Determine what, how, when and by whom results will be measured and evaluated.
Determine the methods for obtaining, monitoring, and reviewing customer satisfaction.
Have an objective, planned, and effectively implemented internal audit.
Top management is to review the quality management system (QMS) at planned intervals.
9.1.1 General
Triad shall:
9.1.1 a Determine what is necessary to inspect
9.1.1 b Determine the methods for inspection, analysis and evaluation
9.1.1 c Determine when to inspect
9.1.1 d Determine when to analyze and evaluate inspection results
9.1.1 Evaluate the performance and effectiveness of the QMS
9.1.1 Retain the documented information on the inspection results
See 7.5
9.1.2 Customer satisfaction
Triad will monitor customers' perceptions of the degree to which their needs and expectations have been fulfilled. Information monitored and used shall include, but is not limited to, product conformity, on-time delivery performance, complaints, general feedback, scope of products or services offerred, important of regulatory certifications. Review and assessment will occur formally, at least once per calendar year. Informally, information is monitored through general interactions.
9.1.2 Regularly monitor customer perception about their level of satisfaction
9.1.2 Determine methods for obtaining and using customer information
Annual survey (formal), ongoing interaction
9.1.2 Include in the information to be monitored and used for evaluation of customer satisfation product and service conformity, on-time delivery performance and customer complaints
Any CAR
9.1.2 Develop and implement plans that address deficiencies identified and access the effectiveness of the results
In order to improve customer satisfaction
9.1.3 Analysis and evaluation
The data and information arising from monitoring and measurement is analyzed and evaluated, specifically as to meeting the following:
9.1.3 Analyze and evaluate inspection data
9.1.3 a Use analysis results - evaluate how requirements are met
See 4.2
9.1.3 b Use analysis results - evaluate the level of customer satisfaction
See 9.1.2
9.1.3 c Use analysis results - evaluate the performance and effectiveness of the QMS
9.1.3 d Use analysis results - evaluate the effectiveness of planning
See 8.1
9.1.3 e Use analysis results - evaluate the effectiveness of risk mitigation and opportunities
See 6.1
9.1.3 f Use analysis results - evaluate external providers
See 8.4
9.1.3 g Use analysis results - evaluate the improvement opportunities of the QMS
See 10.3
Internal audits are planned using a project plan system and conducted at planned intervals to provide information on whether the QMS conforms to both company and standard requirements. The audit project plan controls the schedule, allows visibility to all impacted personnel, allows tasks to be assigned for resolution and creates electronic documentation of results. IA checklists with specific evidence are attached to the project plan.
9.2.1 a1,2 Conduct regularly planned internal audits
Determine whether the QMS meets Triad and standard requirements
9.2.1 b Conduct regularly planned internal audits
QMS effectiveness
9.2.2 a Plan, establish, implement and update an audit program
Schedule, methods, responsibilities, planning, reporting
9.2.2 a Account for essential points
process importance, changes impacting company, results of prior audits
9.2.2 b Define the scope and audit criteria
Define in plan/tasks/reports
9.2.2 c Select auditors
9.2.2 d Communicate audit results to management or concerned parties
See 7.4
9.2.2 e Initiate corrections quickly and initiate corrective action if required
See 10.2
9.2.2 f Retain the documented information on the audit schedule, plan, results
See 7.5
Top management reviews the QMS, at a minimum annually, to ensure its continuing suitability, adequacy, effectiveness and alignment with strategic direction. Inputs are controlled and required, as below and communicated to Top management prior to the meeting.
9.3.1 General
9.3.1 Proceed at least once a year to review the QMS
9.3.2 Management review inputs
9.3.2 a Plan and execute the management review
9.3.2 b Execute the management review while accounting for changes of external/internal issues
9.3.2 c 1 through 7 Account for all information on the performance of the QMS and trends
Customer satisfaction, see 8.7, 10.2
Quality objectives, see 6.2
Process performance/conformity of outputs, see 9.1
Nonconformities and CAR, see 10.2
Inspection results (metrics), see 9.1
Audit results, see 9.2
External provider performance, see 8.4
9.3.2 c8 Account for the information on the performance of the QMS and trends
OTD, see 8.1
9.3.2 d Account for resources
9.3.2 e Account for effectiveness of actions
Risk mitigation, see 6.1
9.3.2 f Account for improvement opportunities
See 10.3
9.3.3 Management review outputs
The outputs of the management review shall include decisions and actions related to the following, with all outputs documented.
9.3.3 a Include decisions regarding continual improvement (if applicable) in outputs
See 10.3
9.3.3 b Include decisions regarding eventual changes to the QMS
See 6.3
9.3.3 c Include decisions regarding new resource needs
See 7.1
9.3.3 d Include decisions regarding RISK mitigation
See 8.1.1
9.3.3 Retain the documented information on outputs of the management review
See 7.5