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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.

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?