· web viewthis checklist has been prepared with reference to the uni cei en iso/iec 17025:2018...

System AssessorChecklist for the assessmentof a Calibration Laboratory

Department of Calibration Laboratories MD-09-05-S-DT rev. 0 UNI CEI EN ISO/IEC 17025:2018 of 24

GENERAL INSTRUCTIONSThis checklist has been prepared with reference to the UNI CEI EN ISO/IEC 17025:2018 standard (hereinafter "ISO/IEC 17025" or simply "the standard") and to the ACCREDIA DT RG-13, RG-09, RT-25, RT-26 and RT-36 in their current versions.The checklist must be completed both by the Laboratory (for self-assessment purposes) and by the System assessor (during the on-site assessment), referring to the indications below.

>>> LaboratoryThe Laboratory must fill in this document exclusively for sections 4, 5, 6, 7 and 8 only in the parts indicated with << self-assessment by the Laboratory >> (and highlighted in yellow) describing in an appropriate and complete manner the methods adopted from the Laboratory itself to meet the requirements of ISO/IEC 17025 and the ACCREDIA DT prescriptions, indicating - where foreseen and required - appropriate procedures and/or reference documents (the name and the revision index of the document must always be indicated).

>>> System AssessorDuring the on-site assessments, the System assessor must fill in this document in all its parts (highlighted in green) in the spaces corresponding to the type of assessment1 in progress and keeping all records related to any previous assessments. In particular, for sections 4, 5, 6, 7 and 8 the System assessor must briefly record all the evidence of conformity or the deficiencies found (with the support, where necessary, of the Technical Assessors of the assessment team), taking care to bring the references to the interviewed people, to the verified equipment, to the documents examined, etc.. The space identified with an "R" must be marked with an asterisk (or other identifying sign) in case the assessment of the specific requirement has given rise to a finding (to be reported in MD-09-03-DT). For the formulation and recording of the findings see procedure PG-09-DT. The System Assessor must also complete section 9 reporting the overall outcome of the closure assessment (performed by the entire assessment team) of the findings of the previous on-site assessment and of the document review in progress, where applicable. The specific evidences and the details of the assessment must be inserted in the respective MD-09-03-DT (received by the FT) by the relative Assessors.Section 10 "Additional notes" can be used for further annotations, if the acquisition of documents is necessary in the course of the on-site assessment (e.g. as evidence of non-compliance found or in case of reservations by the Laboratory), the System assessor must attach these documents to this checklist and record their references in section 11 "Attachments"._____________________ (A) accreditation; (E) extension; (R) renewal; (S) surveillance.



OPENING OF THE ON-SITE ASSESSMENT CLOSURE OF THE ON-SITE ASSESSMENTInternal meeting of the ACCREDIA DT assessment team, preliminary to the assessment opening

Summary to the Assessors of the general criteria for conducting the assessment

Setting up the assessment methods and distributing tasks

Joint review of any findings made by the assessor, their classification and compilation of MD-09-03-DT

Initial meeting with the Laboratory Present the assessment team with the related tasks Clarify roles and responsibilities of any ACCREDIA DT evaluators (EVA), FT,

guides (or persons assigned by the Laboratory to accompany the Assessors), trainee Assessors and observers, according to ISO 19011

Explain the purposes of the on-site assessment, which must be carried out respecting the safety conditions

Explain the on-site assessment plan, clarify any points not included and agree any changes to it

Define the details of any calibration to be carried out in the presence of the Assessor

Explain any subdivisions of the assessment team into subgroups and identifying the verification phases to be assigned to the subgroups, in order to optimize the performing time of the on-site assessment

Agree the times and methods for the assessment of possible off-site calibrations

Agree to any changes in the on-site assessment plan Explain the assessment procedure and the possibility of the Laboratory to

present reservations Recall the commitment of each member of the assessment team to the

confidentiality of information Please note that in the course of the assessment confidential meetings of the

assessors may be necessary Request confirmation of the presence of the Laboratory Direction or of one of

its representatives at least at the final meeting Offer the Laboratory the opportunity to ask for further clarifications Formalize the requirements for safety as required in the notification, verifying

the existence of the safety conditions previously communicated through the MD-19 document

Record the people of the Laboratory taking part in the initial meeting in this checklist

Final meeting with the Laboratory Submit a summary of the activities carried out Present the opinion on the Laboratory formulated by the assessment

team Recall that the results of the on-site assessment are the result of a

sampling and that therefore other problems, in addition to those detected, could be present and be identified in the subsequent on-site assessment of both ACCREDIA DT and during internal audits.

Present any findings detected, explaining the contents and motivations, trying to get the understanding and sharing of the remarks themselves by the Laboratory, specifying that the part relating to the corrective actions proposed by the Laboratory must be completed only after the request for corrective actions by ACCREDIA DT

Collect any reservations presented by the Laboratory; alternatively, the Laboratory may express reservations by completing the relative form (DT-Mod-007) within 3 working days; the acceptance or otherwise of the reservations formulated by the Laboratory is delegated to the Department Director

Request the signature from the Laboratory for acceptance of the report containing the findings and the feedback section of the on-site assessment; this report is also signed by the members of the assessment team, each for their own competence finding

Release to the Laboratory copy of the report containing both the list of findings detected and the feedback, specifying that ACCREDIA DT reserves the right to confirm or not the contents

Register in this checklist the people of the Laboratory taking part in the final meeting.



1. GENERAL INFORMATION<<< back to start of document

Go to section… 2Presences

3 Preliminary assessments

4General requirements

5Structural requirements

6Resource requirements

7Process requirements

8Management system requirements

9Closure of findings assessment

LaboratoryNameLAT n.

On-site assessment ACCREDITATION (A) /RENEWAL (R)

1st SURVEILLANCE(S1)

2nd SURVEILLANCE(S2)

EXTENSION(E)

SiteInitial meeting Date/TimeFinal meeting Date/Time





2. ACCREDIA DT ASSESSMENT TEAM AND LABORATORY PERSONNEL<<< back to start of document

Go to section … 2Presences








Compile at each on-site assessment, keeping any previous recordings present. Add rows to the bottom of the table if necessary.

ACCREDIA DT ASSESSMENT TEAM

Scope1 Name and Surname Role Sectors of competence (only for Technical Assessors)

1 Indicate the scope of the on-site assessment to which the presence refers: (A) Accreditation, (E) Extension, (R) Renewal, (S1) 1st Surveillance, (S2) 2nd Surveillance.



Compile at each on-site assessment, keeping any previous recordings present. Add rows to the bottom of the table if necessary.

PERSONNEL PRESENT FOR THE LABORATORY Initial Meeting Final Meeting

VsC2 Name and Surname Role Indicate the presence with an X



3. PRELIMINARY ASSESSMENTS<<< back to start of document









Specific risks A / E / R S1 S2Indicate if MD-19 is available, duly completed by the Laboratory. If it is directly delivered during on-site assessment, please attach the form to this document by writing it down in section 11Any additional information received from the Laboratory during the initial meeting

Assessment A / E / R S1 S2Indicate date and revision of the Application for Accreditation being assessed (where applicable)Verify that the activities in Chamber of Commerce perusal include those accreditedIndicate if the laboratory performs external calibrations

Indicate if the Laboratory is multi-site

Indicate if the Laboratory is accredited for a flexible scope

(In case of A/E) Indicate, for the calibrations subject to accreditation/extension, the approximate number of calibrations carried out by the Laboratory in the year preceding the application(In case of R) Indicate the number of calibration certificates issued under accreditation during the current cycle



Assessment A / E / R S1 S2(In case of R) Indicate the number of calibration certificates issued out of accreditation but for activities falling within the scope of accreditation during the current cycleCheck with the assessment team whether the accreditation table is correctly expressedVerify that the Laboratory has notified to Accredia any changes to the programme to participate in the comparisons PT/ILC [RT 36]In the event that changes are made to the organization and/or structure of the Laboratory that may affect the maintenance of compliance with the requirements prescribed by ACCREDIA, verify that the Organization has promptly informed ACCREDIAIn case the Laboratory has, in reference to the activities covered by accreditation, pending judicial proceedings and/or administrative and judicial provisions concerning its own internal and external staff, verify that the Organization has promptly informed ACCREDIA(In case of E/R/S) Indicate whether the Laboratory has been suspended in the period since the previous on-site assessmentIndicate if, in the period prior to the assessment, ACCREDIA has received complaints about the work of the LaboratoryIndicate whether the Laboratory provided ACCREDIA assessors with all the necessary cooperation to check that the requirements of ISO/IEC 17025 and ACCREDIA DT have been met



4. GENERAL REQUIREMENTS (§4 UNI CEI EN ISO/IEC 17025:2018)<<< back to start of document

Go to the section …

2Presences








4.1 ImpartialityIndicate how the Laboratory has identified and evaluates

the risks to impartiality

<<self-assessment by the Laboratory>>

RA/E/R

S1

S2

4.2 Confidentiality << self-assessment by the Laboratory >>R

A/E/R

S1

S2



5. STRUCTURAL REQUIREMENTS (§5 UNI CEI EN ISO/IEC 17025:2018)<<< back to start of document









5.1 << self-assessment by the Laboratory >>R

A/E/R

S1

S2


A/E/R

S1

S2

5.3 << self-assessment by the Laboratory >>

RIndicate the document declaring the extension and coverage of the activities carried out in compliance with the standard [RT-25, §5.3]

<< self-assessment by the Laboratory >>

A/E/R

S1

S2




R

(For laboratories that perform external calibrations and multi-site laboratories) Indicate the documents in which the application of the provisions in [RG-13] is documented


A/E/R

S1

S2


RIndicate the documents containing the description of the technical activities that led to the CMCs [RT-25, §5.5]


A/E/R

S1

S2


RIndicate the function that has authority and resources to ensure the functioning of the management system in accordance with the standard [RT-25, §5.6]


A/E/R

S1

S2


Indicate the document defining the methods and responsibilities for managing the change [RT-25, §5.7]


A/E/R

S1



S2



6. RESOURCE REQUIREMENTS (§6 UNI CEI EN ISO/IEC 17025:2018)<<< back to start of document









6.1 General << self-assessment by the Laboratory >>R

A/E/R

S1

S2

6.2 Personnel << self-assessment by the Laboratory >>

R

Indicate the documents in which for each function of the Laboratory, the skills necessary to cover the assigned role are defined [RT-25, §6.2.2]


Indicate the procedure in which the application of personnel requirements is documented 2 [RT-25, §6.2.5]


A/E/R

S1

S2

23 Including personnel performing external calibrations and/or is employed in UOM and UOD [RG13] and the one performing internal calibrations [RT-25 § 10].



6.3 Facilities and environmental conditions


R

Indicate the system document which describes the requirements relating to the facilities and environmental conditions necessary for the implementation of the calibration activities carried out in the permanent laboratory [RT-25, §6.3.2; RG-13]


Indicate the system document which describes the requirements relating to the facilities and environmental conditions necessary for the implementation of the external calibration activities[RT-25, §6.3.5; RG-13]


A/E/R

S1

S2

6.4 Equipment << self-assessment by the Laboratory >>

R

Indicate the metrological confirmation procedure in which the calibration intervals are entered [RT-25, §6.4.7]


Indicate the procedure in which the modalities for carrying out the intermediate checks are described [RT-25, §6.4.10]


(For laboratories that perform external calibrations and multi-site laboratories) Indicate the procedure in which the application of metrological confirmation, transport, use, maintenance, calibration and intermediate checks of the instruments and standards used is documented [RG-13]


A/E/R

S1

S2

6.5 Metrological traceability


RIndicate the method(s) with which the Laboratory ensures the metrological traceability of its measurement results [RT-25, §9]


A/E/R



S1

S2

6.6 Externally provided products and services


RA/E/R

S1

S2



7. PROCESS REQUIREMENTS (§7 UNI CEI EN ISO/IEC 17025:2018)<<< back to start of document









7.1 Review of requests, tenders and contracts


R

Indicate the procedure(s) in which the methods for handling requests, tenders and contracts are described [RT-25, §7.1.1]


Indicate how the Laboratory informs its customers on the meaning of accreditation and on the accreditation of the activities covered by the tender [RT-25, §7.1.1]


Indicate the documents in which the Laboratory has defined the procedures and meets the requirements for the use of the ACCREDIA (and ILAC-ACCREDIA, where applicable) mark in what concerns the communication to the Customers3 [RG-09, §5.4]


A/E/R

S1

S2

7.2 Selection, verification and validation of methods


RIndicate the procedures4 in which the calibration methods used by the Laboratory for its activities are described (also for internal calibrations) [RT-25, §7.2.1.1]


A/E/R

S1

S2

34 For example (non-exhaustive list): commercial, promotional or advertising documents, tariff/price lists, letterheads, website, and vehicles.45 Including uncertainty budget.



7.3 Sampling << self-assessment by the Laboratory >>

RIndicate the procedure that contains the sampling method used by the Laboratory [RT-25, §7.3.1]


A/E/R

S1

S2

7.4 Handling of calibration items

<< self-assessment by the Laboratory >>R

A/E/R

S1

S2

7.5 Technical records << self-assessment by the Laboratory >>R

A/E/R

S1

S2

7.6 Evaluation of measurement uncertainty


R

Indicate the documents in which the uncertainty contributions identified by the Laboratory have been defined [RT-25, §7.6.1]


Indicate whether the laboratory performs internal calibrations and how it meets the relevant prescriptions [RT-25, §10]. In particular, indicate the procedure (s) in which the internal calibration methods used by the Laboratory for its activities are described[RT-25, §3.1.1, §7.6.2, §10]


A/E/R

S1



S2

7.7 Ensuring the validity of results


R

Indicate the established procedures for monitoring the validity of the results and for the statistical analysis of the data collected from the metrological confirmation [RT-25, §7.7.1]


Indicate the documents in which the requirements for the validation of the CMCs through measurement comparisons are defined [RT-36]


A/E/R

S1

S2

7.8 Reporting of results


R

Indicate the documents in which the Laboratory has defined the procedures and meets the requirements for the use of the ACCREDIA mark (and ILAC-ACCREDIA, where applicable) on calibration certificates and other permitted cases (e.g. labels on instruments)[RG-09, §5.4; RT-25, §7.8.4]


A/E/R

S1

S2

7.9 Complaints << self-assessment by the Laboratory >>

RIndicate the procedure in which the entire complaint handling process is documented [RT-25, §7.91; RG-09, §5.4.9]


A/E/R

S1

S2



7.10 Non-conforming work


A/E/R

S1

S2

7.11 Control of data and information management


RA/E/R

S1

S2



8. MANAGEMENT SYSTEM REQUIREMENTS (§8 UNI CEI EN ISO/IEC 17025:2018)<<< back to start of document









Indicate the risk management methods adopted by the Laboratory in its management system, in order to meet the requirements of the standard and/or RT-25


8.1 OptionsIndicate how the Laboratory

has implemented its management system, with

reference to the two possible options (A and B)


RA/E/R

S1

S2

>>> For the purposes of self-assessment, the Laboratory must complete the subsequent sections 8.2 to 8.9 only if Option A is applied.

8.2 Management system documentation


A/E/R

S1

S2



8.3 Control of management system documents


R

Indicate how the laboratory assures the prior positive evaluation by ACCREDIA DT of the documents required by the standard and/or by RT-25, before they become operational and can therefore be applied [RT-25, §8.3.2]


A/E/R

S1

S2

8.4 Control of records << self-assessment by the Laboratory >>R

A/E/R

S1

S2

8.5 Actions to address risks and opportunities


RA/E/R

S1

S2

8.6 Improvement << self-assessment by the Laboratory >>R

A/E/R

S1

S2

8.7 Corrective actions << self-assessment by the Laboratory >>R

A/E/R



S1

S2

8.8 Internal Audits << self-assessment by the Laboratory >>R

A/E/R

S1

S2

8.9 Management reviews


A/E/R

S1

S2



9. CLOSURE ASSESSMENT OF FINDINGS FROM PREVIOUS ASSESSMENTS<<< back to start of document









ON-SITE ASSESSMENTReport the requested information related to the last on-site assessment prior to the current one (not applicable if the current assessment is related to the first accreditation or extension), with reference to the overall set of the related MD-09-03-DT as received from the FT.The specific evidences and the details of the assessment must be inserted in the respective MD-09-03-DT by the relative Assessors.

Date Assessors Findings in MD-09-03-DT Closure5

R 0 NC 0 OSS 0 Cm

S1 0 NC 0 OSS 0 Cm

S2 0 NC 0 OSS 0 Cm

56 Indicate if the closure of findings assessment is generally considered: (P) positive; (N) negative.



DOCUMENT REVIEWReport the requested information relating to the possible document review in progress, with reference to the related MD-08-01-DT as received by the FT.The specific evidences and details of the assessment must be entered in the respective MD-08-01-DT.

Date Scope6 Assessor Conclusions in MD-08-01-DT7 Closure8

PP PC NP AggPP PC NP AggPP PC NP AggPP PC NP AggPP PC NP AggPP PC NP AggPP PC NP AggPP PC NP AggPP PC NP AggPP PC NP AggPP PC NP Agg

67 Indicate the scope of the on-site assessment in which the closure occurs: (A) Accreditation, (E) Extension, (R) Renewal, (S1) 1st Surveillance, (S2) 2nd Surveillance.78 Indicate with an "X" the conclusions indicated on MD-08-01-DT: (PP) Fully positive assessment, (PC) Positive assessment with comments, (NP) Non-positive assessment (even partial, referring to some of the documents evaluated). Indicate with an X in the "Agg" field in case the Laboratory provides during the assessment (or has provided before the assessment) the updated documentation that incorporates the outcome of the document review.89 Indicate if the assessment of the closure of the document findings is generally considered: (P) positive; (N) negative.



10. ADDITIONAL NOTES<<< back to start of document

11. ANNEXES<<< back to start of document

Report the references of any documentation acquired during the assessment and attached to this checklist.

A / E / R S1 S2

End of Checklist

· web viewthis checklist has been prepared with reference to the uni cei en iso/iec 17025:2018...

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