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.

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1.1   General
This document is limited to the aerospace industry, where an approved manufacturer requests a supplier to ship an article against the approved manufacturer’s quality system directly to a customer. The direct ship process is not required or applicable to standard parts or military parts. In this process, the approved manufacturer is responsible for assurance that the article conforms to type design information.
1.2   Purpose
This document provides guidance to approved manufacturers, their suppliers, and customers when an approved manufacturer requests a supplier to ship an article against the approved manufacturer’s purchase document directly to a customer, commonly known as “Direct Ship”.

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1.1   General
This document is limited to the aerospace industry, where an approved manufacturer requests a supplier to ship an article against the approved manufacturer’s quality system directly to a customer. The direct ship process is not required or applicable to standard parts or military parts. In this process, the approved manufacturer is responsible for assurance that the article conforms to type design information.
1.2   Purpose
This document provides guidance to approved manufacturers, their suppliers, and customers when an approved manufacturer requests a supplier to ship an article against the approved manufacturer’s purchase document directly to a customer, commonly known as “Direct Ship”.

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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.

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  • Standard
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  • Standard
    64 pages
    English, Spanish and Russian language
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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.

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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.

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This document provides guidance on the implementation of the ISO 19443 requirements, with examples of possible steps an organization can take to meet the requirements.
It does not add to, subtract from, or in any way modify those requirements.
This document does not prescribe mandatory approaches to implementation, or provide any preferred method of interpretation.

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This document specifies processes that can be used to govern, manage and implement organizational change management (OCM) for organizations, projects or smaller activities. It comprises generic process descriptions that describe the OCM processes. Supporting diagrams describing the processes are also provided.
This document is applicable, but not limited, to change sponsors, change agents, change team members and project managers, particularly those responsible for governing, managing and implementing organizational change.

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This document provides guidance on the implementation of the ISO 19443 requirements, with examples of possible steps an organization can take to meet the requirements.
It does not add to, subtract from, or in any way modify those requirements.
This document does not prescribe mandatory approaches to implementation, or provide any preferred method of interpretation.

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This document gives guidance on the evaluation, development and improvement of organizational quality culture to help an organization to achieve sustained success. This document takes into account the fundamental concepts and quality management principles, with specific focus on people engagement and leadership.
The recommendations in this document are generic and are intended to be applicable to any organization, regardless of its size, industry, location, maturity or the products and services it provides.
NOTE This document provides example tools for the evaluation of organizational quality culture by self-assessment to determine quality culture maturity and potential for improvement

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This document gives guidance on planning, designing, developing, implementing, maintaining and improving an effective and efficient business-to-consumer electronic commerce transaction (B2C ECT) system within an organization.
It is applicable to any organization engaged in, or planning to be engaged in, a B2C ECT, regardless of size, type and activity. The focus of this document is on organizations that directly offer and provide products and services to consumers.
This document aims to enable organizations to set up a fair, effective, efficient, transparent and secure B2C ECT system, in order to enhance consumers’ confidence in B2C ECTs and increase the satisfaction of consumers. It is aimed at B2C ECTs concerning consumers as a sub-set of customers.
The guidance given in this document can complement an organization’s quality management system.

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This document specifies processes that can be used to govern, manage and implement organizational change management (OCM) for organizations, projects or smaller activities. It comprises generic process descriptions that describe the OCM processes. Supporting diagrams describing the processes are also provided. This document is applicable, but not limited, to change sponsors, change agents, change team members and project managers, particularly those responsible for governing, managing and implementing organizational change.

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This International Standard 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 this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
NOTE 1    In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer.
NOTE 2    Statutory and regulatory requirements can be expressed as legal requirements.
This International Standard applies to organizations supplying ITNS products or services.
Application of this standard to organizations performing activities on a licensed nuclear site is subject to prior agreement by the Licensee.
Requirements specified in this International Standard are complementary (not alternative) to customer and applicable statutory and regulatory requirements.

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This document gives guidance on the evaluation, development and improvement of organizational quality culture to help an organization to achieve sustained success. This document takes into account the fundamental concepts and quality management principles, with specific focus on people engagement and leadership. The recommendations in this document are generic and are intended to be applicable to any organization, regardless of its size, industry, location, maturity or the products and services it provides. NOTE This document provides example tools for the evaluation of organizational quality culture by self-assessment to determine quality culture maturity and potential for improvement

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This document is used in conjunction with and is supplementary to EN 16247-1, Energy audits - Part 1: General requirements. It provides additional requirements to EN 16247-1 and is applied simultaneously.
The procedures described here apply to the different modes of transport (road, rail, marine and aviation), as well as the different ranges (local- to long-distance) and what is transported (i.e. goods and people).
This document specifies the requirements, methodology and deliverables specific to energy audits in the transport sector, every situation in which a displacement is made, no matter who the operator is (a public or private company or whether the operator is exclusively dedicated to transport or not), is also addressed in this document.
This document advises on both the optimization of energy within each mode of transport, as well as selecting the best mode of transport in each situation; the conclusions drawn by the energy audit can influence decisions on infrastructure and investment e.g. in teleconferencing or web meetings.
Energy audits of buildings and processes associated with transport can be conducted respectively with the EN 16247-2 Buildings and EN 16247-3 Processes, e.g. pipelines, depots and escalators/travelators. This part of the standard does not include the infrastructure which supplies energy e.g. the electricity generation of energy for railways.

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This document is applicable to specific energy audit requirements in buildings. It specifies the requirements, methodology and deliverables of an energy audit in a building or group of buildings. It is applied in conjunction with, and is supplementary to, EN 16247 1, Energy audits - Part 1: General requirements. It provides additional requirements to EN 16247 1 and is applied simultaneously.
If processes are included in the scope of the energy audit, the energy auditor can choose to apply EN 16247 3, Energy audits - Part 3: Processes. If on-site transport on a site is included in the scope of the energy audit, the energy auditor can choose to apply EN 16247 4, Energy audits - Part 4: Transport.

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This document specifies the requirements, methodology and deliverables of an energy audit within a process. These consist of:
a)   organizing and conducting an energy audit;
b)   analysing the data from the energy audit;
c)   reporting and documenting the energy audit findings.
This part of the standard applies to sites or parts of sites where a significant part of the energy use is due to processes. It is used in conjunction with and is supplementary to EN 16247-1, Energy audits - Part 1: General requirements. It provides additional requirements to EN 16247-1 and is applied simultaneously.
A process can include one or more production lines or services, offices, laboratories, research centres, packaging and warehouse sections with specific operational conditions and site transportation. An energy audit can include the whole site or part of a site.
If buildings are included in the scope of the energy audit, the energy auditor can choose to apply EN 16247-2, Energy Audits - Part 2: Buildings. If on-site transport on a site is included in the scope of the energy audit, the energy auditor can choose to apply EN 16247-4, Energy audits - Part 4: Transport.
NOTE   The decision to apply Parts 2 and/or 4 is expected to be made during the preliminary contact, see 5.1.

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This document specifies the requirements, common methodology and deliverables for energy audits. It is applicable to all forms of establishments and organizations, all forms of energy and energy uses.
This document covers the general requirements common to all energy audits. Specific energy audit requirements complete the general requirements in separate parts dedicated to energy audits for buildings, industrial processes and transport.

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This International Standard 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 this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
NOTE 1    In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer.
NOTE 2    Statutory and regulatory requirements can be expressed as legal requirements.
This International Standard applies to organizations supplying ITNS products or services.
Application of this standard to organizations performing activities on a licensed nuclear site is subject to prior agreement by the Licensee.
Requirements specified in this International Standard are complementary (not alternative) to customer and applicable statutory and regulatory requirements.

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This document gives guidance on planning, designing, developing, implementing, maintaining and improving an effective and efficient business-to-consumer electronic commerce transaction (B2C ECT) system within an organization. It is applicable to any organization engaged in, or planning to be engaged in, a B2C ECT, regardless of size, type and activity. The focus of this document is on organizations that directly offer and provide products and services to consumers. This document aims to enable organizations to set up a fair, effective, efficient, transparent and secure B2C ECT system, in order to enhance consumers’ confidence in B2C ECTs and increase the satisfaction of consumers. It is aimed at B2C ECTs concerning consumers as a sub-set of customers. The guidance given in this document can complement an organization’s quality management system.

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This document gives guidelines for the selection of appropriate statistical techniques that can be useful
to an organization, irrespective of size or complexity, in developing, implementing, maintaining and
improving a quality management system in conformity with ISO 9001:2015.
This document does not provide guidance on how to use the statistical techniques.

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This document gives guidelines for the selection of appropriate statistical techniques that can be useful to an organization, irrespective of size or complexity, in developing, implementing, maintaining and improving a quality management system in conformity with ISO 9001:2015. This document does not provide guidance on how to use the statistical techniques.

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This document gives guidelines for realizing financial and economic benefits by applying a top-down structured approach to achieving financial and economic benefits. The structured approach uses the quality management principles and quality management system described in the ISO 9000 family of management system standards to:
a) monitor and manage trends in key performance metrics;
b) take improvement action based on the observed metrics.
This document is directed specifically to the top management of an organization.
This document is applicable to any organization, whether from the public, private or not-for-profit sector, regardless of its business model, revenue, number of employees, diversity of product and service offerings, organizational culture, complexity of processes, place or number of locations.
This document complements ISOÂ 9001:2015 and ISOÂ 9004:2018 for performance improvements and provides examples of achievable benefits from the application of concepts in those standards. This document identifies associated practical management methods and tools to assist in realizing the benefits.

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This document gives guidance for the development and maintenance of the documented information necessary to support an effective quality management system, tailored to the specific needs of the organization.
This document can also be used to support other management systems, e.g. environmental or occupational health and safety management systems.

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This document gives guidelines for realizing financial and economic benefits by applying a top-down structured approach to achieving financial and economic benefits. The structured approach uses the quality management principles and quality management system described in the ISO 9000 family of management system standards to: a) monitor and manage trends in key performance metrics; b) take improvement action based on the observed metrics. This document is directed specifically to the top management of an organization. This document is applicable to any organization, whether from the public, private or not-for-profit sector, regardless of its business model, revenue, number of employees, diversity of product and service offerings, organizational culture, complexity of processes, place or number of locations. This document complements ISO 9001:2015 and ISO 9004:2018 for performance improvements and provides examples of achievable benefits from the application of concepts in those standards. This document identifies associated practical management methods and tools to assist in realizing the benefits.

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This document gives guidance for the development and maintenance of the documented information necessary to support an effective quality management system, tailored to the specific needs of the organization. This document can also be used to support other management systems, e.g. environmental or occupational health and safety management systems.

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1.1 General
This document provides requirements and guidance for the retention, storage, retrieval and disposal of records for the international aviation, space and defense industry.
1.2 Applicability
1.2.1 This document is applicable to all documents and data records, on current and earlier products, produced using current and previous business agreements and applicable statutory and regulatory requirements.
1.2.2 Documents should be interpreted in the broadest possible sense to include all records, data and information, in paper or in electronic form or on film, including external providers working on own behalf.
1.2.3 Some documents may be retained electronically. The form in which documents are to be retained varies from one jurisdiction to another and varies depending on the document involved. Some countries prescribe that certain documents be retained in their original form as a hardcopy (e.g. board minutes, documents under seal, trust documents and original documents that are subject to specific legal requirements…).

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1.1 Application
This standard defines the common nonconformity data definition and documentation that shall be exchanged between an internal/external supplier or sub-tier supplier, and the customer when informing about a nonconformity requiring formal decision. The requirements are applicable, partly or totally, when reporting a product nonconformity to the owner or operator, as user of the end item (e.g., engine, aircraft, spacecraft, helicopter), if specified by contract.
Reporting of nonconformity data, either electronically or conventionally on paper, is subject to the terms and conditions of the contract. This also includes, where applicable, data access under export control regulations.
1.2 Purpose
The process of exchanging, coordinating, and approving nonconformity data via concession or product quality escape varies with the multiple relationships and agreements among all parties concerned. The information provided by this standard forms architecture for submitting and managing data that allows for concise and accurate communication using various documented methods. The main objective of this standard is to provide the definition of a data set that can be integrated into any form of communication (e.g., electronic data interchange, submission of conventional paper forms).

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This document defines quality management system requirements for product and service supply organizations to the petroleum, petrochemical and natural gas industries.
This document is written as a supplement to ISO 9001:2015. The supplementary requirements and guidance to ISO 9001:2015 have been developed to manage supply chain risks and opportunities associated with the petroleum, petrochemical and natural gas industries and to provide a framework for aligning requirements with complementary standards employed within the industries.

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This document provides guidance on the implementation of the ISO 19443 requirements, with examples of possible steps an organization can take to meet the requirements. It does not add to, subtract from, or in any way modify those requirements. This document does not prescribe mandatory approaches to implementation, or provide any preferred method of interpretation.

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This document provides requirements and guidance for the retention, storage, retrieval and disposal of
records for the international aviation, space and defense industry.

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1.1   Application:
This document defines the common nonconformity data definition and documentation that shall be exchanged between an internal/external supplier or sub-tier supplier, and the customer when informing about a nonconformity requiring formal decision. The requirements are applicable, partly or totally, when reporting a product nonconformity to the owner or operator, as user of the end item (e.g. engine, aircraft, spacecraft, helicopter), if specified by contract.
Reporting of nonconformity data, either electronically or conventionally on paper, is subject to the terms and conditions of the contract. This also includes, where applicable, data access under export control regulations.
1.2   Purpose:
The process of exchanging, coordinating, and approving nonconformity data via waiver/concession or product quality escape varies with the multiple relationships and agreements among all parties concerned. The information provided by this document forms architecture for submitting and managing data that allows for concise and accurate communication using various methods. The main objective of this document is to provide the definition of a data set that can be integrated into any form of communication (e.g. electronic data interchange, submission of conventional paper forms).

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This document gives guidelines for engaging people in an organization's quality management system and on enhancing their involvement and competence within it.
This document is applicable to any organization, regardless of its size, type or activity.

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This document defines quality management system requirements for product and service supply
organizations to the petroleum, petrochemical and natural gas industries.
This document is written as a supplement to ISO 9001:2015. The supplementary requirements and
guidance to ISO 9001:2015 have been developed to manage supply chain risks and opportunities
associated with the petroleum, petrochemical and natural gas industries and to provide a framework
for aligning requirements with complementary standards employed within the industries.

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1.1   Purpose
This European standard establishes requirements when implementing statistical product acceptance methods to meet defined risk requirements. This standard also establishes the minimum content required to be covered in an organization’s documented procedures that govern their application of statistical product acceptance methods.
These general requirements and documented procedures apply the requirements of the EN 9100/EN 9110/EN 9120 quality management system standards, in addition to establishing requirements for retrievability, safety/critical characteristics, and quality parameters that protect the customer.
1.2   Application
This standard is applicable when invoked in a purchasing contract or specification, contractual document, customer agreement, or adopted by the organization. The purchase contract/agreement may or may not identify the appropriate EN 9138 clause(s) to be applied by the organization. All statistical methods of product acceptance require the use of Clause 4 and Clause 5.
To accept product produced:
- by individual lots, see Clause 6;
- under switching rules, see Clause 7;
- under process controls, see Clause 8; and
- by continuous sampling or special case methods, see Clause 9.

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This document defines quality management system requirements for product and service supply organizations to the petroleum, petrochemical and natural gas industries. This document is written as a supplement to ISO 9001:2015. The supplementary requirements and guidance to ISO 9001:2015 have been developed to manage supply chain risks and opportunities associated with the petroleum, petrochemical and natural gas industries and to provide a framework for aligning requirements with complementary standards employed within the industries.

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EN-ISO 16106 gives guidance on the application of a quality management system in the manufacture, measuring and monitoring of design type approved dangerous goods packaging, intermediate bulk containers (IBCs) and large packaging.This document does not include guidance specific to other management systems, such as those for environmental management, occupational health and safety management, or financial management.$0$0It is applicable to an organization that) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;  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 guidance in this document is generic and intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

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This document gives guidelines for engaging people in an organization's quality management system and on enhancing their involvement and competence within it. This document is applicable to any organization, regardless of its size, type or activity.

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This standard gives guidelines for an organization to establish, implement, maintain and improve systems for competence management and people development to positively affect outcomes related to the conformity of products and services and the needs and expectations of relevant interested parties. This document is applicable to all organizations regardless of their type or size. It does not add to, change or otherwise modify requirements for the ISO 9000 family or any other standards.

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This document gives guidelines for an organization to establish, implement, maintain and improve systems for competence management and people development to positively affect outcomes related to the conformity of products and services and the needs and expectations of relevant interested parties. This document is applicable to all organizations regardless of their type or size. It does not add to, change or otherwise modify requirements for the ISO 9000 family or any other standards.

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This document establishes requirements when implementing statistical product acceptance methods to meet defined risk requirements. This standard also establishes the minimum content required to be covered in an organization’s documented procedures that govern their application of statistical product acceptance methods. These general requirements and documented procedures apply the requirements of the EN 9100/EN 9110/EN 9120 quality management system standards, in addition to establishing requirements for retrievability, safety/critical characteristics, and quality parameters that protect the customer. Application This standard is applicable when invoked in a purchasing contract or specification, contractual document, customer agreement, or adopted by the organization. The purchase contract/agreement may or may not identify the appropriate EN 9138 clause(s) to be applied by the organization. All statistical methods of product acceptance require the use of Clause 4 and Clause 5. To accept product produced: - by individual lots, see Clause 6; - under switching rules, see Clause 7; - under process controls, see Clause 8; and - by continuous sampling or special case methods, see Clause 9.

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This document gives guidelines for local governments on understanding and implementing a quality
management system that meets the requirements of ISO 9001:2015, in order to meet the needs and
expectations of their customers/citizens and all other relevant interested parties by consistently
providing them with products and services.
It promotes implementing a quality management system in a responsible and accountable manner,
through the application of ISO 9001 on a comprehensive basis. These guidelines do not add, change or
modify the requirements of ISO 9001.
It is applicable to all local government processes at all levels (i.e. strategical, tactical-managerial and
operational) in order to constitute a comprehensive quality management system that focuses on the
local government achieving its objectives. The comprehensive character of this system is essential to
ensure that all the areas of the local government have a specified level of reliability (i.e. effectiveness of
the processes).
Annex A, as a starting point for users of this document, gives a diagnostic methodology for local
governments to evaluate the scope and maturity of their processes and products and services. Annex B
gives the processes necessary to provide reliable products and services to customers/citizens.

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This document defines terms for the quality assessment of national libraries and specifies the following
methods for the assessment:
— performance measurement, and
— impact assessment.
The results of both methods are of special interest for comparison over time within the same library.
Comparisons between libraries are possible if differences in the mandate, tasks and constituencies of
the libraries are taken into account.
Not all methods described in this document apply to all national libraries. Limitations of the applicability
of individual methods are specified in the descriptions.
This document is not intended to exclude the use of performance indicators or of methods for impact
assessment not specified in it.
This document does not cover web archiving, but refers to ISO/TR 14873 for statistics and quality
issues for this new task of national libraries.

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1.1   General
Limited to the commercial aerospace industry where a request is made for a PO to have Direct Delivery Authorization (DDA), which includes an Appropriate Arrangement (AA) between the PO and the Design Organisation (DO). In this process the DO is responsible for ensuring the continuous updating of design and airworthiness data to the PO, whilst the PO is responsible for assurance that the manufactured article conforms to approved design and airworthiness data. The PO is responsible to provide airworthiness release documentation.
1.2   Purpose
This document provides guidance to a PO and DO on how to comply with the DDA, including AA requirements per the applicable documents referenced in Clause 2 (see Figure 1).
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This standard establishes requirements for performing and documenting APQP and PPAP. APQP begins
with conceptual product needs and extends through product definition, production planning, product
and process validation (i.e. PPAP), product use, and post-delivery service. This standard integrates and
collaborates with the requirements of the EN 9100, EN 9102, EN 9103 and EN 9110 standards.
The requirements specified in this standard are complementary (not alternative) to contractual and
applicable statutory and regulatory requirements. Should there be a conflict between the requirements
of this standard and applicable statutory or regulatory requirements, the latter shall take precedence.

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ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.
If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.
If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.

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The requirements of EN 9100 apply with the following clarification for software.
This European standard supplements the EN 9100 standard requirements for deliverable software and
contains quality management system requirements for organizations that design, develop, and/or
produce deliverable software and services for the aviation, space, and defence industry. This includes,
as required, support software that is used in the development and maintenance of deliverable software
and services. The deliverable software may be stand-alone, embedded, mobile application, or loadable
into a target computer
This deliverable software may also be part of services (e.g., cloud environment, web hosted solutions or
platforms).
Where the use of Hardware Description Language (HDL) or high order language is utilized as the design
source of electronic hardware [e.g., Application Specific Integrated Circuit (ASIC), Programmable Logic
Device (PLD)]; the organization and customer, and/or supplier shall agree on the extent of applicability
of this supplement.
NOTE For airborne electronic hardware guidance, see RTCA/DO-254 or EUROCAE ED-80. For operations
requirements, see EN 9100, clause 8.
Where Commercial-Off-The-Shelf (COTS) or non-developmental software is integrated into a
deliverable product, the organization and customer shall agree on the extent of applicability of this
supplement.
For the purposes of this document, the terms “product” and “software product” are considered
synonymous.
For the purposes of this document, the term “services” may be considered a product.

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1.1   General
Limited to the commercial aerospace industry where a request is made for a PO to have Direct Delivery Authorization (DDA), which includes an Appropriate Arrangement (AA) between the PO and the Design Organisation (DO). In this process the DO is responsible for ensuring the continuous updating of design and airworthiness data to the PO, whilst the PO is responsible for assurance that the manufactured article conforms to approved design and airworthiness data. The PO is responsible to provide airworthiness release documentation.
1.2   Purpose
This document provides guidance to a PO and DO on how to comply with the DDA, including AA requirements per the applicable documents referenced in Clause 2 (see Figure 1).
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1.1   General
This document defines a system for the qualification of standard products for aviation, space, and defenc applications. It defines the principles that shall be adhered to when carrying out product qualification; applied in conjunction with the rules and procedures of the CA. The system enables the CA to confirm compliance is achieved and maintained, in accordance with the requirements of its product definition and associated controlling technical specifications by an Original Component Manufacturer (OCM) of standard products.
This document requires an OCM that has been granted product qualification approval to ensure applicable approvals are maintained and renewed in accordance with the CA’s quality system for that qualified product.
OCMs and OCM designated Value Added Distributors (VADs) requesting product qualification to this standard, shall as a prerequisite, maintain EN 9100 standard quality management system certification approval. This certification shall be visible in the Online Aerospace Supplier Information System (OASIS) database.
1.2   Application
The application of this document will be mandated either in the product standard or its controlling technical specifications. When invoked, the OCM wanting to produce aerospace standard products will need to gain qualification approval from an aerospace CA. The processes defined herein will be performed impartially for the benefit of the aerospace industry, by the CA, to ensure continued compliance of standard products to the requirements defined in their controlling technical specifications.
OCMs will need to ensure they allow sufficient lead-time to complete this process to gain product approval from the CA to support/satisfy their customer delivery requirements. Qualified products using this process shall not be supplied or used without qualification approval and a valid Product Qualification Certificate (PQC) being granted.

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