the information on
customer satisfaction and/or dissatisfaction..."(it seems obvious where
most of the companies’ choice will focus on)? 
The organizations we are working with implementing ISO 9001:2000 are using
BOTH. We are trying to IMPROVE! I guess some organizations will cut corners
and will only use customer satisfaction as their tool. Too bad! They will
be the loosers in the long haul.
8) At paragraph 7.2.1 letter "c" the respect of the legal obligations
towards a Customer becomes a requirement; how is the situation managed with
the co-operation of a mediator (also Internet)? 
I am not sure what you mean by “mediator”, but our clients that are
implementing ISO 9001:2000 have defined Clause 7.2.1 legal requirements in
terms of internal customer and regulatory imposed requirements (OSHA, State
Audits, HCFA, DEA, FDA etc.). 
Palo, I hope that this has helped somewhat.
Best regards,
Bryce E. Carson, Sr.
www.qualityparadigms.com
2) In Reply to: 8 questions about ISO/DIS 9001:2000 posted by paolo on May
26, 2000 at 09:34:21:
Overall, Paolo, the first thing to consider is that 9001:2000 is still in a
pre-release stage. That is, it is not final. Your inconsistency concerns
are probably best addressed to your nation's representative body, who will
probably be glad to have them. Your national body may already be addressing
similar concerns. 
: 3) What it is a device of measurement and monitoring, or which is the
difference between a measurement device and a monitoring one? 
This one I can give a clear answer on; the basic difference is that a
measurement represents a specific point in time, a monitor covers a period.
One common reference may be, the oil stick in your auto engine is a
measuring device, your fuel gauge is a monitoring device. In the industrial
setting, a measuring device will give a specific reading which an operator
will note in a log, perhaps... and a monitor will keep a continous log.
--
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 Clause 8.5.2 is Corrective Action ? Problem ? The same words used in the
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