1. Are decision rules required to be on accredited calibration certificates? What are the requirements of utilizing a decision rule?
If no statements of conformity were utilized, decision rules are not required to be on calibration certificates. According to ISO/IEC 17025, section 7.8.6.1, “When a statement of conformity to a specification or standard is provided, the laboratory shall document the decision rule employed, taking into account the level of risk (such as false accept and false reject and statistical assumptions) associated with the decision rule employed, and apply the decision rule.” This means that only when a statement of conformity, such as a pass or fail statement or in- or out-of tolerance statement is provided, a decision rule must also be provided.
When a decision rule is provided, it must include how the measurement uncertainty was considered when making the determination for the statement of conformity. This is a definitional requirement, as ISO/IEC 17025, section 3.7, states that a decision rule is a “rule that describes how measurement uncertainty is accounted for when stating conformity with a specified requirement.” This means that if a decision rule does not describe how measurement uncertainty is accounted for or states that measurement uncertainty is not accounted for, then it would not be a decision rule, and one must be provided for the statement of conformity that is being applied. More information on decision rules can be found in our guidance document G136.
Although decision rules are required when using statements of conformity, statements of conformity are not required to be on a calibration certificate. Specifically, in ISO/IEC 17025, section 7.8.4.1 e), the phrase “where relevant” is used, meaning that a statement of conformity can be used by an organization if it is relevant to them and their customers. This also means that only the data, with the uncertainty included, must be reported on a calibration certificate. It is left up to the customer to determine if it is within their specifications.
2. What proficiency testing documentation will I need to submit for my ISO/IEC 17025 assessment and when do I need to submit them?
You will need to submit proficiency testing documentation for all normally scheduled assessments. This includes initial, renewal, surveillance assessments, and annual reviews. Though the Touchstone portal may not state that the proficiency testing documentation is required, you will be asked for it by your accreditation officer if you do not submit it to the portal and proficiency testing is available for your lab. You will be expected to submit your proficiency testing plan to the “Proficiency Testing Plan” section of the portal as well as a summary of your results to the “F104 – Proficiency Testing Data Submission Form.”
Please note; even if you do not participate in commercially available proficiency testing, you will be required to submit your plan for any interlaboratory comparisons that your organization will participate in and a summary of results. If no commercially available proficiency tests are available and there are no other laboratories that have the capabilities to participate in an interlaboratory comparison, then you may be permitted to perform intralaboratory comparisons. However, justification must be provided showing that no other options are available
3. What documents should be submitted to the “Quality Documentation” section of the portal?
The “Quality Documentation” section of the portal is where an organization should submit the documents that demonstrate they are compliant with ISO/IEC 17025. There is no specific list of documentation required to be submitted in this section because the documents required will be dependent on each individual organization. This section is, however, related to the C025, which should be submitted to the “ISO/IEC 17025 Accreditation Checklist (C025)” section of the portal.
In the “Reference” section of C025, an organization is to provide references to the documents or parts of their quality management system for each section of the checklist. An organization is required to provide references for each section of the list that has a thick, black border around it, but are encouraged to provide references for every section.
Likewise, what is referred to as “Quality Documentation” are the documents, records, and procedures that are listed in the “Reference” section of the C025. Of these Quality Documents, the ones that are required to be submitted are those referenced for the sections with the thick, black borders. These will be reviewed by your assessor prior to the onsite assessment so they will have a better understanding of your quality management system before the assessment. This process should allow for a more efficient onsite assessment and potentially save time.
It is, therefore, beneficial to upload all Quality Documentation, all documents referenced in the “Reference” section of the C025. This is not mandatory, as stated before; only the documents referenced for the sections with the thick, black border are required to be submitted to the “Quality Documentation” section of the portal.
4. What is the process for scheduling my initial or renewal assessment?
The scheduling of an onsite assessment is determined by both the assigned assessor and the organization being assessed. During the assessment application process, an organization can submit their preferred assessment dates to the portal. These dates will be communicated to any assessor(s) proposed to the assessment if they are within a reasonable timeframe. Be sure to consider the accreditation expiration date so that if any nonconformances are cited, there is sufficient time to address and close them before this date. This is typically no less than two months before the expiration date, though exceptions can be made on a case-by-case basis. Please note assessment dates are typically scheduled to occur within 60 days from the assignment of the assessor(s).
Although assessors are informed of an organization’s preferred dates, an assessor may still accept the assessment without being able to accommodate the preferred dates. The assessor may also inform your accreditation officer of the dates that they would be available to conduct the assessment. Likewise, the accreditation officer will inform the assessor of whether their available dates are acceptable. If they are not, then the accreditation officer will search for an assessor who has the availability to perform the assessment.
Once the assessor is formally assigned, the official scheduling of the assessment will begin. The assessor will reach out to the organization to request recommendations regarding travel and accommodations. Proper planning for assessor travel is especially important for organizations with many locations and certificate numbers, as it can reduce the number of necessary trips, and therefore, the cost, to assess all locations. This is also the time when the assessor will provide a document review and agenda for the assessment, both of which the organization should review and respond to, to ensure a smooth assessment.
To help aid your accreditation officer during this time, please copy them on all communications with your assessor. They will not participate in the scheduling, but it will be beneficial for their own planning purposes and allow them to intervene if any issues arise.
5. Who should be listed as a contact for my organization? What roles should they be assigned to and what are the “purposes” of those specific roles?
Beyond your primary contact, any personnel who are expected to communicate with A2LA, be that a quality technician, manager, or billing specialist, should be added to the portal. If there is a person at your organization who does not want to be involved in the assessment process, but would like to be the person listed on the scope of accreditation and become the directory contact, that person should also be added as a contact.
There are generally two categories of contacts that can be added to the portal: those that have access to the portal and those who don’t. For those who need access to the portal, there are three options, or “purposes” they can have: authorized representative, corporate representative, and deputy. Each of these positions can view and access the customer portion of the Touchstone portal. They can submit documents and corrective actions, as well as review assessor proposals and scope drafts. Each role can perform all actions necessary for the accreditation process to be completed, from application to scope expansions. Each of these contacts is required to complete and sign an R102 and provide it to the organization’s assigned accreditation officer.
An authorized representative will often be one of, if not, the main contact for the organization during the accreditation process. They will be the main person(s) contacted when anything related to the accreditation process occurs. This includes, but is not limited to, when assessments open, assessors are proposed, and when additional information is needed. An authorized representative can also add deputies to their organization through the portal and provide the necessary documentation.
A corporate representative functions similarly to an authorized representative, but typically is the main contact for a system of locations where each have their own scope of accreditation but operate as a single entity. The benefit of a corporate representative is that the assessor and accreditation officer will be able to easily identify the best person to contact for planning a multi assessment trip to reduce travel costs.
A deputy is a person at the organization who can access the portal and communicate with A2LA staff regarding the accreditation process. They can request additional personnel be added to the portal but will not be able to do so through the portal. They must request it through their assigned accreditation officer.
For contacts who will not have access to the portal, the system categorizes them based on their title at their own organization. They may contact the organization’s accreditation officer, but they may not be permitted to have access to certain information regarding the accreditation process. Billing contacts will be able to request confirmation regarding invoices and may be the person that A2LA’s financial department contacts if any issues arise.
Please note; if there is only one person at an organization that has access to the portal, they will be solely responsible for all communications between their organization and A2LA. Additionally, if that person leaves their organization, they should inform A2LA in advance so that a new contact can be added to ensure that communication is not interrupted.
6. How should organizations respond to cited nonconformities?
During the corrective action process, A2LA cannot inform any organization how to respond to any cited nonconformance, nor can A2LA say whether a response would be sufficient before it is submitted. This is considered consulting, which A2LA is not permitted to do. Clarification can be provided if there are questions or concerns about what they have been cited against or why. Ultimately, it will be the responsibility of the organization to respond to any cited nonconformance in a manner that is best for their organization. This process is known as corrective actions.
The elements required for a corrective action are the “cause analysis,” “the actions being taken immediately to directly address the nonconformance,” “the actions to ensure that the nonconformance does not occur again,” and “the objective evidence.”
When completing the cause analysis, please note that the verbiage utilized from an organization’s analysis shall not be a restatement of the nonconformance. A proper cause analysis should address the reason(s) why the nonconformance occurred so that it could be cited; not that it was caught during the assessment. There is no specific answer that A2LA is looking for, rather, this area allows for insight into how an organization determines the areas that need to be addressed to ensure that it does not happen again.
The “actions being taken immediately to directly address the nonconformance” refers to stating what your organization is doing to address the nonconformance, so if reviewed again at the time of the submission, it would not be cited again. For example, if an instrument was found to be out of tolerance, sending it out for adjustment and calibration is an immediate action that ensures that your organization can resume operation.
The “actions to ensure that the nonconformance does not occur again” are exactly that: stating what your organization will do to ensure that the cited nonconformance does not become a recurring issue. You’ll need to address the root cause of the nonconformance and clearly state how it will be mitigated or eliminated moving forward.
Please note; the immediate actions and these preventative actions are not necessarily mutually exclusive. Depending on the cited nonconformance, both can occur at the same time. For example, if it was found that your organization was cited for not following your own procedures and you determine it is because of a lack of training, retraining can be both an immediate and preventative action. The extent to which your organization wishes to pursue the actions is determined by you, so long as the nonconformance is properly addressed.
“Objective evidence” is evidence that demonstrates that your organization is doing what it is claiming to do. For all actions that are being taken, there needs to be evidence that the actions have been taken and completed. This means that if you claim to do one action to directly address the nonconformance and seven actions that you are planning on doing to ensure that this issue will not happen again, you will need to provide evidence for each of these eight actions that you have taken. Additionally, if you state that you are updating a policy, procedure, form, or documents, your accreditation officer may request evidence that the proper personnel have been informed of the updated documents.
Please note; during this process, you will have 30 days from your closing meeting of your assessment to respond to nonconformances. Your responses do not have to be complete upon initial submission; however, submissions will need to be made by the 30-day mark or else adverse actions may be initiated. Your accreditation officer will inform you if any additional information is needed.
7. How and when should we make changes to our scope of accreditation?
A scope expansion may be submitted at any time and can be done by following the directions in the G120 starting on page 34. However, there are several reasons to consider going through this process during renewal application.
There are a few reasons why your organization may want to submit a request for a scope expansion immediately. The first is an obligation to your customers or to fulfill a contract to perform accredited work in an area that you are not currently accredited for. Similarly, it may be due to many of your customers requesting accredited work that you can do but are not yet accredited for. You may also want to add a parameter that was removed during the previous assessment because it was not assessed during the last two assessments or there was a change in personnel or equipment.
In any of these scenarios, you would want to submit a request immediately so that A2LA has time to review and request the proper documentation and schedule an interim assessment to confirm your technical capability. An assessment may be able to be performed remotely depending on the opinion of the previous assessor. When time plays a major factor in being able to do work, you should submit a scope expansion immediately.
All these reasons still apply if you want to update your ranges or uncertainties, but the immediacy of the expansion may be lessened. It may be reasonable to wait a while if you can still perform accredited work for your clients with your current ranges and uncertainties to have it updated during the renewal assessment, depending on their needs. You may be charged for the time utilized by your previous assessor to review your submission, depending on how much is added to your scope, and if the review can be done through a desk audit or on-site. This is most typical for expansions that require an interim assessment or for organizations that have multiple scope expansions per accreditation cycle.
However, if you submit your request for scope expansion as part of your renewal application, no additional fees will be charged for the review. Any additional time reviewing the additions would be present regardless of when you plan to add the parameters, as assessors review all areas while onsite.
If you can wait until the renewal assessment, it may be financially and logistically beneficial to wait until the renewal assessment. However, if it is needed to satisfy customers or work orders, or if the wait would be detrimental to your operation, then submitting immediately would be the most beneficial.
8. When are the initial documents due for each type of assessment? What if I need more time to submit my initial set of documents?
Renewal and surveillance assessments open seven months prior to your expiration or anniversary date and the initial documents are due six months prior. Annual reviews open four months prior to your anniversary date and the documents are due three months prior. Please note; your invoice for an annual review will also be due three months prior to your anniversary date.
If you need additional time to submit your documents to the portal, please reach out to your accreditation officer to inform them. They will work to find the best way to accommodate your needs and provide you with additional time to submit your documents. Please note; the earlier you inform your accreditation officer and the more specificity you provide for when you plan on submitting your documents, the better.
If you need more time and do not inform your accreditation officer prior to your initial due date, they will be required to reach out to you often to inquire about passed due documents until they receive them or receive a general timeline of submission.
Ready to start the process? Request a free accreditation estimate today: https://a2la.org/estimate-request/