ASQ CQE Certified Quality Engineer – Section II – The Quality System (16 Questions) Part 2

5. 2C-1 Quality Standards and Other Guidelines

Subsection two of the body of knowledge of CQE was the quality system. In this we have talked about the elements of quality system and the documentation in previous two subsections. Now coming to two C of the body of knowledge which is quality standard and other guidelines. So what we are going to learn in this subsection is ISO 9001, the history of that, some background of that, some high-level overview of ISO 9000 system. And then in addition to that, we will also look at the quality awards and we will focus on the Malcolm Balkridge National Quality Award. So this is what we are going to cover in this. So let’s start with ISO 9001. So when a company gets certified to ISO 9001 standard, what are the parties involved around that?

Let’s look at that first. So here you see there are three layers which consist of the certification body, the accreditation body and the International Accreditation Forum or the IAF. So these are three layers of confidence for ISO 9001 certification of a company. Let’s say you have a company and you go for a certification. So what you need to do is you contact a certification body. Certification body is also known as the registrar. So you contact the registrar, you award them a contract and they are the one who will come to your organization, do the audit and give you a certification of compliance that this company complies with ISO 9001 requirements. So this is the certification body or the registrar. This is a third party auditing company. And this evaluates your system based on ISO 9001 and issues a certificate.

What are the companies doing this? BSI, SGS, TUV, InterTech, there are a number of companies which do this type of job. So these are the companies which you contact when you want to go for ISO 9001 certification. But then who monitors these certification bodies? These certification bodies are monitored by accreditation bodies. Each country generally has a single accreditation body and these bodies certify the certification bodies. Let’s say you have anab. INAB is in America which basically monitors all the certification bodies which are issuing certificates to the organization. So Enab is in the USA, ukAS is in the UK, and then Standard Council of Canada for Canada and so on. So each country will have one accreditation body. And then on top of all these accreditation body, there is a global organization which is International Accreditation Forum which is IAF. And this is a voluntary association of accreditation bodies. So that’s the symbol of that IAF.

So once you look at an ISO certificate of any organization, generally you will see two of these logos. One logo will be for the certification body who is the organization which did the audit and issued the certificate. So you will see one logo of the certification body and then you will also see a logo of the accreditation body. If your certification body is accredited to an organization and most of the time, this should be so this was the overview of ISO 9001 certification organizations. So if you look at this in another way here you can see that you have an organization.

On top of that, you have certification body. On top of certification body, you have an accreditation body, and then you have international accreditation forum IAF, and below that, you see the standard to which these comply to. So a certification body will evaluate the organization based on ISO 9001 accreditation body will evaluate the certification body based on 17,021, and IAF will accreditate the accreditation bodies based on 1711. So these are the standard which they use to evaluate each layer of these organization. And together, this gives a confidence to the consumer, to the user that this particular company has a stable quality management system.

6. 2C-2 ISO 9000 Series of Standards

At times you will see that instead of referring to ISO 9001, people refer to ISO 9000 series of standards. So what are the standards which are included in this 9000 series? In 9000 series, we have these standards which are listed here. The first one is ISO 9000, not the 9001, it’s ISO 9000. ISO 9000 gives the fundamental and the vocabulary, the definition, the terms. This is what is given in ISO 9000 and this was issued in 2015. Another main standard is 9001, ISO 9001 2015. This is the one against which organizations get certified to. So 9001 certificate is issued to companies for complying to the requirement of this standard.

The previous version of this was 2008, and then this was revised recently in 2015. And once a standard gets revised, you have a certain period of time till you can use the old standard. So, a period of three years was given to the organizations who were certified to 2008 version of the standard. And that term is ending in September 2018. So, after September 2018, the only standard an organization can get certified to is 2015 version of 9001. So this is the second standard in the series of ISO 9000. The third standard is ISO 9004. ISO 9004 is a guideline. This gives a much better perspective how to use ISO 9000 and how to take your organization to the next level. So basically, this is a guideline to achieve sustained success.

But the companies do not get certified to 9004. So this is just a guideline. That’s something which you need to understand. The third standard here is 19,011. It doesn’t look like 9000 series, but this is the standard which gives the guidelines related to auditing the management system. So still I will prefer to have this standard as a part of 9000 series. That 19,011 is the standard for auditing the management system. Not only the quality management system, but other management systems as well. This was very recently revised in 2018, just a few days before I started recording this lecture. So that’s when this was revised, in 2018. Prior to this, the version was 2011. So, these are four main standard related to ISO 9000 series of standards.

7. 2C-3 ISO 9001 Revision History

Previously, when we talked about ISO 9000 series of standards, we said that 9001 is the standard which organizations use to get certified. So this is the key standard in that series. This standard was revised in 2015. We talked about that earlier as well. So in this slide, I just want to give you the history or the revision history of this standard. Standard was first issued in 1987, then revised in 1994. In both of these standards, which are 1987 and 1994, there used to be 20 clauses, but that system is gone now. After 2000 standard now you generally have eight to ten main clauses.

So 2000 was issued with a major upgrade and 2008 was the standard which was with the minor updates. Then in 2015, the latest version of ISO was issued. So there are some major revisions in this standard which was issued in 2015. In next few videos, we will talk about this change, what has happened, why this change has happened and what are the key changes which has happened from 2008 version two, 2015 version let’s start with why there was a need to revise that. What were the key issues behind this change? Let’s look at that in the next video.

8. 2C-4 ISO 9001:2015 Reasons Behind the Revision

Let’s look at some of the key reasons why this standard was revised from 2008 to 2015. Here is the brief summary of the reasons behind the revision. First thing is the reduced documentation. And second key factor is multiple management systems. Let’s understand these. ISO 9001 somehow has become a documentation thing. Like people started thinking that you need to have a lot of documentation for having ISO 9001 standard. So emphasis is more on documentation rather than being on actual quality. So this is how ISO 9001 got perceived as by people. So, in this standard, the emphasis was to reduce the need of documentation rather than focus on what is important, which is delivering value to the client rather than just generating documentation.

So this is one reason behind this new revision, which is reduced documentation. The second key factor is multiple management systems. So with time, number of management systems have been introduced, we have a quality management system, you have a safety management system, you have an environmental management system and so many others. So, ordination which are having multiple certification for these multiple management systems, they need to have different documentation for each of these management systems.

So, what was done here was to create a common structure for all these management standards, so that there is a less emphasis on documentation, so that the documentation gets streamlined. And with that in mind, a common structure was developed for all management systems. We will talk about this in a little bit more detail as we go further into this lecture. So here you can see the multiple management systems. So, you have 9001 for quality management system, you have 14,001 for environmental management system, and then there is a 18,001 which was recently changed to ISO 45,001, which is the ISO standard for occupational safety and health, which was recently published in March 2018. Then for medical devices, you have a 13 485. For automotive production, you have 16 949 for aviation and space, you have as 9100 and so many others.

So, the intent here in this standard was to have a common structure. And what was that common structure? Let’s look at that. So this is Annex SL. Annex SL is a section of ISO directive. Part one. So let’s not go into too much of details of what ISO Directive part One is and all those things. Let’s focus that one annexure of that which is NX SL, gives the standard way of writing a management system which has identical core text. The clause numbers are identical. Then there are common terms which are used by all these standards.

The definitions are common in all these management systems. So that’s how the management systems were sort of a standardized. So this Annex SL will help in aligning the different management systems standards. So this was Annex SL. So ISO 9001 was aligned with Annex SL, which was a standard way of writing a standard. So that was the background of why this standard was needed to be revised. In next lecture, let’s talk about what are the key changes in ISO 9001 2015 as compared to 2008 or major changes has occurred? Let’s see that on the next video.

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