AS/NZS ISO 9004.1:1994

1 - AS/NZS ISO 9004.1:1994 QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS
4 - Preface
5 - Contents
6 - Foreword
8 - Introduction
8 - 0.1 General
8 - 0.2 Organizational goals
9 - 0.3 Meeting customer/organization needs and expectations
9 - 0.4 Benefits, costs and risks
10 - 0.5 Conclusions
11 - 1 Scope
11 - 2 Normative references
11 - 3 Definitions
12 - 3.1 organization:
12 - 3.2 customer:
12 - 3.3 requirements of society:
12 - 3.4 quality plan:
12 - 3.5 product:
12 - 3.6 service:
12 - 4 Management responsibility
12 - 4.1 General
13 - 4.2 Quality policy
13 - 4.3 Quality objectives
13 - 4.3.1
13 - 4.3.2
13 - 4.3.3
13 - 4.4 Quality system
13 - 4.4.1
13 - 4.4.2
13 - 4.4.3
13 - 4.4.4
13 - 5 Quality system elements
13 - 5.1 Extent of application
13 - 5.1.1
13 - 5.1.2
13 - 5.2 Structure of the quality system
13 - 5.2.1 General
14 - 5.2.2 Responsibility and authority
14 - 5.2.3 Organizational structure
14 - 5.2.4 Resources and personnel
14 - 5.2.5 Operational procedures
14 - 5.2.6 Configuration management
15 - 5.3 Documentation of the quality system
15 - 5.3.1 Quality policies and procedures
15 - 5.3.2 Quality system documentation
15 - 5.3.2.1
15 - 5.3.2.2
15 - 5.3.2.3
15 - 5.3.2.4.
15 - 5.3.3 Quality plans
16 - 5.3.4 Quality records
16 - 5.4 Auditing the quality system
16 - 5.4.1 General
16 - 5.4.2 Audit programme
16 - 5.4.3 Extent of audits
17 - 5.4.4 Audit reporting
17 - 5.4.5 Follow-up action
17 - 5.5 Review and evaluation of the quality system
17 - 5.6 Quality improvement
17 - 6 Financial considerations of quality systems
17 - 6.1General
18 - 6.2 Approaches to financial reporting of quality system activities
18 - 6.2.1 General
18 - 6.2.2 Approaches
18 - 6.3 Reporting
18 - 7 Quality in marketing
18 - 7.1 Marketing requirements
19 - 7.2 Defining product specification
19 - 7.3 Customer feedback information
19 - 8 Quality in specification and design
19 - 8.1 Contribution of specification and design to quality
19 - 8.2 Design planning and objectives
19 - 8.2.1
19 - 8.2.2
19 - 8.2.3
20 - 8.2.4
20 - 8.2.5
20 - 8.3 Product testing and measurement
20 - 8.4 Design review
20 - 8.4.1 General
20 - 8.4.2 Elements of design reviews
21 - 8.4.3 Design verification
21 - 8.5 Design qualification and validation
21 - 8.6 Final design review and production release
21 - 8.7 Market-readiness review
22 - 8.8 Design change control
22 - 8.9 Design requalification
22 - 8.10 Configuration management in design
22 - 9 Quality in purchasing
22 - 9.1 General
22 - 9.2 Requirements for specifications, drawings and purchase documents
23 - 9.3 Selection of acceptable subcontractors
23 - 9.4 Agreement on quality assurance
23 - 9.5 Agreement on verification methods
23 - 9.6 Provisions for settlement of disputes
23 - 9.7 Receiving inspection planning and control
23 - 9.8 Quality records related to purchasing
24 - 10 Quality of processes
24 - 10.1 Planning for process control
24 - 10.1.2
24 - 10.1.3
24 - 10.1.4
24 - 10.1.5
24 - 10.1.6
24 - 10.2 Process capability
24 - 10.3 Supplies, utilities and environment
24 - 10.4 Handling
25 - 11 Control of processes
25 - 11.1 General
25 - 11.2 Material control, traceability and identification
25 - 11.2.1 Material control
25 - 11.2.2 Traceability
25 - 11.2.3 Identification
25 - 11.3 Equipment control and maintenance
25 - 11.4 Process control management
25 - 11.5 Documentation
25 - 11.6 Process change control
26 - 11.7 Control of verification status
26 - 11.8 Control of nonconforming product
26 - 12 Product verification
26 - 12.1 Incoming materials and parts
26 - 12.2 In-process verification
26 - 12.3 Finished product verification
26 - 13 Control of inspection, measuring and test equipment
26 - 13.1 Measurement control
27 - 13.2 Elements of control
27 - 13.3 Subcontractor measurement controls
27 - 13.4 Corrective action
27 - 13.5 Outside testing
27 - 14 Control of nonconforming product
27 - 14.1 General
27 - 14.2 Identification
27 - 14.3 Segregation
27 - 14.4 Review
28 - 14.5 Disposition
28 - 14.6 Action
28 - 14.7 Avoidance of recurrence
28 - 15 Corrective action
28 - 15.1 General
28 - 15.2 Assignment of responsibility
28 - 15.3 Evaluation of importance
28 - 15.4 Investigation of possible causes
28 - 15.5 Analysis of problem
29 - 15.6 Elimination of causes
29 - 15.7 Process controls
29 - 15.8 Permanent changes
29 - 16 Post-production activities
29 - 16.1 Storage
29 - 16.2 Delivery
29 - 16.3 Installation
29 - 16.4 Servicing
29 - 16.4.2
29 - 16.4.3
29 - 16.4.4
29 - 16.5 After sales
29 - 16.6 Market feedback
29 - 17 Quality records
29 - 17.1 General
30 - 17.2 Quality records
30 - 17.3 Control of quality records
30 - 18 Personnel
30 - 18.1 Training
30 - 18.1.1 General
30 - 18.1.2 Executive and management personnel
31 - 18.1.3 Technical personnel
31 - 18.1.4 Process supervisors and operating personnel
31 - 18.2 Qualification
31 - 18.3 Motivation
31 - 18.3.1 General
31 - 18.3.2 Applicability
31 - 18.3.3 Quality awareness
31 - 18.3.4 Measuring quality
31 - 19 Product safety
32 - 20 Use of statistical methods
32 - 20.1 Applications
32 - 20.2 Statistical techniques
33 - Annex A - Bibliography

Provides guidelines on quality management for use within an organization in the development and implementation of a comprehensive and effective system designed to satisfy customer needs and expectations while serving to protect the organization's interests. This Standard is identical with and has been reproduced from ISO 9004-1:1994.

This part of ISO 9004 provides guidance on quality management and quality system elements.The quality system elements are suitable for use in the development and implementation of a comprehensive and effective in-house quality system, with a view to ensuring customer satisfaction. This part of ISO 9004 is not intended for contractual, regulatory or certification use. Consequently, it is not a guideline for the implementing of ISO 9001, ISO 9002 and ISO 9003. ISO 9000-2 should be used for that purpose. The selection of appropriate elements contained in this part of ISO 9004 and the extent to which these elements are adopted and applied by an organization depends upon factors such as the market being served, nature of the product, production processes, and customer and consumer needs. References in this part of ISO 9004 to a "product" should be interpreted as applicable to the generic product categories of hardware, software, processed materials or service (in accordance with the definition of "product" in ISO 8402).NOTES1 For further guidance, see ISO 9004-2 and ISO 9004-3.2 For informative references, see annex A.

First published in Australia as AS 3904-1987/ISO 9004:1987.
First published in New Zealand as NZS 5600.2:1987.
AS 3904-1987/ISO 9004:1987 and NZS 5600.2:1987 redesignated in 1990 as Joint Standard AS 3904.1-1987/NZS 9004.1:1990/ISO 9004:1987.
Jointly revised and redesignated as Joint Standard AS/NZS ISO 9004.1:1994.