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ISO 9001:2015 internal Audit Checklist

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ISO 9001:2015 Internal Audit Checklist & Audit Report Format

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ISO 9001:2015 internal Audit Checklist

  1. 1. Internal Audit Report QMS-M1-F12 Rev 0 Effective: 02-01-2019 Page 1 of 17 Audit number : YYYY-IQA-1 Audit date : Audit time : Audit criteria : Audit objectives : Audit scope : Auditees : Audited period : Audit locations : Auditors : Auditors’ signatures :
  2. 2. Internal Audit Report QMS-M1-F12 Rev 0 Effective: 02-01-2019 Page 2 of 17 Audit results summary Total number of nonconformities : Total number of OFI : Statements of nonconformity findings No NCR # ISO 9001 / Quality Manual Clause Findings that require corrective actions YYYY-IQA-1- NCR1 Statements of OFI findings (Opportunity for Improvement) No OFI # ISO 9001 / Quality Manual Clause Findings that requirement improvement actions YYYY-IQA-1- OFI1
  3. 3. Internal Audit Report QMS-M1-F12 Rev 0 Effective: 02-01-2019 Page 3 of 17 Audit notes ISO 9001 Clause Questions to ask or things to check on Findings / Evidence Please ensure adequate identification and traceability of findings and evidence 4 Context of the organization 4.1 Understanding the organization and its context Have external and internal issues relevant to the organization’s purpose and strategic direction been determined, monitored and reviewed? 4.2 Understanding the needs and expectations of interested parties Has the organization defined its interested parties and their requirements? Have issues related to interested parties been determined, monitored and reviewed? 4.3 Determining the scope of the QMS Has the scope of the QMS been defined and documented? 4.4 Quality management system and its processes Has the QMS been defined and impemented in terms of its: a) inputs and outputs b) sequence and interactions c) criteria and methods d) resource requirements e) responsibilities f) risks and opportunities g) performance evaluation, and h) improvement? Is the QMS and its processes supported by adequate documented information?
  4. 4. Internal Audit Report QMS-M1-F12 Rev 0 Effective: 02-01-2019 Page 4 of 17 Audit notes ISO 9001 Clause Questions to ask or things to check on Findings / Evidence Please ensure adequate identification and traceability of findings and evidence 5 Leadership 5.1 Leadership and commitment 5.1.1 General Is there evidence of top management’s leadership and commitment with regards to the QMS in terms of: a) Taking accountability for the QMS b) Establishing the quality policy and objectives c) Integration of the QMS requirements into existing business processes d) Promoting process approach and risk-based thinking e) Provision of resources f) Communicating the importance of the QMS g) Ensuring the QMS achieves its results h) Engaging, directing and supporting persons to contribute to the QMS i) Promoting improvement j) Supporting other relevant management roles? 5.1.2 Customer focus Is there evidence of top management’s leadership and commitment with regards to customer focus, in terms of: a) Determining, understanding and meeting customer and applicable statutory and regulatory requirements b) Determining and addressing risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction c) Maintaining the focus on enhancing customer satisfaction?
  5. 5. Internal Audit Report QMS-M1-F12 Rev 0 Effective: 02-01-2019 Page 5 of 17 Audit notes ISO 9001 Clause Questions to ask or things to check on Findings / Evidence Please ensure adequate identification and traceability of findings and evidence 5.2 Policy Is the Quality Policy documented and does it meet ISO 9001 requirements in terms of: a) being appropriate to the purpose and context of the organization and supports its strategic direction? b) serving as a framework for setting quality objectives? c) commitment to satisfy applicable requirements? d) commitment to continual improvement of the QMS? Has the Quality Policy been communicated to all staff and other interested parties? 5.3 Organizational roles, responsibilities and authorities Have roles, responsibilities and authorities for the QMS and its processes been defined and communicated? 6 Planning 6.1 Actions to address risks and opportunities Have risks and opportunities related to the issues identified in Clauses 4.1 and 4.2 been determined, analysed and evaluated? Are there action plans to address these risks and opportunities? Have these action plans been implemented?
  6. 6. Internal Audit Report QMS-M1-F12 Rev 0 Effective: 02-01-2019 Page 6 of 17 Audit notes ISO 9001 Clause Questions to ask or things to check on Findings / Evidence Please ensure adequate identification and traceability of findings and evidence 6.2 Quality objectives and planning to achieve them Have quality objectives been established at relevant functions, levels and processes? Are they measurable? Are there action plans on how to achieve these objectives? Are they documented, monitored and reviewed? 6.3 Planning of changes Have there been any changes introduced to the QMS or its processes? Prior to the changes, did the organization consider the following? a) Purpose of the changes and their potential consequences b) Integrity of the QMS c) Availability of resources d) Allocation or reallocation of responsibilities and authorities? 7 Support 7.1 Resources People Was there any request for additional human resources? Was this request met by the organization?
  7. 7. Internal Audit Report QMS-M1-F12 Rev 0 Effective: 02-01-2019 Page 7 of 17 Audit notes ISO 9001 Clause Questions to ask or things to check on Findings / Evidence Please ensure adequate identification and traceability of findings and evidence Infrastructure Was there any request for additional infrastructure? Was this request met by the organization? Environment for the operation of processes Is the physical environment suitable for the kinds of work being carried out? Were there any reports or observations of social or psychological issues? Were actions taken? Monitoring and measuring resources Are monitoring and measurement resources identified, maintained, calibrated and preserved effectively? Organizational knowledge Is organizational knowlege provided, maintained and shared? 7.2 Competence Has staff competency been assessed? Have all training or other plans been developed, implemented and completed? Have effectiveness of these plans been evaluated? 7.3 Awareness Have existing / new staff been made aware of the QMS requirements,
  8. 8. Internal Audit Report QMS-M1-F12 Rev 0 Effective: 02-01-2019 Page 8 of 17 Audit notes ISO 9001 Clause Questions to ask or things to check on Findings / Evidence Please ensure adequate identification and traceability of findings and evidence including the quality policy, objectives, benefits of improvement and consequences of nonconformities? 7.4 Communication Have external and internal communication requirements been defined for the QMS ? 7.5 Documented information Are documents identified and controlled effectively in terms of their versions, approval and distribution? Is there any control for external documents? Are records identifiable and retrievable? Are they being preserved effectively? Is there an effective control for the disposal of records? 8 Operation 8.1 Operational planning and control Are operational processes planned and controlled in terms of: a) Determining the requirements for products and services? b) Establishing criteria for the processes and the acceptance of products and services? c) Determining the resources needed d) Implementing control of the processes in accordance with the criteria? e) Controlling planned changes? f) Controlling outsourced processes?
  9. 9. Internal Audit Report QMS-M1-F12 Rev 0 Effective: 02-01-2019 Page 9 of 17 Audit notes ISO 9001 Clause Questions to ask or things to check on Findings / Evidence Please ensure adequate identification and traceability of findings and evidence g) Determining and keeping documented information to have confidence that the processes have been carried out as planned and demonstrate the conformity of products and services to their requirements? 8.2 Requirements for products and services Are products and services information being communicated effectively to customers? How are customer inquiries handled? How are customer requirements reviewed before acceptance? How are sales orders or contracts handled? How are changes to customer requirements controlled? How are customer feedbacks or complaints handled? Is there a procedure for handling customer complaints? 8.3 Design and development of products and services Planning How was the design and development of products and services planned? Did the organization consider the following? a) Nature, duration and complexity of the design and development activities b) Required process stages, including applicable design and
  10. 10. Internal Audit Report QMS-M1-F12 Rev 0 Effective: 02-01-2019 Page 10 of 17 Audit notes ISO 9001 Clause Questions to ask or things to check on Findings / Evidence Please ensure adequate identification and traceability of findings and evidence development reviews c) Required design and development verification and validation activities d) Responsibilities and authorities involved in the design and development process e) Internal and external resource needs for the design and development of products and services f) Need to control interfaces between persons involved in the design and development process g) Need for involvement of customers and users in the design and development process h) Requirements for subsequent provision of products and services i) Level of control expected for the design and development process by customers and other relevant interested parties j) Documented information needed to demonstrate that design and development requirements have been met. Inputs Have the design and development inputs been determined in terms of the following? a) Functional and performance requirements b) Information derived from previous similar design and development activities c) Statutory and regulatory requirements d) Standards or codes of practice that the organization has committed to
  11. 11. Internal Audit Report QMS-M1-F12 Rev 0 Effective: 02-01-2019 Page 11 of 17 Audit notes ISO 9001 Clause Questions to ask or things to check on Findings / Evidence Please ensure adequate identification and traceability of findings and evidence implement e) Potential consequences of failure due to the nature of the products and services. Control Is the design and development process being controlled in terms of the following? a) Results to be achieved are defined b) Reviews are conducted to evaluate the ability of the results of design and development to meet requirements c) Verification activities are conducted to ensure that the design and development outputs meet the input requirements d) Validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use e) Any necessary actions are taken on problems determined during the reviews, or verification and validation activities f) Documented information of these activities is retained. Outputs Do the design and development outputs: a) Meet the input requirements? b) Are adequate for the subsequent processes for the provision of products and services? c) Include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria?
  12. 12. Internal Audit Report QMS-M1-F12 Rev 0 Effective: 02-01-2019 Page 12 of 17 Audit notes ISO 9001 Clause Questions to ask or things to check on Findings / Evidence Please ensure adequate identification and traceability of findings and evidence d) Specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision? Changes Are design and development changes identified, reviewed and controlled during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements? 8.4 Control of externally provided products and services How are purchase requisitions handled? How are new external providers evaluated and selected? Is purchase information adequate for the given purchase order? Is delivery or service order inspected and verified before acceptance? How are outsourced processes controlled? How was nonconforming delivery or service order controlled? Are purchased products traceable within the inventory system? Are suppliers’ performance being evaluated?
  13. 13. Internal Audit Report QMS-M1-F12 Rev 0 Effective: 02-01-2019 Page 13 of 17 Audit notes ISO 9001 Clause Questions to ask or things to check on Findings / Evidence Please ensure adequate identification and traceability of findings and evidence 8.5 Production and service provision Are product and service provisions controlled effectively in terms of: a) Availability of documented information on the products and services, activities to be performed and resuts to be achieved? b) Availability and use of suitable monitoring and measuring resources? c) Implementation of monitoring and measurement activities at suitable stages? d) Use of suitable infrastructure and environment for the operation of processes? e) Appointment of competent persons f) Validation of processes or outputs, where the outputs cannot be verified through subsequent monitoring and measurement? g) Implementation of actions to prevent human error? h) Implementation of release, delivery and post-delivery activities? Are outputs identified and traceable in terms of their monitoring and measurement status? Is customer and external provider property controlled? Is damaged or lost property reported to the owner and resolved? Are outputs preserved effectively prior to delivery?
  14. 14. Internal Audit Report QMS-M1-F12 Rev 0 Effective: 02-01-2019 Page 14 of 17 Audit notes ISO 9001 Clause Questions to ask or things to check on Findings / Evidence Please ensure adequate identification and traceability of findings and evidence Are post-delivery activities implemented as per customer, contractual and / or statutory requirements? Are changes reviewed and approved prior to implementation? 8.6 Release of products and services Are products and services inspected before being released to the customer and traceable to the staff authorizing the release? 8.7 Control of nonconforming outputs Are nonconforming outputs controlled? Are nonconforming outputs verified when corrected? Are there records that: a) Describe the nonconformity? b) Describe the actions taken? c) Describe any concessions obtained? d) Identify the authority deciding the action in respect of the nonconformity? 9 Performance evaluation 9.1 General Is the performance of the QMS and its processes monitored and measured? Customer satisfaction Is customer satisfaction monitored and measured?
  15. 15. Internal Audit Report QMS-M1-F12 Rev 0 Effective: 02-01-2019 Page 15 of 17 Audit notes ISO 9001 Clause Questions to ask or things to check on Findings / Evidence Please ensure adequate identification and traceability of findings and evidence Analysis and evaluation Is monitoring and measurement data analysed and evaluated in terms of: a) Conformity of products and services b) Degree of customer satisfaction c) Performance and effectiveness of the QMS planning d) Effectivensss of actions to address risks and opportunities e) Performance of external providers f) Need for improvements to the QMS? 9.2 Internal audit Have all NCR findings from the previous internal audit been closed out? Have all OFI findings from the previous internal audit been actioned upon? 9.3 Management review Has the top management review the status and performance of the QMS in terms of the following? a) Statuses of actions from previous management reviews b) Changes in external and internal issues c) QMS performance: 1) Customer satisfaction and feedbacks from relevant interested parties 2) Extent to which quality objectives have ben met 3) Process performance and conformity of products and services 4) Nonconformities and corrective actions 5) Monitoring and measurement results 6) Audit results
  16. 16. Internal Audit Report QMS-M1-F12 Rev 0 Effective: 02-01-2019 Page 16 of 17 Audit notes ISO 9001 Clause Questions to ask or things to check on Findings / Evidence Please ensure adequate identification and traceability of findings and evidence 7) Performance of external providers d) Adequacy of resources e) Effectiveness of actions taken to address risks and opportunities f) Opportunities for improvement. Did the management revew outputs include any of the following? a) Opportunities for improvement b) Any need for changes to the QMS c) Resource needs? 10 Improvement 10.1 General Were there any improvement actions implemented to meet customer requirements and enhance customer satisfaction in terms of: a) Improving the products and services? b) Correcting, preventing or mitigating undesirable effects? c) Improving the effectiveness and performance of the QMS? 10.2 Nonconformity and corrective action Were actions taken to address nonconformities effective in terms of: a) Taking action to control and correct them and dealing with the consequences? b) Evaluating the need for action to eliminate the causes of the nonconformity, in order that it does not recur or occur elsewhere? c) Implementing any action needed d) Reviewing the effectiveness of any corrective action taken?
  17. 17. Internal Audit Report QMS-M1-F12 Rev 0 Effective: 02-01-2019 Page 17 of 17 Audit notes ISO 9001 Clause Questions to ask or things to check on Findings / Evidence Please ensure adequate identification and traceability of findings and evidence e) Updating risks and opportunities determined during planning, if necessary f) Making changes to the QMS, if necessary? 10.3 Continual improvement Were there any improvements made to the QMS and its processes as a result of analysis and evaluation of data, and the management review?

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