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    AS/NZS ISO 9004.1:1994

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Quality management and quality system elements Guidelines

    Available format(s):  Hardcopy, PDF 1 User, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Superseded date:  30-06-2017

    Language(s):  English

    Published date:  01-09-1994

    Publisher:  Standards Australia

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    Scope - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee QR-008
    Document Type Standard
    Publisher Standards Australia
    Status Superseded
    Superseded By
    Supersedes

    History - (Show below) - (Hide below)

    Under Revision see DR 99130 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. 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.

    Standards Referencing This Book - (Show below) - (Hide below)

    AS/NZS 3750.15:1998 Paints for steel structures Inorganic zinc silicate paint (Reconfirmed 2013)
    AS 1444-1996 Wrought alloy steels - Standard, hardenability (H) series and hardened and tempered to designated mechanical properties
    HB 97-1997 Integrating quality and environmental management systems ISO 9001 and ISO 14001
    AS 4429(INT)-1996 Methods of test and rating requirements for smoke-spill fans
    AS 1418.10-1996 Cranes (including hoists and winches) - Elevating work platforms
    AS 1324.1-1996 Air filters for use in general ventilation and airconditioning - Application, performance and construction
    AS/NZS 1859.3:1996 Reconstituted wood-based panels - Decorative overlaid wood panels
    AS 1380.1-1998 Fibre-rope slings - Product specification
    AS/NZS 2908.1:2000 Cellulose-cement products Corrugated sheets (Reconfirmed 2020)
    AS 2076-1996 Wire-rope grips for non-lifting applications
    AS 4751(INT)-2000 Electrogalvanized (zinc) coatings on ferrous open sections
    AS 1085.16-1995 Railway permanent way material - Part 16: Cast sleeper plates
    AS 4390.3-1996 Records management - Strategies
    AS 4421-1996 Guards and patrols
    AS/NZS 1859.1:1997 Reconstituted wood-based panels - Particleboard
    AS/NZS 4256.5:1996 Plastic roof and wall cladding materials Polycarbonate
    AS 1085.13-1998 Railway permanent way material - Part 13: Spring fastening spikes for sleeper plates
    AS 1438.1-1998 Wire-coil flat slings Product specification
    AS/NZS 2904:1995 Damp-proof courses and flashings
    AS 1332-2000 Conveyor belting - Textile reinforced (Reconfirmed 2016)
    AS 1085.12-1999 Railway permanent way materials - Part 12: Insulated joint assemblies
    AS 1353.1-1997 Flat synthetic-webbing slings Product specification (Reconfirmed 2014)
    AS 2947.3-1995 Insulators - Porcelain and glass for overhead power lines - Voltages greater than 1000 V a.c. Couplings
    AS 2047-1999 Windows in buildings - Selection and installation
    AS 4390.1-1996 Records management - General
    AS/NZS 3809:1998 Safes and strongrooms
    AS 2766-1997 Petri dishes - Plastic - For single use
    AS/NZS 2179.2(INT):1998 Specifications for rainwater goods, accessories and fasteners - PVC rainwater goods and accessories
    AS 1731.2-2000 Refrigerated display cabinets General mechanical and physical requirements
    AS/NZS 3905.2:1997 Quality system guidelines Guide to AS/NZS ISO 9001, AS/NZS ISO 9002, and AS/NZS ISO 9003 for construction
    AS/NZS 2272:1996 Plywood - Marine
    AS/NZS 4256.1:1994 Plastic roof and wall cladding materials General requirements
    HB 139-2003 Guidance on Integrating the Requirements of Quality, Environment, and Health and Safety Management System Standards
    AS/NZS 1260:1996 PVC pipes and fittings for drain, waste and vent applications
    AS 4750(INT)-2000 Electrogalvanized (zinc) coatings on ferrous hollow sections
    HB 139-2003 Guidance on Integrating the Requirements of Quality, Environment, and Health and Safety Management System Standards
    AS/NZS 4371:1996 Ceramic tableware
    AS/NZS 4256.3:1994 Plastic roof and wall cladding materials Glass fibre reinforced polyester (GRP)
    AS/NZS 4256.2:1994 Plastic roof and wall cladding materials Unplasticized polyvinyl chloride (uPVC) building sheets
    AS/NZS 3750.13:1997 Paints for steel structures Epoxy primer (two-pack)
    AS/NZS 2343:1997 Bullet-resistant panels and elements
    AS/NZS 3879:1995 Solvent cements and priming fluids for use with unplasticized PVC (uPVC) pipes and fittings
    AS/NZS 3905.16:1998 Quality system guidelines Guidelines to quality in project management
    AS/NZS 1748:1997 Timber - Stress-graded - Product requirements for mechanically stress-graded timber
    AS/NZS 4380:1996 Cargo restraint systems - Webbing load restraint systems
    AS/NZS 4792:1999 Hot-dip galvanized (zinc) coatings on ferrous hollow sections, applied by a continuous or a specialized process
    AS/NZS 1477:1996 PVC pipes and fittings for pressure applications
    AS/NZS 2544:1995 Grey iron pressure fittings
    AS/NZS 3905.4:1995 Quality system guidelines - Guide to quality system Standards AS/NZS ISO 9001:1994 and AS/NZS ISO 9002:1994 for the pressure equipment industry
    AS/NZS 4130:1997 Polyethylene (PE) pipes for pressure applications
    AS 1085.8-1995 Railway permanent way material - Part 8: Dogspikes
    AS/NZS 4131:1997 Polyethylene (PE) compounds for pressure pipes and fittings
    AS/NZS 4158:1996 Thermal-bonded polymeric coatings on valves and fittings for water industry purposes
    AS/NZS 1859.4:1997 Reconstituted wood-based panels Hardboard
    AS 4441(INT)-1996 Oriented PVC (OPVC) pipes for pressure applications
    AS/NZS 1221:1997 Fire hose reels (Reconfirmed 2020)
    AS 4497.1-1997 Roundslings - Synthetic fibre - Product specification
    AS/NZS 4791:1999 Hot-dip galvanized (zinc) coatings on ferrous open sections, applied by an in-line process
    AS/NZS 1605:2000 Methods for sampling and analysing timber preservatives and preservative-treated timber
    AS/NZS 4513:1995 Medical electrical equipment - Fundamental aspects of safety standards (Reconfirmed 2022)
    AS 4187-1998 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities
    AS/NZS 4065:2000 Concrete utility services poles
    AS/NZS 2699.3:2000 Built-in components for masonry construction Lintels and shelf angles (durability requirements)
    AS 2913-2000 Evaporative airconditioning equipment (Reconfirmed 2016)
    AS/NZS 2588:1998 Gypsum plasterboard (Reconfirmed 2016)
    AS/NZS 4357:1995 Structural Laminated Veneer Lumber
    AS 1085.15-1995 Railway permanent way material - Part 15: Aluminothermic rail welding
    AS/NZS 4677:2000 Steel utility services poles
    AS/NZS 4256.4:1995 Plastic roof and wall cladding materials - Unplasticized polyvinyl chloride (uPVC) wall cladding boards
    AS/NZS 3750.14:1997 Paints for steel structures High-build epoxy (two-pack)
    AS/NZS 4345:1995 Cargo restraint systems - Transport fibre rope
    AS/NZS 3750.17:1998 Paints for steel structures Etch primers (single pack and two-pack) (Reconfirmed 2013)
    AS/NZS 1594:1997 Hot-rolled steel flat products
    AS 1085.4-1999 Railway permanent way material - Part 4: Fishbolts and nuts
    AS 4290-2000 Design and installation of Revolving doors
    AS/NZS 1595:1998 Cold-rolled, unalloyed, steel sheet and strip (Reconfirmed 2016)
    AS/NZS 4804:1997 Occupational health and safety management systems - General guidelines on principles, systems and supporting techniques
    AS/NZS 4344:1995 Cargo restraint systems - Transport chain and components
    AS 1085.14-1997 Railway permanent way material - Part 14: Prestressed concrete sleepers
    AS 4429-1999 Methods of test and rating requirements for smoke-spill fans
    AS 4454-1997 Composts, soil conditioners and mulches
    AS 3582.1-1998 Supplementary cementitious materials for use with portland and blended cement Fly ash
    AS 2317-1998 Collared eyebolts
    AS/NZS 2699.2:2000 Built-in components for masonry construction Connectors and accessories
    AS/NZS 3679.1:1996 Structural steel Hot-rolled bars and sections
    AS 1666.1-1995 Wire-rope slings - Product specification
    AS 2537-1994 Mechanical jointing fittings for use with cross-linked polyethylene (PE-X) pipe for hot and cold water applications
    AS 2216-1997 Packaging for poisonous substances
    AS 1085.1-2000 Railway permanent way material Steel rails
    AS/NZS 4455:1997 Masonry units and segmental pavers
    AS/NZS 2280:1995 Ductile iron pressure pipes and fittings
    AS/NZS 1859.2:1997 Reconstituted wood-based panels - Medium density fibreboard (MDF)
    AS/NZS 3750.6:1995 Paints for steel structures - Full gloss polyurethane (two-pack)
    AS/NZS 3750.16:1998 Paints for steel structures Waterborne primer and paint for galvanized, zinc/aluminium alloy-coated and zinc-primed steel (Reconfirmed 2013)
    AS/NZS 3905.14:1998 Quality system guidelines - Guide to AS/NZS ISO 9001, 9002 and 9003 for health services
    AS 3818.1-1998 Timber - Heavy structural products - Visually graded General requirements
    AS/NZS 4129(INT):1997 Fittings for polyethylene (PE) pipes for pressure applications
    AS/NZS 3905.12:1999 Quality system guidelines - Guide to AS/NZS ISO 9001 for architectural and engineering design practices
    AS 3743-1996 Potting mixes
    AS 3771-1998 Road lighting luminaires with integral control gear
    AS/NZS 4534:1998 Zinc and zinc/aluminium-alloy coatings on steel wire
    AS/NZS 4290:1995 Design and installation of revolving doors
    AS 1890-1999 Thermally released links (Reconfirmed 2016)
    AS/NZS 2699.1:2000 Built-in components for masonry construction Wall ties
    AS 1672.1-1997 Limes and limestones Limes for building
    AS 1085.10-1995 Railway permanent way material - Part 10: Rail anchors
    AS/NZS 2648.1:1995 Underground marking tape Non-detectable tape (Reconfirmed 2020)
    AS 4285-1995 Skylights
    AS/NZS 3678:1996 Structural steel - Hot-rolled plates, floorplates and slabs
    AS 1597.2-1996 Precast reinforced concrete box culverts Large culverts (from 1500 mm span and up to and including 4200 mm span and 4200 mm height)
    AS/NZS 4049.3:1996 Paints and related materials - Road marking materials - Waterborne paint - For use with drop-on beads
    AS 1085.3-2000 Railway permanent way material - Part 3: Sleeper plates
    AS/NZS 3679.2:1996 Structural steel - Welded I sections
    AS/NZS 4680:1999 Hot-dip galvanized (zinc) coatings on fabricated ferrous articles
    AS/NZS 2041:1998 Buried corrugated metal structures
    AS/NZS 2208:1996 Safety glazing materials in buildings
    HB 139-2003 Guidance on Integrating the Requirements of Quality, Environment, and Health and Safety Management System Standards
    AS/NZS 1859.5:1997 Reconstituted wood-based panels Fibre insulating board (insulation board)
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