Review, verification and validation
...sufficient evidence available to demonstrate that the process considers the review, verification and validation of each stage of the project plan, testing as appropriate, to measure the functionality of the product to determine feasibility to the specification requirements.
(QMS) ensures that the system in place quickly identifies a non-compliance status and corrects it.
The management system provides the mechanisms to identify upfront compliance requirements and ensures appropriate controls are in place to positively manage compliance / regulatory status.
The audit report provides evidence of process auditing with commentary covering - Quality manual / Standards / procedural requirements, lateral documents and activities that provide an input into the process under audit.
The review report provides an overview of the status for each of the designated topics - overall it provides the necessary input detail to enable management to determine system improvements and output actions.
The...management review...agenda format covers the requirements of the standard. Topic commentary is minuted which is based upon input reports concerning performance.
Planning, scheduling and forecasting
...significant effort (has been) put in to implementing a proactive approach of the business in terms of planning, scheduling and forecasting, talking to customers to determine their trends, using this to manage production and in turn develop a proactive service provision from other areas such as the lab.
Corrective and preventative actions
The system for recording corrective and preventative actions arising from all sources (including complaints, non-conforming work, management review and audits), is well managed and the effectiveness is monitored.
Customer feedback…there is a suitable system ready for trending and using the data to seek improvement.
(Top management involved)…the day to day operation of the management system
(Top management demonstrates involvement in)…the day to day operation of the management system…in the formulation of the quality policy and objectives, the allocation of resources, the importance of meeting customer requirements and the communication of these requirements through the organisation.