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TCB Process and Confidence Building. Denis Ward American TCB. FCC confidence in a TCB?. This is the process all TCBs know and understand The FCC gains initial confidence in the TCB by its accreditation: ISO Guide 65 General Requirements The Quality System The Technical Staff ISO 17025
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TCB Process and Confidence Building Denis Ward American TCB
FCC confidence in a TCB? This is the process all TCBs know and understand The FCC gains initial confidence in the TCB by its accreditation: • ISO Guide 65 • General Requirements • The Quality System • The Technical Staff • ISO 17025 • General Requirements • The Quality System • The Technical Staff
Continued Audits to ISO Guide 65 and ISO17025 maintain confidence • To work, this process must: • reflect the actual working the TCB • Have continued auditing by the FCC and the applicable accrediting body of the TCB to show the TCB is performing in a manner that reflects its quality system thus giving the FCC continued confidence in the TCB
The TCB must have confidence in the Test lab. • The certification body is responsible for accepting applications and data from reliable test labs. • The TCB can only accept test reports that are in accordance with established and approved FCC procedures. • The process of confidence building • If the test lab is accredited and if the scope covers the testing being done, confidence is easier to establish. • If the test lab is not accredited then the TCB is responsible establish confidence by other means.
Non-Accredited lab confidence building • The TCB will need to determine acceptability • How each TCB confirms confidence varies, but it must satisfy all parties including the FCC. • The FCC and Accreditors of TCBs are concerned about this issue.
Non-Accredited lab confidence building • It is easier to use a system already in place and accepted by most of the world than to reinvent the wheel. • Confidence is generally evaluated by the TCB auditing the lab to ISO17025 or equivalent criteria. • This should Include evaluation of: • the quality system • This is important as a good quality system properly enforced more adequately shows a responsible test lab • Test procedures • The test lab must have adequate procedures in place • The test lab must also have the appropriate approved test procedures for the FCC and the appropriate RSS standard for IC
Non-Accredited lab confidence building • Report production • Test labs should have a measurement reporting process that removes ambiguity as much as possible. • References to correct procedures • Removal of non associated ‘canned text’ info • Adequately explain and report test results • ISO17025 test reporting section should be followed whenever possible. • Individual engineers technical abilities to perform testing • The engineers involved with actual testing of equipment being submitted for certification should be evaluated by the TCB when possible. Changes in engineering staff may mean reassessment of the new staff • When not possible, evidence of adequate training of the test engineer involved should be available and should be reviewed by the TCB.
Non-Accredited lab confidence building • Confidence can also be established by Other means. • an historical working relationship between the TCB and the lab which shows the laboratory is competent to perform testing to the specific scope. • History can be good or bad. • Continued errors by the same lab or engineer should not be ignored and will affect confidence in ability. • Continued improvement in work bolsters confidence. Does the lab repeat the same mistakes or do they learn and implement improvements and corrective actions? • Other methods of providing evidence of competence should be carefully evaluated by the TCB before acceptance of data is done. • What ever process is used in establishing confidence of a test lab submitting test reports involved with the certification process should to be clearly stated and identified in the TCBs QA system as well as demonstrated such system is the actual practice of the test lab.
The Applicants need confidence in the TCB • The applicant must also have confidence in the TCB’s ability to issue good reliable service. • This includes the TCB having: • a reliable review process supported by procedures etc. • technical experts who review and Certify. • Low dismissal rates.
The Applicants confidence in the TCB? • Applicants can do this by: • Asking the hard questions before submittal • Ask to see and review the process and procedures for reviewing an application • Ask to see evidence of training of the TCB staff if you have doubts • Ask if the TCB generates comments or requests for information as a routine part of the reviews. If not, why not? If so, what kind of comments? • Ask how many dismissals occurred because the TCB did not review properly. • Ask about the experience level of the TCB – how many grants for your type device have been issued by the TCB. • Look samples of grants of equipment authorizations processed by the TCB (this can also be done on the FCC website)