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ISO 9001:2008 Procedures/Forms/FlowCharts

Proced. # Clause 4 AP-423 Document Control Procedure Name Included FlowChart FD-4.0 FD-410 FD-415 FD-423 FD-424 FD-5.0 FD-510 FD-540 FD-545 FD-6.0 FD-610 FlowChart Name Quality management system Business process map Process interactions Document control Control of records Management responsibility Quality policy, objectives & principles QMS planning process Quality objectives planning Resource management Management of resources for the QMS Included Form# F-423-001 F-423-002 F-423-003 F-423-004 F-424-001 F-500-001 F-500-002 F-824-001 A-500-001 Form Name Master Document List Software Inventory Spreadsheet Document Change Request Form Document Revision Checklist Quality Records Table QMS Monitoring, Measuring and Analysis Table Key Process Master List Product Realization Monitoring, Measuring and Analysis Table Quality Policy Minutes of management review meetings Referenced Documents NOT Included

AP-424 Clause 5 AP-500

Control of Quality Records Management Responsibility

Clause 6 AP-622 EP-630 Clause 7 MP-710

Competence, Awareness and Training Infrastructure

F-622-001 Action Plan F-622-002 Group Training Record None

Employee resume or application with qualifications Preventive Maintenance Spreadsheet or database. Preventive maintenance summaries

Planning of Product Realization Processes


Customer Related Processes

FD-7.0 FD-710 FD-712 FD-714 FD-720

Product realization Process flow diagram 5-M contributors to product realization Service / quality plan Customer related processes

F-710-001 Quality Planning Table None

Order Database Customer feedback spreadsheet Order forms Customer Inquiry Form


Design and Development

FD-730 FD-731 FD-732 FD-740




Control of Production and Service Provision

MP-753 MP-754 MP-755 MP-760 Clause 8 AP-821 QP-822

Identification and Traceability Customer Property Preservation of Product Control of Measuring and Monitoring Equipment

FD-750 FD-751 FD-752 FD-753

Design and development process F-730-001 Design Plan Project timing chart F-730-002 Design Review Record Product service development stage-gate process F-730-003 Design Change F-824-001 Product Realization Monitoring, Measuring and Analysis Table Purchasing process F-740-001 Supplier Quality Reports F-740-002 Supplier Corrective Action Request F-740-003 Approved Supplier List F-824-001 Product Realization Monitoring, Measuring and Analysis Table Process control activities None Control inspection points / data Post delivery service process Identification and traceability process None None None F-760-001 Calibration List

Purchasing documents required for traceability Records of verification of purchased product

Product Realization Procedures and Work Instructions Process Validation Work Instruction

Equipment Logs Calibration Certificates and Records

Monitoring, Measuring and Analysis of Customer Satisfaction Internal Audits


Measurement, analysis & improvement

None F-822-001 F-822-002 F-822-003 F-822-004

Internal Audit Plan Internal Audit Report Applicable Procedures by Work Area Audit Checklist

MP-824 QP-830

Monitoring, Measuring & Analysis of Product & Realization Processes Control of Nonconforming Product

F-824-001 Product Realization Monitoring, Measuring and Analysis Table None

Department Scrap Reports NCR forms Corrective and Preventive Action Requests

QP-852 QP-853

Corrective Action Preventive Action

FD-840 FD-852

Continual improvement via data analysis Corrective action

F-852-001 Corrective/Preventive Action Request F-852-001 Corrective/Preventive Action Request