All You Want to Know About Conformity Assessment Schemes (Relax, It’s Legit!)

[Πουσική] Hello everybody, good morning, good evening and good afternoon wherever you are all over the world. This is George and I'm Stas Hoppillars, PGLA Technical and International Business Development Manager. And I am welcoming you to one of many, I could say, webinars. We are presenting every month, trying to provide you information, knowledge and competence related to conformity assessment market. Today, our topic is conformity assessment schemes. This is a topic that probably not many people are familiar but all the people involved in certification, testing, inspection, they are involved with conformity assessment schemes. And this is a term, this is an activity of conformity assessment that becomes more and more popular. So the decision to present this webinar was based on equations of many of you asking what are the requirements of conformity assessment schemes, how to control and so on. So today, I will try to provide you some information on that topic. But before we start a few words about us, PGLA Perigoncion Laboratory Accreditation is an accreditation body, American Accreditation Body Based Introy Michigan, established in 1999 by Mr. Perigoncion and we have provided more than 2200 accreditations globally in more than 32 countries all over the world. We provide many different programs, a testing, inspection, project certification, proficiency testing, referential material, producer accreditation, medical labs, personnel certification and training providers of certificate program, so many different programs and you are invited, welcome to check our website and to learn about more about PGLA. We also have recognition, achieved recognition by many regulators in United States and all over the world providing the best recognized accreditation services that you need per specific applications in different sectors. Today, we are going to talk about conformity assessment schemes. Conformity assessment schemes are the foundation in trust and certification, accreditation and regulatory conformity assessment worlds. And what are they? Conformity assessment schemes establish the set of rules and procedures to verify that specific requirements are met. This way they enable global acceptance of certification or testing or inspection results and they are ensuring consistency across conformity assessment bodies all over the world through the MRAs and the MLAs of Iowa, Iowa, which is the new now the merge on the new organization global ACI, I will explain you about that process a little later on in our presentation. The conformity assessment schemes are here to provide confidence also to regulators industry and then users of course the consumers. And it is true that many professionals operate within schemes daily but even they don't recognize it or they lack a complete understanding of the structure and government of schemes. So this webinar is designed exactly to provide you more information. What are those schemes after all and after what rules they have to be developed and they have to be operated. So before I start with official definitions and so on, I would like to give you two examples of very common schemes that most of you know for example product certification product certification is performed to different schemes one very popular scheme all over the world, the sea marking, which is the mandatory conformity assessment scheme for products, and so you can see the sea marking in many products in your mouse pad, in your mouse, sorry in your telephone cell phone and many electronic toys and different kinds of products are 27 different categories of products. So the description of how to achieve sea marking is a product certification scheme also for all of you that you are performing audits management system audits and the insertification bodies again, either product certification and so on, you may be familiar with another very popular scheme, the management system auditor scheme. So I perceive that national personnel certification association scheme, which is the only management system auditor scheme endorsed by I have global ACI now. So I see the scheme describes how to become an auditor for example, you know that you know that you know that you know that you have to take a test, you have to present probably a demonstration or simulation of an audit and then you need I don't know 10 to 20 15 audits as a auditor as a lead auditor to become an auditor and how to maintain your status of auditor all these rules. So the rules are described on the management system auditor scheme developed by IPC, so those totally different schemes I bring and I gave you a typical example, but I have more examples later on on projects certification or certification of persons. Now I call it the scheme paradox and why at the beginning I said we it is legit because in some areas of the world, included United States and American English, the word scheme has sometimes a negative understanding so it is associated with fraud or manipulation, but typically and technically, scheme just means in English in plain English, a structured system or a framework and the world scheme comes from the Greek word the schema, which means structure form shape or an arrangement. So in the in the let's say the definitions and in the vocabulary of the international organization for standardization, we use the neutral and the technical and foundational definition of scheme, which is a formalized framework of rules and procedures. So don't worry schemes is not something bad or not suspicious, they are just the essential structures of trust used in conformity assessment, many organizations used before to the term program, so it is a certification program, which is okay, it's fine, just the official word, we use a scheme on each neutral plain English meaning formalized framework of rules and procedures. Now what is a conformity assessment scheme? So in standard 17, no 67 and I am going to use the new draft international standard addition to the latest version 17, no 67, which is under development in all my presentation. And defines also this standard includes the terminology related to conformity assessment schemes, a conformity assessment schemes is a set of rules and procedures that define the object of conformity assessment identify specific requirements and provide the methodology for assessment. So not just a standard like an ESTM or a BSI or just a technical standard, but it's a complete framework of operation under conformity assessment, a program as I called before of conformity assessment either related to persons either related to products either related to management systems inspections testing and accreditation, there are also accreditation schemes. So for different categories of conformity assessment, we have embedding different kinds of schemes and you may ask me in testing, in testing, we are just using technical standards, what are you talking about schemes, yes, I'm talking about scheme because there is a reference if you go to close 787 statement of conformity says when a customer requires a pass fail or intolerance result, the laboratory must use a defined scheme decision rule. That accounts for measurement of a study to make this judgment so the logic of scheme is also involved in 70 no 25 although there it's not really very popular because in testing we usually were using the standards and we are fine, but on the other programs, the other categories of standards of conformity assessment, the schemes are becoming more and more popular. And they are full closes in standards in 1824 and 65 and so on that they set requirements for the conformity assessment schemes in addition now to the main conformity assessment standards, those standards I mentioned before here that they are standards to be accredited. We have also some additional standards that they provide support for schemes and these standards. Αλλά σχεσσάμε ότι δεν έχουμε πάντα χρειαζόντας, αλλά δεν έχουμε πάντα δεκαιδίτες γεφιώσεις. Οι πρώτος, πρώτος, πρώτος, είχε πάντα 17, 16, 17, όπως πρέπει να δούμε πάντα σε το βιζό. 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If needed, what are these surveillance mechanisms? And what is the governance structure? How we will control the whole process? All these elements together will provide what we call a credible, reliable scheme and scheme that can create confidence to the market, to the end user and to the regulators. So that is what we should always have in mind. Now, conformity assessment activities are categorized as fair party, self declaration, and I will give you examples. Second party, customer based, and third party, independent certification or accreditation compliance. Usually third party is the most, let's say, provides the highest level of trust, but it does not only apply to that. For example, on the scheme of sea marking, the product certification scheme I presented you earlier in European Union for safety of products, the self declaration option is there. So if we have products that they have a low risk level, then the manufacturer can self declare compliance to the sea requirements. So it is not something we will not meet often, depends probably on the risk level or the requirements of the scheme. But of course, third party type of certification or accreditation is usually expected. Now, I mentioned before that the organizations who develop the schemes are called Schemowners. And there is another document. I have a MD 25 criteria for the evaluation of conformity assessment schemes that define the requirements for the Schemowners. So I repeat once again, the Schemowner can be the organization who is going to use the scheme. It can be, for example, the certification body or it can be a third organization like I gave you the example of IPC, the International Personnel Certification Association, who develops the scheme for the certification of management system model that is used by many different certification bodies. So what is the responsibility of the Schemowner? Simple, straightforward, develop the scheme, but not only develop, maintain and update it. Authorize the conformity assessment bodies. If it's not your own scheme and it is a third party scheme, how do you give access to your scheme to third party conformity assessment bodies? And how do you ensure consistent? So, Schemowner, who can be Schemowners? Schemowners can be government. We see many cases that the government says that those are the requirements for the certification of this product like sea marking. So the sea marking in Europe is not defined by private companies. The sea marking requirements for the product safety are defined by European Union. And then they are implemented from certification bodies. They are called notified bodies and we had a few weeks, a few months ago, a special webinar about that to use it. So the Schemowner in that case is the government. It is the entity which is called in the sea marking European Union. Also Schemowner can be an industry association. So we have the example, the scheme for safety of food they presented before and can be an association of supermarkets that they will develop a scheme for the safety of the products. They are going to provide to their consumers and they want the certification bodies to check if those products are safe according to that scheme. And of course they can be independent organization and can be a conformity assessment body that they develop their own scheme for their own usage. So those are the three main categories of the scheme owners. Now, who are the main players in the process of implementation of the scheme requirements or the certification scheme requirements? Definitely the conformity assessment bodies. What are the definitely the conformity assessment bodies? They are test laboratories. They are inspection bodies, product certification bodies, personnel certification bodies. So though they are performing the assessment or the tests or the inspections to verify compliance of products, processes, services, systems, persons to this specific scheme requirements. It can also accreditation bodies because the accreditation bodies have their own scheme in order to evaluate the compliance of conformity assessment body competence. So through the mechanism of accreditation and accreditation body can check for example, the impartiality, the competence, the consistency of the performance of conformity assessment bodies. So on different level, but both can be included in the process, the conformity assessment body role and the accreditation body role. That's why the IFMD25 I am mentioning the this document from IF, which is now global ACI. Is a document issued for the attention to the attention of accreditation bodies, but the requirements are implemented in conformity assessment bodies. So all those elements I described in you right now, they have to be checked by the accreditation bodies, but they have to be implemented by conformity assessment bodies. So those are documents that both conformity assessment bodies and accreditation bodies should be aware. Now I mentioned before and I gave you six examples of endorsed schemes from the IF that now is global ACI and there is a so called multilateral recognition arrangement. And we call it also MLA structure in order to achieve the global recognition of results of accreditation for different and specific conformity assessment schemes. Now this structure and I will present you in the next PowerPoint is structured in different five different level, the first level of this confidence, let's say pyramid is the level one and it is referring supported by the IJOIC 1711 standard. It is described over there which describes and introduces the requirements for the operation of accreditation bodies. So on the highest level of our conformity assessment pyramid, we describe how accreditation bodies should work. The level two and three of these MLA structure are the main scopes which is actually the accreditation programs and standards, for example, we are talking about 17,025 research the requirements for laboratories or 21 such the requirements for management system certification bodies or 24 for personnel certification bodies or 65 for product certification and then at the lowest level, 4 and 5, we have the so called subscopes of the MLA which are the specific schemes. So the schemes I showed you before I tell you see marking or I mentioned the IPC scheme for auditors or the food safety or the ICO for the airplane, the transportation industry, all those are the schemes on the lowest level. So if you check on this map, you see on top, this is the table that presents this MLA structure with some examples, you see on top level one 17,011 standard which is the main starter for accreditation bodies and then we have for example different level two and level three, the standards related to the conformity assessment bodies which can be 65 for product or the very popular man and management systems, 17,021 or certification of persons 17,024 and show on validation and certification and so we have different standards on level two and three that they will be used to provide evidence that the conformity assessment bodies provide the consistent service of certification or testing or whatever. And then we have level four and five that they set the specific scheme requirements and those are schemes like I said, all your global gap. Okay, or it is a family, this is for food for animals or it is the FCC 22,000 for food safety, the IPC scheme, I mentioned you about the auditors. management system, auditors, personal certification, ViCa, and so on. The actual schemes are the level five of global ACI-ML structure, but in order to be accepted and included on level five of the global ACI, you have to go through an evaluation. It's not automatic. It's not like the technical standards on the testing accreditation, ASTM standards and BS standards or whatever EN standards. The moment that they are produced by recognized standardization body, they are automatically accepted as validated standards for testing. In the case of the non-standard versions, we need to have additional validations. If we talk about ISO 22,000, it is fine. It is validation. If we are talking about the FAMI for food, because it is developed not by a standardization body, but an association, then the global ACI former IA, they will do a special check, especially evaluation on the scheme. So the Scheme owners, they have to become members of global ACI, and then they have to apply for their schemes to be recognized by that structure. So if you visit the global ACI website, there is a page over there which is called the recognized schemes and dorset schemes. And you can find all those schemes consisting level 5. So if a Scheme is not recognized and is not included in this list, in this webpage, then you cannot use before the IA vlogo, now in the future of the global ACI vlog. Except if it is the recognized standard like ISO 9,022,000, 14,000 or a technical standard for testing that they are issued by recognized standardization body like ISO, which automatically are recognized as validated, and they don't have to go through the endorsement process of global ACI. I think that helps and explain a bit the confusion on which schemes are accepted, by the accreditation and global ACI as endorsed schemes. Now, the next step we have to consider and remember is the life cycle of a Scheme. Is the Scheme forever? Not really, it depends. Scheme follows a structured life cycle. First is the need, a defecation of the need of the Scheme. Before we develop a Scheme, we have to define why we need the Scheme. And actually, when I have before and global ACI now are evaluating the Scheme to endorse the first thing, they ask you, "Okay, why do you need it? Do you have a study of identification of the need? Why is the Scheme developed and what is coming to satisfy?" So, you need, let's say, an analysis study to explain the reasons why this Scheme is useful, who needs it, and why it is developed. And then you develop the Scheme according to the requirements, for example, of 17 or 67. And then you validate the Scheme, which is a whole process I'm going to provide you with our point in a while. And then you implement the Scheme. Actually, validation of the Scheme is appropriate to be used. And then you implement it. Either if you are a third-part Scheme owner, you provide it to the conformity assessment bodies that they will implement it. Or if it's your own Scheme, you implement it by yourself. You monitor the performance of the Scheme and you revise it. Or if the Scheme is not applicable anymore, you may withdraw it. So, it is definitely very important to provide evidence of the continuous improvement and monitoring of the Scheme. So, it's not enough for the endorsed, let's say, global ACI Scheme for my RIF Scheme. To say, "Okay, I developed, I validated it's out in the market and working, but you have to continuously monitor and update the Scheme. Okay, so keep it always valid and updated. Now, what I promised you before, Scheme validation, very important, very important process. And for this process, two different documents are useful. 17.67, the 100 development, also the IFMD25. So, the validation of the Scheme ensures that the Scheme is fit for its purpose, for what it was designed to perform. And must demonstrate clear objectives for the Scheme. The requirements of the Scheme should be appropriate and clear again. What is the methodology for to perform the Scheme validation? How do you know that the Scheme is valid and justify the conformity assessment approach? How you validate Scheme, it's a whole study. A few days presentation, Scheme validation, but technically, you follow methods like utilize or implement the Scheme and try it on, for example, select group, or do a simulation, or perform an evaluation, for example, for personal certification on a group of professionals. And you have to reply to many questions, if, for example, in the personal certification, different people with the same knowledge will take the test. Will they also get, they will pass, or half of them will fail, you have for them with the pass in one test, the competent will pass, and the other test, the competent will fail. So, this is, you have to prove it. And this can be done through statistical methods, but also can be done through evaluation and simulations on actual sample. Also, somebody can ask, okay, you have an examination, and do you say that the people will pass with 70% of the exam. Why 70%? Why people with 69 are incompetent and simple, people that they get 71 score are competent. So, how do you define the pass, for example, score on an exam? This is part of the validation of your personal certification program. The same can apply for a product. If you say that this, after in the product certification, this specific device complies, what tests it has to pass successfully in order to comply. And how, for example, will you guarantee that if this product is produced on mass production, that product with serial number 1000 is equal good with the number one that was exhaustively tested. So, how can you guarantee that your products in a production line are continuously complying? And how you do that and how you perform that. So, you say, I may combine testing and management systems. This way, I check that the processes are consistent. Or you may say, I have to test every batch, so there are different approaches. So, all these approaches, either you will do by batch or you will do combination of management system. And testing should, are elements of the validation of your scheme, because your scheme should give an answer to how you will approve your products, how you will certify the professionals and so on. So, all those methods that will be used, they have to be fair, they have to be valid, they have to be reproducible. All those are elements of the scheme validation. Unfortunately, I don't have more time to spend, to invest, to tell you the truth on that nice subject. But, probably we can have in the future a presentation on how to validate a scheme. The MD-25 IF document also provides specific requirements for the evaluation of a scheme from the accreditation body. So, the accreditation body, in order to approve a scheme, they have to be sure about the serious of elements. The most important of them is transparency of the scheme. So, you don't exclude. So, you cannot say, "Ah, this is only available to my members, then it cannot be accreditable." It is an issue there. There are some requirements that it can be done, but it has to be fully transparent and fully publicly available the scheme to be accredited. If you want to have your own tribe, which is not accredited, you can do whatever you want. The evidence of validation, all the elements I presented before, they have to be documented and they have to be presenting to the accreditation body that the validation study is performed in the appropriate way. And you have to present the procedure for the governments and impartiality of the scheme and the consistency, consistent operation of the scheme across conformity assessment bodies. That's right. 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