As applicable, the organization How you deal with nonconforming shall deal with nonconforming process outputs, products and process outputs, products and services in terms of: services in one or more of the Correction; following ways: Segregation, containment, return a) correction; or suspension of provision of b) segregation, containment, products and services? return or suspension of provision Informing the customer? 8.7 of products and services; Obtaining authorization for use q3 c) informing the customer; d) obtaining authorization for: Release, continuation or - use “as-is’; of the products and - release, continuation or service? of the products and Acceptance under concession? services; - Acceptance under concession. Where nonconforming process How do you verify conformance outputs, products and services are where process outputs, products corrected, conformity to the and services are corrected 8.7 requirements shall be verified. following nonconformance? q4 The organization shall retain What documented information Documented information for actions documented information of actions taken following nonconformance, do you keep following actions taken on nonconforming process taken to address nonconformities, including concessions and authority outputs, products and services, including any concessions granted. including on any concessions 8.7 obtained and on the person or obtained and on the person or authority that made the decision q5 authority that made the decision regarding dealing with the regarding dealing with the nonconformance. nonconformity. 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General The organization shall determine: Show me how you determine: a) what needs to be monitored What needs to be monitored and and measured; measured? b) the methods for monitoring, Methods for monitoring, measurement, analysis and measurement, analysis and evaluation, as applicable, to evaluation to ensure valid results? ensure valid results; When to perform monitoring and 9.1.1 c) when the monitoring and measuring? q1 measuring shall be performed; When results shall be analysed d) When the results from and evaluated? monitoring and measurement shall be analysed and evaluated. The organization shall ensure that What documented information can Documented information of monitoring and measurement monitoring and measurement you show me that monitoring and activities are implemented in measurement activities have been activities in accordance with accordance with the determined implemented in accordance with determined requirements. 9.1.1 requirements and shall retain determined requirements? q2 appropriate documented information as Evidence of the results.
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.
Portrait-Audit-Checklist.docx