CEN/TS 15358:2006

SLOVENSKI STANDARD
01-marec-2007
Trdno alternativno gorivo - Sistemi vodenja kakovosti - Posebne zahteve za
njihovo uporabo pri proizvodnji trdnih alternativnih goriv
Solid recovered fuels - Quality management systems - Particular requirements for their
application to the production of solid recovered fuels
Feste Sekundärbrennstoffe - Qualitätsmanagementsysteme - Besondere Anforderungen
für die Anwendung bei der Herstellung von festen Sekundärbrennstoffen
Combustibles solides de récupération - Systemes de management de la qualité -
Exigences particulieres relatives a leur application a la production de combustibles
solides de récupération
Ta slovenski standard je istoveten z: CEN/TS 15358:2006
ICS:
03.120.99 Drugi standardi v zvezi s Other standards related to
kakovostjo quality
75.160.10 Trda goriva Solid fuels
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

TECHNICAL SPECIFICATION
CEN/TS 15358
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
May 2006
ICS 75.160.10
English Version
Solid recovered fuels - Quality management systems - Particular
requirements for their application to the production of solid
recovered fuels
Combustibles solides de récupération - Systèmes de Feste Sekundärbrennstoffe -
management de la qualité - Exigences particulières Qualitätsmanagementsysteme - Besondere Anforderungen
relatives à leur application à la production de combustibles für die Anwendung bei der Herstellung von festen
solides de récupération Sekundärbrennstoffen
This Technical Specification (CEN/TS) was approved by CEN on 30 January 2006 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available
promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)
until the final decision about the possible conversion of the CEN/TS into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 15358:2006: E
worldwide for CEN national Members.

Contents Page
Foreword.3
Introduction .4
1 Scope .6
2 Normative references .6
3 Terms and definitions .6
4 Quality management system.6
5 Management responsibility .10
6 Resource management .15
7 Product realization.17
8 Measurement, analysis and improvement .30
Bibliography .38

Foreword
This document (CEN/TS 15358:2006) has been prepared by Technical Committee CEN/TC 343 “Solid
recovered fuels”, the secretariat of which is held by SFS.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this CEN Technical Specification: Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden,
Switzerland and United Kingdom.
Introduction
In the context of solid recovered fuels (SRF) production, the Quality Management (QM) strategy is mainly
based on the fact that, by increasing knowledge about the whole production-process, it is possible to reduce
the amount of sampling and testing to be carried out on the final products. This strategy is expressed by good
Quality Management Procedures in the manufacturing process, including good record-keeping. In the context
of SRF, Quality Management offers a route through which the confidence of customers and regulators can be
established and maintained.
The goal of this Technical Specification is the development of a Quality Management System (QMS) for SRF
production and trade that provides for continual improvement, emphasising the fulfilment of quality
requirements.
This Technical Specification is a base for developing a QMS for a SRF supplier organization which has not
earlier established a QMS. It can also be used as a supporting document for a supplier which already has a
QMS established.
This Technical Specification, coupled with applicable customer-specific requirements and the normative
references specified in Clause 2, defines the fundamental quality management system requirements for those
subscribing to this Technical Specification.
The development of a quality management system for solid recovered fuels based on this TS does not involve
a compulsory third party certification, however this certification is recommended.
The emphasis of this Technical Specification is on:
1) giving wider confidence to the production and trading of SRF;
2) defining the documentation to be used for internal procedures and communicating to all parties the
specifications needed to ensure the achievement of the quality objectives;
3) verifying the origin and demonstrating the properties of the input materials (i.e. non hazardous
wastes).
The Quality Management Systems accords with EN ISO 9001 to cover the whole process from the point of
waste reception to the point of delivery of SRF to the customer. Quality Management Systems have several
important features, including the definition of:
a) key steps in the process;
b) person(s) who is/are responsible for each step of the process, and for the overall co-ordination of quality-
management;
c) training – policies and procedures for execution;
d) procedures for production;
e) procedures for record-keeping, to provide full traceability;
f) procedures for dealing with failures, and self-improvement;
g) procedures for the development of the processing.
To accomplish CEN Internal Regulations for the drafting of documents in this Technical Specification boxed
text is used for the original EN ISO 9001:2000 text, while sector-specific supplemental requirements are
outside the boxes.
Paragraphs marked “NOTE” are for guidance in understanding or clarifying the associated requirement.
Where the term “such as” is used, any suggestions given are for guidance only.
1 Scope
This Technical Specification specifies requirements for the quality management system for the production of
solid recovered fuels from the reception of waste(s) up to the delivery of solid recovered fuels (Figure 1).

Figure 1 — Quality management systems within the solid recovered fuels chain
2 Normative references
The following referenced documents are indispensable for their application of this Technical Specification. For
dated references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
CEN/TS 15357:2006, Solid recovered fuels — Terminology, definitions and descriptions
CEN/TS 15359, Solid recovered fuels — Specifications and classes
EN ISO 9000:2005, Quality management systems — Fundamentals and vocabulary (ISO 9000:2005)
3 Terms and definitions
For the purposes of this Technical Specification, the terms and definitions given in EN ISO 9000:2005,
CEN/TS 15357:2006 and the following apply.
3.1
product realization
production of solid recovered fuels
4 Quality management system
4.1 General requirements
EN ISO 9001:2000, Quality management systems – Requirements

4 Quality management system
4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system and
continually improve its effectiveness in accordance with the requirements of this International Standard.
The organization shall
a) identify the processes needed for the quality management system and their application throughout the
organization,
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and control of these processes
are effective,
d) ensure the availability of resources and information necessary to support the operation and monitoring of
these processes,
e) monitor, measure and analyse these processes, and
f) implement actions necessary to achieve planned results and continual improvement of these processes.
These processes shall be managed by the organization in accordance with the requirements of this
International Standard.
Where an organization chooses to outsource any process that affects product conformity with requirements,
the organization shall ensure control over such processes. Control of such outsourced processes shall be
identified within the quality management system.
NOTE Processes needed for the quality management system referred to above should include processes for
management activities, provision of resources, product realization and measurement.
The organization shall establish and maintain a programme for achieving its objectives and targets. It shall
specify:
a) designation of responsibilities to named personnel for achieving objectives and targets at each relevant
function and level of the organization;
b) means and timeframe by which they are to be achieved.
If a project relates to new developments and new or modified activities, or products or services, programme(s)
shall be reviewed and amended as necessary to ensure that quality management is applied appropriately to
such projects.
The organization shall establish and maintain internal procedures for defining responsibility and authority for
handling and investigating non-conformity, taking action to mitigate any impacts caused and to initiate and
complete corrective and preventive actions.
Any corrective or preventive action taken to eliminate the causes of actual and potential non-conformities shall
be appropriate to the magnitude of the problems and commensurate with the quality impact encountered.
The organization shall implement and record any changes in the documented procedures resulting from
corrective and preventive actions.
The supplier of solid recovered fuels is responsible for the conformity with the agreed specification. The
quality management system shall be as comprehensive as is necessary to meet the quality objectives and
shall be included in quality systems of different operators in the production chain.
The responsibility for the inputs, the partly-processed materials and/or the finished solid recovered fuels in the
different parts of the production chain shall be transferred to the next operator in the chain, and eventually to
the end user as soon as it has been accepted that the material correspond to the quality agreed between the
parties.
4.1.1 Outsourced processes
Among the outsourced processes, the transport of input waste and of solid recovered fuels and the selection
and control of laboratories for analysis should be managed according to documented procedures.
Other outsourced processes should be managed in line with in-house processes.
4.2 Documentation requirements
4.2.1 General
EN ISO 9001:2000, Quality management systems - Requirements
4.2 Documentation requirements
4.2.1 General
The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures required by this International Standard,
d) documents needed by the organization to ensure the effective planning, operation and control of its
processes, and
e) records required by this International Standard (see 4.2.4).
NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the
procedure is established, documented, implemented and maintained.
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to
a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
NOTE 3 The documentation can be in any form or type of medium.
4.2.2 Quality manual
EN ISO 9001:2000, Quality management systems - Requirements
4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions,
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system
The quality manual is a document prepared by the organization that systematically defines procedures
needed to implement a quality management system for a solid recovered fuels supply chain.
The quality manual is a tool to demonstrate to all parties (producers, customers, authorities, other interested
organizations etc.) how the requirements are fulfilled.
4.2.3 Control of documents
EN ISO 9001:2000, Quality management systems - Requirements
4.2.3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special type of
document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are
retained for any purpose
4.2.4 Control of records
EN ISO 9001:2000, Quality management systems - Requirements
4.2.4 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and of the
effective operation of the quality management system. Records shall remain legible, readily identifiable and
retrievable. A documented procedure shall be established to define the controls needed for the identification,
storage, protection, retrieval, retention time and disposition of records.
5 Management responsibility
5.1 Management commitment
EN ISO 9001:2000, Quality management systems – Requirements
5 Management responsibility
5.1 Management commitment
Top management shall provide evidence of its commitment to the development and implementation of the
quality management system and continually improving its effectiveness by
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory
requirements,
b) establishing the quality policy,
c) ensuring that quality objectives are established,
d) conducting management reviews, and
e) ensuring the availability of resources.
5.2 Customer focus
EN ISO 9001:2000, Quality management systems – Requirements
5.2 Customer focus
Top management shall ensure that customer requirements are determined and are met with the aim of
enhancing customer satisfaction (see 7.2.1 and 8.2.1).
5.3 Quality policy
EN ISO 9001:2000, Quality management systems – Requirements
5.3 Quality policy
Top management shall ensure that the quality policy
a) is appropriate to the purpose of the organization,
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality
management system,
c) provides a framework for establishing and reviewing quality objectives,
d) is communicated and understood within the organization, and
e) is reviewed for continuing suitability.
The organization's quality policy shall be available to the public.
5.4 Planning
5.4.1 Quality objectives
EN ISO 9001:2000, Quality management systems – Requirements
5.4 Planning
5.4.1 Quality objectives
Top management shall ensure that quality objectives, including those needed to meet requirements for
product [see 7.1 a)] are established at relevant functions and levels within the organization. The quality
objectives shall be measurable and consistent with the quality policy.
The organization shall establish and maintain the procedure(s) to identify the aspects of its activities, products
or services that it can control and over which it can be expected to have an influence, so as to determine
those which have or can have significant impacts on the quality.
The organization shall ensure that the aspects related to these significant impacts are considered in setting its
objectives. This includes the use of the format for declaration of conformity with this Technical Specification
(CEN/TS 15359).
The organization shall keep this information up-to-date.
5.4.1.1 Legal and other requirements
The organization shall establish and maintain a procedure to identify and provide to appropriate persons
access to legal and other requirements to which the organization subscribes, that are applicable to its
activities, products or services.
5.4.1.2 Objectives and targets
The organization shall establish and maintain documented objectives and targets, at each relevant function
and level within the organization.
When establishing and reviewing its objectives, the organization shall consider the legal and other
requirements, its significant environmental aspects if established, its technological options and its financial,
operational and business requirements, and the views of interested parties.
The objectives and targets shall be consistent with the quality policy, including the commitment to the
prevention of pollution.
5.4.2 Quality management system planning
EN ISO 9001:2000, Quality management systems – Requirements
5.4.2 Quality management system planning
Top management shall ensure that
a) the planning of the quality management system is carried out in order to meet the requirements given in
4.1, as well as the quality objectives, and
b) the integrity of the quality management system is maintained when changes to the quality management
system are planned and implemented.

Management shall take responsibility for the quality planning of the organization. This planning should focus
on defining the processes needed to meet effectively and efficiently the organization's quality objectives and
requirements consistent with the strategy of the organization.

Inputs for effective and efficient planning include:

a) strategies of the organization,
b) defined organizational objectives,
c) defined needs and expectations of the customers and other interested parties,
d) evaluation of statutory and regulatory requirements,
e) evaluation of performance data of the products,
f) evaluation of performance data of processes,
g) lessons learned from previous experience,
h) indicated opportunities for improvement, and
i) related risk assessment and mitigation data.
Outputs of quality planning for the organisation should define processes required to support the realization of
the products such as:
j) skills and knowledge needed by the organization,
k) responsibility and authority for implementation of process improvement plans,
l) resources needed, such as financial and infrastructure,
m) metrics for evaluating the achievement of the organization's performance improvement,
n) needs for improvement including methods and tools, and
o) needs for documentation, including records.

Management shall systematically review the outputs to ensure the effectiveness and efficiency of the
processes of the organization.

5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
EN ISO 9001:2000, Quality management systems – Requirements
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
Top management shall ensure that the responsibilities and authorities are defined and communicated within
the organization.
5.5.1.1 Responsibility for quality

Production operations across all shifts shall be staffed with personnel in charge of, or delegated responsibility
for, ensuring product quality.
Personnel responsible for product quality shall have the authority to stop production to correct quality
problems.
Managers with responsibility and authority for corrective action shall be promptly informed of products or
processes which do not conform to requirements.

5.5.2 Management representative
EN ISO 9001:2000, Quality management systems – Requirements

5.5.2 Management representative
Top management shall appoint a member of management who, irrespective of other responsibilities, shall
have responsibility and authority that includes

a) ensuring that processes needed for the quality management system are established, implemented and
maintained,
b) reporting to top management on the performance of the quality management system and any need for
improvement, and
c) ensuring the promotion of awareness of customer requirements throughout the organization.

NOTE The responsibility of a management representative can include liaison with external parties on matters relating
to the quality management system.

5.5.2.1 Customer representative
Top management shall designate personnel with responsibility and authority to ensure that customer
requirements are addressed. This includes selection of special characteristics, setting quality objectives and
related training, corrective and preventive actions, product design and development.

5.5.3 Internal communication
EN ISO 9001:2000, Quality management systems – Requirements

5.5.3 Internal communication
Top management shall ensure that appropriate communication processes are established within the
organization and that communication takes place regarding the effectiveness of the quality management
system.
5.6 Management review
5.6.1 General
EN ISO 9001:2000, Quality management systems – Requirements

5.6 Management review
5.6.1 General
Top management shall review the organization's quality management system, at planned intervals, to ensure
its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for
improvement and the need for changes to the quality management system, including the quality policy and
quality objectives.
Records from management reviews shall be maintained (see 4.2.4).

5.6.1.1 Quality management system performance
The review process by top management shall ensure that the necessary information is collected. This review
shall be documented.
The management review shall address the possible need for changes to policy, objectives and other elements
of the quality management system, in the light of quality system audit results, changing circumstances,
environmental legislation and requirements and the commitment to continual improvement. These reviews
shall include all requirements of the quality management system and its performance trends as an essential
part of the continual improvement process.
The results of these reviews shall be recorded to provide, as a minimum, evidence of the achievement of:
a) quality objectives and
b) satisfaction of the customer(s) with the product supplied.
5.6.2 Review input
EN ISO 9001:2000, Quality management systems – Requirements

5.6.2 Review input
The input to management review shall include information on
a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement.
5.6.3 Review output
EN ISO 9001:2000, Quality management systems – Requirements

5.6.3 Review output
The output from the management review shall include any decisions and actions related to
a) improvement of the effectiveness of the quality management system and its processes,
b) improvement of product related to customer requirements, and
c) resource needs.
6 Resource management
6.1 Provision of resources
EN ISO 9001:2000, Quality management systems – Requirements

6 Resource management
6.1 Provision of resources
The organization shall determine and provide the resources needed
a) to implement and maintain the quality management system and continually improve its effectiveness, and
b) to enhance customer satisfaction by meeting customer requirements.

6.2 Human resources
6.2.1 General
EN ISO 9001:2000, Quality management systems – Requirements

6.2 Human resources
6.2.1 General
Personnel performing work affecting product quality shall be competent on the basis of appropriate education,
training, skills and experience.

6.2.2 Competence, awareness and training
EN ISO 9001:2000, Quality management systems – Requirements

6.2.2 Competence, awareness and training
The organization shall
a) determine the necessary competence for personnel performing work affecting product quality,
b) provide training or take other actions to satisfy these needs,
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and importance of their activities and how they
contribute to the achievement of the quality objectives, and
e) maintain appropriate records of education, training, skills and experience (see 4.2.4).
The organization shall identify training needs. It shall require that all personnel, whose work may create a
significant impact on solid recovered fuels quality, have received appropriate training.

It shall establish and maintain procedures to make its employees or members at each relevant function and
level aware of:
a) importance of conformance with the quality policy and procedures and with the requirements of the quality
management system;
b) significant impacts, actual or potential, of their work activities and the benefits of improved personal
performance;
c) their roles and responsibilities in achieving conformance with the quality policy and procedures and with
the requirements of the quality management system, including emergency preparedness and response
requirements;
d) potential consequences of departure from specified operating procedures.
Personnel performing the tasks that can cause significant impacts on the quality of solid recovered fuels shall
be competent in terms of their education, training and/or experience.

6.3 Infrastructure
EN ISO 9001:2000, Quality management systems – Requirements

6.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to
product requirements.
Infrastructure includes, as applicable
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport or communication).

Management should define the infrastructure necessary for the realisation of products while considering the
needs and expectations of interested parties. The infrastructure includes resources such as plant, workspace,
tools and equipment, support services, information and communication technology and transport facilities.

The process to define the infrastructure necessary for achieving effective and efficient product realization
should include the following:
a) provision of an infrastructure, defined in terms such as objectives, function, performance, availability, cost,
health and safety, security and renewal;
b) development and implementation of maintenance methods to ensure that the infrastructure continues to
meet the organization's needs; these methods should consider the type and frequency of maintenance
and verification of operation of each infrastructure element, based on its criticality and usage;
c) evaluation of the infrastructure against the needs and expectations of interested parties;
d) consideration of environmental issues associated with infrastructure, such as conservation, pollution,
waste and recycling.
Natural phenomena that cannot be controlled can affect the infrastructure. The plan for the infrastructure
should consider the identification and mitigation of associated risks and should include strategies to protect
the interests of interested parties.

6.4 Work environment
EN ISO 9001:2000, Quality management systems – Requirements

6.4 Work environment
The organization shall determine and manage the work environment needed to achieve conformity to product
requirements.
7 Product realization
7.1 Planning of product realization
EN ISO 9001:2000, Quality management systems – Requirements

7 Product realization
7.1 Planning of product realization
The organization shall plan and develop the processes needed for product realization. Planning of product
realization shall be consistent with the requirements of the other processes of the quality management system
(see 4.1).
In planning product realization, the organization shall determine the following, as appropriate:

a) quality objectives and requirements for the product;
b) the need to establish processes, documents, and provide resources specific to the product;
c) required verification, validation, monitoring, inspection and test activities specific to the product and the
criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements
(see 4.2.4).
The output of this planning shall be in a form suitable for the organization's method of operations.

NOTE 1 A document specifying the processes of the quality management system (including the product realization
processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.

NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization
processes.
NOTE 3 Product acceptance criteria should be defined and agreed by the customer and the producer using
specifications and classification system defined in CEN/TS 15359.
7.1.1 Product and process validation
Management should ensure that when validation activities are carried out such validation of products should
demonstrate that the SRF meets the needs of customers Validation activities could include modelling,
simulation and trials, as well as reviews involving customers.

7.1.2 Control of changes
The organization shall have a process to control and react to changes that can affect product realisation.
The effects of any change, including changes such as those induced by:

a) variability of some incoming waste (composition, structure of deliveries, new suppliers etc.);
b) availability of waste streams
shall be assessed and verification and validation activities shall be defined, to ensure compliance with
customers' requirements.
Changes should be identified, recorded, evaluated, reviewed and controlled to derive an understanding of the
effect on other processes and the needs of customers.

7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
EN ISO 9001:2000, Quality management systems – Requirements
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
The organization shall determine
a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,
b) requirements not stated by the customer but necessary for specified or intended use, where known,
c) statutory and regulatory requirements related to the product, and
d) any additional requirements determined by the organization.

Requirements for solid recovered fuels shall be stated in accordance with CEN/TS 15359.
Conformity with item c) includes all applicable government, health and safety and environmental regulations,
applied to reception, storage, handling, recycling, recovery or disposal of incoming waste and solid recovered
fuels.
7.2.2 Review of requirements related to the product
EN ISO 9001:2000, Quality management systems – Requirements

7.2.2 Review of requirements related to the product
The organization shall review the requirements related to the product. This review shall be conducted prior to
the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of
contracts or orders, acceptance of changes to contracts or orders) and shall ensure that
a) product requirements are defined,
b) contract or order requirements differing from those previously expressed are resolved, and
c) the organization has the ability to meet the defined requirements.

Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).

Where the customer provides no documented statement of requirement, the customer requirements shall be
confirmed by the organization before acceptance.

Where product requirements are changed, the organization shall ensure that relevant documents are
amended and that relevant personnel are made aware of the changed requirements.

NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can
cover relevant product information such as catalogues or advertising material.

Any waiver of the requirement stated in 7.2.2 for a formal review shall require the authorisation of the
customer.
7.2.3 Customer communication
EN ISO 9001:2000, Quality management systems – Requirements
7.2.3 Customer communication
The organization shall determine and implement effective arrangements for communicating with customers in
relation to
a) product information,
b) enquiries, contracts or order handling, including amendments, and
c) customer feedback, including customer complaints.

The organization shall establish and maintain procedures for receiving, documenting and responding to
relevant communication from external interested parties (customer, authorities, other interested organizations
etc.).
The organization should consider processes for external communication on its significant environmental
aspects and record its decision.

7.3 Design and development
The requirements of 7.3 include product and manufacturing process design and development and focus on
error prevention rather than detection. These requirements may be excluded provided that such exclusions do
not affect the organization's ability, or responsibility, to provide product that meets customer and applicable
regulatory requirements.
7.3.1 Design and development planning
EN ISO 9001:2000, Quality management systems – Requirements

7.3 Design and development
7.3.1 Design and development planning
The organization shall plan and control the design and development of product.
During the design and development planning, the organization shall determine
a) the design and development stages,
b) the review, verification and validation that are appropriate to each design and development stage, and
c) the responsibilities and authorities for design and development.

The organization shall manage the interfaces between different groups involved in design and development to
ensure effective communication and clear assignment of responsibility.

Planning output shall be updated, as appropriate, as the design and development progresses.

7.3.2 Design and development inputs
EN ISO 9001:2000, Quality management systems – Requirements
7.3.2 Design and development inputs
Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs
shall include
a) functional and performance requirements,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs, and
d) other requirements essential for design and development.

These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in
conflict with each other.
The organization should identify process inputs that affect the design and development of products and
facilitate effective and efficient process performance in order to satisfy the needs and expectations of
customers, and those of other interested parties.
These external needs and expectations, coupled with those internal to the organization, should be suitable for
translation into input requirements for the design and development processes.
Examples are as follows:
a) External inputs such as:
 customer or marketplace or other interested parties needs and expectations, and
 suppliers’ and users’ contributions.
b) Internal inputs such as:
 policies and objectives,
 needs and expectations of people in the organization,
 technological developments,
 competence requirements for people performing design and development,
 feedback information from past experience,
 records and data on existing processes and products, and
 outputs from other processes.
c) Inputs that identify those characteristics of processes or products that are crucial to safe and proper
functioning and maintenance, such as:
- operation, installation and application,
- storage, handling and delivery,
- physical parameters and the environment, and
- requirements for treatment of the products.
Product-related inputs based on an appreciation of the needs and expectations of end users, as well as those
of the direct customer, can be important. Such inputs should be formulated in a way that permits the product
to be verified and validated effectively and efficiently.

7.3.3 Design and development outputs
EN ISO 9001:2000, Quality management systems – Requirements
7.3.3 Design and development outputs
The outputs of design and development shall be provided in a form that enables verification against the design
and development input and shall be approved prior to release.
Design and development outputs shall
a) meet the input requirements for design and development,
b) provide appropriate information for purchasing, production and for service provision,
c) contain or reference product acceptance criteria, and
d) specify the characteristics of the product that are essential for its safe and proper use

The output should include information to enable verification and validation to planned requirements.
Examples of the output of design and development include:

- data demonstrating the comparison of process inputs to process outputs,
- product specifications, including acceptance criteria,
- process specifications,
- material specifications,
- testing specifications,
- training requirements,
- user and consumer information,
- purchase requirements, and
- reports of qualification tests.

Design and development outputs should be reviewed against inputs to provide objective evidence that outputs
have effectively and efficiently met the requirements for the process and product.

7.3.4 Design and development review
EN ISO 9001:2000, Quality management systems – Requirements

7.3.4 Design and development review
At suitable stages, systematic reviews of design and development shall be performed in accordance with
planned arrangements (see 7.3.1)
a) to evaluate the ability of the results of design and development to meet requirements, and
b) to identify any problems and propose necessary actions.
Participants in such reviews shall include representatives of functions concerned with the design and
development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall
be maintained (see 4.2.4).
7.3.5 Design and development verification
EN ISO 9001:2000, Quality management systems – Requirements

7.3.5 Design and development verification
Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design
and development outputs have met the design and development input requirements. Records of the results of
the verification and any necessary actions shall be maintained (see 4.2.4).
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