Internal Audit checklist for ISO 17025 – ISO 17025 technical requirements
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.
- 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?
- 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?
- Is a Branch Quality Coordinator appointed with defined job responsibilities?
- Is there a monthly reporting from the Branch Quality coordinator to QSD?
- Are guidelines and other communication received by the branch effectively communicated to the concerned personnel?
- 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?
- Are the buildings, workspaces, associated utilities adequate to meet the work requirements?
- Are necessary equipment and supporting services like communication etc, available?
- 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?
- 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?
- 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?
- 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?
- 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?