765/2008 - REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93

This document specifies general requirements for the competence and impartiality of proficiency
testing (PT) providers and consistent operation of all proficiency testing schemes. This document can
be used as a basis for specific technical requirements for particular fields of application.
Users of proficiency testing schemes, regulatory authorities, organizations and schemes using peer-
assessment, accreditation bodies and others can use these requirements in confirming or recognizing
the competence of proficiency testing providers.

This document establishes principles and specifies general requirements that are applicable to all types of product-related environmental statements and environmental statement programmes. Environmental statements result from environmental statement programmes and include self-declared environmental claims, ecolabels, environmental product declarations (EPDs) and footprint communications.
This document is intended to be used in conjunction with other standards in the ISO 14020 family.
NOTE      Those other standards contain additional terms and definitions, principles and requirements that are relevant to their specific scopes.

This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE            International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

This document specifies principles and requirements for bodies performing validation and verification of environmental information statements.
Any programme requirements related to bodies are additional to the requirements of this document.
This document is a sector application of ISO/IEC 17029:2019, which contains general principles and requirements for the competence, consistent operation and impartiality of bodies performing validation/verification as conformity assessment activities.
This document includes sector-specific requirements in addition to the requirements of ISO/IEC 17029:2019.

This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately.
The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A.
Examinations of properties with results reported on a nominal or ordinal scale are not included.
This document is not applicable to medical laboratories.
NOTE       Requirements for medical laboratories are specified in ISO 15189[1].

This document specifies principles and requirements for bodies performing validation and verification
of environmental information statements.
Any programme requirements related to bodies are additional to the requirements of this document.
This document is a sector application of ISO/IEC 17029:2019, which contains general principles
and requirements for the competence, consistent operation and impartiality of bodies performing
validation/verification as conformity assessment activities.
This document includes sector-specific requirements in addition to the requirements of
ISO/IEC 17029:2019.

This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality.
This document is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development.
Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks.
This document does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use.
NOTE 1    International, national or regional regulations or requirements can also apply to specific topics covered in this document.
NOTE 2    For entities handling human materials procured and used for diagnostic and treatment purposes ISO 15189 and other clinical standards are intended to apply first and foremost.

This document defines terms used in documents in the fields of environmental management systems and tools in support of sustainable development. These include management systems, auditing and other types of assessment, communications, footprinting studies, greenhouse gas mitigation and adaptation to climate change.

This document specifies general terms and definitions relating to conformity assessment (including the
accreditation of conformity assessment bodies) and to the use of conformity assessment to facilitate trade.
The general principles of conformity assessment and a description of the functional approach to
conformity assessment are provided in Annex A.
Conformity assessment interacts with other fields such as management systems, metrology,
standardization and statistics. The boundaries of conformity assessment are not defined in this
document.

ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories.
ISO/IEC 17025:2017 is applicable to all organizations performing laboratory activities, regardless of the number of personnel.
Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use ISO/IEC 17025:2017 in confirming or recognizing the competence of laboratories.

ISO/IEC 17011:2017 specifies requirements for the competence, consistent operation and impartiality of accreditation bodies assessing and accrediting conformity assessment bodies.

This document gives guidelines to organizations for general principles, policy, strategy and activities relating to both internal and external environmental communication. It uses proven and well-established approaches for communication, adapted to the specific conditions that exist in environmental communication.
It is applicable to all organizations regardless of their size, type, location, structure, activities, products and services, and whether or not they have an environmental management system in place.
It can be used in combination with any of the ISO 14000 family of standards, or on its own.
NOTE 1  A reference table to the ISO 14000 family is provided in Annex A.
NOTE 2  ISO 14020, ISO 14021, ISO 14024, ISO 14025 and ISO 14026 provide specific environmental communication tools and guidance relating to product labels and declarations.

This document defines terms used in documents in the fields of environmental management systems
and tools in support of sustainable development. These include management systems, auditing and
other types of assessment, communications, footprinting studies, greenhouse gas mitigation and
adaptation to climate change.

This document gives guidelines to organizations for general principles, policy, strategy and
activities relating to both internal and external environmental communication. It uses proven and
well-established approaches for communication, adapted to the specific conditions that exist in
environmental communication.
It is applicable to all organizations regardless of their size, type, location, structure, activities, products
and services, and whether or not they have an environmental management system in place.
It can be used in combination with any of the ISO 14000 family of standards, or on its own.
NOTE 1 A reference table to the ISO 14000 family is provided in Annex A.
NOTE 2 ISO 14020, ISO 14021, ISO 14024, ISO 14025 and ISO 14026 provide specific environmental
communication tools and guidance relating to product labels and declarations.

This document specifies general terms and definitions relating to conformity assessment (including the
accreditation of conformity assessment bodies) and to the use of conformity assessment to facilitate trade.
The general principles of conformity assessment and a description of the functional approach to
conformity assessment are provided in Annex A.
Conformity assessment interacts with other fields such as management systems, metrology,
standardization and statistics. The boundaries of conformity assessment are not defined in this
document.

This document contains general principles and requirements for the competence, consistent operation and impartiality of bodies
providing validation and verification as conformity assessment.
Bodies operating to this document can be internal (first party), collaborative (second party) as well as independent (third party) bodies
and need not offer both, validation and verification activities.
This document is applicable to validation and verification bodies in any sector, providing assurance through confirmation that claims or
declarations are either plausible with regard to the intended purpose (validation) or correctly stated (verification).
This document shall be applied in conjunction with sector specific programmes that contain requirements for validation and verification
processes and rules.
This document can be used as a basis for accreditation by accreditation bodies, peer assessment within peer assessment groups, or
other forms of recognition of validation and verification bodies by international or regional organizations, governments, regulatory
authorities, program or scheme owners, industry bodies, companies, customers or consumers.
NOTE This document contains generic requirements and is neutral with regard to the operated validation or verification programme. Requirements of
the applicable programmes are additional to the requirements of this document.

This document specifies principles and requirements and provides guidance at the project level for the quantification, monitoring and reporting of activities intended to cause greenhouse gas (GHG) emission reductions or removal enhancements. It includes requirements for planning a GHG project, identifying and selecting GHG sources, sinks and reservoirs (SSRs) relevant to the project and baseline scenario, monitoring, quantifying, documenting and reporting GHG project performance and managing data quality.
The ISO 14060 family of standards is GHG programme neutral. If a GHG programme is applicable, the requirements of that GHG programme are additional to the requirements of the ISO 14060 family of standards.

This document specifies principles and requirements and provides guidance for verifying and validating greenhouse gas (GHG) statements.
It is applicable to organization, project and product GHG statements.
The ISO 14060 family of standards is GHG programme neutral. If a GHG programme is applicable, requirements of that GHG programme are additional to the requirements of the ISO 14060 family of standards.

This document contains general principles and requirements for the competence, consistent operation and impartiality of bodies
providing validation and verification as conformity assessment.
Bodies operating to this document can be internal (first party), collaborative (second party) as well as independent (third party) bodies
and need not offer both, validation and verification activities.
This document is applicable to validation and verification bodies in any sector, providing assurance through confirmation that claims or
declarations are either plausible with regard to the intended purpose (validation) or correctly stated (verification).
This document shall be applied in conjunction with sector specific programmes that contain requirements for validation and verification
processes and rules.
This document can be used as a basis for accreditation by accreditation bodies, peer assessment within peer assessment groups, or
other forms of recognition of validation and verification bodies by international or regional organizations, governments, regulatory
authorities, program or scheme owners, industry bodies, companies, customers or consumers.
NOTE This document contains generic requirements and is neutral with regard to the operated validation or verification programme. Requirements of
the applicable programmes are additional to the requirements of this document.

This document specifies principles and requirements at the organization level for the quantification and reporting of greenhouse gas (GHG) emissions and removals. It includes requirements for the design, development, management, reporting and verification of an organization's GHG inventory.
The ISO 14064 series is GHG programme neutral. If a GHG programme is applicable, requirements of that GHG programme are additional to the requirements of the ISO 14064 series.

This document specifies principles and requirements and provides guidance for verifying and validating
greenhouse gas (GHG) statements.
It is applicable to organization, project and product GHG statements.
The ISO 14060 family of standards is GHG programme neutral. If a GHG programme is applicable,
requirements of that GHG programme are additional to the requirements of the ISO 14060 family of
standards.

This document specifies principles and requirements and provides guidance at the project level for the
quantification, monitoring and reporting of activities intended to cause greenhouse gas (GHG) emission
reductions or removal enhancements. It includes requirements for planning a GHG project, identifying
and selecting GHG sources, sinks and reservoirs (SSRs) relevant to the project and baseline scenario,
monitoring, quantifying, documenting and reporting GHG project performance and managing data
quality.
The ISO 14060 family of standards is GHG programme neutral. If a GHG programme is applicable, the
requirements of that GHG programme are additional to the requirements of the ISO 14060 family of
standards.

This document specifies the requirements for competence to carry out reference measurement
procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative
reference and listing additional requirements for calibration laboratories to perform their tasks
adequately.
The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in
Annex A.
Examinations of properties with results reported on a nominal or ordinal scale are not included.
This document is not applicable to medical laboratories.
NOTE Requirements for medical laboratories are specified in ISO 15189[1].

This document specifies principles and requirements at the organization level for the quantification
and reporting of greenhouse gas (GHG) emissions and removals. It includes requirements for the design,
development, management, reporting and verification of an organization’s GHG inventory.
The ISO 14064 series is GHG programme neutral. If a GHG programme is applicable, requirements of
that GHG programme are additional to the requirements of the ISO 14064 series.

ISO 14024:2018 establishes the principles and procedures for developing Type I environmental labelling programmes, including the selection of product categories, product environmental criteria and product function characteristics, and for assessing and demonstrating compliance. ISO 14024:2018 also establishes the certification procedures for awarding the label.

This document provides guidance on auditing management systems, including the principles of auditing,
managing an audit programme and conducting management system audits, as well as guidance on
the evaluation of competence of individuals involved in the audit process. These activities include the
individual(s) managing the audit programme, auditors and audit teams.
It is applicable to all organizations that need to plan and conduct internal or external audits of
management systems or manage an audit programme.
The application of this document to other types of audits is possible, provided that special consideration
is given to the specific competence needed.

This document provides guidance on auditing management systems, including the principles of auditing, managing an audit programme and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process. These activities include the individual(s) managing the audit programme, auditors and audit teams.
It is applicable to all organizations that need to plan and conduct internal or external audits of management systems or manage an audit programme.
The application of this document to other types of audits is possible, provided that special consideration is given to the specific competence needed.

This document establishes the principles and procedures for developing Type I environmental labelling
programmes, including the selection of product categories, product environmental criteria and
product function characteristics, and for assessing and demonstrating compliance. This document also
establishes the certification procedures for awarding the label.

ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories.
ISO/IEC 17025:2017 is applicable to all organizations performing laboratory activities, regardless of the number of personnel.
Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use ISO/IEC 17025:2017 in confirming or recognizing the competence of laboratories.

This document specifies requirements for the competence, consistent operation and impartiality of
accreditation bodies assessing and accrediting conformity assessment bodies.
NOTE In the context of this document, activities covered by accreditation include, but are not limited to,
testing, calibration, inspection, certification of management systems, persons, products, processes and services,
provision of proficiency testing, production of reference materials, validation and verification.

ISO 17034:2016 specifies general requirements for the competence and consistent operation of reference material producers.
ISO 17034:2016 sets out the requirements in accordance with which reference materials are produced. It is intended to be used as part of the general quality assurance procedures of the reference material producer.
ISO 17034:2016 covers the production of all reference materials, including certified reference materials.

This International Standard specifies general requirements in accordance with which a reference material producer has to demonstrate that it operates, if it is to be recognized as competent to carry out the production of reference materials.
This International Standard is intended for the use by reference material producers in the development and implementation of their management system for quality, administrative and technical operations. Reference material customers, regulatory authorities and accreditation bodies may also use it in confirming and recognizing the competence of reference material producers.
This International Standard sets out the requirements in accordance with which reference materials shall be produced. It is intended to be used as part of a reference material producer's general quality assurance (QA) procedures.
This International Standard covers the production of all reference materials. For certified reference materials, the production requirements are more stringent than for other reference materials.

ISO 14021:2016 specifies requirements for self-declared environmental claims, including statements, symbols and graphics, regarding products. It further describes selected terms commonly used in environmental claims and gives qualifications for their use. This International Standard also describes a general evaluation and verification methodology for self-declared environmental claims and specific evaluation and verification methods for the selected claims in this International Standard.
ISO 14021:2016 does not preclude, override, or in any way change, legally required environmental information, claims or labelling, or any other applicable legal requirements.

ISO 14004:2016 provides guidance for an organization on the establishment, implementation, maintenance and improvement of a robust, credible and reliable environmental management system. The guidance provided is intended for an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability.
This International Standard helps an organization achieve the intended outcomes of its environmental management system, which provides value for the environment, the organization itself and interested parties. Consistent with the organization's environmental policy, the intended outcomes of an environmental management system include:
-      enhancement of environmental performance;
-      fulfilment of compliance obligations;
-      achievement of environmental objectives.
The guidance in this International Standard can help an organization to enhance its environmental performance, and enables the elements of the environmental management system to be integrated into its core business process.
NOTE          While the environmental management system is not intended to manage occupational health and safety issues, these can be included when an organization seeks to implement an integrated environmental and occupational health and safety management system.
ISO 14004:2016 is applicable to any organization, regardless of size, type and nature, and applies to the environmental aspects of its activities, products and services that the organization determines it can either control or influence, considering a life cycle perspective.
The guidance in this International Standard can be used in whole or in part to systematically improve environmental management. It serves to provide additional explanation of the concepts and requirements.
While the guidance in this International Standard is consistent with the ISO 14001 environmental management system model, it is not intended to provide interpretations of the requirements of ISO 14001.

This International Standard provides guidance for an organization on the establishment,
implementation, maintenance and improvement of a robust, credible and reliable environmental
management system. The guidance provided is intended for an organization seeking to manage its
environmental responsibilities in a systematic manner that contributes to the environmental pillar of
sustainability.
This International Standard helps an organization achieve the intended outcomes of its environmental
management system, which provides value for the environment, the organization itself and interested
parties. Consistent with the organization’s environmental policy, the intended outcomes of an
environmental management system include:
— enhancement of environmental performance;
— fulfilment of compliance obligations;
— achievement of environmental objectives.
The guidance in this International Standard can help an organization to enhance its environmental
performance, and enables the elements of the environmental management system to be integrated into
its core business process.
NOTE While the environmental management system is not intended to manage occupational health and
safety issues, these can be included when an organization seeks to implement an integrated environmental and
occupational health and safety management system.
This International Standard is applicable to any organization, regardless of size, type and nature,
and applies to the environmental aspects of its activities, products and services that the organization
determines it can either control or influence, considering a life cycle perspective.
The guidance in this International Standard can be used in whole or in part to systematically
improve environmental management. It serves to provide additional explanation of the concepts and
requirements.
While the guidance in this International Standard is consistent with the ISO 14001 environmental
management system model, it is not intended to provide interpretations of the requirements of
ISO 14001.

This International Standard specifies requirements for self-declared environmental claims, including
statements, symbols and graphics, regarding products. It further describes selected terms commonly
used in environmental claims and gives qualifications for their use. This International Standard also
describes a general evaluation and verification methodology for self-declared environmental claims
and specific evaluation and verification methods for the selected claims in this International Standard.
This International Standard does not preclude, override, or in any way change, legally required
environmental information, claims or labelling, or any other applicable legal requirements.

ISO 9000:2015 describes the fundamental concepts and principles of quality management which are universally applicable to the following:
organizations seeking sustained success through the implementation of a quality management system;
customers seeking confidence in an organization's ability to consistently provide products and services conforming to their requirements;
organizations seeking confidence in their supply chain that their product and service requirements will be met;
organizations and interested parties seeking to improve communication through a common understanding of the vocabulary used in quality management;
organizations performing conformity assessments against the requirements of ISO 9001;
providers of training, assessment or advice in quality management;
developers of related standards.
ISO 9000:2015 specifies the terms and definitions that apply to all quality management and quality management system standards developed by ISO/TC 176.

ISO 9001:2015 specifies requirements for a quality management system when an organization:
a)    needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
b)    aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.