Archive for the ‘The Quality according to the ISO 9001 2008’ Category

Dedicated to ………

Tuesday, March 9th, 2010
  • Category association
  • Producers
  • Traders
  • Importers
  • Locators
  • Hirers
  • Services importers with instruments
  • And to all those for who it does not care

There is a “Cinderella” among all the Directives that could become (we hope) in the mother of all the Directives: it is the 2001/95/CEE Directive.

To this it is related the DL 21 May 2004 n° 172 that indicates the receivement in Italy and how to apply the 2001/95/CEE and also what are the sanctions for the trasgressors.

Everyone who think to be able to put in the market with stupid tricks products that are dangerous or unsafe, may read both the Directive and the DL very accurately.

Here there is a little part of the 11 Article:

  1. The fact is a very bad crime and the producer or the importer that put in the market dangerous products in contrast with the prohibition in article 6, comma 2, letter e) is punished with the arrest for an year or with a fine from 10.000 euro to 50.000
  2. The fact is a very bad crime and the producer or the importer that put in the market dangerous products is punished with the arrest for an year or with a fine from 10.000 euro to 50.000 euro.
  3. The fact is a very bad crime and the producer or the importer that does not respect the rules in the article 6, comma 2, letters b), numbers 1) and 2), c) and d), 1) and 2), is punished with a fine from 10.000 euro to 25.000 euro.
  4. The producer or distributor who does not collaborate to the activities in the article 6, comma 2, letter a), has to pay a fine from 2.500 euro to 40.000 euro.
  5. The fact is a very bad crime and the producer who does not respect the dispositions in article 3, comma 2, 3, 5, 7, 8, 9 and the distributor who does not respect the dispositions in the same article at the comma 6, 7, 8, 9, have to pay a fine from 1.500 euro to 30.000 euro.

We do not think we have to write more, neither for the transgressors nor for the controllers.

Everyone has to take his own responsibilities.

“Quality” in everyday life

Sunday, March 7th, 2010

I thought a lot before writing these few lines but nothing will change if nothing changes and so I hope to help someone for a better quality in our everyday life.

Our social relations and the education are aspects of a big model that the society has created.

The rules may be different between Countries ore cultures, but courtesy and respect are present in every society, in every country and in every time, at least between equals. And because in our occidental society we considered to be equal, respect and courtesy are characteristic of a good social relation.

So we can not accept that the basilar rules of respect and education are forgotten in social relations, mostly in the web.

I hope that everyone of us know that a dialogue begins and ends with a greeting and that, if we have to ask someone for something, we have to be gentle and to say “Please” before asking.

Maybe it is not clear that under an e-mail address there is a person like us that would like to be greeted.

We do not know why to accept request like: “Imported ship from America 33feet what to do and how much does it cost the CEE mark” without anything more (and it is only one of the examples).

We sent them back to the sender as the anonymous telephone requests; maybe these persons are unaware of asking without permission and courtesy.

Our web pages are open and we like to have new guests, but those who are not educated are gently accompanied to the exit: also this makes better the quality of life

I thought a lot before writing these few lines but nothing will change if nothing changes and so I hope to help someone for a better quality in our everyday life.

Our social relations and the education are aspects of a big model that the society has created.

The rules may be different between Countries ore cultures, but courtesy and respect are present in every society, in every country and in every time, at least between equals. And because in our occidental society we considered to be equal, respect and courtesy are characteristic of a good social relation.

So we can not accept that the basilar rules of respect and education are forgotten in social relations, mostly in the web.

I hope that everyone of us know that a dialogue begins and ends with a greeting and that, if we have to ask someone for something, we have to be gentle and to say “Please” before asking.

Maybe it is not clear that under an e-mail address there is a person like us that would like to be greeted.

We do not know why to accept request like: “ Imported ship from America 33feet what to do and how much does it cost the CEE mark” without anything more (and it is only one of the examples).

We sent them back to the sender as the anonymous telephone requests; maybe these persons are unaware of asking without permission and courtesy.

Our web pages are open and we like to have new guests, but those who are not educated are gently accompanied to the exit: also this makes better the quality of life

Sil, who was this man?

Friday, February 19th, 2010

We quote from Manzoni and Don Abbondio to remind that Italian is still our language and that the use of abbreviations, while simplifying the scripture, very often creates confusion or misunderstandings.

In fact if we may mention the CEI, many will read Italian Episcopal Conference, others will read electro technical Italian committee, so abbreviations can often be treacherous.

When they are clear they are a language for experts and since many wish to be experts, we look at the proliferation of acronyms, which are taken from English and then are used in Italy, forcing the translation and then the interpretation.

Let us return to SIL, which is the level of integrity of the system. It is not so much dark.

Looking at rules and directives we understand that it is absolutely useful to know the level of safety of a system and its level of integrity and sometimes it is necessary to evaluate the safety of what we use. Then why do we not try to simplify and make clear the languages?

The answer is simple. Technicians, also the good ones, are concerned with resolving the problems, to make sure machines and security systems, but they do not worry if they are not understood and they do not care in speaking a common language. This way each person can become important in its own back yard, almost as in politics.

Discovering after many research and studies that what in service would refer to RESS (essential safety requirements and health) corresponds, also if not directly, to SIL means discovering that the problem of security is common to all the productive and social sectors, and so it would be more useful and convenient for us to have a single language!

Clearly for the technical is not worth the same logic because they divide up the knowledge and have them evolve in watertight compartments. In addition of being a source of prestige this is also a source of profit, but the person who pays is always the consumer!

And the consumer pays in terms of money and pays also in terms of security, because if they make complicated what is really simple, it means that in the end nothing is applied and we found situations in which the RESS are unknown to the mechanics and the SIL is unknown to electronic.

At this point, a compliment to the engineers and especially to those who have the task of creating and disseminating the safety rules, it is absolutely essential!

This is a quotation from a colonel in force in 1976: -The army management is made in order to make it difficult the easy through the unnecessary-. And we add: -not only there-.

CE marking, Standards ISO 9001 which reports?

Wednesday, January 27th, 2010

We have already in various forums, on the site qualitiamo, on encolo blog, expressed our opinion on the disaster which in Italy we have managed to do with the ISO 9001.

We have transformed a great opportunity, which had origin in top 100 us immediately after war, passing through the development of the most advanced Japanese industries, to get to us, a rule which had as principal objective the satisfaction of the customer in a chaotic set of unnecessary procedures and pre-packaged forms and copies.

Who knows the business issues has the situation clear, because after a first period of euphoria, which led many to spend high figures and the same regions to finance unlikely projects, we moved on to find that are not modules and cards that improve the management, and we have reached today to a sense of generalised refusal and widespread scepticism.

Who writes for years has ceased to be as consultant for ISO 9001 to draw attention on the effectively control and improvement of management, using in practice the most useful criteria specified by the standards, almost in silence and without advertising it within the companies.

Of course, the ISO (someone still cite the 9002) has influenced many employees, such that almost daily, when for the CE marking we need to have the procedures for control of production (FPC to put it likes to so many consultants, the clear objective to speak between similar), many are asking:-but then do we need ISO?-

No, clear and categorical answer. Procedures are the way of working which companies have because they produce all days, and are not related to ISO, so to make the CE marking, they do not need ISO or other documentations.

It is important to Work well, with constant attention to safety and health of anyone who produces and of those who use the product. All the rest are things that you do with good sense, a bit of commitment to learn new things and especially to understand them.

Are we damaging ourselves? No, we are realistic, sincere and honest.

CE marking, ISO 9001 and other “amenities”

Monday, December 14th, 2009

Dealing in this site with the CE marking, we wonder if it is appropriate to spend some line about ISO 9001 and thanks also to the interest shown by the friends of the site Qualitiamo, we decided to talk about quality. Then one day we will open a blog dedicated only to this, but for now we use this space.

We have talked of shortcoming detectors in the system of quality management and we have mentioned the incorrect application of the CE marking as a sign of a deep problem in the application of ISO 9001. This concerns companies with the obligation to CE MARKING the products, let’s see now another “detector” which concerns all the companies without distinction.

In many certified companies a subject that creates confusion and doubt is that of the management of the documents of external origin and fortunately the new edition of the regulations has made something more clear.

However it remains the problem of identifying these documents and then the problem of how to treat them and the fact is that very few companies apply the protocol of the documents in entry, considering that this is a bureaucracy more suited to a public body that to a private company.

Well, if there is something to copy from the management of entities is the protocol of the documents and the management of the budget, and while of this last it would be too complicated to speak in here (because it falls in the logic of quality) on the protocol it is appropriate to spend a little time.

How can a company establish on which documents intend to base its work if it does not identifies them? Those which are producted within thw system, thanks also to business programs and to the correct management of the computer documents, are treated properly, but how can be used those which come from the outside if they are not even identified?

So if a company does not perform the protocol of the entry documents we can conclude without fear of contradiction that its management system has a big problem and if they are certified, then the problem is also present in the certification body.

Our experience suggests that the 90% of the certified companies that we know does not apply the protocol of the entry documents. We are faced with two assumptions: are we unfortunate or actually the certification method applied is very elusive?

Those of you who deal with applied quality can see.

CE marking, the litmus ISO 9001

Friday, December 11th, 2009

The litmus test is a so simple and useful instrument that its significance has exceeded the limits of Chemistry and today it is also used in common language to indicate a simple way to discover some particular aspects of something.

Obviously it is not sophisticated, but when we see a chromatic signal it means that it has identified something.

Can we find something similar in the field of quality? Or better, is there a way to demonstrate that a management system of quality is not managed correctly or even worse, that a certification was “granted” also if there are serious non-conformity?

Yes! The answer is called CE!

When an organisation decided to adopt the management system of quality respecting the ISO 9001 2008 (Ex 2000), they must follow the mandatory standards, which should be respected anyway, but in this situation the conditional is not permitted.

Therefore to check immediately, simply and effectively if there is a’ hole‘ in the system, a non-conformity criticism, it is sufficient to investigate the presence or absence of CE marking on the products if it is provided.

It would seem obvious that in the presence of mandatory standards operating for the safety of the product organizations are in accordance regardless whether ISO 9001 2008, but it is not.

Who writes met lots of companies with management system for the quality, certified by notified bodies, which not only did not mark the products correctly, but in some cases they did not even mark them.

Is it possible that notified bodies, which in some of their operational areas also provide the service of the EC certification of the product, do not monitor the application and the respect of the directives on CE marking? Yes! strange, but possible.

This is one of many warped aspects of ISO 9001 IN ITALY, where it’s easier to buy a title that studying; but not everywhere: in other countries there are controls and the criterion is that controlled and controllers cannot and must not have common interests and common objectives and that circumventing law costs much more that respecting it.

Perhaps also here someday to say ISO 9001 will mean talking about quality and not only of cards, taste for the well done and not sick for unnecessary modules. Perhaps.

ISO 9001 2008 and EC mark

Thursday, December 10th, 2009

The new version of the ISO 9001 2008 is in for us better than the previous, because it clarifies some points that before had to be interpreted during the works. So now we can work better.

That said, a little for us and a little to stimulate some curiosity about this provision which many consultants have contributed to ridicule during these years transforming it from excellent opportunity to unnecessary illusion and expensive disappointment, let’s see if it deals something with the EC.

ISO 9001 and the EC depart from the same point: quality is not or is not only benefit, the quality is the respect for what was expected, so for both is important the model, the project or the reference standard.

For the ISO the point of departure is what you want, in general with corporate targets, in particular with the activities of process, for the EC the point of departure are the Directives and Harmonised standards, but the criterion remains the same for both.

We can say that the CE marking is a species of ISO9001, also if restricted, but with contours well defined by laws, directives and regulations, and the same time it can be assumed that ISO9001 includes automatically the CE marking, as this is governed by binding rules (those famous that often some do not identify).

Another common aspect of these two systems is the fact that they supplies guarantee of respect towards a model, they provide security but they do not certify the “quality”. This means that we can have a safe product but with limited benefits, we can have a company with a good system of management, but in bankrupt

Then what are they FOR? We can not confuse the necessary with the sufficient, because to manage a company as to make the marking we must necessary things, but these may not be sufficient for the prosperity of the company or the success of a product. To obtain these last objectives we need to introduce the criterion of Total Quality, but this is another story. Perhaps we will talk about it another time.

Quality, we speak clearly.

Thursday, December 10th, 2009

I took part in some forums and at some conference on the subject “quality”, and I had the impression that in addition to the “politichese” in our country is born the “qualitatese”, as many other “ESE” that each restricted group tends to create.

I manage to understand the need to have a group, that for negative facts is called Branco. I also admit that it is not always easy to find simple terms to all the arguments, but the search for simplicity in the communication should be a method and not an option.

Already regulations are written in “normatese” and the reason is that they are the maximum level of compromise. I speak as ex component of Commission UNI, and therefore who has to use them and must “implement” them, not applicate but implement, would have to make them easier to a public that already has very difficult to read them.

In fact if it is true that we do not read as we would have to do also of arguments of our choice, think what may be the approach of the wood craftsman to the various points in the ISO 9001 which should show the quality in the production process.

Of course, we must not lower the level of all because some are down, but I would remind the motto of the Greek fleet when it was the undisputed ruler of the seas, first of Imperial Rome:-we have the strength to navigate the speed of the slower ship.

If in our daily work in contact both with the theoretical quality written in the rules and the quality practice produced by the millions of people who work with commitment we could create a thread which colleagues them and makes it clear that they are not helping anyone being “each against the other”, perhaps there would start a constructive work.

Certainly more constructive than writing procedures or instructions which are more inspired by the desire to put the slings to the world than to improve the quality of the products, of the work and to the bottom of life.

The objective quality of the rules is inspired by the good sense and not by the rigid bureaucratic, it is supported by the will to do well and not by the need of filling out forms and it is rewarded by the customer satisfaction and not from the weight of the cards.

Following the virtuous circle “plan do check Act”, which translated in practice means 1- plan, design, think before doing, 2- do, work, construct as you planned, 3- check, verificate, test, 4- correct if there is something inconsistent with what you expected and resume the tour, you get the quality.

In order to show without cheating that we have followed this virtuos path it is necessary to formalise, that is writing the more important things. It is not necessary, because it is a useless cost, to write Treaties that explain the profound causes that have generated a loss of the value of 1 euro.

There is another explanation that adapts to all the “ESE”, and it is the desire to speak a coded language that only few followers can understand and which does not spread culture but division, with the aim of discrimination and make money.

Well, I put these hypothesis on one a plate of a balance and on the other side ethics and then let’s see what happens.

Start speaking clearly and to act clear; if professionals refer to ethics, then we expect to see it, to measure it, to count on it. Too expensive ethics (for the other) is no good in the end its rejection is only a matter of time.

Once upon a time

Sunday, December 6th, 2009

Do someone remember a provision that was called vision? One of the advantages of the age is to have seen many things, a disadvantage is that you forget them.

Returning to the vision, it was the first version of norms ISO 9001 and it spoke extensively of vision (also in the name) and mission. Now it seems that as many other futility (as the Lecciso) these terms belong to a distant past.

I must confess, that the first time I met these terms in technical publications, as the rules I was perplexed, then by deepening this subject with documents I found not in the Sacred Texts of standardisation, I understood and I was convinced of the goodness of this approach, but in the meantime they changed the name to the rule.

Perhaps rightly someone thought that in a country in which everything is for sale, from driving licences to degrees, from seats in Parliament to Quality Certifications, talking about topics that concerned the more high ambitions of men and also of companies was a loss of time.

Moreover the same end has made the term “ethics” that for a bit has animated the national debates, as well as “independence information” and “political correct“, but this speech would lead us out of our framework or to put it to Lucarelli;-this is another story-.

Let us return to vision and mission, these terms represent ( I do not use the past) the first: the more longer objective, the more important ambition, the enterprise port of destination, while the second: the way to operate, the objectives in short and medium terms, the intermediate ports.

To make practical examples, which of course a “serious” standard never makes,a vision is the achievement of a leading position in the market, the conquest of an image of excellence at the own customers, a mission is the satisfaction of customers, the reliability of the suppliers, the happiness of workers.

Now, if these are vision and mission they belong both to companies and people, in all places and in all time, on the condition that at the basis there are values. And it is on this point that perhaps rules do not have time, desire and competence to enter, that are the values that should always be the basis on which we build a company as the unfolding of life.

But talking about values within the business world and not only that brings us immediately to discover our deep contradictions, one for all: Christianity and the human over-exploitation.

Few want to accept their contradictions and to define the values that inspire all their activities and lives because it is much better to be free to move in all directions.

However, however, HOWEVER, if it is true that making quality is to be able to respect a project, a planning, a commitment, then what quality can born from an activity that has not determined the basic values on which it should be based? How will it demonstrate that the success achieved is exactly what it wanted? And the customer satisfaction is really important, also more of its economic interest?

Well, without values we can get efficient products, appreciated services, exceptional economic results (also Madoff has obtained them), but the satisfaction of having truly achieved the objectives, the confirmation that our most ambitious projects were correct and were well made, we can never obtain them.

Values, vision and mission have left their place to terms and arguments more “concrete”. Better to speak of things that can be touched and measured, infact what ISO wants is to make everything measurable, but there is a small problem: what is the unit of measurement of honesty? and that of respect? And for last, how can we measure the freedom?

These are the arguments that it would be appropriate to approach with talking of quality, risking to seem “strange”, but finally talking about the quality of life. Or maybe it is better to have a mobile phone that can do everything and a life of s…? To you the choice.