ISO 9001: 2015 - Introductory elements (Part 1)

  

In this post we begin an analysis of the ISO 9001-2015 standard, and we will be identifying first what in other previous posts I have called “the context” of this standard, to later analyse "the text" of each one of the specific requirements that make it up this document.

If you are establishing, or intend to establish, a quality management system in an organization in compliance with this standard, or more importantly, you dedicate or want to dedicate yourself professionally to the field of quality management supporting other organizations to comply with this ISO 9001 standard, it is very important that you know and properly understand each of the requirements of this standard, either to comply with each of them correctly, or that you can offer a valuable consulting service or technical support to organizations that they work in one or some economic fields. Otherwise, you should rely on someone who can provide that support.

Personally, over the course of a few decades, I have met hundreds, and I could say thousands, of people whose professional performance is related to ISO 9001 standard and, in general, I have seen that what I mention in the previous paragraph. Most of these people have been concerned with knowing and understanding the requirements of the standard, but not more than that.

However, I have mentioned in this blog that if someone wants to correctly comply with a standard, it is important to know not only the requirements of that standard, but also its complementary elements, which are what make up its context.

As an example of this, I will tell you an anecdote about something that personally happened to me. When the promotion of quality schemes in compliance with ISO 9001 standard began in Mexico, I had the opportunity to lead the technical coordination of the first certification body that was accredited in Mexico to certify quality management systems. The group that carried out the accrediting evaluation of this body performed reasonably well, but made what has been one of the most common mistakes made by those who carry out evaluations and audits of management systems, which is to consider that if they do not come out of that assessment or audit with some documented nonconformity, customers will may think that the process was not complete or deep enough. In this evaluation group that I mentioned before, when they did not find any nonconformity that justified their work, it occurred to them to document a nonconformity, which they considered critical, so this body did not deserve to be accredited. What these evaluators did not know, but fortunately I did, was that they were mistakenly basing that nonconformity on the accreditation standard requirement (back then, Guide 62 ISO-IEC) with No. 0. Introduction.

As I mentioned, fortunately I knew, because I had been concerned with understanding the structure and information that standards must contain, that when a standard contains an element, or Clause, named Introduction, generally this one is not part of its technical content, so in that case should be assigned the number 0, or with no number at all. That simple detail helped us to get rid of that ill-founded non-conformity and we obtained, after that scare, the accreditation in a simple way.

In relation to people who work on a daily basis with the ISO 9001 standard, very few of them take care for knowing and understanding "the context" of said standard. That is, they usually know "the text" of the standard's requirements, but not the context of using those requirements, which sometimes leads to very costly mistakes in developing a quality management system.

Due to this importance, we will begin the analysis of this context of the ISO 9001 standard, based on its Foreword, which describes the organization that has issued this international standard, indicating which part of its structure, this is the technical committee and its subcommittee responsible for preparing this standard, as well as some basic elements for its structure and drafting.

It tells us that ISO (International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is usually carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

It explains that the procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html. This point is important in order to assure that this kind of standard is not considered as technical barrier to trade.

The committee responsible for this document is Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 2, Quality systems.

This fifth edition cancels and replaces the fourth edition (ISO 9001:2008), which has been technically revised, through the adoption of a revised clause sequence and the adaptation of the revised quality management principles and of new concepts. It also cancels and replaces the Technical Corrigendum ISO 9001:2008/Cor.1:2009.

With all this information, you can find out who develops this standard, under what criteria, what is the current version, among several other elements that you can access in greater depth.

Regarding the Foreword of the Spanish version, it indicates that this International Standard has been translated by the Spanish Translation Task Force (STTF) of the Technical Committee ISO / TC 176, Quality management and quality assurance, in which participate representatives of national standardization bodies and representatives of the business sector from the following countries:

Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Ecuador, Spain, the United States of America, Honduras, Mexico, Peru and Uruguay.

Likewise, representatives of COPANT (Pan American Commission on Technical Standards) and INLAC (Latin American Institute of Quality) participate in the aforementioned Working Group.

This translation is part of the work that the ISO / TC 176 Group has been developing since its creation in 1999 to achieve the unification of terminology in the Spanish language in the field of quality management.

This translation work, if another language is used in your country, is not transcendent, but for the countries where the Spanish language is spoken, it has been a very important work, because, originally, the standards issued by the ISO are in three languages: French, English and Russian. For publications in other languages, the necessary translations must be made. In the case of these countries where the Spanish language is spoken, those who had an interest in ISO standards, carried out the translation corresponding to the first two versions, and it really seemed that each of these standards was translated into a different language. And this caused the concept of an international standard to be lost. The Mexican standard "equivalent to ISO 9001 standard" was very different from the Chilean standard "equivalent to ISO 9001 standard", and both were very different from the Colombian standard "equivalent to ISO 9001 standard", and this was repeated for each country. For this reason, it was very important that, starting in 1999, this Spanish Translation Task Force (STTF) working group be created within the Technical Committee ISO/TC 176, Quality management and quality assurance, since 2000, when the Third version of this standard, all Spanish-speaking countries have the same text. 

In the following post, I will analyse the Introduction element of this standard.

Author:

Ernesto Palomares Hilton