Internal Audit checklist for ISO 17025 – ISO 17025 technical requirements

Internal Audit checklist for ISO 17025 – ISO 17025 technical requirements

internal Audit Checklist as per ISO 17025

ISO 17025 – Internal audit checklist defines a description information of QMS internal audit check list to comply ISO 17025 technical requirements. The document covered all processes are in scope of ISO 17025 – technical requirements.

Quality Manual

  • Is there a defined Quality Policy Statement?
  • Does the Quality Manual define the scope of the QMS including details and justifications for exclusions?
  • Does the Quality Manual include documented procedures for the QMS or provide reference to them?
  • Does the Quality Manual describe the interaction between the processes of the QMS?

Control of Documents

  • Is a documented procedure available for control of documents required by the QMS?
  • Are document references given as defined in the regional procedure for Document Control
  • Is there a distribution list for documents that are circulated as hard copies or in CDs / diskettes?
  • Do all hard copies / CDs bear the remark ‘Controlled Document’ and the indication of originating site / authorized person?
  • Is there a master copy of all valid documents / forms available?
  • Do all documents/forms in use show the correct version number as indicated on the master copies?
  • Do documents that need control for a limited period indicate the validity date?
  • Are all requirements for changes sent to QSD?
  • Are changes to documents handled as described under para 3.5 – ‘Mechanism of change’ of the regional document control procedure?
  • Are obsolete documents taken out from points of use and suitably marked to prevent their unintended use?
  • Are standards and specifications checked for updates and validity?
  • Are local procedures / work instructions / forms referenced as per work instruction?

Control of Records

  • Are records suitably referenced for easy identification and retrieval?
  • Are records securely stored and protected against dust, rodents, humidity / fungi, flood, heat, or any other source of damage to ensure legibility throughout retention?
  • Is the integrity of records checked during internal audits?
  • Is the retention period for records defined in the Record Retention Matrix?
  • Are records disposed of after the stipulated retention period mentioned in the records retention matrix?

Handling, Storage & Disposal of Samples

  • Are samples inspected on receipt for their condition or contamination?
  • Are the containers used to store samples suitable to the specific samples?
  • Do all samples have clear identification for easy traceability to the respective jobs?
  • Do the sample tags / labels have the minimum details as under para 3.5.5 of work instruction?
  • Are all received samples properly registered in a sample log / register?
  • Are samples stored in secure premises?
  • Are adequate arrangements made / precautions taken for samples which have special storage requirements?
  • Are samples stored taking into consideration the nature of the samples in order to prevent contamination or other potential hazards caused by incompatible materials?
  • Is authorization available for samples to be disposed?
  • Is a record of disposed samples updated in the sample register?
  • Is sample disposal carried out as per sector specific procedures?

Management Responsibility

  • Is there a Quality Policy defined by the top Management?
  • Are all personnel aware of the organization’s Quality Policy?

Planning, Quality Objectives 

  • Are Quality Objectives established?
  • Are Quality Objectives measurable and in line with the Quality Policy?

Responsibility & Authority

  • Is a responsibility Matrix defined in the branch?
  • Are alternatives deputies defined for key positions?

Management Representative

  • Is a Branch Quality Coordinator appointed with defined job responsibilities?
  • Is there a monthly reporting from the Branch Quality coordinator to QSD?

Internal communication

  • Are guidelines and other communication received by the branch effectively communicated to the concerned personnel?

Reviews

  • Are management reviews planned and conducted on a monthly basis in the branch?
  • Does the Management Review cover the agenda described in the Regional Management Review procedure?
  • Are the minutes of the review sent to QSD for further review?
  • Are actions for the improvement and effectiveness of the QMS defined in the Minutes of the Management Review Meetings?
  • Are responsible personnel and time frames for actions defined?

Competence, awareness and training

  • Does the branch administration / HR maintain personal files of all employees?
  • So all personal files contain the personal data form?
  • Are the required qualification records required for the employee available?
  • Is there a training plan?
  • Are training attendance sheets and any certificates (if applicable) of training conducted for employees available?
  • Is the capability matrix available?
  • Are employee expertise levels defined in the capability matrix in line with the education, training or experience of the employee?
  • Are inspectors assigned to jobs as per expertise defined in the capability matrix?
  • Is skill / competence evaluation of an employee made after appropriate training?
  • Is the capability matrix updated according to the skill evaluation made after training, or on a periodic basis?
  • Is the capability matrix updated every 6 months?

Infrastructure

  • Are the buildings, workspaces, associated utilities adequate to meet the work requirements?
  • Are necessary equipment and supporting services like communication etc, available?

Work environment

  • Is the work environment monitored and controlled as may be required?
  • Where required are incompatible activities separated?
  • Is access controlled where required?
  • Is good housekeeping ensured?
  • Are emergency exists and assembly points clearly identified?
  • Are all employees aware of the Company’s Safety Policy?
  • Controlling Access and regulating use of areas affecting Quality

Planning of product realization

  • Are inspection / test methods defined to meet the service requirements?
  • Are test & calibration methods and method validation defined
  • Is contract review carried out for each order?
  • Are any discrepancies in the review notified to the client?
  • Are customer requirements related to the job clearly established?
  • Are any requirements differing from those previously expressed or standard are resolved?
  • Are availability of sufficient resources and capability for accurate & timely completion of the job ensured?
  • Does the review take into consideration any statutory, health & safety, environmental issues that may be applicable?
  • Are any implied requirements clearly communicated to the customer?
  • Are any changes / modifications to the contract reviewed against the previous documents?
  • Are any deviations from the original agreement clearly informed to the customer?
  • Is confirmation for proposal obtained from the customer?
  • Is the client kept informed of the job progress if required by the contract?
  • Is all client feedback / complaints duly acknowledged?

Purchasing

  • Are there approved requisitions for the purchases made?
  • Are potential suppliers evaluated for conformity to supply requirements?
  • Are supplier appraisal forms available?
  • Is a record of approved suppliers?
  • Are purchase orders made for the required supplies and duly authorized?
  • Are purchase orders followed up and monitored for delivery?
  • Is supplier performance monitored and where applicable, the supplier appraisal updated?
  • Is the incoming material verified for conformity to quantity and quality requirements before issuance for use?
  • Are non-conforming goods segregated and clearly marked to prevent unintended use before rectification / replacement?
  • Is declaration obtained from all suppliers who are applicable as per para 3.5 of the purchasing procedure?
  • Are all subcontractors evaluated to ensure that service provide provided conforms to the requirements?
  • If any job is needed to be subcontracted, is the necessary advice given to the client?
  • Is there a record of approved subcontractors?

Production and Service provision

  • Are verbal orders suitably recorded?
  • Are all files uniquely numbered for identification?
  • Is the job order log / register updated with each job file?
  • Are necessary procedures / work instructions standards, etc required for the job available?
  • Is an inspection job schedule maintained?
  • Are job instructions briefed to inspectors?
  • Do inspectors confirm having received and understood the job instructions?
  • Where applicable, is validation of test methods done?
  • Is the inspection / sampling done in accordance with the job instructions provided
  • Are all received samples recorded in the sample register?
  • Are samples coded before sending to the lab for analysis?
  • Are all relevant documents in a file clearly identified for traceability to the file?
  • Is the use of any customer equipment for the job or witnessing of operations at customers’ facilities duly noted in the report?
  • Are all jobs monitored against key control points where applicable?
  • Are draft reports / certificates / debit notes made and vetted for accuracy before final issuance?
  • Are job files checked for completeness and receipt of fees before closure?

Control of monitoring and measuring devices

  • Are all monitoring and measuring devices maintained in a good condition?
  • Do all measuring / testing instruments have valid calibrations and is calibration status clearly indicated on the instruments?
  • Where applicable, are the instruments used by personnel who are trained and authorized?
  • Is the status of calibration and condition of any client owned / provided instrument verified and duly mentioned in the report?
  • Are records of calibration maintained?
  • Are the calibration certificates traceable to relevant national / international standards?
  • Are instruments stored in suitable condition to prevent damage or deterioration?

Monitoring and measurement

  • Are feedback forms sent to clients?
  • Is feedback received from clients (even other than feedback forms) suitably recorded?
  • Is the feedback received from clients analyzed to establish performance trends?
  • Are results from client feedback reviewed for improvements?
  • Are client contact reports available?
  • Are client contacts made to obtain feedback from existing clients as well as to check potential business opportunities?
  • Is further action taken in the context of the client contact reports?

Internal audit

  • Is a documented procedure for internal audits available?
  • Is there an approved internal audit plan?
  • Are internal audits conducted against a defined internal audit checklist?
  • Are internal audits conducted by auditors independent of the areas being audited?
  • Are field audits conducted as per plan?
  • Are all inspectors covered by field audits?
  • Are file audits conducted as per sample size mentioned in the quality objectives?
  • Are all audit reports prepared and reviewed at Management review meetings?

Monitoring and measurement of processes

  • Are internal checks / vetting carried out necessary stages during the execution of the job?
  • Are any discrepancies / areas for improvement note during the checks subjected to corrective / preventive / improvement actions?

Monitoring and measurement of product

  • Are all drafts vetted before issuance of the final report / certificate, etc.?
  • Are final reports / certificates, etc. approved for release to clients by authorized signatories?

Control of non-conforming product

  • Is a documented procedure for control of non-conforming product available?
  • Is a CAR form prepared for any non-conformity detected?
  • Is a root cause analysis done of the non-conformity?
  • Where applicable, is the non-conforming material segregated and suitably identified to prevent its unintended use before rectification of the non-conformity?
  • Where non conformity is detected, is the affected client(s) contacted unless the remedial action does not result in loss of quality of service or delay?
  • Are all client complaints recorded and CAR prepared?
  • Are replies to client complaints made in consultation with the Branch Manager and Branch Quality Coordinator and where applicable with the Business Manager and NQM?

Corrective Action

  • Is a documented procedure for Corrective Actions available?
  • Is a CAR prepared for any non-conformity detected?
  • Is the CAR reviewed to find the root cause of the problem?
  • Are proposed corrective actions reviewed and approved by the concerned managers / authority?
  • Is the corrective action time bound and its implementation monitored?
  • Is a CAR log / register maintained to follow up the status of CARs?
  • Are CARs closed after verifying the effectiveness of the corrective action?
  • Does the CAR form provide objective evidence of the verification of the corrective action?
  • Are copies of closed CARs distributed to all concerned parties?
  • Is the CAR log / register updated to show the status of open / closed CARs?

Preventive Action

  • Is a documented procedure on preventive actions available?
  • Are areas for potential non conformities reviewed during the BQC meetings?
  • Are proposed preventive actions reviewed for feasibility and approved for implementation?
  • Are approved preventive actions monitored during implementation and verified for effectiveness?

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Orbit is a expert in solutions of industrial problems viz quality, production, planning, inspection etc. Orbit is writes about manufacturing's problems and its state solutions for quality lovers..

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