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 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 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 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 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 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 gives guidance on how to conduct an environmental due diligence (EDD) assessment through a systematic process of identifying environmental aspects, issues and conditions as well as determining, if appropriate, their business consequences.
This document does not provide guidance on how to conduct other types of environmental assessment, such as:
a) environmental audits;
b) environmental impact assessments;
c) environmental performance, efficiency, or reliability assessment;
d) intrusive environmental investigations and remediation.

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 gives guidance on how to conduct an environmental due diligence (EDD) assessment through a systematic process of identifying environmental aspects, issues and conditions as well as determining, if appropriate, their business consequences.
This document does not provide guidance on how to conduct other types of environmental assessment, such as:
a) environmental audits;
b) environmental impact assessments;
c) environmental performance, efficiency, or reliability assessment;
d) intrusive environmental investigations and remediation.

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 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 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 performing validation/verification as conformity assessment activities.
Bodies operating according to this document can provide validation/verification as a first-party, second-party or third-party activity. Bodies can be validation bodies only, verification bodies only, or provide both activities.
This document is applicable to validation/verification bodies in any sector, providing confirmation that claims are either plausible with regards to the intended future use (validation) or truthfully stated (verification). However, results of other conformity assessment activities (e.g. testing, inspection and certification) are not considered to be subject to validation/verification according to this document. Neither are situations where validation/verification activities are performed as steps within another conformity assessment process.
This document is applicable to any sector, in conjunction with sector specific programmes that contain requirements for validation/verification processes and procedures.
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/verification bodies by international or regional organizations, governments, regulatory authorities, programme owners, industry bodies, companies, clients or consumers.
NOTE    This document contains generic requirements and is neutral with regard to the validation/verification programme in operation. 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 performing validation/verification as conformity assessment activities.
Bodies operating according to this document can provide validation/verification as a first-party, second-party or third-party activity. Bodies can be validation bodies only, verification bodies only, or provide both activities.
This document is applicable to validation/verification bodies in any sector, providing confirmation that claims are either plausible with regards to the intended future use (validation) or truthfully stated (verification). However, results of other conformity assessment activities (e.g. testing, inspection and certification) are not considered to be subject to validation/verification according to this document. Neither are situations where validation/verification activities are performed as steps within another conformity assessment process.
This document is applicable to any sector, in conjunction with sector specific programmes that contain requirements for validation/verification processes and procedures.
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/verification bodies by international or regional organizations, governments, regulatory authorities, programme owners, industry bodies, companies, clients or consumers.
NOTE    This document contains generic requirements and is neutral with regard to the validation/verification programme in operation. 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.

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.

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.