5.1.2 Customer focus 5.1.2 q1 Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that: a) customer requirements and applicable statutory and regulatory requirements are determined and met; b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed; c) the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements is maintained; d) The focus on enhancing customer satisfaction is maintained. Show me how top management demonstrates leadership and commitment w.r.t. customer focus ensuring requirements and applicable statutory and regulatory requirements are determined and met. How are risks and opportunities that can affect conformity of products and services determined? How is the ability to enhance customer satisfaction determined and addressed? How is the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements maintained? How is customer satisfaction maintained? 5.2 Quality policy 5.2.1 5.2.1 q1 Top management shall establish, review and maintain a quality policy that: a) is appropriate to the purpose and context of the organization; b) provides a framework for setting and reviewing quality objectives; c) includes a commitment to satisfy applicable requirements; d) Includes a commitment to continual improvement of the quality management system. How does top management establish, review and maintain a quality policy? How is it determined to be appropriate to the purpose and context of the organization? Does it provide a framework for setting and reviewing quality objectives? Does it contain a commitment to satisfy applicable requirements? Does it include a commitment to continual improvement of the QMS? 5.2.2 5.2.2 q1 The quality policy shall: a) be available as documented information; b) be communicated, understood and applied within the organization; c) Be available to relevant interested parties, as appropriate. Where is the quality policy available as documented information? How is it communicated? Show me how it is understood and applied within the organization. How have you made it available to relevant interested parties? Quality Policy as document information 5.3 Organizational roles, responsibility and authorities 5.3 q1 Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization. How does top management ensure that responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization?
7.3 Awareness 7.3 q1 Persons doing work under the organization’s control shall be aware of: a) the quality policy; b) relevant quality objectives; c) their contribution to the effectiveness of the quality management system, including the benefits of improved quality performance; d) The implications of not conforming to the quality management system requirements. How are people aware of: The quality policy? Relevant quality objectives? Their contribution to the effectiveness of the QMS? The benefits of improved performance? The implications of not conforming to the QMS requirements? 7.4 Communication 7.4 q1 The organization shall determine the internal and external communications relevant to the quality management system including: a) on what it will communicate; b) when to communicate; c) with whom to communicate; d) How to communicate. How do you determine internal and external communications relevant to the QMS? How do you determine: What? When? With Whom? How? 7.5 Documented information 7.5.1 General 7.5.1 q1 The organization’s quality management system shall include: a) documented information required by this International Standard; b) Documented information determined by the organization as being necessary for the effectiveness of the quality management system. What documented information do you have as required by this standard? What documented information do you have as being necessary for the effectiveness of your QMS? Documented information required by this standard. Documented information necessary for the effectiveness of the QMS. NOTE The extent of documented information for a quality management system can differ from one organization to another due to: a) the size of organization and its type of activities, processes, products and services; b) the complexity of processes and their interactions; c) The competence of persons. 7.5.2 Creating and updating 7.5.2 q1 When creating and updating documented information the organization shall ensure appropriate: a) identification and description (e.g. a title, date, author, or reference number); b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic); c) Review and approval for suitability and adequacy. Show me that your documented information contains: Identification; Description; In what media format? Show me how the documented information is reviewed and approved for suitability and adequacy. Documented information (in various media) needs identification, description. Review / approval process?
8 Operation 8.1 Operational planning and control 8.1 q1 The organization shall plan, implement and control the processes, as outlined in 4.4, needed to meet requirements for the provision of products and services and to implement the actions determined in 6.1, by: a) determining requirements for the product and services; b) establishing criteria for the processes and for the acceptance of products and services; c) determining the resources needed to achieve conformity to product and service requirements; d) implementing control of the processes in accordance with the criteria; e) Retaining documented information to the extent necessary to have confidence that the processes have been carried out as planned and to demonstrate conformity of products and services to requirements. How are processes needed to meet requirements for provision of products and services planned, implemented and controlled? How are requirements for products and services determined? How is criteria for processes and acceptance for products and services determined? How are resources determined? How is process control implemented? Show me the documented information that shows confidence in that the processes have been carried out as planned and can demonstrate conformity of products and services. Documented information to show processes have been carried out as planned and can demonstrate conformity of products and services. 8.1 q2 The output of this planning shall be suitable for the organization's operations. How have you determined that the output from the planning process is suitable for your operations? 8.1 q3 The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary. How do you control planned changes? How do you review the consequences of unintended changes? What action is taken to mitigate any adverse effects? 8.1 q4 The organization shall ensure that outsourced processes are controlled in accordance with 8.4. How do you control outsourced processes?
8.4 Control of externally provided products and services 8.4.1 General 8.4.1 q1 The organization shall ensure that externally provided processes, products, and services conform to specified requirements. How do you ensure externally provided processes, products and services conform to specified requirements? 8.4.1 q2 The organization shall apply the specified requirements for the control of externally provided products and services when: a) products and services are provided by external providers for incorporation into the organization’s own products and services; b) products and services are provided directly to the customer(s) by external providers on behalf of the organization; c) A process or part of a process is provided by an external provider as a result of a decision by the organization to outsource a process or function. Show me how you apply specified requirements for the control of externally provided products and services when: Products and services are provided by external providers for incorporation into your own products and services; You provide products and services directly to customers by external providers on your behalf; A process or part-process is provided by an external provider as a result of a decision to outsource a process or function. 8.4.1 q3 The organization shall establish and apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers based on their ability to provide processes or products and services in accordance with specified requirements. Show me how you establish and apply criteria for evaluation, selection, monitoring of performance and re-evaluation of external providers. How do you assess their ability to provide processes or products and services in accordance with specified requirements? 8.4.1 q4 The organization shall retain appropriate documented information of the results of the evaluations, monitoring of the performance and re-evaluations of the external providers. What documented information do you have of the results of evaluations, monitoring of performance and re-evaluations of external providers? Documented information of external providers’ performance.
8.7 q3 As applicable, the organization shall deal with nonconforming process outputs, products and services in one or more of the following ways: a) correction; b) segregation, containment, return or suspension of provision of products and services; c) informing the customer; d) obtaining authorization for: - use “as-is’; - release, continuation or of the products and services; - Acceptance under concession. How you deal with nonconforming process outputs, products and services in terms of: Correction; Segregation, containment, return or suspension of provision of products and services? Informing the customer? Obtaining authorization for use Release, continuation or of the products and service? Acceptance under concession? 8.7 q4 Where nonconforming process outputs, products and services are corrected, conformity to the requirements shall be verified. How do you verify conformance where process outputs, products and services are corrected following nonconformance? 8.7 q5 The organization shall retain documented information of actions taken on nonconforming process outputs, products and services, including on any concessions obtained and on the person or authority that made the decision regarding dealing with the nonconformity. What documented information do you keep following actions taken to address nonconformities, including any concessions obtained and on the person or authority that made the decision regarding dealing with the nonconformance. Documented information for actions taken following nonconformance, including concessions and authority granted. 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General 9.1.1 q1 The organization shall determine: a) what needs to be monitored and measured; b) the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results; c) when the monitoring and measuring shall be performed; d) When the results from monitoring and measurement shall be analysed and evaluated. Show me how you determine: What needs to be monitored and measured? Methods for monitoring, measurement, analysis and evaluation to ensure valid results? When to perform monitoring and measuring? When results shall be analysed and evaluated? 9.1.1 q2 The organization shall ensure that monitoring and measurement activities are implemented in accordance with the determined requirements and shall retain appropriate documented information as Evidence of the results. What documented information can you show me that monitoring and measurement activities have been implemented in accordance with determined requirements? Documented information of monitoring and measurement activities in accordance with determined requirements.
9.2 Internal audit 9.2.1 9.2.1 q1 The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system; a) conforms to: 1) the organization’s own requirements for its quality management system; 2) the requirements of this International Standard; b) Is effectively implemented and maintained. Are internal audits being conducted at planned intervals? Do they determine whether the QMS conforms to the requirements of ISO 9001 and to the other requirements established by Organization? (Review records to demonstrate conformance) Do they determine whether the QMS is effectively implemented and maintained? (Review records) 9.2.2 9.2.2 q1 The organization shall: a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the quality objectives, the importance of the processes concerned, customer feedback, changes impacting on the organization, and the results of previous audits; b) define the audit criteria and scope for each audit; c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process; d) ensure that the results of the audits are reported to relevant management; e) take necessary correction and corrective actions without undue delay; f) Retain documented information as evidence of the implementation of the audit programme and the audit results. Can you show me audit programme(s) that takes into consideration the quality objectives, importance of the processes, customer feedback, changes impacting the organization and the results of previous audits? Where are the audit criteria and scope for each audit? Can you demonstrate that selection of auditors and the conduct of audits are objective and impartial and that auditors don’t audit their own work? How are audit results reported to relevant management? Can you demonstrate that necessary correction and corrective actions are taken without undue delay? Can you show me documented information of the audit programme and the audit results? Documented information of the audit programme and results NOTE See ISO 19011 for guidance. 9.3 Management Review 9.3.1 9.3.1 q1 Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy, and effectiveness. What is the frequency that top management reviews the organization's QMS? How is the QMS deemed suitable, adequate and effective?
9.3.1 q2 The management review shall be planned and carried out taking into consideration: a) the status of actions from previous management reviews; b) changes in external and internal issues that are relevant to the quality management system including its strategic direction; c) information on the quality performance, including trends and indicators for: 1) nonconformities and corrective actions; 2) monitoring and measurement results; 3) audit results; 4) customer satisfaction; 5) issues concerning external providers and other relevant interested parties; 6) adequacy of resources required for maintaining an effective quality management system; 7) process performance and conformity of products and services; d) the effectiveness of actions taken to address risks and opportunities (see clause 6.1); e) new potential opportunities for continual improvement. What kinds of information are reviewed in management reviews? These must include: actions status of previous reviews; changes to internal/external issues relevant to the QMS; issues that affect strategy; KPIs for nonconformities and corrective actions; monitor and measurement of results; audit results; customer satisfaction; issues concerning external providers; issues concerning other relevant parties; adequacy of resources and effectiveness of QMS; process performance; conformity of products and services; actions taken to address risks and opportunities and their effectiveness; new potential opportunities for continual improvement. 9.3.2 9.3.2 q1 The outputs of the management review shall include decisions and actions related to: a) continual improvement opportunities; b) any need for changes to the quality management system, including resource needs. Show me that management reviews include decisions and actions relating to: Continual improvement opportunities; The need for changes to the QMS including resource needs. 9.3.2 q2 The organization shall retain documented information as evidence of the results of management reviews. Show me what documented information you have as evidence of management reviews. Documented information of management reviews. 10 Improvement 10.1 General 10.1 q1 The organization shall determine and select opportunities for improvement and implement necessary actions to meet customer requirements and enhance customer satisfaction. How do you determine and select opportunities for improvement? What necessary actions have you implemented so that you have met customer requirements and enhanced customer satisfaction?
10.3 Continual improvement 10.3 q1 The organization shall continually improve the suitability, adequacy, and effectiveness of the quality management system. Demonstrate that you continually improve the suitability, adequacy and effectiveness of the QMS. 10.3 q2 The organization shall consider the outputs of analysis and evaluation, and the outputs from management review, to confirm if there are areas of underperformance or opportunities that shall be addressed as part of continual improvement. Demonstrate that outputs of analysis and evaluation and the outputs from management review are considered to confirm if there are areas of underperformance or opportunities that shall be addressed as part of continual improvement. 10.3 q3 Where applicable, the organization shall select and utilise applicable tools and methodologies for investigation of the causes of underperformance and for supporting continual improvement. What applicable tools and methodologies for investigation of the causes of underperformance and to support continual improvement are selected?