EA evaluering af DANAK Maj Erik Øhlenschlæger, DANAK april 2016

Transkript

1 EA evaluering af DANAK Maj 2016 Erik Øhlenschlæger, DANAK april

2 Omfang af peer evaluering for laboratorieområdet - 2 prøvningslaboratorier (1 aflyst pga. sygdom) - 2 kalibreringslaboratorier - 1 medicinsk laboratorium - 1 PT udbyder Witnessed DANAK LA i området: 6 af 9 (1 sygemeldt) EA team members: 5 (af et samlet team på 12) 2

3 Resultat af peer evaluering for laboratorieområdet - DANAK kan opretholde sin status som medlem af EA MLA på prøvning (inklusiv medicinsk undersøgelse) og kalibrering. - DANAK kan tilslutte sig EA s MLA på præstationsprøvning (may be signatory ) Forudsætningen for ovenstående er tilfredsstillende lukning af konstaterede afvigelser (NC) og concerns (CN). 3

4 NC DANAK had a sectorial committee for medical laboratories that was closed in In a letter sent to the committee members, DANAK declared that it would use the existing professional associations when to further developing accreditation of medical laboratories. However, DANAK has not followed up this and established a policy on how to adopt/develop new technical fields. Beskrive samarbejde med DEKS, Videnskabelige selskaber, regioner, mm og forankre i DANAK IP 4

5 NC DANAK does not establish a specific plan for sampling [in testing]. In some cases not all accredited technical fields have been checked during an accreditation cycle DANAK Procedures does not define a policy for: - Planning sites in case of multi-site laboratories - In case of multisite testing laboratories, DANAK produces only one list of tests [methods] without specification where the single test is accredited. - Revidere samtlige kompetencematricer - Forbedre samplingprocedure inkl. Kriterier - Krav om at sites angives på metodelister (AB3) 5

6 NC DANAK reaccredited a CAB although there is little evidence that chapter 4 of ISO/IEC has been assessed properly. At the previous surveillance visit there is also little evidence that chapter 4 of ISO/IEC has been assessed. DANAK did not realise this gap in the report. At the decision-making DANAK waived the requirement. - Dummy rapport for ISO udarbejdes - Bedømmelsesholdet informeres om vigtighed af bedre/mere omfattende rapportering. 6

7 7.15 NC 15 In the AB cl.3.9 DANAK requests from the laboratory to elaborate a plan for participating in PT that makes it possible to evaluate whether the extent adequately covers the scope of the accreditation. In some cases in testing, no evidence for the assessment of the plan was found. Alle LA og TA instrueres i, at alle PT planer bedømmes (inklusiv historiske data jf AB3) 7

8 CN In the quality manual a reference to the procedure IP(P)8 for accreditation according to ISO/IEC is missing in section (paragraph 6) Document RL 16 in both versions (Danish and English) refers to an obsolete standard (EN 16001) Simple tilretninger i disse dokumenter 8

9 CN The Annex to IP(P)19 contains the competence profile of a LA. However, this are the criteria for hiring new staff. (same for technical assessors in IP(P) 18). The competence criteria for assessors are not properly defined. DANAK vil klarificere kompetenceprofilen af TA og LA i reevante IP. 9

10 CN Personnel files of internal LAs for medical laboratories: Training activities for ISO 15189:2012 and ISO 22870:2006 are not documented - Alle LA og TA på området trænes fremover i både ISO og ISO TA som ikke er trænet de sidste to år modtager information (kopi af TA nyhedsbrev 2014) - Kvalifikation sikres i DANAK s system. 10

11 CN DANAK policy on traceability does not include ILAC P10 option 3a and 3b. By doing so there is a risk that not all measurement quantities are metrologically traceable. (DANAK document AB 3 cl. 4) DANAK opdaterer AB 3 med mulighed for at bruge eksterne kalibreringslaboratorier, som ikke er dækket af EA MLA eller CIPM MRA forudsat at laboratoriet sikrer dokumentation for at dette overholder relevante krav i ISO

12 CN Accreditation scopes medical laboratories: Locations on the front page and in the method list are not always explicitly given, example:.abbreviations used in the method list are not identifiable on the front page [for a specific client].. DANAK vil sikre at koder klart fremgår af forsiden/angivelsen af sites. 12

13 CN A CAB has notified DANAK that they were closing the lab by end of December However, DANAK suspended the lab and did still not update the website to state that the lab is closed down. Tilståelsessag. Sagen nu lukket og ikke suspenderet. 13

14 Cm In section of the quality manual about the technical assessors procedure IP(P)8 is mentioned. However, a team of a lead assessor and technical experts performs assessments. This is also not clarified in IP(P)8. Simpel tilretning om at TA benyttes som tekniske eksperter på PTP (17043). 14