QMS AUDIT CHECKLIST (ISO9001:2008)

Clause / Requirements 4.1 General Has the QMS and the processes been maintained? Check MR minutes of meeting. Check with Site Rep for ISO for site ISO status. Has there been any change in the processes? Check with Site Rep for ISO. If change has been made, has this led to improvement?(also see data & measurement) (Note the change either in the QMS or the processes and the improvement achieved)

Auditee

Doc Ref

Response

4.2 Documentation Any changes to the IMS Manuals? If yes, is control of documents procedure followed? Check the Doc Change Control/Record. Are the IMS Policy & Objectives maintained? If not changed, has it been reviewed during the last management review for continued suitability & effectiveness? Are the IMS or project records / documents legible, identifiable, properly filed and easily accessed? Are documents (such as drawings & specifications, etc) verified & approved before use? Are documents of external origin eg standards, references, etc identified and distribution controlled? Are standards updated? Are documents, especially reference documents available at point of use? Are obsolete documents identified and properly disposed of?

5.1 Management commitment Does the management continue to communicate to the staff on importance & how to satisfy requirements of customers & authority regulations?
Page 1 of 11

QMS AUDIT CHECKLIST (ISO9001:2008)

Clause / Requirements 5.2 Customer focus How does the Top Management ensure that customers requirements are determined and met for projects? 5.3 Policy Is the IMS Policy appropriate to the purpose of the organisation? Is it communicated and understood within the organisation? If changed, why was it changed & whether it has resulted in any improvement? Has it been reviewed for continued suitability Does the Policy incl a commitment to comply with requirements and continually improve the effectiveness of the IMS? Does it provide a framework for establishing and reviewing quality objectives? Auditee Doc Ref Response

5.4 Planning 5.4.1 Objectives Have the established objectives been achieved? Have they been reviewed during the last management review? Any changes to the QMS since the last MR?

5.4.2 QMS planning Have the statutory & regulatory requirements been reviewed and updated, where necessary? Has any major nonconformities occurred?

5.5 Responsibility, authority & communication 5.5.1 Responsibility & authority Has there been any change in the organisation structure, especially in the maintenance of the QMS?

Page 2 of 11

QMS AUDIT CHECKLIST (ISO9001:2008)

Clause / Requirements 5.5.2 Management representative Has the management representative maintained the QMS effectively through performance of his functions as a MRrep? 5.5.3 Communication By what means has communication been made to the staff, suppliers & sub-contractors? 5.6 Management Review 5.6.1 Is the QMS reviewed by management at planned intervals? When was last MR meeting? 5.6.2 Input Does the MRv include: Info on audit results, customer feedback, process performance/product conformity, status of PA/CA, follow-up actions from previous MRv, changes, and recommendations for improvements? Additionally: EMS/OHS evaluation of compliance with legal/other requirements, OHS/EMS performance of organisation, extent to which objectives have been met, changes in circumstances incl developments in legal/other requirements (for EMS, relating to aspect only) OHS status of incident investigation, results of participation/consultation EMS communication from external interested parties, incl complaints Auditee Doc Ref Response

5.6.3 Output Does the MRv include any decision and actions related to improvement of the effectiveness of the IMS and its processes, improvements of product related to customer requirements and resource needs? Additionally: EMS/OHS decisions and actions related to possible changes to performance, policy & objectives, resources and other elements of the EMS/OHS MS. 6.0 Resource management 6.1 Provision of resources Are resources (incl manpower, training, IT, office provisions) provided adequate for maintaining the QMS?

Page 3 of 11

QMS AUDIT CHECKLIST (ISO9001:2008)

Clause / Requirements Are present resources adequate to meet customer requirements and/or improvement? Auditee Doc Ref Response

6.2 Human resources Are the people performing work found competent with suitable education, sufficient training & experience?

How are training needs identified and planned, where applicable? Are training records maintained?

Is the effectiveness of training evaluated?

6.3 Infrastructure Are the buildings, workspace adequate for operation & work? Is the process equipment adequate? (list examples)

6.4 Work Environment Has the work environment been determined and managed to achieve conformity to product requirement? 7.0 Product realization 7.1 Planning of production realization Are the quality objectives of the product and customer requirements maintained? Are the established processes still maintained? Is there any change in the processes? Are the documentation and records maintained? Any change in the records required?
Page 4 of 11

QMS AUDIT CHECKLIST (ISO9001:2008)

Clause / Requirements Do the records show evidence of: verification, validation, monitoring, inspection & testing and criteria for acceptance? Are there records to provide as evidence that the processes and the resulting product/work meet requirements? (Eg. Inspection records) Auditee Doc Ref Response

7.2 Customer related processes Are requirements specified by the customer (including inspection, delivery, etc) Any requirements not specified by the customer but necessary to meet purpose of use or statutory and regulatory requirements? Any additional requirements specified by the company?

Are the product requirements defined?

Are differences and changes of contract clarified and resolved? Are these changes documented?

Are records of review & actions arising maintained?

How is effective communication with customers carried out?

7.3 Design & development 7.3.1 Planning What are the D&D stages? Are these stages reviewed, verified and validated as appropriate? Are the responsibilities & authorities determined?

Page 5 of 11

QMS AUDIT CHECKLIST (ISO9001:2008)

Clause / Requirements 7.3.2 Inputs What are the D&D inputs? Are the following determined functional/performance requirements, stat. & regulatory reqms, previous similar design, other reqm essential for D&D? Are these inputs reviewed for adequacy & by whom? Are records available? Auditee Doc Ref Response

7.3.3 Outputs Do the outputs meet input requirements, provide appropriate info for purchasing, production & service provision, contain or reference product acceptance criteria and specify characteristics of products for safe use? Who will approve the design outputs prior to release and has it been done? 7.3.4 Review Are the results reviewed at specified stages? Are there records available for these reviews?

7.3.5 Verification Are records maintained for results of verification & actions to be taken? To ensure output has met D&D input requirements. 7.3.6 Validation How is the validation done? To ensure resulting product can meet the requirements for specified application or intended use, where known. Is validation done prior to delivery or implementation of the product/project? Are records for validation maintained?

7.3.7 Changes How are D&D changes controlled? Who will review, verify & approve the changes?

7.4 Purchasing 7.4.1 Purchasing process Are suppliers & sub-contractors evaluated?
Page 6 of 11

QMS AUDIT CHECKLIST (ISO9001:2008)

Clause / Requirements Are records maintained? Is an Approved Vendors List available? Are the suppliers & sub-contractors re-evaluated for consistency in performance? Auditee Doc Ref Response

7.4.2 Purchasing information Are requisition, purchase orders or contracts issued? 7.4.3 Verification of purchased product How are the purchased product/service verified, inspected or tested to ensure that they meet specified requirements? 7.5 Production & Service provision 7.5.1 Control Is the production / service provision carried out under controlled conditions? What are the controls? (Eg. Specifications, standards, CP, regulations, use of suitable equipment, use of measuring/monitoring equipment, etc) 7.5.2 Validation of processes for production & service provision For product or service where deficiency will only show after delivery & use, is there any process used to verify & validate the resulting output? (Eg. Concrete strength, piling) For such process, are criteria for review & approval defined? Is there approval of equipment & qualification of personnel? Is there use of any specific methods and procedures?

Are records maintained?

7.5.3 Identification & traceability Is identification & traceability necessary for production/service?
Page 7 of 11

QMS AUDIT CHECKLIST (ISO9001:2008)

Clause / Requirements How is the status of production monitored & measured? Are records maintained? (if traceability is required) Auditee Doc Ref Response

7.5.4 Customer property Is customer supplied property used? If so, how is it handled, stored & recorded? What happens if customer supplied property is damaged or lost?

7.5.5 Preservation of product How is the product preserved during production and before delivery? Are special identification, packaging, storage & protection required?

7.6 Control of monitoring & measuring devices Are monitoring & measuring devices used? If so, is a record maintained on their calibration status?

Are they labeled with dates of calibration &/or expiry? Are they properly stored and handled?

8.0 Measurement, analysis & improvement 8.1 General Has the organization planned and implemented monitoring, measurement, analysis & improvement: To show conformity to product requirements To ensure conformity of the QMS (i.e. IQA) For continual improvement of QMS (i.e. management review)

8.2 Monitoring & measurement 8.2.1 Customer satisfaction How is customer satisfaction measured? What is the analysis of customer satisfaction?
Page 8 of 11

QMS AUDIT CHECKLIST (ISO9001:2008)

Clause / Requirements 8.2.2 Internal audit (IQA) Has IQA been conducted as planned? Have the results of findings been reported for management review? Has the IQA covered a complete cycle and important processes & areas? Were there findings of nonconformity & reports (NCRs) issued? Have the corrective actions been carried out in time & the NCRs closed? Have the corrective actions for NCRs been followed up and verified? Auditee Doc Ref Response

8.2.3 Monitoring & measurement of processes Process Improvement What are the methods used in monitoring or measuring (where applicable) the operational processes to show that these processes can achieve planned results? (Eg. Cycle times, Productivity of work processes, etc) 8.2.4 Monitoring & measurement of product How are the characteristics of the product(s) monitored and measured to verify that product requirements have been met? Is evidence of conformity with acceptance criteria maintained? What are the records? (check: inspection checklist, test reports, etc) What is the procedure used for release of the final product? (check: inspection record, approval/acceptance records for authorization and acceptance)

8.3 Control of nonconforming product Any instances non-conforming product since the last MR? If yes, how was the NC product dealt with? Is there any record to show identification, correction, disposition, concession, and mitigation of the effects of nonconforming product if already delivered or used?
Page 9 of 11

QMS AUDIT CHECKLIST (ISO9001:2008)

Clause / Requirements Was the corrected product subjected to re-inspection & verification? Auditee Doc Ref Response

8.4 Analysis of data Have data been collected and analysed for: - customer satisfaction (trend over last years results) - product requirements conformity - process characteristics - suppliers/sub-contractors (vendor evaluation) To show suitability and effectiveness of the QMS and evaluate where CI of effectiveness can be made. Are there records of the data collected and analysed?

8.5 Improvement 8.5.1 Continual improvement Are there areas identified for improvement?-(through policy, objectives, audit results, analysis of data, corrective & preventive actions & management review)

8.5.2 Corrective action Has the procedure for corrective action been maintained? Has any nonconformity been identified during operation? If yes, what is the root cause? Are there records of Corrective Action Request (CAR) being issued? Has the corrective action been reviewed for effectiveness and closed? Any other form of corrective action? Have these led to preventive actions? (to prevent recurrence)

8.5.3 Preventive action Has the procedure for preventive action been maintained?

Page 10 of 11

QMS AUDIT CHECKLIST (ISO9001:2008)

Clause / Requirements Have potential nonconformities been identified? Are there records of Preventive Action Request (PAR) being issued? Were the preventive actions appropriate? Have these preventive actions been implemented, reviewed and PAR closed? Auditee Doc Ref Response

Other observations: ____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________________________

Page 11 of 11