ISO 19301:2020
(Main)Graphic technology — Guidelines for schema writers — Template for colour quality management
Graphic technology — Guidelines for schema writers — Template for colour quality management
This document provides a framework that organisations can follow, and that can be used as the structure for market or sector specific schemes. It is intended to be a process certification. The goal of this document is to have comparable attestations or certifications worldwide.
Titre manque
Grafična tehnologija - Smernice za oblikovanje (certifikacijskih) shem - Predloga za vodenje barvne kakovosti
Ta dokument podaja okvir, ki mu lahko organizacije sledijo in ga je mogoče uporabiti kot strukturo za sheme trženja ali sheme posameznih sektorjev. Namenjen je potrjevanju procesa.
Cilj tega dokumenta je primerljivo potrjevanje oziroma certificiranje po vsem svetu.
General Information
Relations
Buy Standard
Standards Content (Sample)
SLOVENSKI STANDARD
SIST ISO 19301:2022
01-oktober-2022
Grafična tehnologija - Smernice za oblikovanje (certifikacijskih) shem - Predloga
za vodenje barvne kakovosti
Graphic technology - Guidelines for schema writers - Template for colour quality
management
Titre manque
Ta slovenski standard je istoveten z: ISO 19301:2020
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
37.100.01 Grafična tehnologija na Graphic technology in
splošno general
SIST ISO 19301:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST ISO 19301:2022
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SIST ISO 19301:2022
INTERNATIONAL ISO
STANDARD 19301
First edition
2020-03
Graphic technology — Guidelines for
schema writers — Template for colour
quality management
Reference number
ISO 19301:2020(E)
©
ISO 2020
---------------------- Page: 3 ----------------------
SIST ISO 19301:2022
ISO 19301:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
SIST ISO 19301:2022
ISO 19301:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Template for requirements of colour quality and production management system
of the organization . 2
4.1 General . 2
4.2 Colour quality and production management system requirements . 2
4.3 Additional requirements . 3
4.4 Print(s) being in accordance and certification claims . 4
4.4.1 Claims of conformity . 4
4.4.2 Certification marks . 4
4.5 Outsourced printing . 4
4.6 Colour quality policy . 5
4.7 Colour champion . 5
4.8 Press and digital output device maintenance . 5
4.9 Purchasing . 7
4.9.1 Purchasing of consumables . 7
4.9.2 Selection and purchase of measuring equipment . 7
4.10 Identification and traceability . 7
4.10.1 Identification and records . 7
4.10.2 Proof verification . 7
4.10.3 Control of measuring equipment . 7
4.10.4 Measuring equipment . 7
4.10.5 Maintenance activity . 7
4.10.6 Records of measuring equipment . 8
4.10.7 Monitoring accuracy of equipment . 8
4.10.8 Fitness for purpose of computer software . 8
4.11 Customer complaints . 8
4.12 Internal audit . 8
4.13 Monitoring and measurement of the product . 8
4.13.1 Evidence of product conformity . 8
4.13.2 Dry back. 9
4.14 Provision of infrastructure . 9
4.15 Monitoring and measurement of process . 9
4.16 Competence, training and awareness . 9
4.16.1 Knowledge of ICC profiles . 9
4.16.2 Colour champion . . 9
5 Template for requirements of demonstration of product conformity .10
5.1 Certification body product test .10
5.2 Product conformity in day-to-day production .10
5.3 Declaration of product conformity method .10
5.4 Sampling requirements: day-to-day production.11
5.4.1 Defining the sampling regime .11
5.4.2 Sampling.11
5.4.3 Reporting .11
5.4.4 Test print . .12
6 Certification for accredited bodies .13
6.1 General .13
6.2 Accreditations .13
6.3 Certification body competences .13
© ISO 2020 – All rights reserved iii
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SIST ISO 19301:2022
ISO 19301:2020(E)
6.3.1 General.13
6.3.2 Auditor competence .13
6.3.3 Technical expert competence .13
6.3.4 Reviewer competence .14
6.4 Audit time and frequency .14
6.5 Audit product test .14
6.5.1 Suitable test form .14
6.5.2 Certification body’s auditor .14
6.5.3 Retention of the test samples .14
6.5.4 Conformity with the THE REFERENCED STANDARD .14
6.5.5 Requirements of the sample .14
6.6 Requirements for the provision of information to customers .15
Bibliography .16
iv © ISO 2020 – All rights reserved
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SIST ISO 19301:2022
ISO 19301:2020(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 130, Graphic technology.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2020 – All rights reserved v
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SIST ISO 19301:2022
ISO 19301:2020(E)
Introduction
This document specifies requirements for certification schemes for certifying the production of printed
products. Quality and repeatability are ensured by applying total quality control according to ISO 9001
as the overarching method, coupled with print specific ISO standards.
A certification can be centred around any ISO standard related to print production. It will therefore
use the term THE REFERENCED STANDARD as a pointer to the actual standard that is referenced in
the certification scheme. Digital presses that can match an output condition of THE REFERENCED
STANDARD are also intended to be included for certification.
While this scheme assumes familiarity and adoption of a quality management systems based on the
requirements of ISO 9001, it doesn’t intend to assess or audit an organization’s conformity to a complete
implementation of ISO 9001.
The use of this document should make it easier to compare certifications worldwide.
A scheme developed according to this document can be validated by accreditation organisations to
produce verifiable results.
In this document:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.
vi © ISO 2020 – All rights reserved
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SIST ISO 19301:2022
INTERNATIONAL STANDARD ISO 19301:2020(E)
Graphic technology — Guidelines for schema writers —
Template for colour quality management
1 Scope
This document provides a framework that organisations can follow, and that can be used as the
structure for market or sector specific schemes. It is intended to be a process certification.
The goal of this document is to have comparable attestations or certifications worldwide.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 3664, Graphic technology and photography — Viewing conditions
ISO 12646, Graphic technology — Displays for colour proofing — Characteristics
ISO 13655, Graphic technology — Spectral measurement and colorimetric computation for graphic
arts images
ISO/IEC 17011, Conformity assessment — Requirements for accreditation bodies accrediting conformity
assessment bodies
ISO/IEC 17065, Conformity assessment — Requirements for bodies certifying products, processes and
services
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
product
final output (printed matter) supplied to the customer
Note 1 to entry: In the context of an attestation or certification this means that the emphasis is on a specific
compliant print production process, and not on the organisation as such.
3.2
colour quality and production management system
range of processes, including those of a quality management system, as outlined in this document, which
are required to consistently produce printed products compliant with ISO colour quality standards
3.3
accredited body
authoritative body that performs accreditation
Note 1 to entry: The authority of an accreditation body is generally derived from government.
© ISO 2020 – All rights reserved 1
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SIST ISO 19301:2022
ISO 19301:2020(E)
3.4
certification
third party attestation related to products, processes, systems, or persons
[SOURCE: ISO/IEC 17000:2004, 5.5]
4 Template for requirements of colour quality and production management
system of the organization
4.1 General
To achieve and maintain certification, the organization shall be in accordance with the requirements of
this scheme.
4.2 Colour quality and production management system requirements
Requirements for the colour quality and production management system are as specified in ISO 9001,
but with a scope specified for the colour quality system.
The scope shall be defined according the following:
— Tone and colour reproduction to < THE REFERENCED STANDARD > : < PRODUCTION METHOD(s),
(as applicable); , (as applicable); < CUSTOMISED PRINTING CONDITION > , (as and if
applicable).
— Outsourced tone and colour reproduction to < THE REFERENCED STANDARD > : < PRODUCTION
METHOD(s) > , (as applicable); , (as applicable) < CUSTOMISED PRINTING CONDITION > ,
(as and if applicable).
Any change to the scope of the certification shall be agreed to by the certification body.
Site locations of the certified organization shall be defined within the scope. Site locations can only be
included if the colour quality system applies at a particular site to be included, and an audit product test
has been successfully conducted at that site.
Processes which can be included in the scope of the certification are the following:
— pre-press, proofing and PDF file submission to an agreed printing conditions;
— press* only, including plate calibration and TVI curves;
— proofing and press*, including plate calibration and TVI curves;
— pre-press, proofing and press*;
— outsourced printing in any of the above categories.
Organisations are deemed to provide pre-press services when some or all of the following activities are
undertaken by the organization itself.
— Process and correct and/or colour manage clients application files.
— Process, colour manage and/or retouch images.
— Pre-flight and correct and/or colour manage PDF or other file formats.
— Scan analogue colour originals, if required.
*A press for the purposes of this scheme is any conventional printing device or printing press covered
by THE REFERENCED STANDARD and digital printing devices outputting to THE REFERENCED
STANDARD conditions. For presses with other TVI, or no TVI, than assumed by this document, for
2 © ISO 2020 – All rights reserved
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SIST ISO 19301:2022
ISO 19301:2020(E)
example digital presses, adjustments to or simulation of the expected TVI in this document shall be
implemented to ensure that the tone levels are reproduced in the same way.
Compliant product claims
Certified organisations shall only make compliant claims relating to specific printed products, via
invoices and delivery notes, and other product specific documents, to customers, where it is documented
that those products meet the requirements of the certification scheme, and when the organization has
an existing valid accredited certification under this scheme at the time of production.
Organisations shall not claim to be in accordance to THE REFERENCED STANDARD, other than in
relation to a specific printed product.
Customised printing
Customised printing conditions involving the use of non-THE REFERENCED STANDARD or amended
THE REFERENCED STANDARD colour data sets and profiles including digital printing.
It is recognized that there are cases of customer requirements, including non- standard papers,
processes including digital printing, papers, boards and other substrates, inks, etc. may require the use
of printing conditions and ICC profiles which are not covered within THE REFERENCED STANDARD
colour quality standards.
A customised printing condition is defined as: A printing condition that uses a combination of substrates,
inks and printing methods that are not referenced by current THE REFERENCED STANDARD standard
printing conditions.
In this case, any printing company can be certified to these customised printing conditions by
demonstrating that the same controls, systems, policies and measurement tolerances required by this
scheme and the associated ISO standards are adhered to, where it is demonstrated that it is possible
and appropriate to do so. Any proposed certification for a customised printing condition, and relevant
aim values, shall be agreed by the printer seeking certification in advance with the certifying body for
this certification scheme.
4.3 Additional requirements
In addition to the requirements of 5.1, the organization shall:
a) maintain records needed to provide evidence that individual printed products meet the referenced
ISO colour quality standard requirements;
b) where appropriate, ensure adequate control over outsourced printing processes through
identification and use of suppliers with valid certification through this scheme, when printing
products intended to be compliant with the requirements of this scheme and THE REFERENCED
STANDARD;
c) determine if the customer requires a product to be printed in accordance with a specific ISO
standard and that the organization is capable of producing a complaint product (e.g. the printed
matter) according to this standard. Where product requirements are such that the organization
cannot meet the requirements of THE REFERENCED STANDARD, this shall be communicated and
explained to the customer prior to order acceptance;
d) determine and implement effective methods for communicating with customers and suppliers in
relation to:
— acceptability of artwork and/or proofs supplied (for example by providing artwork guides and
references to referenced standards), and
— printed product being in accordance claims on delivery notes, invoices and other customer
related documentation.
© ISO 2020 – All rights reserved 3
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SIST ISO 19301:2022
ISO 19301:2020(E)
e) ensure that only authorized and competent personnel have access to systems and files, and that
only authorized users are able to access and manipulate data files. All changes to data files should
be documented and fully attributed to those making the changes;
f) ensure the provision and maintenance of necessary and appropriate controlled lighting conditions,
and access to and use of appropriate colour measuring equipment and software.
4.4 Print(s) being in accordance and certification claims
4.4.1 Claims of conformity
Where the printed matter is claimed to be in accordance with THE REFERENCED STANDARD as defined
by this scheme, the organization can make a claim to the customer, and if so, then shall use only the
following wording:
“this print is in compliance (accredited certification: certification body name;
certificate number)”*
The wording shall be legible and shall be used on invoices, delivery notes, quotations, and other customer
related documentation, and will distinguish between compliant products and others identified on the
documentation.
*in this example the language is English, but this can of course be in the local language.
4.4.2 Certification marks
The organization may make use of the relevant marks and logos supplied by the certification body as
proof of being certified, but only in the way specified by that body.
Claims regarding certification shall only be made in terms that state that:
— the certified organization is capable of consistently printing to meet the requirements of THE
REFERENCED STANDARD (s).
— the certified organization operates a colour quality and production management system, to ensure
that, where required, products are compliant with THE REFERENCED STANDARD(s).
4.5 Outsourced printing
For organisations which outsource the printing of a product(s) and intend to claim that the print(s) are
in accordance, there shall be assurance of that printed matter being in accordance. The organization
shall ensure that:
— a procedure for ensuring the accurate identification of the validity of the certification of the
outsourced supplier is documented and implemented;
— the organization providing the printed product has a valid, accredited and current certification to
THE REFERENCED STANDARD under this scheme and for the relevant printing process at the time
of production;
— records are kept of the validation of the certification of the relevant outsourced suppliers;
— other relevant scheme requirements are met.
4 © ISO 2020 – All rights reserved
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SIST ISO 19301:2022
ISO 19301:2020(E)
4.6 Colour quality policy
The colour quality policy represents the quality policy as far as the colour quality system is concerned.
Senior management shall ensure that the colour quality policy covers, where applicable:
— the ISO standards, and methods of production, within the scope of the certification and the method
of demonstrating to be in accordance;
— the development and maintenance of the competence of all personnel within the scope of the colour
quality and production management system;
— the provision of the necessary infrastructure and equipment necessary for the production of
compliant products and the review of the capabilities of such infrastructure and equipment in the
light of technological and other changes;
— the method for external publication of the Colour quality policy to interested parties.
4.7 Colour champion
The organization shall ensure that there is a colour champion, or equivalent, who fulfils the role of
management representative in relation to the colour quality system, appointed with authority to
manage, monitor, evaluate and coordinate the colour quality and production management system.
The colour champion may also be the organization’s management representative, but shall have
responsibility and authority which includes:
— ensuring that processes needed for t
...
INTERNATIONAL ISO
STANDARD 19301
First edition
2020-03
Graphic technology — Guidelines for
schema writers — Template for colour
quality management
Reference number
ISO 19301:2020(E)
©
ISO 2020
---------------------- Page: 1 ----------------------
ISO 19301:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 19301:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Template for requirements of colour quality and production management system
of the organization . 2
4.1 General . 2
4.2 Colour quality and production management system requirements . 2
4.3 Additional requirements . 3
4.4 Print(s) being in accordance and certification claims . 4
4.4.1 Claims of conformity . 4
4.4.2 Certification marks . 4
4.5 Outsourced printing . 4
4.6 Colour quality policy . 5
4.7 Colour champion . 5
4.8 Press and digital output device maintenance . 5
4.9 Purchasing . 7
4.9.1 Purchasing of consumables . 7
4.9.2 Selection and purchase of measuring equipment . 7
4.10 Identification and traceability . 7
4.10.1 Identification and records . 7
4.10.2 Proof verification . 7
4.10.3 Control of measuring equipment . 7
4.10.4 Measuring equipment . 7
4.10.5 Maintenance activity . 7
4.10.6 Records of measuring equipment . 8
4.10.7 Monitoring accuracy of equipment . 8
4.10.8 Fitness for purpose of computer software . 8
4.11 Customer complaints . 8
4.12 Internal audit . 8
4.13 Monitoring and measurement of the product . 8
4.13.1 Evidence of product conformity . 8
4.13.2 Dry back. 9
4.14 Provision of infrastructure . 9
4.15 Monitoring and measurement of process . 9
4.16 Competence, training and awareness . 9
4.16.1 Knowledge of ICC profiles . 9
4.16.2 Colour champion . . 9
5 Template for requirements of demonstration of product conformity .10
5.1 Certification body product test .10
5.2 Product conformity in day-to-day production .10
5.3 Declaration of product conformity method .10
5.4 Sampling requirements: day-to-day production.11
5.4.1 Defining the sampling regime .11
5.4.2 Sampling.11
5.4.3 Reporting .11
5.4.4 Test print . .12
6 Certification for accredited bodies .13
6.1 General .13
6.2 Accreditations .13
6.3 Certification body competences .13
© ISO 2020 – All rights reserved iii
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ISO 19301:2020(E)
6.3.1 General.13
6.3.2 Auditor competence .13
6.3.3 Technical expert competence .13
6.3.4 Reviewer competence .14
6.4 Audit time and frequency .14
6.5 Audit product test .14
6.5.1 Suitable test form .14
6.5.2 Certification body’s auditor .14
6.5.3 Retention of the test samples .14
6.5.4 Conformity with the THE REFERENCED STANDARD .14
6.5.5 Requirements of the sample .14
6.6 Requirements for the provision of information to customers .15
Bibliography .16
iv © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 19301:2020(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 130, Graphic technology.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2020 – All rights reserved v
---------------------- Page: 5 ----------------------
ISO 19301:2020(E)
Introduction
This document specifies requirements for certification schemes for certifying the production of printed
products. Quality and repeatability are ensured by applying total quality control according to ISO 9001
as the overarching method, coupled with print specific ISO standards.
A certification can be centred around any ISO standard related to print production. It will therefore
use the term THE REFERENCED STANDARD as a pointer to the actual standard that is referenced in
the certification scheme. Digital presses that can match an output condition of THE REFERENCED
STANDARD are also intended to be included for certification.
While this scheme assumes familiarity and adoption of a quality management systems based on the
requirements of ISO 9001, it doesn’t intend to assess or audit an organization’s conformity to a complete
implementation of ISO 9001.
The use of this document should make it easier to compare certifications worldwide.
A scheme developed according to this document can be validated by accreditation organisations to
produce verifiable results.
In this document:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.
vi © ISO 2020 – All rights reserved
---------------------- Page: 6 ----------------------
INTERNATIONAL STANDARD ISO 19301:2020(E)
Graphic technology — Guidelines for schema writers —
Template for colour quality management
1 Scope
This document provides a framework that organisations can follow, and that can be used as the
structure for market or sector specific schemes. It is intended to be a process certification.
The goal of this document is to have comparable attestations or certifications worldwide.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 3664, Graphic technology and photography — Viewing conditions
ISO 12646, Graphic technology — Displays for colour proofing — Characteristics
ISO 13655, Graphic technology — Spectral measurement and colorimetric computation for graphic
arts images
ISO/IEC 17011, Conformity assessment — Requirements for accreditation bodies accrediting conformity
assessment bodies
ISO/IEC 17065, Conformity assessment — Requirements for bodies certifying products, processes and
services
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
product
final output (printed matter) supplied to the customer
Note 1 to entry: In the context of an attestation or certification this means that the emphasis is on a specific
compliant print production process, and not on the organisation as such.
3.2
colour quality and production management system
range of processes, including those of a quality management system, as outlined in this document, which
are required to consistently produce printed products compliant with ISO colour quality standards
3.3
accredited body
authoritative body that performs accreditation
Note 1 to entry: The authority of an accreditation body is generally derived from government.
© ISO 2020 – All rights reserved 1
---------------------- Page: 7 ----------------------
ISO 19301:2020(E)
3.4
certification
third party attestation related to products, processes, systems, or persons
[SOURCE: ISO/IEC 17000:2004, 5.5]
4 Template for requirements of colour quality and production management
system of the organization
4.1 General
To achieve and maintain certification, the organization shall be in accordance with the requirements of
this scheme.
4.2 Colour quality and production management system requirements
Requirements for the colour quality and production management system are as specified in ISO 9001,
but with a scope specified for the colour quality system.
The scope shall be defined according the following:
— Tone and colour reproduction to < THE REFERENCED STANDARD > : < PRODUCTION METHOD(s),
(as applicable); , (as applicable); < CUSTOMISED PRINTING CONDITION > , (as and if
applicable).
— Outsourced tone and colour reproduction to < THE REFERENCED STANDARD > : < PRODUCTION
METHOD(s) > , (as applicable); , (as applicable) < CUSTOMISED PRINTING CONDITION > ,
(as and if applicable).
Any change to the scope of the certification shall be agreed to by the certification body.
Site locations of the certified organization shall be defined within the scope. Site locations can only be
included if the colour quality system applies at a particular site to be included, and an audit product test
has been successfully conducted at that site.
Processes which can be included in the scope of the certification are the following:
— pre-press, proofing and PDF file submission to an agreed printing conditions;
— press* only, including plate calibration and TVI curves;
— proofing and press*, including plate calibration and TVI curves;
— pre-press, proofing and press*;
— outsourced printing in any of the above categories.
Organisations are deemed to provide pre-press services when some or all of the following activities are
undertaken by the organization itself.
— Process and correct and/or colour manage clients application files.
— Process, colour manage and/or retouch images.
— Pre-flight and correct and/or colour manage PDF or other file formats.
— Scan analogue colour originals, if required.
*A press for the purposes of this scheme is any conventional printing device or printing press covered
by THE REFERENCED STANDARD and digital printing devices outputting to THE REFERENCED
STANDARD conditions. For presses with other TVI, or no TVI, than assumed by this document, for
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ISO 19301:2020(E)
example digital presses, adjustments to or simulation of the expected TVI in this document shall be
implemented to ensure that the tone levels are reproduced in the same way.
Compliant product claims
Certified organisations shall only make compliant claims relating to specific printed products, via
invoices and delivery notes, and other product specific documents, to customers, where it is documented
that those products meet the requirements of the certification scheme, and when the organization has
an existing valid accredited certification under this scheme at the time of production.
Organisations shall not claim to be in accordance to THE REFERENCED STANDARD, other than in
relation to a specific printed product.
Customised printing
Customised printing conditions involving the use of non-THE REFERENCED STANDARD or amended
THE REFERENCED STANDARD colour data sets and profiles including digital printing.
It is recognized that there are cases of customer requirements, including non- standard papers,
processes including digital printing, papers, boards and other substrates, inks, etc. may require the use
of printing conditions and ICC profiles which are not covered within THE REFERENCED STANDARD
colour quality standards.
A customised printing condition is defined as: A printing condition that uses a combination of substrates,
inks and printing methods that are not referenced by current THE REFERENCED STANDARD standard
printing conditions.
In this case, any printing company can be certified to these customised printing conditions by
demonstrating that the same controls, systems, policies and measurement tolerances required by this
scheme and the associated ISO standards are adhered to, where it is demonstrated that it is possible
and appropriate to do so. Any proposed certification for a customised printing condition, and relevant
aim values, shall be agreed by the printer seeking certification in advance with the certifying body for
this certification scheme.
4.3 Additional requirements
In addition to the requirements of 5.1, the organization shall:
a) maintain records needed to provide evidence that individual printed products meet the referenced
ISO colour quality standard requirements;
b) where appropriate, ensure adequate control over outsourced printing processes through
identification and use of suppliers with valid certification through this scheme, when printing
products intended to be compliant with the requirements of this scheme and THE REFERENCED
STANDARD;
c) determine if the customer requires a product to be printed in accordance with a specific ISO
standard and that the organization is capable of producing a complaint product (e.g. the printed
matter) according to this standard. Where product requirements are such that the organization
cannot meet the requirements of THE REFERENCED STANDARD, this shall be communicated and
explained to the customer prior to order acceptance;
d) determine and implement effective methods for communicating with customers and suppliers in
relation to:
— acceptability of artwork and/or proofs supplied (for example by providing artwork guides and
references to referenced standards), and
— printed product being in accordance claims on delivery notes, invoices and other customer
related documentation.
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ISO 19301:2020(E)
e) ensure that only authorized and competent personnel have access to systems and files, and that
only authorized users are able to access and manipulate data files. All changes to data files should
be documented and fully attributed to those making the changes;
f) ensure the provision and maintenance of necessary and appropriate controlled lighting conditions,
and access to and use of appropriate colour measuring equipment and software.
4.4 Print(s) being in accordance and certification claims
4.4.1 Claims of conformity
Where the printed matter is claimed to be in accordance with THE REFERENCED STANDARD as defined
by this scheme, the organization can make a claim to the customer, and if so, then shall use only the
following wording:
“this print is in compliance (accredited certification: certification body name;
certificate number)”*
The wording shall be legible and shall be used on invoices, delivery notes, quotations, and other customer
related documentation, and will distinguish between compliant products and others identified on the
documentation.
*in this example the language is English, but this can of course be in the local language.
4.4.2 Certification marks
The organization may make use of the relevant marks and logos supplied by the certification body as
proof of being certified, but only in the way specified by that body.
Claims regarding certification shall only be made in terms that state that:
— the certified organization is capable of consistently printing to meet the requirements of THE
REFERENCED STANDARD (s).
— the certified organization operates a colour quality and production management system, to ensure
that, where required, products are compliant with THE REFERENCED STANDARD(s).
4.5 Outsourced printing
For organisations which outsource the printing of a product(s) and intend to claim that the print(s) are
in accordance, there shall be assurance of that printed matter being in accordance. The organization
shall ensure that:
— a procedure for ensuring the accurate identification of the validity of the certification of the
outsourced supplier is documented and implemented;
— the organization providing the printed product has a valid, accredited and current certification to
THE REFERENCED STANDARD under this scheme and for the relevant printing process at the time
of production;
— records are kept of the validation of the certification of the relevant outsourced suppliers;
— other relevant scheme requirements are met.
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ISO 19301:2020(E)
4.6 Colour quality policy
The colour quality policy represents the quality policy as far as the colour quality system is concerned.
Senior management shall ensure that the colour quality policy covers, where applicable:
— the ISO standards, and methods of production, within the scope of the certification and the method
of demonstrating to be in accordance;
— the development and maintenance of the competence of all personnel within the scope of the colour
quality and production management system;
— the provision of the necessary infrastructure and equipment necessary for the production of
compliant products and the review of the capabilities of such infrastructure and equipment in the
light of technological and other changes;
— the method for external publication of the Colour quality policy to interested parties.
4.7 Colour champion
The organization shall ensure that there is a colour champion, or equivalent, who fulfils the role of
management representative in relation to the colour quality system, appointed with authority to
manage, monitor, evaluate and coordinate the colour quality and production management system.
The colour champion may also be the organization’s management representative, but shall have
responsibility and authority which includes:
— ensuring that processes needed for the colour quality system are established, implemented and
maintained,
— periodic reporting to senior management on the performance of the colour quality system and any
need for improvement or additional resources,
— ensuring the promotion of awareness of the requirements of THE REFERENCED STANDARD through
the organization
— ensuring that necessary training is provided and adequately resourced, keeping up to date with
technology and market developments which can have an impact upon the effectiveness or currency
of the organization’s methodologies to be in accordance;
— advising senior management of developments relevant to being in accordance, or to improving
working methods,
— maintaining contact with production and customer services (or equivalent) staff in order to monitor
customer relations, and
— making recommendations for customer communications to help customers improve the quality of
data files delivered for compliant production workflows.
4.8 Press and digital output device maintenance
The orga
...
SLOVENSKI STANDARD
kSIST ISO/FDIS 19301:2020
01-januar-2020
Grafična tehnologija - Smernice za oblikovanje (certifikacijskih) shem - Predloga
za vodenje barvne kakovosti
Graphic technology - Guidelines for schema writers - Template for colour quality
management
Ta slovenski standard je istoveten z: ISO/FDIS 19301:2019
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
37.100.01 Grafična tehnologija na Graphic technology in
splošno general
kSIST ISO/FDIS 19301:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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kSIST ISO/FDIS 19301:2020
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kSIST ISO/FDIS 19301:2020
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 19301
ISO/TC 130
Graphic technology — Guidelines for
Secretariat: SAC
schema writers — Template for colour
Voting begins on:
20191125 quality management
Voting terminates on:
20200120
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/FDIS 19301:2019(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. ISO 2019
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kSIST ISO/FDIS 19301:2020
ISO/FDIS 19301:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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kSIST ISO/FDIS 19301:2020
ISO/FDIS 19301:2019(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements for organization . 2
4.1 General . 2
4.2 Colour quality and production management system requirements . 2
4.3 Additional requirements . 3
4.4 Print(s) being in accordance and certification claims . 4
4.4.1 Claims of conformity . 4
4.4.2 Certification marks . 4
4.5 Outsourced printing . 4
4.6 Colour quality policy . 5
4.7 Colour champion . 5
4.8 Press and digital output device maintenance . 5
4.9 Purchasing . 7
4.9.1 Purchasing of consumables . 7
4.9.2 Selection and purchase of measuring equipment . 7
4.10 Identification and traceability . 7
4.10.1 Identification and records . 7
4.10.2 Proof verification . 7
4.10.3 Control of measuring equipment . 7
4.10.4 Measuring equipment . 7
4.10.5 Maintenance activity . 7
4.10.6 Records of measuring equipment . 8
4.10.7 Monitoring accuracy of equipment . 8
4.10.8 Fitness for purpose of computer software . 8
4.11 Customer complaints . 8
4.12 Internal audit . 8
4.13 Monitoring and measurement of the product . 8
4.13.1 Evidence of product conformity . 8
4.13.2 Dry back. 9
4.14 Provision of infrastructure . 9
4.15 Monitoring and measurement of process . 9
4.16 Competence, training and awareness . 9
4.16.1 Knowledge of ICC profiles . 9
4.16.2 Colour champion . . 9
5 Demonstration of product conformity .10
5.1 Certification body product test .10
5.2 Product conformity in day-to-day production .10
5.3 Declaration of product conformity method .10
5.4 Sampling requirements: day-to-day production.11
5.4.1 Defining the sampling regime .11
5.4.2 Sampling.11
5.4.3 Reporting .11
5.4.4 Test print . .12
6 Certification requirements .13
6.1 General .13
6.2 Accreditations .13
6.3 Certification body competences .13
6.3.1 General.13
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6.3.2 Auditor competence .13
6.3.3 Technical expert competence .13
6.3.4 Reviewer competence .13
6.4 Audit time and frequency .14
6.5 Audit product test .14
6.5.1 Suitable test form .14
6.5.2 Certification body’s auditor .14
6.5.3 Retention of the test samples .14
6.5.4 Conformity with the THE REFERENCED STANDARD .14
6.5.5 Requirements of the sample .14
6.6 Requirements for the provision of information to customers .15
Bibliography .16
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kSIST ISO/FDIS 19301:2020
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 130, Graphic technology.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
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kSIST ISO/FDIS 19301:2020
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Introduction
This document specifies requirements for certification schemes for certifying the production of printed
products. Quality and repeatability are ensured by applying total quality control according to ISO 9001
as the overarching method, coupled with print specific ISO standards.
A certification can be centred around any ISO standard related to print production. It will therefore
use the term THE REFERENCED STANDARD as a pointer to the actual standard that is referenced in
the certification scheme. Digital presses that can match an output condition of THE REFERENCED
STANDARD are also intended to be included for certification.
While this scheme assumes familiarity and adoption of a quality management systems based on the
requirements of ISO 9001, it doesn’t intend to assess or audit an organization’s conformity to a complete
implementation of ISO 9001.
The use of this document should make it easier to compare certifications worldwide.
A scheme developed according to this document can be validated by accreditation organisations to
produce verifiable results.
In this document:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.
vi © ISO 2019 – All rights reserved
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kSIST ISO/FDIS 19301:2020
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 19301:2019(E)
Graphic technology — Guidelines for schema writers —
Template for colour quality management
1 Scope
This document provides a framework that organisations can follow, and that can be used as the
structure for market or sector specific schemes. It is intended to be a process certification.
The goal of this document is to have comparable attestations or certifications worldwide.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 3664, Graphic technology and photography — Viewing conditions
ISO 12646, Graphic technology — Displays for colour proofing — Characteristics
ISO 13655, Graphic technology — Spectral measurement and colorimetric computation for graphic
arts images
ISO/IEC 17011, Conformity assessment — Requirements for accreditation bodies accrediting conformity
assessment bodies
ISO/IEC 17065, Conformity assessment — Requirements for bodies certifying products, processes and
services
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
product
final output (printed matter) supplied to the customer
Note 1 to entry: In the context of an attestation or certification this means that the emphasis is on a specific
compliant print production process, and not on the organisation as such.
3.2
colour quality and production management system
range of processes, including those of a quality management system, as outlined in this document, which
are required to consistently produce printed products compliant with ISO colour quality standards
3.3
accredited body
authoritative body that performs accreditation
Note 1 to entry: The authority of an accreditation body is generally derived from government.
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3.4
certification
third party attestation related to products, processes, systems, or persons
[SOURCE: ISO 1700:2004, 5.5]
4 Requirements for organization
4.1 General
To achieve and maintain certification, the organization shall be in accordance with the requirements of
this scheme.
4.2 Colour quality and production management system requirements
Requirements for the colour quality and production management system are as specified in ISO 9001,
but with a scope specified for the colour quality system.
The scope shall be defined according the following:
— Tone and colour reproduction to < THE REFERENCED STANDARD > : < PRODUCTION METHOD(s),
(as applicable); , (as applicable); < CUSTOMISED PRINTING CONDITION > , (as and if
applicable).
— Outsourced tone and colour reproduction to < THE REFERENCED STANDARD > : < PRODUCTION
METHOD(s) > , (as applicable); , (as applicable) < CUSTOMISED PRINTING CONDITION > ,
(as and if applicable).
Any change to the scope of the certification shall be agreed to by the certification body.
Site locations of the certified organization shall be defined within the scope. Site locations can only be
included if the colour quality system applies at a particular site to be included, and an audit product test
has been successfully conducted at that site.
Processes which can be included in the scope of the certification are the following:
— pre-press, proofing and PDF file submission to an agreed printing conditions;
— press* only, including plate calibration and TVI curves;
— proofing and press*, including plate calibration and TVI curves;
— pre-press, proofing and press*;
— outsourced printing in any of the above categories.
Organisations are deemed to provide prepress services when some or all of the following activities are
undertaken by the organization itself.
— Process and correct and or colour manage clients╒ application files.
— Process, colour manage and/or retouch images.
— Pre-flight and correct and/or colour manage PDF or other file formats.
— Scan analogue colour originals, if required.
*A press for the purposes of this scheme is any conventional printing device or printing press covered
by THE REFERENCED STANDARD and digital printing devices outputting to THE REFERENCED
STANDARD conditions. For presses with other TVI, or no TVI, than assumed by this document, for
2 © ISO 2019 – All rights reserved
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kSIST ISO/FDIS 19301:2020
ISO/FDIS 19301:2019(E)
example digital presses, adjustments to or simulation of the expected TVI in this document shall be
implemented to ensure that the tone levels are reproduced in the same way.
Compliant product claims
Certified organisations shall only make compliant claims relating to specific printed products, via
invoices and delivery notes, and other product specific documents, to customers, where it is documented
that those products meet the requirements of the certification scheme, and when the organization has
an existing valid accredited certification under this scheme at the time of production.
Organisations shall not claim to be in accordance to THE REFERENCED STANDARD, other than in
relation to a specific printed product.
Customised printing
Customised printing conditions involving the use of nonTHE REFERENCED STANDARD or amended
THE REFERENCED STANDARD colour data sets and profiles including digital printing.
It is recognized that there are cases of customer requirements, including non- standard papers,
processes including digital printing, papers, boards and other substrates, inks, etc. may require the use
of printing conditions and ICC profiles which are not covered within THE REFERENCED STANDARD
colour quality standards.
A customised printing condition is defined as: A printing condition that uses a combination of substrates,
inks and printing methods that are not referenced by current THE REFERENCED STANDARD standard
printing conditions.
In this case, any printing company can be certified to these customised printing conditions by
demonstrating that the same controls, systems, policies and measurement tolerances required by this
scheme and the associated ISO standards are adhered to, where it is demonstrated that it is possible
and appropriate to do so. Any proposed certification for a customised printing condition, and relevant
aim values, shall be agreed by the printer seeking certification in advance with the certifying body for
this certification scheme.
4.3 Additional requirements
In addition to the requirements of 5.1, the organization shall:
a) maintain records needed to provide evidence that individual printed products meet the referenced
ISO colour quality standard requirements;
b) where appropriate, ensure adequate control over outsourced printing processes through
identification and use of suppliers with valid certification through this scheme, when printing
products intended to be compliant with the requirements of this scheme and THE REFERENCED
STANDARD;
c) determine if the customer requires a product to be printed in accordance with a specific ISO
standard and that the organization is capable of producing a complaint product (eg the printed
matter) according to this standard. Where product requirements are such that the organization
cannot meet the requirements of THE REFERENCED STANDARD, this shall be communicated and
explained to the customer prior to order acceptance;
d) determine and implement effective methods for communicating with customers and suppliers in
relation to:
— acceptability of artwork and/or proofs supplied (for example by providing artwork guides and
references to referenced standards), and
— printed product being in accordance claims on delivery notes, invoices and other customer
related documentation.
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ISO/FDIS 19301:2019(E)
e) ensure that only authorized and competent personnel have access to systems and files, and that
only authorized users are able to access and manipulate data files. All changes to data files should
be documented and fully attributed to those making the changes;
f) ensure the provision and maintenance of necessary and appropriate controlled lighting conditions,
and access to and use of appropriate colour measuring equipment and software.
4.4 Print(s) being in accordance and certification claims
4.4.1 Claims of conformity
Where the printed matter is claimed to be in accordance with THE REFERENCED STANDARD as defined
by this scheme, the organization can make a claim to the customer, and if so, then shall use only the
following wording:
“this print is in compliance (accredited certification: certification body name;
certificate number)”*
The wording shall be legible and shall be used on invoices, delivery notes, quotations, and other customer
related documentation, and will distinguish between compliant products and others identified on the
documentation.
*in this example the language is English, but this can of course be in the local language.
4.4.2 Certification marks
The organization may make use of the relevant marks and logos supplied by the certification body as
proof of being certified, but only in the way specified by that body.
Claims regarding certification shall only be made in terms that state that:
— the certified organization is capable of consistently printing to meet the requirements of THE
REFERENCED STANDARD (s).
— the certified organization operates a colour quality and production management system, to ensure
that, where required, products are compliant with THE REFERENCED STANDARD(s).
4.5 Outsourced printing
For organisations which outsource the printing of a product(s) and intend to claim that the print(s) are
in accordance, there shall be assurance of that printed matter being in accordance. The organization
shall ensure that:
— a procedure for ensuring the accurate identification of the validity of the certification of the
outsourced supplier is documented and implemented;
— the organization providing the printed product has a valid, accredited and current certification to
THE REFERENCED STANDARD under this scheme and for the relevant printing process at the time
of production;
— records are kept of the validation of the certification of the relevant outsourced suppliers;
— other relevant scheme requirements are met.
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kSIST ISO/FDIS 19301:2020
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4.6 Colour quality policy
The colour quality policy represents the quality policy as far as the colour quality system is concerned.
Senior management shall ensure that the colour quality policy covers, where applicable:
— the ISO standards, and methods of production, within the scope of the certification and the method
of demonstrating to be in accordance;
— the development and maintenance of the competence of all personnel within the scope of the colour
quality and production management system;
— the provision of the necessary infrastructure and equipment necessary for the production of
compliant products and the review of the capabilities of such infrastructure and equipment in the
light of technological and
...
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