Iso_9001_2008_Gap | Iso 9000 | Quality Management System

ISO 9001:2008 AUDIT CHECKLIST ISO 9001:2008 GAP – GAP AUDIT

COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause
Element Title

SUMMARY

AUDITOR OBSERVATIONS (Note all pertinent details)
Documented

Documented

Implemented

COMPANY/AREA AUDITED: ______________________________________________________ DATE: ____________ Point Score Implemented Point Score

4.0 QUALITY MANAGEMENT SYSTEM 4.1 General Requirements 4.2 Documentation Requirements 5.0 MANAGEMENT RESPONSIBILITY 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, Authority and Communication 5.6 Management Review 6.0 RESOURCE MANAGEMENT 6.1 Provision of Resources 6.2 Human Resources 6.3 Infrastructure 6.4 Work Environment 7.0 PRODUCT REALIZATION 7.1 Planning of Product Realization 7.2 Customer-Related Processes 7.3 Design and Development 7.4 Purchasing 7.5 Production and Service Provision 7.6 Control of Monitoring and Measuring Devices 8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1 General 8.2 Monitoring and Measurement 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5 Improvement TOTALS:

TEAM LEADER _____________________________

DATE ____________________

Point Score Calculation (if applicable): The maximum score for each point is 20 and the minimum score is 10 to comply the requirements. Final score is obtained by adding the point scored and dividing by the number of applicable scored elements.

ISO 9001 - 2008 Gap Checklist

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ISO 9001:2008 GAP AUDIT CHECKLIST
COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause
Note: place N/A if the point is not applicable. SCOPE ISO 9001:2008 requires that you determine the scope of the quality management system by defining the “Products” and “Services” which your organization supplies. Complete the sections, which follow. Products/Product Types/Product Categories:     ___________________________________ ___________________________________ ___________________________________ __________________________________

AUDITOR OBSERVATIONS (Note all pertinent details)

Documented

Implemented

Services/Service Types/Service Categories:     ___________________________________ ___________________________________ ___________________________________ ___________________________________

For each type or category of Product/service, you also need to identify which “Types of Requirements” you are committed to meeting from your customer. Complete the section which follows for each Product/Service that has been identified. Note 1: For each “requirement” you promise to meet, there must be a corresponding “process” to make sure it happens. Note 2: Customer requirements are what your customer needs, wants and expects from your organization.

FOR PRODUCT/SERVICE: _______________________________ TYPES OF REQUIREMENTS (including Del & Post-Del Reqt’s) Applicable? (Y/N)  Specification Req’ts  Quantity Req’ts  Packaging Req’ts  Identification, Labeling, Traceability Req’ts  Statutory/Regulatory Req’ts  Availability Req’ts  Delivery/Timing Req’ts  Warranties/Guarantees  Operating Instructions  Technical Support Req’ts  Specification Information/Description Req’ts  General Information/Description Req’ts  Other Req’ts? Scoring: For Documented Documented = 10 Partially documented = 5 Not documented = 0 For Implemented Implemented = 10 Partially implemented = 5 ISO 9001 - 2008 Gap Checklist

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and maintain a quality management system.2. in accordance with the requirements of the ISO 9001:2008 International Standard? Does the organization: a) identify the processes needed for the quality management system and their application throughout the organization? Documented Implemented b) determine the sequence and interaction of these processes? QUALITY MANAGEMENT SYSTEM GENERAL REQUIREMENTS – cont’d c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective? d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes? e) f) monitor. product realization and measurement. does the organization ensure control of such processes? Does the organization identify. measure and analyse these processes? implement actions necessary to achieve planned results and continual improvement of these processes? Does the organization manage these processes in accordance with the requirements of the ISO 9001:2008 International Standard? Where the organization chooses to outsource any process that affects product conformity with requirements. provision of resources.ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 4. document. and continually improve its effectiveness.1 AUDITOR OBSERVATIONS (Note all pertinent details) QUALITY MANAGEMENT SYSTEM GENERAL REQUIREMENTS Does the organization establish.1 DOCUMENTATION REQUIREMENTS GENERAL Does the quality management system documentation include: a) documented statements of a quality policy and quality objectives? b) a quality manual? c) documented procedures required by the ISO 9001:2008 International Standard? Page 3 of 27 ISO 9001 .0 4. implement. the control of such outsourced processes? NOTE Processes needed for the quality management system referred to above should include processes for management activities.2008 Gap Checklist . 4.2 4. within the quality management system.

any exclusions (see 1.1 AUDITOR OBSERVATIONS (Note all pertinent details) DOCUMENTATION REQUIREMENTS GENERAL – cont’d d) documents needed by the organization to ensure the effective planning.ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 4.2.4)? NOTE 1 Where the term “documented procedure” appears within the ISO 9001:2008 International Standard.2 QUALITY MANUAL Has a quality manual been established and maintained that includes: a) the scope of the quality management system. and justification for.2 4.2.2008 Gap Checklist Page 4 of 27 . 4. implemented and maintained.2)? b) the documented procedures established for the quality management system. operation and control of its processes? Documented Implemented e) records required by the ISO 9001:2008 International Standard (see 4. and c) the competence of personnel NOTE 3 The documentation can be in any form or type of medium. or reference to them? c) a description of the interaction between the processes of the quality management system? ISO 9001 . including details of. b) the complexity of processes and their interactions. NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to: a) the size of the organization and type of activities.2. this means that the procedure is established. documented.

3 AUDITOR OBSERVATIONS (Note all pertinent details) CONTROL OF DOCUMENTS Are documents required by the quality management system controlled? Are documents defined as records controlled (see 4. retention time and disposition of records? ISO 9001 .ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 4. and to apply suitable identification to them if they are retained for any purpose? 4.4 CONTROL OF RECORDS Are records established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system? Are records legible. retrieval. readily identifiable and retrievable? Is a documented procedure established to define the controls needed for the identification.2008 Gap Checklist Page 5 of 27 . protection.4)? Is a documented procedure established to define controls needed: a) to approve documents for adequacy prior to issue? Documented Implemented b) review. and update as necessary and re-approve documents? c) to ensure that changes and the current revision status of documents are identified? d) to ensure that relevant versions of applicable documents are available at points of use? e) f) to ensure that documents remain legible and readily identifiable? to ensure that documents of external origin are identified and their distribution controlled? g) to prevent the unintended use of obsolete documents. storage.2.2.2.

2008 Gap Checklist Page 6 of 27 .ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 5.0 5.2 CUSTOMER FOCUS Does top management ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.2.1 AUDITOR OBSERVATIONS (Note all pertinent details) MANAGEMENT RESPONSIBILITY MANAGEMENT COMMITMENT Does top management provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by: a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements? Documented Implemented b) establishing the quality policy? c) ensuring that quality objectives are established? d) conducting management reviews? e) ensuring the availability of resources? 5.1)? 5.3 QUALITY POLICY Does top management ensure that the quality policy: a) is appropriate to the purpose of the organization? b) includes a commitment to comply with requirements and to continually improve the effectiveness of the quality management system? c) provides a framework for establishing and reviewing quality objectives? d) is communicated and understood within the organization? e) is reviewed for continuing suitability? ISO 9001 .1 and 8.

including those needed to meet requirements for product (see 7. are established at relevant functions and levels within the organization? AUDITOR OBSERVATIONS (Note all pertinent details) Documented Implemented Are the quality objectives measurable and consistent with the quality policy? 5.4. as well as the quality objectives? b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented? ISO 9001 .4.ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 5.2 QUALITY MANAGEMENT SYSTEM PLANNING Does top management ensure that: a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1a).2008 Gap Checklist Page 7 of 27 .1.4 5.1 PLANNING QUALITY OBJECTIVES Does top management ensure that quality objectives.

irrespective of other responsibilities.5. implemented and maintained? b) reporting to top management on the performance of the quality management system and any need for improvement? c) ensuring the promotion of awareness of customer requirements throughout the organization? NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.2 MANAGEMENT REPRESENTATIVE Does top management appoint a member of management who.ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 5. AUTHORITY AND COMMUNICATION RESPONSIBILITY AND AUTHORITY Does top management ensure that the responsibilities and authorities are defined and communicated within the organization? Documented Implemented 5.1 AUDITOR OBSERVATIONS (Note all pertinent details) RESPONSIBILITY.5.5 5.2008 Gap Checklist Page 8 of 27 . have responsibility and authority that includes: a) ensuring that processes needed for the quality management system are established.3 INTERNAL COMMUNICATION Does top management ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system? ISO 9001 .5. 5.

ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 5.2 REVIEW INPUT Do inputs to management review include information on: a) results of audits? b) customer feedback? c) process performance and product conformity? d) status of preventive and corrective actions? e) follow-up actions from previous management reviews? f) changes that could affect the quality management system? g) recommendations for improvement? ISO 9001 . to ensure its continuing suitability.6 5.6.1 AUDITOR OBSERVATIONS (Note all pertinent details) MANAGEMENT REVIEW GENERAL Does top management review the organization’s quality management system. at planned intervals. including the quality policy and quality objectives? Are records from management reviews maintained (see 4.4)? 5.6 5.2008 Gap Checklist Page 9 of 27 .6.2. adequacy and effectiveness? Documented Implemented Does this review include assessing opportunities for improvement and the need for changes to the quality management system.

3 AUDITOR OBSERVATIONS (Note all pertinent details) MANAGEMENT REVIEW (Ctnd.) REVIEW OUTPUT Do the outputs from the management review include any decisions and actions related to: a) improvement of the effectiveness of the quality management system and its processes? Documented Implemented b) improvement of product related to customer requirements? c) resource needs? 6. training. skills and experience? ISO 9001 .1 RESOURCE MANAGEMENT PROVISION OF RESOURCES Does the organization determine and provide the resources needed: a) to implement and maintain the quality management system and continually improve its effectiveness? b) to enhance customer satisfaction by meeting customer requirements? 6.2 6.6.6 5.1 HUMAN RESOURCES GENERAL Are personnel competent on the basis of appropriate education.ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 5.2008 Gap Checklist Page 10 of 27 .0 6.2.

2. AWARENESS AND TRAINING Does the organization: a) determine the necessary competence for personnel performing work affecting product quality? Documented Implemented b) provide training. or take other actions.2. as applicable: a) buildings.ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 6. to satisfy these needs? c) evaluate the effectiveness of the actions taken? d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives? e) maintain appropriate records of education.2008 Gap Checklist Page 11 of 27 . workspace and associated utilities? b) process equipment (both hardware and software)? c) supporting services (such as transport or communication)? d) Information system? 6.4)? 6. training. humidity. skills and experience (see 4. lighting and weather)? ISO 9001 .3 INFRASTRUCTURE Does the organization determine. provide and maintain the infrastructure needed to achieve conformity to product requirements? Does it include.4 WORK ENVIRONMENT Does the organization determine and manage the work environment needed to achieve conformity to product requirements (Work environment relates to those conditions under which work is performed including physical environmental and other factors (such as noise. temperature.2 AUDITOR OBSERVATIONS (Note all pertinent details) COMPETENCE.

ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 7.1 CUSTOMER-RELATED PROCESSES DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT Does the organization determine: a) requirements specified by the customer. 7.1)? In planning product realization. for example. actions under warranty provisions. as appropriate: a) quality objectives and requirements for the product? Documented Implemented b) the need to establish processes. project or contract can be referred to as a quality plan.4)? Is the output of this planning in a form suitable for the organization’s method of operations? NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product. including the requirements for delivery and post-delivery activities? b) requirements not stated by the customer but necessary for specified or intended use. validation. NOTE 2 The organization may also apply the requirements given in 7. inspection and test activities specific to the product and the criteria for product acceptance? d) the records needed to provide evidence that the realization processes and resulting product meet requirements (see 4. monitoring.0 7.2. does the organization determine the following.3 to the development of product realization processes.2. documents.2 7.1 AUDITOR OBSERVATIONS (Note all pertinent details) PRODUCT REALIZATION PLANNING OF PRODUCT REALIZATION Does the organization plan and develop the processes needed for product realization? Is planning of product realization processes consistent with the requirements of the other processes of the quality management system (see 4. contractual obligations such as maintenance services and supplementary services such as recycling or final disposal. ISO 9001 .2008 Gap Checklist Page 12 of 27 . and provide resources specific to the product? c) required verification. where known? c) statutory and regulatory requirements related to the product? d) any additional requirements determined by the organization? e) Post delivery activities include.

2.4)? Where the customer provides no documented statement of requirement.2.2 7. acceptance of contracts or orders. acceptance of changes to contracts or orders )? Does the review ensure that: a) product requirements are defined? Documented Implemented b) contract or order requirements differing from those previously expressed are resolved? c) the organization has the ability to meet defined requirements? Are records of the results of the review. submission of tenders.2 AUDITOR OBSERVATIONS (Note all pertinent details) REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT Does the organization review the requirements related to the product? Is this review conducted prior to the organization’s commitment to supply a product to the customer (eg. does the organization ensure that relevant documents are amended? Does the organization ensure that relevant personnel are made aware of the changed requirements? 7. including customer complaints? ISO 9001 . are requirements confirmed by the organization before acceptance? Where product requirements are changed.2008 Gap Checklist Page 13 of 27 .3 CUSTOMER-RELATED PROCESSES CUSTOMER COMMUNICATION Does the organization determine and implement effective arrangements for communicating with customers in relation to: a) product information? b) enquiries. maintained (see 4.ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 7. and actions arising from the review.2. contracts or order handling. including amendments? c) customer feedback.

2.ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 7. as appropriate. unambiguous and not in conflict with each other? ISO 9001 .2 DESIGN AND DEVELOPMENT INPUTS Are inputs relating to product requirements determined and records maintained (see 4. information derived from previous similar designs? d) other requirements essential for design and development? Are these inputs reviewed for adequacy? Are requirements complete. verification and validation that are appropriate to each design and development stage? c) the responsibilities and authorities for design and development? Are interfaces between different groups involved in design and development managed to ensure effective communication and clear assignment of responsibility? Is the planning output updated.2008 Gap Checklist Page 14 of 27 .3. as the design and/or development progresses? 7.4)? Do these inputs include: a) functional and performance requirements? b) applicable statutory and regulatory requirements? c) where applicable.3.1 AUDITOR OBSERVATIONS (Note all pertinent details) DESIGN AND DEVELOPMENT DESIGN AND DEVELOPMENT PLANNING Does the organization plan and control design and development of product? During the design and development planning does the organization determine: a) the design and development stages? Documented Implemented b) the review.3 7.

production and service provision (see 7.4 DESIGN AND DEVELOPMENT REVIEW At suitable stages.3.3.1): a) to evaluate the ability of the results of design and development to meet requirements? b) to identify any problems and propose necessary actions? Do participants in such reviews include representatives of functions concerned with the design and development stage(s) being reviewed? Are records of the results of the reviews and any necessary actions maintained (see 4.5)? c) contain or reference product acceptance criteria? d) specify the characteristics of the product that are essential for its safe and proper use? 7.2.4)? ISO 9001 .2008 Gap Checklist Page 15 of 27 .3 AUDITOR OBSERVATIONS (Note all pertinent details) DESIGN AND DEVELOPMENT OUTPUTS Are the outputs of design and development process provided in a form that enables verification against the design and development input? Are design outputs approved prior to release? Documented Implemented Does design and development output: a) meet the input requirements for design and development? b) provide appropriate information for purchasing.ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 7. are systematic reviews of design and development performed in accordance with planned arrangements (see 7.3.

3. verified and validated.4)? ISO 9001 .2. and approved before implementation? Does this review include evaluation of the effect of the changes on constituent parts and product already delivered? Are records of the results of the review of changes and any necessary actions maintained (see 4.7 CONTROL OF DESIGN AND DEVELOPMENT CHANGES Are design and development changes identified and records maintained? Are the changes reviewed.6 DESIGN AND DEVELOPMENT VALIDATION Is design and development validation performed in accordance with planned arrangements (see 7.2.3.1) to ensure the design and development outputs have met the design and development input requirements? Documented Implemented Are records of the results of the verification and any necessary actions maintained (see 4. where known? Wherever practicable. as appropriate.3. is validation completed prior to the delivery or implementation of the product? Are records of the results of validation and any necessary actions maintained (see 4.3.5 AUDITOR OBSERVATIONS (Note all pertinent details) DESIGN AND DEVELOPMENT VERIFICATION Is verification performed in accordance with planned arrangements (see 7.4)? 7.3.2.ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 7.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use.4)? 7.2008 Gap Checklist Page 16 of 27 .

2008 Gap Checklist Page 17 of 27 .4)? 7.2.ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 7.1 PURCHASING PURCHASING PROCESS Does the organization ensure that purchased product conforms to specified purchase requirements? Are the type and extent of control applied to the supplier and the purchased product dependent upon the effect of the purchased product on subsequent product realization or final product? AUDITOR OBSERVATIONS (Note all pertinent details) Documented Implemented Does the organization evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements? Are criteria for selection.4 7. evaluation and re-evaluation established? Are records of the results of evaluations and any necessary actions arising from the evaluation maintained (see 4.2 PURCHASING INFORMATION Does purchasing information describe the product to be purchased.4. including where appropriate: a) requirements for approval of: product? procedures? processes? equipment? - - - b) requirements for qualification of personnel? c) quality management system requirements? Does the organization ensure the adequacy of specified purchase requirements prior to their communication to the supplier? ISO 9001 .4.

2 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION Does the organization validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement? Does this include any processes where deficiencies become apparent only after the product is in use or the service has been delivered? Does validation demonstrate the ability of the processes to achieve planned ISO 9001 . as necessary? c) the use of suitable equipment? d) the availability and use of monitoring and measuring devices? e) f) the implementation of monitoring and measurement? the implementation of release.5.3 AUDITOR OBSERVATIONS (Note all pertinent details) VERIFICATION OF PURCHASED PRODUCT Does the organization establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements? Documented Implemented Where the organization or its customer intends to perform verification at the supplier’s premises.5 7. delivery and post-delivery activities? 7.ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 7. does the organization state the intended verification arrangements and method of product release in the purchasing information? 7. as applicable: a) the availability of information that describes the characteristics of the product? b) the availability of work instructions.5.2008 Gap Checklist Page 18 of 27 .4.1 PRODUCTION AND SERVICE PROVISION CONTROL OF PRODUCTION AND SERVICE PROVISION Does the organization plan and carry out production and service provision under controlled conditions? Do controlled conditions include.

4)? e) revalidation? 7.ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause AUDITOR OBSERVATIONS (Note all pertinent details) results? VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION (Ctnd.5.3 IDENTIFICATION AND TRACEABILITY Does the organization identify. ISO 9001 .2008 Gap Checklist Page 19 of 27 .4)? NOTE In some industry sectors.) Does the organization establish arrangements for these processes including. where traceability is a requirement (see 4.2.2. configuration management is a means by which identification and traceability are maintained. as applicable: a) defined criteria for review and approval of the processes? Documented Implemented b) approval of equipment and qualification of personnel? c) use of specific methods and procedures? d) requirements for records (see 4. where appropriate. the product by suitable means throughout product realization? Does the organization identify the product status with respect to monitoring and measurement requirements? Does the organization control and record the unique identification of the product.

verify. packaging. PRESERVATION OF PRODUCT Does the organization preserve the conformity of product during internal processing and delivery to the intended destination? Does this preservation include identification.2008 Gap Checklist Page 20 of 27 .5. handling.2. protect and safeguard customer property provided for use or incorporation into the product? Is any customer property that is lost.5.5 Customer property can include intellectual property. storage and protection? Is preservation also applied to the constituent parts of a product? ISO 9001 .ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 7.4 AUDITOR OBSERVATIONS (Note all pertinent details) CUSTOMER PROPERTY Does the organization exercise care with customer property while it is under the organization’s control or being used by the organization? Documented Implemented Does the organization identify. including personal data. damaged or otherwise found to be unsuitable for use reported to the customer and records maintained (see 4.4)? NOTE 7.

maintenance and storage? 7. are measuring equipment: a) calibrated or verified at specified intervals.2.1)? Does the organization establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements? Where necessary to ensure valid results. Does the organization undertake this prior to initial use and reconfirm it as necessary? ISO 9001 .ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 7. or prior to use.4)? Does org demonstrate confirmation of the ability of the computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use. against measurement standards traceable to international or national measurement standards? Where no such standards exist. is the basis used for calibration or verification recorded? b) adjusted or re-adjusted as necessary? c) identified to enable the calibration status to be determined? Documented Implemented d) be safeguarded from adjustments that would invalidate the measurement result? e) be protected from damage and deterioration during handling.2008 Gap Checklist Page 21 of 27 .2.6 CONTROL OF MONITORING AND MEASURING DEVICES – cont’d Does the organization assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements? Does the organization take appropriate action on the equipment and any product affected? Are records of the results of calibration and verification maintained (see 4.6 AUDITOR OBSERVATIONS (Note all pertinent details) CONTROL OF MONITORING AND MEASURING EQUIPMENTS Does the organization determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements (see 7.

and the extent of their use? 8.0 8.2008 Gap Checklist Page 22 of 27 . as one of the measurements of performance of the quality management system? Are the methods for obtaining and using this information determined? ISO 9001 . measurement.2.1 MONITORING AND MEASUREMENT CUSTOMER SATISFACTION Does the organization monitor information relating to customer perception as to whether the organization has met customer requirements.1 GENERAL Does the organization plan and implement the monitoring.2 8. analysis and improvement processes needed: a) to demonstrate conformity of the product? AUDITOR OBSERVATIONS (Note all pertinent details) MEASUREMENT.ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 8. ANALYSIS AND IMPROVEMENT Documented Implemented b) to ensure conformity of the quality management system? c) to continually improve the effectiveness of the quality management system? Does this include determination of applicable methods including statistical techniques.

2.2008 Gap Checklist Page 23 of 27 .ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 8.5. frequency and methods defined? Does the selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process? Does the organization ensure that auditors do not audit their own work? Does a documented procedure define the responsibilities and requirements for planning and conducting audits.2 INTERNAL AUDIT Does the organization conduct internal audits at planned intervals to determine whether the quality management system: a) conforms to the planned arrangements (see 7.1). and for reporting results and maintaining records (see 4.4)? Does the management responsible for the area being audited ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes? Do follow-up activities include the verification of the actions taken and the reporting of verification results (see 8. scope. conforms to the requirements of the ISO 9001:2008 Standard? conforms to the quality management system requirements established by the organization? b) is effectively implemented and maintained? Does the organization plan the audit programme taking into consideration the status and importance of the processes and areas to be audited as well as the results of previous audits? AUDITOR OBSERVATIONS (Note all pertinent details) Documented Implemented Are the audit criteria. ISO 9001 .2)? .2.

and where applicable.2.1) have been satisfactorily completed.2.ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 8.2.3 AUDITOR OBSERVATIONS (Note all pertinent details) MONITORING AND MEASUREMENT OF PROCESSES Does the organization apply suitable methods for monitoring. to ensure conformity of the product? 8. is correction and corrective action taken.1)? Is evidence of conformity with the acceptance criteria maintained? Do records indicate the person(s) authorizing release of product (see 4.4 MONITORING AND MEASUREMENT OF PRODUCT Does the organization monitor and measure the characteristics of the product to verify that product requirements have been met? Is this carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.2008 Gap Checklist Page 24 of 27 . where applicable.4)? Does the organization ensure that product release and service delivery does not proceed until all the planned arrangements (see 7. unless otherwise approved by a relevant authority and. measurement of the quality management system processes? Documented Implemented Do these methods demonstrate the ability of the processes to achieve planned results? When planned results are not achieved. by the customer? ISO 9001 . as appropriate.

by the customer? c) by taking action to preclude its original intended use or application? Are records maintained (see 4. is it subjected to re-verification to demonstrate conformity to the requirements? When nonconforming product is detected after delivery or use has started. of the nonconformity? ISO 9001 .2008 Gap Checklist Page 25 of 27 . including concessions obtained? When nonconforming product is corrected.ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 8.2.4) of the nature of nonconformities and any subsequent actions taken. where applicable. or potential effects. does the organization take action appropriate to the effects.3 AUDITOR OBSERVATIONS (Note all pertinent details) CONTROL OF NONCONFORMING PRODUCT Does the organization ensure that product which does not conform to product requirements is identified and controlled to prevent unintended use or delivery? Documented Implemented Are the controls and related responsibilities and authorities for dealing with nonconforming product defined in a documented procedure? Does the organization deal with nonconforming product by one or more of the following ways: a) by taking action to eliminate the detected nonconformity? b) by authorizing its use. release or acceptance under concession by a relevant authority and.

5 8.1 IMPROVEMENT CONTINUAL IMPROVEMENT Does the organization continually improve the effectiveness of the quality management system through the use of the quality policy.1)? Documented Implemented b) conformity to product requirements (see 7. corrective and preventive actions and management review? ISO 9001 .4 AUDITOR OBSERVATIONS (Note all pertinent details) ANALYSIS OF DATA Does the organization determine. analysis of data.2. audit results.5.2. quality objectives. collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made? Does this include data generated as a result of monitoring and measurement and from other relevant sources? Does the organization analyse this data to provide information relating to: a) customer satisfaction (see 8.ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 8.2008 Gap Checklist Page 26 of 27 .1)? c) characteristics and trends of processes and products including opportunities for preventive action? d) suppliers? 8.

5.4)? e) reviewing preventive action taken? ISO 9001 .2008 Gap Checklist Page 27 of 27 .2.2.5.ISO 9001:2008 GAP AUDIT CHECKLIST COMPANY/AREA: _______________________ AUDITOR: ____________________ DATE: ____________ Element/ Clause 8.4)? reviewing corrective action taken? 8.3 PREVENTIVE ACTION Does the organization determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence? Are preventive actions appropriate to the effects of the potential problems? Does the documented procedure for preventive action define requirements for: a) determining potential nonconformities and their causes? b) evaluating the need for action to prevent occurrence of nonconformities? c) determining and implementing action needed? d) Records of results of action taken (see 4.2 AUDITOR OBSERVATIONS (Note all pertinent details) CORRECTIVE ACTION Does the organization take action to eliminate the cause of nonconformities in order to prevent recurrence? Are corrective actions appropriate to the effect of the nonconformities encountered? Does the documented procedure for corrective action define requirements for: a) reviewing nonconformities (including customer complaints)? b) determining the causes of nonconformities? c) evaluating the need for action to ensure that nonconformities do not recur? Documented Implemented d) determining and implementing action needed? e) f) records of the results of action taken (see 4.

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