Delving into the differences between ISO 9001 and EN 9100

In this episode, we talk with Gaëlle LeBouar about the differences between ISO 9001 and EN 9100 and how they complement each other.

ISO 9001 certification signifies a company's commitment to delivering consistent quality products/services that meet customer expectations based on the seven principles of ISO 9001: customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision-making, and relationship management.

Specific to aviation, space, and defense (ASD) products and services industry, the IAQG 9100 standard (EN 9100, AS 9100, and JIS Q 9100) provides definitions and topics to address sector-unique requirements. Important topics within 9100 include operational risk management, configuration management, control of externally provided processes/products/services, and nonconformity treatment process.

We explain the distinction between the 9100 ICOP Scheme and the "traditional" scheme. Additionally, we learn how OASIS (Online Aerospace Supplier Information System) plays a crucial role in sharing accurate supplier information and simplifying the certification process.

Being ISO 9001 certified demonstrates a commitment to quality management, while the 9100 certification specifically validates compliance with aviation, space, and defense industry standards.

Listeners will gain insights into the significance of ISO 9001 and 9100 in quality management, particularly for aviation, space, and defense products and services sector.

More about our guest:
Gaëlle LeBouar

·      Quality performance manager for ArianeGroup
·      IAQG Vice Lead for PSCI  
·      EAQG sector lead for PSCI
·      International Document Liaison (IDL) for the 9163 standard 

Transcript

The Quality Horizon – Differences between ISO 9001 and EN 9100 

[00:00:00]  

Susan Matson: Greetings everyone, and welcome. I'm your host, Susan Matson, and with me today is Gaëlle LeBouar. Gaëlle is the Quality Performance Manager for the Aaron Group. Additionally, she is the IAQG Vice Lead for PSCI. As well as the EAQG sector lead for PSDI. In addition to that, one more thing she has is the IDL, which is the International Document Liaison for the 9163 standard. Gaëlle welcome to the show.  

Gaëlle LeBouar: Thank you, Susan.  

Susan Matson: Thank you. Gail, one of the reasons why we're talking today, not too long ago, we were discussing the differences between ISO 9001 and the EN 9100. And what I'd really love to do is continue that conversation with our listeners, if you don't mind. 

Susan Matson: But before we dive [00:01:00] into those differences, I want to cover some basics. So first, if you could, please describe to me what does it mean for them to be an ISO 9001 certified supplier? 

Gaëlle LeBouar: ISO 9001 is international organizations for standardizations. So 9001 is a standard which is the basic of quality management system. For your questions, first of all, I shall explain what does ISO means. ISO means International Organization for Standardization. These organizations has written standards to support industrial, to create a quality management system. This standard [00:02:00] is the ISO 9001. The intent of the standards is to get a criteria and organizational requirements to build their company management systems. 

Gaëlle LeBouar: These systems should help them to deliver products and service, which will meet their customer requirements. And this is a standard which can be used by any organizations, a small companies, a medium, or a large, regardless of its own field activity. That's why this standard is used all over the world. It's used over by over 1 million companies [00:03:00] and we can find ISO 9001 certified industry in more than 170 countries. 

Susan Matson: Wow, that is a global baseline for standard is, and certification, so what are some of specific sectors or the industries that, that use those standards?  

Gaëlle LeBouar: So the standards gives the baselines to support the industry, but I mentioned, it gives the first pillar, for each field. 

Gaëlle LeBouar: Indeed, each industry has its own specificity. That's why the ISO has developed a range of other documents based on this ISO 9001. [00:04:00]  I can give several examples. The ISO 13485, which is for medical devices. We can find also the railway applications through the ISO 22163. We can find also the ISO as base of the petroleum industries as well as for software and for electoral organizations at all level of governance. They have the standard ISO 54001, which is also based on the ISO 9001.  

Susan Matson: So, how does the aerospace, the aviation space and defense industry come into play with this? 

Gaëlle LeBouar: So the other industry, yes, we [00:05:00] found a good content of requirements in the standards. 

Susan Matson: Aviation space and defense industry, very specific, as medical devices, whereas, petroleum they're all very specific as our industry is. How do we fit into this? What do we do over probably more.  

Gaëlle LeBouar: Yes, the aeronautics space and defense industry found a good base on this ISO 9001. However, we needed some additional requirements to secure that our specificity and the criticality of our products will be taken into account in the development of the product or the services. So that's why we [00:06:00] have created within the IAQG. 

Gaëlle LeBouar: The ISO is interesting, but do not seek does not secure all off our expectations. You won't request to electoral organizations, which is ISO 9001 to build a product for our own on companies. So that's why we implement some requirements on top of this ISO in the EN 9100 requirements. I should specify that as for the example given previously, the aeronautical base and defense industry has created its own organization, the International Aerospace Quality Group. 

Gaëlle LeBouar: This organizations is based [00:07:00] on three sectors mentioned aeronautics space and defense for industry America, Europe and Asia Pacific. This industry had assessed this ISO 9000. And we committed that this ISO 9001 needed to be enriched with supplemented requirements to secure that the specificity of our fields are mentioned and taken into account in the standards. So, that's why we have the EN 9100, which is the standard for Europe, and its brother, the AS 9100 for America. [00:08:00] And the second brother, the GISQ 9100 for the Asia Pacific.  

Susan Matson: So if I'm understanding you correctly, you've got ISO 9001, that's the base for our industry. But then there is a more specific elevated set of requirements specifically for the aerospace industry and that's the 9001 and you've got the three depending on what part of the world you're in, it would be the EN 9001 or the 9100. I'm sorry. I'm saying it incorrectly. The EN 9100, the AS9100 and the JISQ9100, depending on where the world, where in the world you are. 

Gaëlle LeBouar: Exactly. So they are all equivalent. They are all equivalent. It just, it depends just on the continent in which it has been raised or published.  

Susan Matson: Okay. [00:09:00] Good point to make. So these additional requirements what do they cover? That we're not seeing in ISO 9000. What are some of the things that we're taking from an industry standpoint, even a closer look at? 

Gaëlle LeBouar: This additional EN 9100 is built on the ISO 9001 requirement plus the complemented requirements for the ASD industries.  

Susan Matson: Okay 

Gaëlle LeBouar: So we have introduced some aspects that were not covered, as you mentioned, for instance, in the definition chapter we have introduced the definitions of critical items, which are the classification, the ranking of items to be considered and seen as critical [00:10:00] for our programs. We have the key characteristics which is introduced in this standard and in which you can find additional requirements to manage them in the other standard of the 9000 from the IAQG, the 9001 and you have special requirements 

Gaëlle LeBouar: So this aspect are linked to the developments of our product to secure that criticity are well managed. And after we have also product safety aspects or a counter counterpart aspect that are introduced. And as we are in the aerospace and defense industry, the cleanliness aspect is also a main point to consider, and so we introduce [00:11:00] additional requirements linked to foreign objects. 

Susan Matson: So that's completely new. 

Gaëlle LeBouar: Yes, so this is a part for the definitions, but within the standard itself, there are some specificity. That we should this deal with responsibility. This is important to consider because if you have a ISO 9001 you should assess how does he manage a change and when will he inform you of the change? And so you have to implement mitigations if you see a risk.  

Susan Matson: So it clarifies and further defines the process.  

Gaëlle LeBouar: Exactly.  

Susan Matson: Understood. 

Gaëlle LeBouar: We need to master our supply chain and own. We need to master our industrialization. So all [00:12:00] change should be considered and with their criticity. 

Susan Matson: Wonderful. So one of the other topics moving on. I know there's so much more enhancement is done in the 9100. But we also reference we talk about control of externally provided processes, products and services. That's a new topic introduced, what does that mean?  

Gaëlle LeBouar: Yes. So the 9100 implement a lot of recommendations and requirements. We need to secure that our whole supply chain will allow us to deliver a product conform but also a safe product.  

Gaëlle LeBouar: Meaning that we, our supply chain is reliable up to the raw material supplier. That's why we request that each 9100 supplier [00:13:00] follow its own supply chain fully. So that means that receiving a certificate of conformity and put the hardware on the shell is not enough. We should control of external provided process, product, and services. Control of externally provided products and services is part of our ISD job. We should secure that our own supply chain is reliable. 

Gaëlle LeBouar: Having a assembly process and mastering this assembly process is one thing, but ensuring that the parts and the material, for instance, used to build this product are conform [00:14:00] will secure that our product will be reliable and safe. So we request to master the and to survey the supply chain, getting a certificate of conformity and putting the product on the shell is not enough. 

Gaëlle LeBouar: We should be sure that the supplier has a relevant quality management system and that he or she follow his own supply chain also  

Susan Matson: Just really making sure the entire process is covered. And then, there's two more other points that I saw were introduced as new topics. The first one talking about production and service provisions and nonconformity. Can you talk a little more about those as well?  

Gaëlle LeBouar: Yes, of course. So the chapter [00:15:00] 8.5 is linked to production and service provisions. It is the chapter of the 9001, which has been the more completed because it's linked to the field of the industry. 

Gaëlle LeBouar: It's linked to and service provisions is the topic which has the most change in the 9100 compares to the 9001, ISO 9001. Yes, the reason is that his is the biggest difference from one industry to the other, one field to the other. So the changes includes the production processes as well as the required controls on production equipment and support after the delivery [00:16:00] of the product. 

Gaëlle LeBouar: That's the second point that you raise is the nonconformity treatment process. IAQG define more specific requirements on how to handle non conformity and how to take actions on processes and products included what corrective action need to take care if a non conformity is found.  

Susan Matson: So all of this, if I'm understanding, this there's many more requirements on top of the 240 that I that, that make up the ISO 9001. We've got another 160 additional requirements specifically for this industry. That help further secure, further provide certification and understanding to those [00:17:00] that that everything it's being done the way it should be getting done. 

Susan Matson: But so how does. If, what is the difference in, in the scheme? We've got the traditional scheme and then we have ICOP. We have that industry controlled other party scheme. Can you talk a little bit about that and how this all works?  

Gaëlle LeBouar: Yes, yes we we know that to be certified an industrial contact self certification body, which will send auditors in the company. And which will audit and after that will be a board in the certification body to decide if not the company may be certified. This certification body is controlled itself by the accreditation bodies. So it is a vertical shapes accreditation, certifications, and suppliers. And in parallel, the industry [00:18:00] control its own supply chain. 

Gaëlle LeBouar: So these are two vertical industry. The peculiarity of the IAQG is that we have introduced the ICOP shames. ICOP means Industry Control Other Party. The industry want to secure that the suppliers, the certification bodies, and the accreditation bodies. Understand our needs. So there is on top of the first pillar accreditation body, certification body and suppliers, the industry within the IAQG survey. This first pillar with [00:19:00] assessing within oversight. Oversight is a kind of audit with oversighting the accreditation body with oversighting the certification body, the auditors in order to secure that the needs are well managed. 

Gaëlle LeBouar: There are no discrepancy. There are full independency,and to secure that the certifications are equivalent from one industry to one country to another, by securing that the requirements are well masters.  

Susan Matson: So these two verticals are no longer completely separate. We're interacting at each layer.  

Gaëlle LeBouar: Yes. So instead of the two verticals, there is one vertical and the industry interact with the certification chain. [00:20:00] 

Gaëlle LeBouar: So we survey and in parallel, we can also the industry can also survey its own. Supply chain, but it is with the same mindset and the same needs the industry can have more interaction with the certification body. And we can, as industry can refer to the certification body with sharing what are our needs to take care on the specificity of one peculiarity, I said risk analysis so we can mention. Yes, there is this chapter of this this chapter 8.1.1 in which you should focus on to secure that it is well taken into account and people are people in the ICOP [00:21:00] shapes are more aware of the industry needs, operational needs. 

Susan Matson: So awareness, conformity understanding at each level, this is all an enhancement.This is all something that is, that, that is enhancing how we are ensuring certifications globally.  

Gaëlle LeBouar: Yes, yes. And that is one aspect or so that you can be aware is that the IAQG members, which are ASD, can propose one member of his company to become an OP assessor, other party assessor. And so after, in counterpart, you can request to perform additional supplemented oversight. To the sector management system. 

Susan Matson: It really makes a global check and balance. Inherent within the industry. [00:22:00] 

Gaëlle LeBouar: Yes. Yes. It gives more confidence and more links between the shames and industry.  

Susan Matson: Making it globally stronger. So what does OASIS, what is the role of OASIS within the IAQG, within this ICOP scheme, within the 9100? Can you touch on that for just a moment?  

Gaëlle LeBouar: Yes, we spoke about requirements. We spoke about the ICOP shames, but you should be aware of a third a third aspect is IAQG has built a database, which is called OAISIS. Online aerospace supplier information system in which you can find the list of the supplier the list of the industry which are certified.  

Gaëlle LeBouar: With this list, [00:23:00] this is so a reliable source for aerospace supplier certifications and registration that you can as customer of 9100 standard or 9110 or 9120, you can request to your supplier the access of their certification report. It is a part of a contractual clause to be certified. 

Gaëlle LeBouar: And this information you can find in OASIS. After you have also the possibility to use the OASIS feedback, you can contact the certification body through the OASIS tool in order to inform about complaint. You can contact [00:24:00] your supplier also directly via OASIS and this can be register and keep to keep the traceability of your complaint. 

Gaëlle LeBouar: And in the other side, the certification body can inform you. For instance, if they find if they suspend or withdraw certifications, you can be informed. through the OASIS database.  

Susan Matson: So it really is the place where certification, registration data, everything is there and available.  

Gaëlle LeBouar: Yes. There are lots of data available that can support you to assess and to survey your your supply chain. And it is also a good [00:25:00] base of industrial. industry list to rely on because they are certified and they are followed in a relevant way with qualified auditors and with trained auditors and auditors which are have a link with the industry.  

Susan Matson: And I believe this is, this particular system, OASIS in general, or this type of system is pretty unique to, to, to the aerospace industry. Summing this all up, this whole conversation, what's the one thing people need to understand that, between ISO, between being an ISO 9001 supplier and A-E-N-A-S or JISQ 9100 certified supplier, why should our listeners care that there are 9100 

Gaëlle LeBouar: [00:26:00] So the 9100 versus the ISO 9000 R, which first understand that it is not a typo on the certificate. There are lots of information behind it. We have the additional requirements to secure that the industrialization and the development are well taken into account as well of our safety aspect and so on. 

Gaëlle LeBouar: And if I summarize the ISO 9001 is the baseline of industry QMS and 9100 supplier versus an ISO 9001, it's not a in the certificate. It is much more rigorous. [00:27:00] We deal with so the development aspect, we deal with safety aspect, and with the industrialization aspect. 

Gaëlle LeBouar: So since the conformity of the product or services. But this conformity is associated also to a real management of the supply chain because we need the whole supply chain to be compliant to our needs to secure the final product. 

Gaëlle LeBouar: But it's not just require additional requirement to consider we have also this certification shame aspect with a close relations between the certifications [00:28:00] and the industry and with this survey and aspect, which secure the independency and the performance of the certifications. And the last point is this OASIS database, which is a huge and deep database, which will give you the list of certified industry. 

Gaëlle LeBouar: You do not have this with the other organizations. So it is a good tool to consider. And I recommend you to put your nose in this database and to share this information with the procurement. You can complain about operational non conformities, [00:29:00] but if you have a look on the quotations by the certification body, you may find a relations between what the and the issues that you made in your own programs. 

Susan Matson: Wow, thank you, Gaëlle. For those of you listening, one of the things I do want to touch on, because, Gaëlle you gave us so much information, people want to learn more or hear more or read more we can, you can access the OASIS database. That is, you can go to IAQG.org and click on the tools and look for OASIS. 

Susan Matson: That will lead you there. We didn't even touch on, and that could be a whole other conversation. The how between, there's the, what of the tool of the 9100 standard but there is also All sorts of guidance material and information found in SCMH, which is part of Gaëlle’s team under the PSCI that gives you lots of tools [00:30:00] and information on how to achieve or learn more about what is needed for the 9100 standard. 

Susan Matson: And then, there’s just a wealth of information, other podcasts that we have, as well as the the information found on on IAQG. org. But, Gaëlle, thank you. Thank you very much. I really appreciate you joining us today and talking all about ISO 9001 and the 9100 that is very specific to our organization. 

Susan Matson: Thank you.  

Gaëlle LeBouar: Thank you.  

Susan Matson: Yes. Best of luck to you, everyone. This is Susan Matson. You have been listening to the Quality Horizon, or I should say the IAQG Quality Horizon. Until next time, stay safe.