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Quality Assurance Form
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12) Preventive action reports
13) SPC data
14) New product review results
15) New product verification results
16) New product validation results
17) Improvement plans
18) Interview summaries
19) Employment applications
20) Contract review forms
21) Purchase orders
22) Audit reports
23) Design inputs
24) Design outputs
25) Design reviews
26) Customer satisfaction surveys
27) Preventive action form
28) Statistical studies
29) Trend analysis
ISO 9001 Requirements
For ISO 9001 registration, records prove the product or service meets requirements. Records demonstrate the Quality Management System is effective and operating as prescribed by your documented systems.A record must be readable, identifiable (it states its purpose) and retrievable. In addition I recommend every form include a date and employees identification.
| For ISO 9001 certification, you need a documented procedure that discusses how you handle a Quality Assurance Form or Quality Records. |
This procedure needs to cover:
- Form Identification
- Storage
- Protection
- Retrieval method
- Retention period.
- Disposition after retention
The procedure can be a spreadsheet with the above headers. Group records together into categories. Inspection records may include final inspection, in process inspection, receiving inspection, audits and SPC. HR records may include applications, interview summaries and training.
Auditing Records
An auditor, internal or external, reviews records to find objective evidence of your inspections and your quality management system inputs and outputs. The records may be digital or handwritten.
Dr. Edward Deming, a quality guru, created a famous cycle for implementing change. It is called Plan-Do-Check-Act or the PDCA cycle. Although the ISO 9001 standard doesnt explicitly state PDCA, it integrates this practice throughout the standard. Quality records are needed for the Plan and Check phases.
Applications That Drive Improvement
Robert Broughton
(805) 200-7979
USA
