ISO/IEC 17025:2017 Transition Webinar Questions & Answers

Transcription

1 Contents 1. Complaints Decision Rules General MS Options Risk Sampling Traceability Transition Complaints Is the Complaints process expected to be available to any interested party on request? If a description of the complaint handling process has to be available to any interested party. In some UK countries (e.g. Wales) this would have to be bilingual for public body laboratories. Would we rely on the lab s translation or would we have to use an external translation resource? Is it in your view acceptable for small labs to have the 2nd person for complaint handling to come in annually to look over de complaints as part of the internal auditing process? says, A description of the handling process for complaints shall be available to any interested party on request. Not mandatory to send to complainant. A description of the process, yes. This may be a brief account rather than a copy of the process. We assess the lab s compliance with 17025, not explicitly their compliance with Law. See other related question on this topic. The requirement is that it is reviewed before giving to client, so probably generally not. Would need to be accessible on demand. Yes, a description of the process is easier than a copy of the procedure. It could just be a sentence to complainant? Page 1 of 8

2 2. Decision Rules Fail is based on 95% Confidence level, should this be stated in Compliance statement? Will it be allowed on a test certificate to provide the results, together with the specification, but leave it to the customer to decide pass/fail, rather than indicating it on the test certificate? Can the decision rule be declared as not taking the uncertainty into account? If the customer says for example, they do not require Uncertainty to be taken into account of a pass/fail criteria what level of documentation does this require? It is worth pointing out that M3003 Appendix M contains specific detail on decision rules and risk levels (probability) associated with false acceptance or reject. Do the decision rules apply to observational results e.g. positive identification of amosite asbestos in a sample of lagging? The decision rule is to be stated. Fail will be based on agreed criteria. Absolutely yes, unless the lab has contracted with you for a decision, or it is part of the test spec. Depends on contract review. It should take it into account (i.e. ensure it is not ridiculously large for example) Sometimes the test specs suggest it can be ignored. So, sometimes it can be accounted for but dismissed and not included in the calculation. This would be described in the statement on test report. Not a matter of documentation, the contract review will conclude what is to be done. The lab must maintain its integrity. It should take it into account (ie ensure it is not ridiculously large for example) Sometimes the test specs suggest it can be ignored. So, sometimes it can be accounted for but dismissed and not included in the calculation. This would be described in the statement on test report. If the customer has supplied a decision rule, no further assessment of risk is required, but it must be sound. Yes, Thank you. The point here is that now we appreciate that almost any decision rule is acceptable rather than relying on the ILAC model. If there are pass/fail criteria, Yes. Page 2 of 8

3 3. General Should external Proficiency Testing be done annually? Can opportunities be raised as mandatory findings? Can an organisation holding ISO accreditation legitimately claim ISO9001 certification? The copy I have of the Final Draft ISO/EC FDIS does not have a Section under as discussed in the first part of this talk. 5.3 Is it OK for the laboratory to simply say its scope is defined on the UKAS schedule? Will we expect the scope to cover all activities, or just those relevant to ISO 17025? I read from clause that the extent analysis is more clearly required than the 2005 version of the standard requires. Do you agree? Does this mean that any change [to the report] must be explained in the report? In annex for example but not in a mail associated with the report? No such prescription. It depends on technical and availability considerations. Failure to cover opportunities and risks in the MS would be a finding. No. It should rely on the equivalence statements in the Standard and the tripartite agreement. All references should have been to the ISO/IEC 17025:2017 and not to the DIS or FDIS. I am aware of a couple of errors. Thanks. If that is true, I don t see why the same document should not be used, but bear in mind that they must not depend on us for the conformity with That is against So, they would need to reproduce it and keep it up to date, not just link to our website. I take this to be about technical scoping for sampling, calibration and testing. The requirement is, I agree, clearer now. I believe the intent is the same. Reporting may be in various forms as agreed with client, but normally, I would say yes so that any reader may see this in the context of the report. Page 3 of 8

4 4. MS Options There has been no reference made to the context of the organisation which is a key ISO 9001 requirement; is this applicable to ISO 17025? If a laboratory has opted for an option B quality system, should the assessor assess that the laboratory meet the requirements of section 4 to 7? If the lab take Option B can you confirm that we still have to assess the management system. I am already getting labs asking me if the assessment effort can go down as we don t need to assess this area anymore. For option B Do we allow non-accredited certification? Having assessed labs which were part of an ISO 9001 certified manufacturer I have a certain amount of scepticism about the quality of some ISO 9001 audits. With Option B are [we] going to be able to raise NCs against the management system as accepted under ISO9001 e.g. in the quality and effectiveness of their audits, document control process etc? Could a lab easily apply for ISO 9001 and not have to change anything in their management system if they hold ISO 17025:2017? If taking Option B then the lab will be expected to ensure it adequately covers requirements. That s all, so I suppose not. However, although the word context is not used, the intention is much the same. Yes sections 4 to 7 in all cases to be covered by the MS, but issues are raised against for MS issues, not 8.2. We assess that the lab s MS adequately covers cl 4 to 7. This may be more or less than if taking option A. It depends on the complexity of the MS. Initially I would expect no change but later effort may go up or down. At present there is no policy on this. It is not for us to allow or not, Accredited certification is likely to need less assessment by us to see that it is adequate. Yes, we assess the suitability of the MS to cover requirements. Deficiencies in the MS would be or Technical deficiencies would be in Cl 4 to 7. It is not a matter of accepted. The MS may not be certificated anyway, or may have used a non-accredited registrar. There is presently no policy on this. Probably not. Some things in 9001 like development, research etc don t appear in Anyway, if it is only a lab there is no point. See the tripartite agreement and joint communique. Page 4 of 8

5 5. Risk A labs own perception of risk may be very different to ours. How do you deal with this? How will the laboratory be in a position to quantify the risk to the client? The laboratory may not be aware of the clients requirements, and their risk strategy. Should the process of evaluation of a specific risk be documented? In order to assess the suitability of the labs determination of risk, does this mean that the AM or Lead Assessor must have knowledge of the industry sector the laboratory is involved in? So, the risk based approach will require assessors to make judgement calls on the laboratory's own judgement calls. Won't that lead to greater 'disagreement' about whether requirements of the Standard are met or not? Do you see any changes from a monitoring perspective as to what is being accepted as an acceptable risk management process? Are UKAS going to look at the risks associated with us assessing risk and opportunity in the new standard? It s not about impartiality but about consistency of assessment. By persuasion and being a great assessor. The decision is the lab s but whether the handling of risk and opportunity is adequate is ours. By contract review, especially when considering decision rules. It depends on the complexity of the lab. In order to achieve this, they will need to know what the process is and it may therefore need documentation. It certainly would help but ultimately the decision is that of the lab anyway. Yes, but it is clear that the lab decides which risks to attack. We comment on degrees of compliance with and these judgement calls comprise the difference between assessing and auditing. No, but I expect the necessary measures to vary greatly, but it is very clear that this should be ongoing. Interesting point. I would say that the assessment is now more skilled and about competence rather than conformity so findings will vary between labs for good reason. This is essentially the difference between skilled assessing and simple auditing. Page 5 of 8

6 6. Sampling In sampling e.g. for deposition of pollutants, a soil sampling grid can have a very large uncertainty due to patchy deposition. Does this large uncertainty need to be (a) defined and (b) combined into the overall uncertainty of the result of the pollutant in 'concentration units per square metre'? Must the subsequent calibration/testing be accredited? Does sampling include the taking of sub samples in the lab? Reporting sampling of [sic] [if] a lab declares that it has sampled in accordance to a known standard/standard requirement, would that negate the need to evaluate measurement uncertainty? Can an organisation be accredited according to ISO for sampling alone? Remember that they are to report components relevant to later establishing the uncertainty of measurement in the subsequent testing. This is not an uncertainty of sampling which is covered by the very nature of the sampling, sampling plan design, agreement and understanding of the client etc. The laboratory is required to report items affecting the uncertainty of measurement and anything else that could affect the validity of the test results. Comments perhaps on the adequacy of the sampling plan if supplied by the client, comments on the need or not to homogenise or sub sample, features of the sampling site in practice, observation of adjacent features, weather conditions, etc. The important thing is that the contract review establishes the needs. This will vary; sometimes the sampling lab is the main contractor, sometimes the test lab or the client. Discussions and agreement are vital. Lessened, of course, if this is covered in a comprehensive specification containing it all. The standard is not about accreditation, so fundamentally no, but EA policy and our ACC1000 requires the subsequent testing to be accredited, as far as the sampling lab can ensure. So, it depends on the contractual setup. Effectively yes, but that may be included in the test regime sometimes. Either way, any sampling undertaken shall comply. The lab is expected to pass on all information on things that could affect uncertainty of measurement, not to evaluate measurement uncertainty because it is not making measurements. The use of a known standard handling such matters certainly helps. Yes, provided it is intended for subsequent testing or calibration, not necessarily by the same entity. Page 6 of 8

7 7. Traceability Is there guidance for accredited laboratories on what sections of the new standard are to be covered when determining the technical competence for traceability requirements? Traceability of test results are still the key added value of a third party lab to me. If customer is taken to court, the lab shall be able to provide traceable and reliable results Does a lab supplying traceability need to be accredited? If not, how to ensure it complies with ISO 17025? No, Labs shall comply with all the clauses if they are claiming conformity with A supplier of calibrations shall be competent; ILAC MRA accredited, CIPM NMI listed or the third way. If the third way then they would need to be assessed as competent. Conformity with is an indicator of such competence. Traceability is provided by features that do not require independence. See Annex A and JCGM, VIM etc. It is for the customer to be happy with lack of independence. Some 1 st party manufacturer s labs are the very best as they are the experts in their kit and have a direct interest in getting the right answer. It does not need to be accredited, nor CIPM MRA listed but if not, establishing competence would be difficult. See Appendix to 17025, and the help in ILAC G8 Appendix continues to apply. Page 7 of 8

8 8. Transition How will the transition plan be managed for Enterprise labs where they do not have an AM? Can new customers be accredited against the new standard i.e. for an initial assessment in May 2018? After March 2018, will all applications have to be for the new standard? Will the IAR form have two dropdowns, one for each version, so that IAs and Observations can be documented? Will the charges be relevant to the changes made by the lab rather than the size? I have been asked - will there be specific guidance provided for lab customers? When assessing to the new version of the standard, should this be an Initial assessment approach, i.e. longer time on site, more depth covered. This could be during the labs SU cycle. If the assessment against the new standard is a surveillance visit and recommendation is not positive and only includes one assessor could this not be an issue and how will we handle this? The Case Manager acts as AM, and will call for help as required. See transition plan. Possibly, if our resources are available and signed off. No, but this is advised as assessments after 1 Jan 2019 are only to new standard. The Accreditation standard column auto populates with the standard only, not the year, so the next column, Additional accreditation standards, will also need to be used where assessment is against both 2005 and 2017 versions (free text fields). I would say, complexity, rather than changes or size. It is determined initially by simple UKAS man day size rule but you may represent to your manager if you disagree in a case. Complex cases should be charged more. There is help from ISO/CASCO and we are putting some information on our website. We are also offering awareness seminars. We expect the site time to be as normal for that visit in the cycle. WE would adjust the other topics covered to suit. The extra work is in the transition template analysis etc. as desktop. I would say that we handle it as we would any findings and it should not be a problem. If we have messed up then the corrective activity would be at our expense so maybe best to have an experienced assessor or AM attend that visit. I think it unlikely that we would need all the technical assessors present to conclude if the transition had been made, but the use of decision rules in different areas needs to be watched. Page 8 of 8