AS 3905.

1—1991

Australian Standard
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Quality system guidelines

Part 1: Guidelines to
AS 3901/NZS 9001/ISO 9001 for
the chemical and allied
industries
 This Australian Standard was prepared by Committee QR/-/2, Chemical Guidelines
Quality Committee. It was approved on behalf of the Council of Standards Australia
on 1 November 1991 and published on 11 November 1991.
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The following interests are represented on Committee QR/-/2:

Australian Chemical Industry Council
Chemical manufacturers
Quality systems certification bodies

Review of Australian Standards. To keep abreast of progress in industry, Australian Standards are subject
to periodic review and are kept up to date by the issue of amendments or new editi ons as necessary. It is
important therefore that Standards users ensure that they are in possession of the latest edit ion, and any
amendments thereto.
Full detail s of all Australi an Standards and related publications wil l be found in the Standards Australia
Catalogue of Publi cati ons; this informati on is supplemented each month by the magazine ‘The Australi an
Standard’, which subscribing members receive, and which gives detail s of new publications, new edit ions
and amendments, and of withdrawn Standards.
Suggesti ons for improvements to Australi an Standards, addressed to the head offi ce of Standards Australia,
are welcomed. Noti fi cati on of any inaccuracy or ambiguity found in an Australi an Standard should be made
without delay in order that the matter may be investigated and appropriate action taken.
 AS 3905.1—1991

Australian Standard
This is a free 8 page sample. Access the full version at http://infostore.saiglobal.com.

Quality system guidelines

Part 1: Guidelines to
AS 3901/NZS 9001/ISO 9001 for
the chemical and allied
industries

First publi shed as AS 3905.1—1991.

PUBLISHED BY STANDARDS AUSTRALIA

(STANDARDS ASSOCIATION OF AUSTRALIA)
1 THE CRESCENT, HOMEBUSH, NSW 2140
ISBN 0 7262 7181 0
 AS 3905.1—1991 2

PREFACE

These Guidelines were prepared by a Committee convened by the Australian Chemical Industry Council
comprising chemical manufacturers and quality systems certification bodies.
These Guidelines have been prepared for the chemical and allied industries and are based on the Chemical
Industries Association (U.K.) publication, ISO 9001, EN 29001, BS 5750: Part 1: 1987 Guidelines for use
by the Chemical and Allied Industries. The cooperation of the CIA (U.K.) in making this document
available is gratefully acknowledged.
The Guidelines are considered relevant to those organizations involved in process industries such as
petroleum, food, mining, building materials, adhesives and sealants, detergents, cosmetics, pharmaceuticals,
inks, paints, etc.
While a copy of the Standard AS 3901/NZS 9001/ISO 9001, Quality systems for design/development,
production, installation and servicing, to which these Guidelines are directed is not enclosed, it can be
obtained from any Standards Australia office (addresses on back cover). Copies of ISO 8402, Quality
vocabulary and AS 3904.1/NZS 9004.1/ISO 9004, Quality management and quality system elements –
Guidelines (referred to within the Guidelines) can also be obtained from Standards Australia.
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 Copyri ght STANDARDS AUSTRALIA

Users of Standards are reminded that copyri ght subsists in all Standards Australi a publications and soft ware. Except where the
Copyri ght Act all ows and except where provided for below no publications or software produced by Standards Austr alia may be
reproduced, stored in a retri eval system in any form or transmitt ed by any means without pri or permission in wri ti ng fr om
Standards Australi a. Permission may be conditi onal on an appropriate royalt y payment. Requests for permission and information on
commercial soft ware royalti es should be dir ected to the head off ice of Standards Australi a.
Standards Australi a wil l permit up to 10 percent of the technical content pages of a Standard to be copied for use
exclusively in-house by purchasers of the Standard without payment of a royalty or advice to Standards Austr alia.
Standards Australi a wil l also permit the inclusion of its copyri ght material in computer soft ware programs for no royalt y
payment provided such programs are used exclusively in-house by the creators of the programs.
Care should be taken to ensure that material used is fr om the current editi on of the Standard and that it is updated whenever the
Standard is amended or revised. The number and date of the Standard should therefore be clearly identif ied.
The use of material in pri nt form or in computer soft ware programs to be used commercially, with or without payment, or in
commercial contracts is subject to the payment of a royalty. This policy may be vari ed by Standards Austr alia at any ti me.
 3 AS 3905.1—1991

CONTENTS
Page
FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

0 INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1 SCOPE AND FIELD OF APPLICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.2 Field of application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

3 DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

4 THE ELEMENTS OF THE STANDARD . . . . . . ... . . . ... . . . .. . . ... .. . . .. . . . 6

4.1 Management responsibility . . . . . . . . . . . . .... .. ... .. . .. .. ... .. . ..... . 6
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4.2 Quality system . . . . . . . . . . . . . . . . . . . . . ... .. ... .. . .. .. ... .. . . .. .. . 7

4.3 Contract review . . . . . . . . . . . . . . . . . . . . . ... .. ... .. . .. .. ... .. . . .. .. . 8
4.4 Design control . . . . . . . . . . . . . . . . . . . . . .... .. ... .. . .. .. ... .. . .. ... . 9
4.5 Document control . . . . . . . . . . . . . . . . . . ... . .. ... .. . .. .. ... .. . ... .. . 10
4.6 Purchasing . . . . . . . . . . . . . . . . . . . . . . . .... .. ... .. . .. .. ... . . . .... . . 10
4.7 Purchaser supplied product . . . . . . . . . . . . .... .. ... .. . .. .. ... .. . ..... . 12
4.8 Product identification and traceability . . . . .. .. . . . .. .. . .. .. . .. .. . ..... . 12
4.9 Process control . . . . . . . . . . . . . . . . . . . . . ... .. ... .. . .. .. ... .. . . .. .. . 12
4.10 Inspection and testing . . . . . . . . . . . . . . . . ... .. ... .. . .. .. ... .. . .. ... . 13
4.11 Inspection, measuring and test equipment . . .. .. .. . .. .. . .. .. ... .. . ..... . 14
4.12 Inspection and test status . . . . . . . . . . . . . ... . .. .. . .. . .. .. ... .. . .... . . 15
4.13 Control of non-conforming product . . . . . . ... . . . ... . . . .. . . ... .. . ..... . 15
4.14 Corrective action . . . . . . . . . . . . . . . . . . . .. .. .. ... .. . .. .. ... . . . .. .. . . 15
4.15 Handling, storage, packaging and delivery . ... . . . .. . . . . .. . . ... . . . ..... . 16
4.16 Quality records . . . . . . . . . . . . . . . . . . . . . ... .. ... .. . .. .. ... .. . . .. .. . 16
4.17 Internal quality audits . . . . . . . . . . . . . . . . ... .. ... .. . .. .. ... .. . .. ... . 16
4.18 Training . . . . . . . . . . . . . . . . . . . . . . . . . .... .. ... .. . .. .. .. . . . . .. ... . 16
4.19 Servicing . . . . . . . . . . . . . . . . . . . . . . . . .... .. ... .. . .. . . ... .. . ... .. . 17
4.20 Statistical techniques . . . . . . . . . . . . . . . . .... . . ... .. . .. .. ... .. . . .... . 17

APPENDICES
A GUIDANCE NOTES RELATING TO REGISTRATION SCHEMES OPERATED
BY ACCREDITED CERTIFICATION BODIES FOR THE CHEMICAL AND
ALLIED INDUSTRIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
B ‘RULES OF REGISTRATION’ UNDER WHICH REGISTRATION OF A
FIRM’S COMPLETE BUSINESS ACTIVITY MAY OCCUR . . . . . . . . . . . . . . . . . . . . 19
C CHECKLIST FOR CONSUMERS AGAINST A SUPPLIER’S CLAIM OF
‘REGISTRATION AGAINST AS 3901, AS 3902 OR AS 3903’ . . . . . . . . . . . . . . . . . . 20
 AS 3905.1—1991 4

FOREWORD

These Guidelines are intended to be used by a company in the role of a supplier as an aid to the
interpretation of the requirements of AS 3901 for the chemical and allied industries. Where AS 3901 is
referenced in this document it implies ISO 9001 and NZS 9001. AS 3901 includes AS 3902/NZS 9002/ISO
9002 and AS 3903/NZS 9003/ISO 9003. In these Guidelines, supplier and company are synonymous.
It is suggested that these Guidelines may also be used, with few alterations, for other process industries.
This edition addresses AS 3901 (which includes all the requirements of AS 3902 and AS 3903), though
AS 3902 remains the Standard most suited to the majority of chemical industry businesses when
manufacturing rather than development is the main focus.
Attention is drawn to AS 3904.1/NZS 9004.1/ISO 9004 which is a general guide to quality management
and quality system elements, although no guidance specific to the chemical and allied industries is given.
This gives guidance to the application of AS 3901, AS 3902 and AS 3903. Such guidance will not be
specific to any particular industrial sector, whereas these Guidelines are particular to the chemical and
allied industries.
The requirements relating to health, safety and environment are limited to those under the heading of
Design Control (see Clause 4.4). However, since these have become an integral part of the operations, they
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should, of necessity, form part of all relevant procedures.

The requirements relating to product liability are limited to those under the heading of Design Control (see
Clause 4.4).
Where documents are part of a requirement, the electronic equivalent is acceptable.
In the appendices to this document, guidance is given in relation to the operation of third party registration
schemes. This information is intended for use as broad guidance only and reference should be made to the
appropriate certification body in individual circumstances.

DEFINITIONS
In addition to the definitions of ISO 8402–1986, the following definitions are useful in relation to the
chemical industry. Individual usage of the terms may differ from company to company but the definitions
listed are those used throughout these Guidelines.
Agent
A person or company appointed by a principal to sell product on a commission basis. An agent does not
have ownership of the product.
Batch
In a batch process, this is the quantity of finished chemical produced at one time. In a continuous or
semi-continuous process, it is not possible to define a batch in the above sense and consequently it is usual
to talk in terms of a lot (q.v.).
Certificate of analysis
A statement relating specifically to results of testing of a sample drawn from the material to be delivered.
It incorporates test results, the detail of which should be agreed between customer and supplier.
Certificates of analysis should be requested by the supplier for the quality system only where specific use
is to be made of the information—for example, in statistical examination of performance and in the
absence of any statistical control by the subcontractor.
It is appreciated that, with exports, firms are sometimes requested to provide certificates of analysis which,
for diverse reasons, cannot meet the above definitions.
Certificate of conformity
A statement of conformity to specification.
The provision of a certificate of conformity is not a requirement of the Standard although customers may
request suppliers to provide this document. See the guidance notes to Clauses 4.3 and 4.6.
A certificate of conformity does not imply that the actual material delivered has been tested but that all
the material from which the delivery has been made up has, at some stage, been inspected and tested
according to the requirements of the established quality system and found to conform to specification.
Consignment stock
A quantity of product owned by the supplier but kept in the customer’s store for that customer’s specific
use and the ownership is transferred when used. Consignment stock may be either packed or bulk product.
Design
In the chemical industry, the term ‘design’ includes all the operations that are normally included in
research and development activities where these include the development of both products and processes.
 5 AS 3905.1—1991

Distributor
One who is formally appointed by a principal to buy, stock and re-sell all or part of the principal’s product
range, e.g. within defined geographical areas, use sectors and load size limitation for delivery. The
principal may be an Australian or non-Australian manufacturer, may supply in part, purchase for resale
product (PFR q.v.) and may also have his own direct sales organization in Australia with whom a close
liaison will exist. A distributor takes ownership of the product in contrast to an agent (q.v.) who does not.
Lot
The quantity of chemical from which a representative sample is available, for example, a quantity of
chemical drummed off or packed out from bulk tank or silo storage.
Process
Any operation which intentionally changes the performance, chemical nature, physical form or composition
of the raw materials.
Purchase for resale (PFR)
A situation where finished product has been purchased by the principal, with a view to re-selling under
the principal’s own label. Purchase for resale product is often abbreviated to the phase ‘PFR product’. Two
circumstances for PFR product are recognized:
(a) Where there is no manufacturing capacity.
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(b) Where the principal is covering shortfalls in capacity, peak demands, plant shutdowns, emergencies,
etc.
PFR product may exist as—
(i) product delivered to the principal in drums or bags, etc.
(ii) product delivered to the principal in bulk for tanks or silos, etc.
In PFR the principal is acting as a trader (q.v.).
Principal
For the purpose of these guidance notes, the principal is the supplier, i.e. the organization using the quality
system.
Trader
One who purchases product from a variety of sources and sells under his or her own name usually without
acknowledgement of the source. Where the principal is supplying product to a trader, that trader should
be regarded as a customer within the chemical industry.
Specification
A precise statement, or set of requirements (quantities, characteristics or properties) to be satisfied by a
material, process or product with an indication of the test methods used.
Subcontractor
Any supplier of goods or services; includes everything, for example, from a raw materials supplier to a
toll manufacturer, test laboratory, haulier, or shipping agent.
Swap deal
A situation where one firm accepts an order (see Clause 4.3) for a product and then arranges that another
firm should supply and deliver against that order. Such deals may also be referred to as product exchange
deals.
Where the product source is disclosed to the customer, the principal is, in fact, acting as a
distributor (q.v.). However, when the product source is not disclosed the principal should be regarded as
a trader (q.v.). A company can act in both capacities.
Toll manufacturer
A subcontractor who undertakes a prescribed part of the manufacturing process.
 AS 3905.1—1991 6

STANDARDS AUSTRALIA

Australian Standard
Quality system guidelines

Part 1: Guidelines to AS 3901/NZS 9001/ISO 9001 for the chemical

and allied industries

TITLE OF AS 3901
QUALITY SYSTEMS FOR DESIGN/DEVELOPMENT, PRODUCTION, INSTALLATION AND
SERVICING
NOTE: The tit le of the ISO Standard is—
QUALITY SYSTEMS—MODEL FOR QUALITY ASSURANCE IN DESIGN/ DEVELOPMENT, PRODUCTION, INSTALLATION
AND SERVICING
Guidance:
The term ‘production’ is recognized as embracing all the elements of chemical production, including
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mixing, blending, refining and various intermediate processes such as distillation, fractionation,
crystallization, etc. The term ‘installation’ should be read as ‘supply’.

0 INTRODUCTION
Guidance:
The introduction serves all three Standards, AS 3901, AS 3902 and AS 3903 and is identical in each. As
already seen above, some reinterpretation is necessary to make the titles appropriate for the chemical
industry. Thus ‘design/development’ should be read to mean ‘research, new product development and
existing product enhancement’. Without this change, AS 3901 could be used only for a quality system for
manufacture, etc. of chemical plant which is not the objective of these Guidelines.

1 SCOPE AND FIELD OF APPLICATION

1.1 Scope
Guidance:
In the chemical industry, references to the supplier’s capability to design should be taken as a capability
to carry out research and/or develop a product to comply with agreed specifications.
1.2 Field of application
Guidance:
In (a) reference to design should be taken as referring to the conduct of research and/or product
development. In (b) the word ‘installation’ may appropriately be read as ‘supply’.
NOTE: In a simil ar Clause in AS 3902, reference to ‘design’ in (a) has been deleted.

2 REFERENCES
Only two references are cited and these require no guidance.

3 DEFINITIONS
Guidance:
In addition to the definitions of ISO 8402, the definitions in the Foreword of these Guidelines are useful
in relation to the chemical industry. Individual usage of the terms may differ from company to company
but the definitions listed are those used throughout these Guidelines.

4 THE ELEMENTS OF THE STANDARD

4.1 Management responsibility
4.1.1 Quality policy
Guidance:
The company’s senior management needs to produce a quality policy statement which should be signed
by the most senior executive then distributed and explained to all employees. It is the management’s
responsibility to ensure that the implications of this policy are communicated and understood, and the
policy updated as appropriate, to meet organizational changes.

COPYRIGHT
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AS 3905.1-1991, Quality system guidelines

Guidelines to AS 3901/NZS 9001/ISO 9001 for
chemical and allied industries
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