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Iso 9001 Audit Preparation Sheet

This document outlines an ISO audit preparation sheet for an organization. It lists the organization's quality policy and objectives statements. It identifies the management representative and key processes. The ISO 9001 documentation includes a quality manual describing the quality policy, objectives, structure, and how requirements are fulfilled. There are six mandatory procedures and work instructions, quality plans, and department records. Internal audits review the documented systems and note any non-conformances. Management reviews achievement of objectives. The eight clauses of ISO 9001 are outlined relating to top management responsibilities, customer processes, purchasing, design, production, stores, quality, HR, and administration. External audits are done by a certification agency. The eight principles of quality management are also

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926 views2 pages

Iso 9001 Audit Preparation Sheet

This document outlines an ISO audit preparation sheet for an organization. It lists the organization's quality policy and objectives statements. It identifies the management representative and key processes. The ISO 9001 documentation includes a quality manual describing the quality policy, objectives, structure, and how requirements are fulfilled. There are six mandatory procedures and work instructions, quality plans, and department records. Internal audits review the documented systems and note any non-conformances. Management reviews achievement of objectives. The eight clauses of ISO 9001 are outlined relating to top management responsibilities, customer processes, purchasing, design, production, stores, quality, HR, and administration. External audits are done by a certification agency. The eight principles of quality management are also

Uploaded by

SUBODHH
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© © All Rights Reserved
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ISO AUDIT PREPARATION SHEET

QUALITY POLICY-STATEMENT

QUALITY OBJECTIVES STATEMENT


----------------is Management Representative (Internal coordinator for ISO 9001 related activities)
Key Processes for ISO are Sales, Design, Purchase, Production, Quality, Stores, HR and Admin; MR
and Top Management
The ISO 9001 documentation generally comprise of:
Quality Manual (which mentions Quality Policy, Quality Objectives, organization structure, job
description and how We fulfill ISO 9001 requirements)
Six mandatory Procedures
QSP-01 Control of Documents
QSP-02 Control of Quality Records
QSP-03 Control of Non conforming Product
QSP-04 Corrective Action
QSP-05 Preventive Action
QSP-06 Internal Audit

Work instructions:
Quality Plans: Checklist for incoming inspection, stage-wise inspection, jobwork inspection and final
inspection
Department-wise Records

Internal audits Internal review of the documented systems by trained auditors
Internal audit NC-
--------------------------------------------------------------------------------------------------------------------------------------
Management review- Review of achievement of Quality objectives as well as Departmental
objectives by core team (The core team consists of MD and heads of all departments)- -------------------
-----------------------------------------------------
There are 8 Clauses in ISO:
Main Clauses-Area-wise are as follows:
Top Management-Management Responsibility (5.1, 5.2, 5.3, 5.4 , 5.5, 5.6), Resource Provision (6.1)
Sales and Marketing-Customer related process (7.2), Customer satisfaction (8.2.1)
Purchase-7.4
Design and development-7.3
Production-Control of production (7.5.1); Validation of process (7.5.2); Identification and
traceability (7.5.3); Customer property(7.5.4); Work environment (6.4)
Control of nonconforming Product (8.2.3)

Stores- Preservation of product (7.5.5) ; Customer property(7.5.4); Work environment (6.4)
Control of nonconforming Product (8.2.3)
Quality: Verification of Purchased Product (7.4.3); Monitoring and measurement of Product
(8.2.4); Calibration (7.6); Corrective, preventive action and continual improvement (8.5)
Control of nonconforming Product (8.2.3)

HR and Admin- Human resources (6.2); Infrastructure-(6.3); Work environment (6.4); Corrective,
preventive action and continual improvement (8.5)
Machine maintenance-Infrastructure-6.3;
MR- Control of documents (4.2.3); Control of records (4.2.4); Internal audit(8.2.2); Management
review (5.6); Corrective, preventive action and continual improvement (8.5); Analysis of data (8.4)
General- Control of documents (4.2.3); Control of records (4.2.4); Corrective, preventive action and
continual improvement (8.5); Planning (7.1)
External audits are done by certification agency
Eight Principles of Quality Management:
1. Customer focus
2. Leadership
3. Involvement of people
4. Process Approach
5. System approach to Management
6. Continual Improvement
7. Factual approach to decision making
8. Mutually beneficial supplier relationships

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