NA-S10: Checklist for laboratories (NS-EN ISO 17025)

Norsk akkreditering DoC.ID.: 6.2.1.25

NA-S10: Checklist for laboratories (NS-EN ISO 17025) Skjema/FormIssued by::

SBEApproved by:

ICLVerson:

5.03Valid from:01.08.2016

Page nr.:

1 of 21

This checklist shall be filled in by laboratories that are applying for, or wish to renew its accreditation. If an accredited laboratory has made big changes in the management system’s structure, the checklist also shall be filled in.

The paragraphs arranged in the checklist are in the same order as given in NS-EN ISO/IEC 17025 (2005). In some cases they are also referred to other requirement documents.

The progress in the handling of an application will depend upon how correct this form has been completed and that the sufficient details have been provided. The application will be returned without handling if this form is not filled in completely.

If the quality documentation provides a clear answer to all points of the checklist, then it is sufficient to give reference to relevant section of the documentation. Such references shall be given as detailed as possible. For matters where it is needed to provide more information than what has been provides in the quality documentation, then the remark column shall be filled in.

PS! For those points in the checklist that are not valid for the laboratory’s practice, the remark column shall be filled in with ”not relevant”.For insufficient place please provide additional information as annex.

To be completed by the applicant

To be completed by NA

Name of the laboratory: Accr. no/ Appl. no: Case no.:

Address: E-mail: Evaluated by:

Telephone: Telefax: Date:

NA-S10: Checklist for laboratories (NS-EN ISO 17025)Dok.id.: 6.2.1.25Versjon: 5.03Side: 2 av 21

Contact person: Date: NA’s technical officer:

Requirement Explanation Location in the management system documentation (chapter, section, book, procedure, work instructions etc)

Remarks

§ 4.1 Organization Information about type of company, f. example limited company, association, foundation etc.

Organization chart and description of structure of the laboratory giving information about activities and reporting lines (technical and administrative)

Description of responsibility and authority within the organization’s structure

Description of management personnel and technical personnel who, independent from other responsibilities, have the necessary authority and recourses to conduct their tasks.

Organization chart for the laboratory and if so, a description of the bigger organisation which that laboratory is a part of.

Presentation of the laboratory’s key personnel and quality manager together with their deputies for these positions.



Remarks

A description of that the quality manager has access to the top management.

Description of key clients covering also internal customer.

Clarify potential conflicts of interest regarding impartiality, independence and integrity and how the laboratory has solved this.

Description of other activities the laboratory is involved in besides accredited testing and how these are organised with respect to each other.

Description of how the laboratory ensures sufficient recourses in order to perform its duties – own book keeping and budget.

A statement that all activities are conducted independent to any pressure that may influence the results of the work.

Information about wage system (salary) for laboratory personnel.- the salary of the laboratory’s staff shall be independent of total number of samples and their results.



Remarks

A description of how confidential information from the clients and their ownership rights are protected, included procedures to protect electronic storage and transmission of results.A description of how the management has established appropriate communication processes in the laboratory.

§ 4.2 Management system

An authorised statement about the quality policy included the objectives for the management system related to quality

A description of establishing of the objectives and how it is reviewed during the management review.

A description of the management commitment to work according to the requirements in the standard an continuously improve the management system.

A description of how the management ensures that the personnel understand the importance of the client’s requirements and needs.

A list or similar which gives the information about all documents that are part of the management system

Description of structure of the management system.

Clarifying the roles and responsibilities of the



Remarks

technical management and the management system.

A description how the management ensures that the integrity in the management system is maintained by changes of the system.

§ 4.3 Document control

A description of who has the authority to approve different types of documents.

Procedure for document control which gives rules for valid version number and distribution together with withdrawal and archiving of obsolete documents.

A document register with indication of valid issues of different documents and working instructions.

Procedure(s) for development and a unique identification of documents.

Procedure for periodical evaluation and updating of documents.

Rule for changes in documents (evaluation, approval etc) including hand made changes if this is allowable.

A description of identification of changes or new text.



Remarks

Procedure for changes of documents in the computer system.

Procedure for use of copied procedures/routines, overview of personnel holding copies and total number of copies.For electronic systems: Procedures for who can print out and rules and status for such copies.

How the quality manual and relevant annexes are made available to laboratory personnel.Are working instructions available where the work is conducted.

§ 4.4 Reviews of requests, tenders and contracts

Procedure describing how the laboratory handles requests, tenders and contracts and agreements the laboratory may have for all types of assignments.

Procedure(s) for handling of changes in the contract after it has been signed.

Procedure for registrations from contract reviews and changes in the contracts.

Procedure for information to the client about deviation from, or changes in the contract/



Remarks

agreement.

§ 4.5 Subcontracting of tests and calibrations

Procedure for use of subcontractor for accredited services with the scope of the laboratory’s accreditation.

Procedures for documentation of the subcontractor’s competence.

Procedure how the client get information about use of subcontractors and how to get he client’s acceptance for using subcontractor.

Cross reference to a register showing all subcontractors with description of topical methods/parameters for each subcontractor.

§ 4.6 Purchasing services and suppliers

Policy and procedure for selection and procurement of services, consumable materials and reagents.

Routines for receiving, control and storage of material, reagents and consumption material.

Procedure(s) that describe how the laboratory assess suppliers and surveillance of suppliers.

List of approved suppliers.

§ 4.7 Service to the Procedure(s) describing that the laboratory is willing



Remarks

customer to cooperate with the customer to clarify their needs and to describe how the laboratory ensures confidential handling regarding other customers.

A description how the laboratory measures customer satisfaction and how the feedback from customers are evaluated.

§ 4.8 Complaints Policy and procedure(s) for registration, handling, follow up and feedback to customers when receiving of complaints.

§ 4.9 Control of non-conforming testing and/or calibration work

Policy and procedure(s) for registration and handling of non-conformities regarding own procedures or requirements agreed with the customer.

Clarification of responsibility and authority.

§ 4.10 Improvement A description of how the laboratory continually improve the effectiveness of its management system by use of the quality policy, audit results, analysis of data, corrective and preventive actions and management review.

§ 4.11 Corrective action

Description of policy and procedure for appointment of personnel with authority to carry out corrective



Remarks

actions.

Rules for cause analysis.

Rules for selection and implementation of corrective action.

Rules for monitoring of corrective actions.

Rule for when additional audits shall be performed in connection with corrective actions.

§ 4.12 Preventive action

Procedure for how potential source for non-conformities shall be identified. Rule for issuing, implementation and monitoring of action plans.

§ 4.13 Control of records

Procedure for identification, collection, recording, access to, archiving, storage, maintenance and disposal of records.

Routines for recording of all necessary information that will be necessary to repeat test/calibration.

Rule for changes in records like raw data.

§ 4.14 Internal audits Procedure and distribution of responsibility for conducting internal audits (both horizontal and vertical) including audit of quality manager work related to the management system.



Remarks

Guidelines for the preparation of plans, reporting, following up and archiving of results.

An annual plan showing; what shall be audited, when it shall be performed and by whom.

Information about the qualification requirements for auditors.

§ 4.15 Management reviews

Procedure for planning, performing and follow up of results from management review of the management system, included a list of subjects that shall be discussed during the meeting.

Description of how the results shall be implemented in the laboratory’s system for planning of the coming years.

Description of reporting and archiving of the minutes from the management review of the management system.

§ 5.2 Personnel Laboratory goal for education, training and skill.

Policy for identification of need for training and training programme.

Description of how the effectiveness of training shall be evaluated.



Remarks

Procedure for training, maintenance and updating of staff qualification within the management system.

Procedure for training, maintenance and updating of staff qualifications within the different technical assignments like:

Persons who performs testing/calibration Sampling Responsible for approval of results Responsible for preparation of plans for

development and validation of in house/modified methods

Those who sign test reports/ calibration certificates.

Routine(s) for approval of different category of staff (see above), which competence is required together with the criteria, which is used for approval.

Overview of responsible person(s) for development and validation of non-standard methods.

Overview of staff showing who is qualified to perform the individual methods and the date for the approval.



Remarks

Overview showing who is approved to assume the technical responsibility for testing/calibration results from the individual methods.

Cross reference to updated and signed CVs for laboratory staff.

Job descriptions for each post category/function.Specification of job assignments, deputies can take over.

Cross reference to declaration of confidentiality signed by the staff.

§5.3 Accomodation and environmental conditions

Description of the test facility - preferably in form of a drawing.

Description of the laboratory’s access control.

Description of actions that shall be taken to avoid any cross contamination.

Specification of requirements for laboratory environment.

A description and a system how environmental parameters are recorded.



Remarks

Description of actions performed when environmental parameters are not longer in conformity with the specified requirements.

§ 5.4 Test and calibration methods and method validation

Cross reference to written work instructions/procedures for all methods in the accreditation scope.

Overview of laboratory testing /calibration scope (including accredited methods).

§ 5.4.2 Selection of methods

Policy showing how laboratory selects its methods and procedures for clarifying the method of selection with the client.

Describing of procedure verifying that the laboratory is capable of performing standard methods in a correct way.

Description of routines ensuring that the laboratory uses the latest version of standard methods (updating of method collection, subscription of standards).

Cross reference to documentation, which shows that the laboratory get acceptable results using standard methods.

§ 5.4.3 / § 5.4.4 Procedure for development of own (in house)



Remarks

Laboratory-developed methods / non standard methods

methods / non-standard methods.

§ 5.4.5 Validation of methods

Procedure and documentation, including cross reference to these, for validation of non-standard methods, modified methods and in-house methods.

Rules for mapping, planning performance and reporting of validations.

§ 5.4.6 Estimation of uncertainty of measurement

Procedure describing how measurement uncertainty for testing/calibration/possible sampling is estimated or calculated.

Cross reference to reports or other equivalent document, which document the estimated or calculated measurement uncertainty.

When it is not required/used uncertainty budget. Specify how the important contributors to measurement uncertainty have been identified.

§ 5.4.7 Control of data

Procedure for control of raw data, calculations, registrations, registration of recorded values.

Procedure for control of calibration / test results.

Procedure(s) and documentation including cross-



Remarks

reference to these, for validation/control of computer software that are used for calculation, data transfer or archiving of data.

§ 5.5 Equipment Cross reference to a list giving an overview of all equipment that is used in connection with accredited testing/calibration (included software). The equipment outside the laboratory premises and equipment, which is not directly controlled by the laboratory, is included in the list.

A description of how equipment is labelled for example with calibration labels or quarantine labels.

Program and yearly plan with distribution of responsibility for calibration and control of equipment (traceability chart).

Cross reference to procedures for handling laboratory equipment.

A program for maintenance and verification of equipment.

§ 5.6 Measurement traceability

Description of laboratory system for achieving traceability for testing and calibrations.

Cross reference to procedures for use and storage of



Remarks

laboratory’s standards and/or reference materials.

§ 5.7 Sampling(requires a separate application)

Procedure describing how sampling is planned and conducted.

Procedure(s) for registration of relevant data in connection with sampling.

Procedure describing how the laboratory handles in case of change in the sampling plan and how the client approves this.

§ 5.8 Handling of test and calibration items

Procedure for receipt and receipt control of test items/ test- and calibration objects, and a system for making test items/ test objects anonymous in the laboratory.

Procedure(s) describing how the laboratory takes care of sampling and calibration items with irregularity or deviations from normal or specified conditions, or if the item is not in accordance with its description.

A system for identification of test and calibration items either with the help of documents or labelling.

Procedure for handling, storage, transport and



Remarks

disposal of test and calibration items.

§ 5.9 Assuring the quality of test and calibration results

Procedure describing how the laboratory monitors the quality of testing (for example control samples, inter laboratory comparison (ILC), certified reference material) or calibration. This should also cover the handling of results.

A description of how trends in quality control data are detectable and evaluated.

An overview of inter laboratory schemes in which the laboratory participates and frequency of its participation.

Procedure describing analysis of quality control data and actions that has to be taken to avoid reporting of incorrect results.

§ 5.10. Reporting the results

Description of the contents of calibration certificates or test reports including system for their identification and publication.

Description of and cross-reference to, preparation of calibration certificates or test reports (for example reference to a template)

If relevant, a procedure for publication of simplified



Remarks

reports

Description of how non-accredited activities/results are identified in the report (for example sampling, opinion and interpretation, results from non-accredited methods).

Description of how intermediate results are quality ensured when this is relevant (This can be both in written or verbal reporting).

Procedure for correction of published reports/additional reports.

Procedure for referring to possible sub-contractors that have been used.

NA Dok. 14 and 25/31

Guidelines for referring to accreditation and use of calibration labels in advertisement and on web site and in all other situations.

NA Dok. 25/31, pkt. 2, 4, 6 og 7, Cooperation

Description of co-operation with the accreditation body.

NA Dok. 25/31 Disclosure requirements

Guidelines describing how major changes in the laboratory are communicated to NA.



Remarks

Additional requirements for area P32 ”Opinion and interpretation” (require a separate application)

§4.2 Management system

Procedure describing the system for opinion and interpretation including information what is to be interpreted and limitation of the system.

A detailed description of type of statements laboratory can make. Possible cross-reference to literature where this is adequately described. (If it is referred to literature then this has to be attached with the application, if not agreed before hand).

§4.1 Organization Description of responsibility and authority in connection with opinion and interpretations.

§4.13 Control of records

Description of how the basis for opinion and interpretation will be recorded.

§5.2 Personnel Description of what competence is required from personnel who shall make statements on opinion and interpretations. This should also cover the criteria for approval of these personnel.

Procedure for training, maintenance and updating of qualifications of the personnel who shall make/approve opinion and interpretations.

An overview of personnel who can make/approve



Remarks

opinion and interpretation of test and calibration results.

§5.10 Reporting the results

Description of the contents of the report and how opinion and interpretation are identified. (Relevant examples of the reports should be attached).

Additional requirement for area P31 “Flexible accreditation” (require a separate application) See also NA Dok 50

§4.2 Management system

Procedure describing the system for flexible accreditation including information about what can be allowed and limitations of the system.

§4.1 Organization Description of responsibility and authority in connection with flexible accreditation.

§4.13 Control of records

Descriptions showing how changes related to flexibility are recorded.

§5.2 Personnel Description of what competence is required from personnel who shall develop and validate plans.Criteria for approval of these personnel.

Procedure for training, maintenance and updating of qualifications of the personnel who shall be involved in the development and validation of plans

An overview of personnel who are responsible for



Remarks

validation.

§5.4.3 Laboratory-developed methods

Procedure for preparation of a plan for development of methods and how this shall be carried out.

§5.4.4 Non-standard methods

Procedure for preparation of a validation plan and how the validation shall be carried out.

References

External References

Documents

NA-S10: Checklist for laboratories (NS-EN ISO 17025)