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CHECKLIST FOR INTERNAL QUALITY AUDITING

The checklist suggested here is indicative only. The internal auditors have to develop their own checklist considering applicable clauses to the identified processes within the Quality Management System. The reading, understanding & co-relating of the documented system with the requirements mentioned in quality manual would facilitate the auditors to be effective & efficient. 1.0 TOP MANAGEMENT Clause Audit Questions No. 5.1 a) What are the inputs used for establishing Quality Policy and Quality Objectives? i.e. Mission, Vision, Corporate Policy, Top Management interests and priorities etc. b) How continual improvement of effectiveness of QMS is ensured? c) How do you communicate to the organization the importance of meeting the customer requirements including the statutory and regulatory requirements? i.e. Memos, Displays, Meetings etc. 5.2 a) What are the inputs provided to you so that the customer requirements are determined and met? i.e. order review meetings, random checking of customer correspondence, customer meetings and feedbacks etc. b) What are the inputs do you get to ensure enhancement in customer satisfaction? i.e. customer feedback, customer audits, customer, survey, feedback to obtain product image in the market, handling customer complaints, repeat orders, cost effectiveness, enhancement in product properties, product development and innovations etc. 5.3 Is Quality Policy: a) Appropriate to the purpose of the organization? i.e. Policy should be in line with the current business priorities such as Increase in market share, Reduction in waste / rejection, cost, Customer satisfaction etc. b) Includes the commitment to comply with requirements and continually improve the effectiveness of QMS. c) Provide the framework for establishing Quality Objectives? d) How is it ensured that the Quality Policy is communicated and understood within the organization? e) How is the Quality Policy reviewed for continuing suitability? i.e. Policy shall be under “Control of Documents.” 5.4.1 a) Are the Quality Objectives consistent with the Quality Policy and are measurable? b) Are objectives deployed at relevant functions and levels within the organization? 5.5.1 a) How do you ensure that the responsibilities and authorities are defined? b) How are these communicated within the organization? i.e. documented by means of manuals, meetings, training, appraisals etc.

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criterions for the processes and objectives. a) Are management reviews done at planned intervals? b) Are records of management review maintained? c) Are criterions determined to check the effectiveness of Management Reviews? i. electronic media etc. Business performance.0 8. notice board. d) Are the decisions and actions communicated to the various departments? Are following inputs reviewed in the management reviews: a) Result of audits b) Customer feedback c) Process performance i. on time implementation of actions. customer complaints. Preventive & Corrective action and any other business requirements. new products. How do you ensure availability of resources. Analysis of data.e. h) Recommendations for improvement i. reorganization. 5.3 6. Analysis of data.: Effective Date: Page: 2 of 9 .e. Objectives. revised procedures. Objectives. Audit result. being appointed? a) What is the process of communication established in your organization? i. a) What are the inputs to you for identification of areas for continual improvement? i. product conformance. Quality Policy.5.5.6.6 5. internal rejections.2 5.e.5. f) Follow up of last management reviews g) Changes that could affect QMS i.R. c) Resource needs. follow ups required etc.e.e.e. Process performance. b) Improvement of product related to customer requirements. b) Is the communication covers effectiveness of QMS? i. new markets. environment related to product conformity. meetings.6. d) Product conformity e) Status of corrective and preventive actions i.1                   Document ID: Ver. infrastructure and work environment? i. Are actions and decisions included in the records for the following three outputs: a) Improvement of the effectiveness of QMS and its processes.e. deployment of Quality Objectives. process trends etc.<COMPANY NAME & LOGO>  Clause No. Procedures. Preventive & Corrective action and management review. b) What is the area for continual improvement?   5. Quality Policy.3 CHECKLIST FOR INTERNAL QUALITY AUDITING Audit Questions Is M.e.e. Audit result.2 5.

4 Is a documented procedure available for controls needed for identification. 4. Control of Documents. List of Approved Suppliers etc. storage. b) Justification of exclusions? c) Documented procedures? i. certification scope.e. verbal or documented based on the complexity of the process. Organization charts. product profile.2 Does a Quality Manual includes: a) Scope of QMS? i. operation and controls of processes are identified? i.e. Management review and Methodology for process measurements and status of objectives.5. Identification of resources. Specifications.e.e. Internal audits. Internal audits.e. Process Description / Matrix. b) How do you ensure that these processes are established? i.2. Quality Plans. Control of Non – conforming products. 4.2. sites.e.e. activities. Process Flow Charts. Continual improvement etc.3 Is documented procedure available to define controls for: a) Approval? b) Review. Corrective & Preventive actions. provision of resources.1 a) Are documented statements of Quality Policy and Objectives available? b) Are other documents needed by the organization to effective planning.3 How are the changes in documents communicated to various departments?   Document ID: Ver.2. outsourced activities. processes. protection. d) Description of interaction of processes? i.: Effective Date: Page: 3 of 9 . c) Are records specified in the International Standard identified? 4. Management reviews. Update and Re .0 MANAGEMENT REPRESENTATIVE Clause Audit Questions No.2. retrieval.<COMPANY NAME & LOGO>  CHECKLIST FOR INTERNAL QUALITY AUDITING 2. if retained? 4.1 a) Which are the processes identified in the QMS in the organization? i. Internal communication. for management activities. Control of Records. c) Is the sequence and interaction of these processes determined? d) Which processes are you directly responsible for? i. 4. retention time and disposition of records? 5. Work Instructions. Customer complaints.approve? c) Changes and current revision status of documents are identified? d) Relevant versions of applicable documents are available at point of use? e) Legible and readily identifiable? f) External origin documents are identified and their distribution controlled? g) Prevent unintended use of obsolete documents and to apply suitable identification to them. additional processes / procedures required. Documentation. product realization and measurement.

Auditor competence. reporting results and record maintenance? c) Are inputs identified to execute the complete audit process? i. 8.2.<COMPANY NAME & LOGO>  Clause No. Scope etc. d) Are internal audits conducted as per plan? e) Is the criterion of internal auditor’s competence defined? f) Are auditors not auditing their own work? g) Are the actions taken without undue delay by the area being audited? h) Are causes detected and non – conformities eliminated? i) Are follow up activities done? j) Are the audit results including the verification results are reported and records maintained? k) Is the criterion determined for checking the effectiveness of internal audit? l) Are corrections and corrective actions taken if the criterions are not met?             Document ID: Ver.: Effective Date: Page: 4 of 9 . results of previous audits to determine he frequency of audits. Status and importance of process of the area to be audited. checklist.e.2 CHECKLIST FOR INTERNAL QUALITY AUDITING Audit Questions a) Is documented procedure available for internal audits? b) Does the procedure contain responsibility of planning & conducting the audits.

e. f) Implementation of release. also includes intellectual property. if necessary.e.4 Is the work environment needed for the conformity of the product (service) determined and managed? 7.5.1 Are the resources required for the process available? 6.2. c) Are the methods available for above criterions? d) Are controls of processes determined? e) Are process monitored. c) Suitable equipment. various support stages can be taken as processes. preservation of product etc.<COMPANY NAME & LOGO>  CHECKLIST FOR INTERNAL QUALITY AUDITING 3. b) Work instructions or procedures. b) Are criterions determined to ensure that the support process is effective? i. damaged and is reported to the customer? i.4 a) Are customer properties identified. monitoring and measurement.2 Are actions taken for the non – conformities identified in internal audit without any undue delay? 8. delivery and post delivery activities. 7. 6. 7. achievement of targets.1 Are the Quality Objectives deployed in the support department? 6. % rejection. e) Implementing. verified.2.4.0 SERVICE PROVISION Clause Audit Questions No.1 Are the inputs identified for carrying out the production & service provisions under controlled conditions? a) Characteristics of product (service).3 Is there a documented procedure available for non – conforming product (service)? 8.e. workspace etc. costs etc.5 Are the products and their constituents identified. if required? 7. Buildings.6 Are the instruments used calibrated or verified? 8. packed.3 a) Are products (service) identified by suitable means at all stages? b) Is the product (service) inspection status identified at all stages? c) Is product traceability maintained during all phases.5.3 Is infrastructure required for the conformity of the product (service) determined and maintained? i.2 a) Is the competence defined for the personnel performing support process? b) Are these competence requirements complied with? 6. measured and analyzed? 5. d) Availability and use of monitoring & measuring devices.1 a) How many processes are identified in the support department? i.3 Are correction and corrective actions taken in case the criterions are not met? 8. protected and safe guarded? b) Are records maintained for the customer property that is lost. customer property. 4. identification & traceability.e.5. stored and protected to preserve conformity? 7.5.4 Is data generated for monitoring and measurement of the process?   Document ID: Ver.: Effective Date: Page: 5 of 9 . handled.

b) Analyzed for determining cause. b) Analyzed for determining cause. d) Determining and implementing action.3                                   Document ID: Ver.5.5. c) Evaluated for the need of action. e) Reviewing the action.: Effective Date: Page: 6 of 9 .<COMPANY NAME & LOGO>  Clause No. f) Are the records of results of action taken maintained? Are potential non – conformities determined and a) Reviewed. e) Reviewing the action taken. 8. d) Determining and implementing actions. f) Are records of results of action taken maintained?   8.2 CHECKLIST FOR INTERNAL QUALITY AUDITING Audit Questions Are areas of continual improvement identified for improving effectiveness of QMS in support department? Are non – conformities of products. processes including customer complaints: a) Reviewed.5 8. c) Evaluated for the need of action.

2. identified unstated requirement dictated by the end use of the product. d) Any additional requirements i.2 a) Are the requirements reviewed and necessary inputs from the various departments obtained prior to organization commitment? b) Are the records of above reviews and actions arising due to this review maintained? c) Are the relevant documents amended and communicated to the relevant departments in case of amendment to the order? d) Are verbal orders confirmed to the customer before acceptance? e) Is the output from the sales department communicated to the relevant departments? 7.e.<COMPANY NAME & LOGO>  CHECKLIST FOR INTERNAL QUALITY AUDITING 4.1 How are requirements related are identified as an input? a) Stated delivery. measured and analyzed? 5. delivery compliance.5 Are areas of continual improvement identified for improving effectiveness of QMS in sales department?   Document ID: Ver.2. customer feedback including customer complaints determined? 8.4. pre dispatch information.3 Are arrangements for communicating to the customer for product information.2.0 SALES Clause Audit Questions No. customer complaints.e. sales target. 4.2 a) Is the competence defined for the personnel performing support process? b) Are these competence requirements complied with? 7.1 How is customer related process identified and established? 7. inquiries. customer returns etc.2.1 a) Are criterions determined to ensure that the sales process is effective? i.2.e.2.1 Are the resources required for the process available? 6. c) Statutory & regulatory requirements related to the product. b) Unstated requirements i.4 Is data generated for monitoring and measurement of the process? 8.1 a) Is method of measurement of customer satisfaction / perception determined? b) Are corrective actions identified if the customer requirements are not full filled? 8. post delivery customer requirements. customer satisfaction.1 Are the Quality Objectives deployed in the sales department? 6.: Effective Date: Page: 7 of 9 . 7.3 Are correction and corrective actions taken in case the criterions are not met? 8.2 Are actions taken for the non – conformities identified in internal audit without any undue delay? 8. pre dispatch inspection etc. b) Are the methods available for above criterions? c) Are controls of processes determined? d) Are process monitored.

e) Are requirements contained in the purchasing information is checked for adequacy prior to communication to the supplier? 7. Procurement – Local. if required? c) Are criterions established for selection. evaluation and re – evaluation of suppliers? d) Are records of evaluation maintained? 7. b) Where ever appropriate.2 Are actions taken for the non – conformities identified in internal audit without any undue delay? 8.e. measured and analyzed? e) Are there any outsourced process identified in the organization? f) Are controls of these outsourced processes identified in the QMS? 5. b) Are the inputs identified for the purchasing process? i. 7.5 Are the products received identified. handled.e.4. % rejection.e.1 a) What are the processes identified and established? i. selected suppliers etc. material cost targets etc. procedures.2.3 a) Is the acceptance criteria established and implemented to ensure that purchase product meets specified purchase requirements? b) Does the purchasing information contain the intent of customer or organization.: Effective Date: Page: 8 of 9 . processes. b) Are the methods available for above criterions? c) Are controls of processes determined? d) Are process monitored. d) QMS requirements. Despatch plan.<COMPANY NAME & LOGO>  CHECKLIST FOR INTERNAL QUALITY AUDITING 5.1 a) Are criterions determined to ensure that the procurement process is effective? i.0 PROCUREMENT & LOGISTICS Clause Audit Questions No. c) Requirement of qualification of personnel.5. requirement / criterion for approval of a product. packed and stored adequately to preserve the conformity of the product? 8.4. 4.1 Are the resources required for the process available? 6.4.2 Does purchase information contain: a) Product description.5 Are areas of continual improvement identified for improving effectiveness of QMS in procurement & logistics department?   Document ID: Ver.2. Bill of material.4 Is data generated for monitoring and measurement of the process? 8.1 Are the Quality Objectives deployed in the procurement & logistics department? 6. Vendor selection & evaluation etc.3 Are correction and corrective actions taken in case the criterions are not met? 8.2 a) Is the competence defined for the personnel performing support process? b) Are these competence requirements complied with? 7. Imported.

skill & experience determined for various personnel? b) Are these competence requirements complied with? c) Are there any gaps between the above needs and actual? 7. b) Are the methods available for above criterions? c) Are controls of processes determined? d) Are process monitored.<COMPANY NAME & LOGO>  CHECKLIST FOR INTERNAL QUALITY AUDITING 6.3 Are correction and corrective actions taken in case the criterions are not met? 8. trainings required.0 HUMAN RESOURCE & ADMINISTRATION Clause Audit Questions No.4 Is data generated for monitoring and measurement of the process? 8. gaps between competence required and actual etc. measured and analyzed? 5.1 Are the resources required for the process available? 6.2.1 How is HRD process established? 8.1 Are the Quality Objectives deployed in the HRD department? 6.1 a) Are criterions determined to ensure that the HRD process is effective? i.4.2.: Effective Date: Page: 9 of 9 .e.2 Are actions taken for the non – conformities identified in internal audit without any undue delay? 8.5 Are areas of continual improvement identified for improving effectiveness of QMS in HRD?   Document ID: Ver. 4. training hrs per employee. training.2 a) Is necessary competence on the basis of education.

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