Quality system implementation key areas:
BS 5750:ISO-9001,2,3, 14001, ISO9001:20000
 | Complete documentation systems |
| Standard Operating Procedures, |
| Work center procedures and instructions, |
| Develop and writing of quality manuals for ISO and GMP compliance. |
| Conformance to requirements: |
| Control charting and concepts |
Design reviews
| Developing customer requirements and specifications, |
| Design verification, design validation, |
| Pilot build and production simulations, |
| Tool build and verification, Tool qualification, |
|
Process development,
| Process stressing experiments, |
| Conformance analysis, |
| Design for 6-sigma compliance, |
| Zero defects, |
| Cp, Cpk, Cpr, Cpm, |
| Loss Function and other indicators of conformance, |
| Benchmarking and verification of improvements, |
| Validation and qualification protocols and reporting, |
Internal auditing,
| Supplier and system audits for G MP and ISO requirements. |