03.120.10 - Quality management and quality assurance
ICS 03.120.10 Details
Quality management and quality assurance
Qualitatsmanagement. Qualitatssicherung
Management et assurance de la qualité
Vodenje in zagotavljanje kakovosti
General Information
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This document specifies the method for declaring the technical classification relating to acoustics for a Product Standard including DoP, or European assessment document (EAD) including European Technical Approval (ETA) for a specific building product or equipment, or a family of building products or equipment. In particular, it gives advice on how to write technical specifications in response to the mandated characteristics on acoustics under the Construction Products Regulation.
NOTE 1 In the remainder of this document, the terms used relate to CEN and product standards. The concepts are, however, equally applicable to the European Organisation for Technical Approvals (EOTA).
The purpose of this document is to assist the Technical Committees in preparing acoustic clauses to ensure that such product standards:
- are as homogeneous as possible, with each individual product standard having the same basic structure;
- are in full accordance with the standards for the measurement and declaration of acoustic properties;
- reflect the latest technical knowledge of methods of determining the acoustical properties from the specific family of building products or equipment under consideration.
NOTE 2 Annex A lists the European and International Standards to be used in the drafting of acoustic provisions standards. Annex B contains guidance on choosing appropriate properties. Annex C describes the relevant measured acoustic properties for common products.
- Technical report41 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the method for declaring the technical classification relating to acoustics for a Product Standard including DoP, or European assessment document (EAD) including European Technical Approval (ETA) for a specific building product or equipment, or a family of building products or equipment. In particular, it gives advice on how to write technical specifications in response to the mandated characteristics on acoustics under the Construction Products Regulation.
NOTE 1 In the remainder of this document, the terms used relate to CEN and product standards. The concepts are, however, equally applicable to the European Organisation for Technical Approvals (EOTA).
The purpose of this document is to assist the Technical Committees in preparing acoustic clauses to ensure that such product standards:
- are as homogeneous as possible, with each individual product standard having the same basic structure;
- are in full accordance with the standards for the measurement and declaration of acoustic properties;
- reflect the latest technical knowledge of methods of determining the acoustical properties from the specific family of building products or equipment under consideration.
NOTE 2 Annex A lists the European and International Standards to be used in the drafting of acoustic provisions standards. Annex B contains guidance on choosing appropriate properties. Annex C describes the relevant measured acoustic properties for common products.
- Technical report41 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives guidance on the application of ISO 9001:2015 in police organizations.
This document can assist a police organization to demonstrate its ability to consistently provide products and services that meet expectations of interested parties as well as applicable statutory and regulatory requirements. This document can assist a police organization in the satisfaction of interested parties.
This document does not provide definitive interpretations of ISO 9001.
This document is applicable to police organizations of all types, sizes, maturity level service and geographic location (e.g. police stations, border crossings, correctional facilities, civil defence).
- Standard103 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard89 pagesEnglish languagesale 15% off
This document gives guidance on the application of ISO 9001:2015 in police organizations. This document can assist a police organization to demonstrate its ability to consistently provide products and services that meet expectations of interested parties as well as applicable statutory and regulatory requirements. This document can assist a police organization in the satisfaction of interested parties. This document does not provide definitive interpretations of ISO 9001. This document is applicable to police organizations of all types, sizes, maturity level service and geographic location (e.g. police stations, border crossings, correctional facilities, civil defence).
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1 Scope
1.1 General
The aviation, space, and defence industries rely on the development and manufacture of complex products comprised of multiple systems, subsystems, and components each designed by individual designers (design activities) at various levels within the supply chain. Each design or manufacturing activity controls various aspects of the configuration and specifications related to the product. When a change to design or process is requested or required, the change is typically required to be evaluated against the impacts to the entire system.
Proposed changes to design data/information that the design activity identifies to be minor and have no effect on the product requirements or specifications, have the potential to be implemented and approved, where authorized to do so, but requires notification. Changes that affect customer mandated requirements or specifications shall be approved prior to implementation. In many cases, the design activity is not conducted by the DAH or design authority. The design activity may be several layers below the design approval. Irrespective of where the design activity is conducted in the supply chain, notification is required. The typical change notification flow is presented in Figure 1.
[Figure 1]
Submitting NOC data either electronically or conventionally on paper is subject to the terms and conditions of the customer’s contract. This also includes, where applicable, data access under the regulations of export control.
The process of exchanging, coordinating, and approving NOC data varies with the multiple relationships and agreements among all organizations concerned. An 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). A sample form can be found in the Supply Chain Management Handbook (SCMH).
If all or part of this document is contractually invoked, design organizations and design holders (i.e. the organization responsible for the product end item design) that have responsibility for change management of products used on other higher-level designs shall use the information and processes defined in this document for submitting change notifications.
1.2 Application
This document defines the common NOC requirements for aviation, space, and defence organizations. The requirements that a design organization are to use when submitting a NOC to the customer for either change authorization or notification are included herein. A NOC informs the customer of physical or functional (e.g. design, material, software, maintenance) changes or any associated process changes to an established baseline configuration.
Retention of the NOC establishes a means of configuration control and captures the evolution of the part. This requirement is of utmost importance in commercial/civil aviation products where changes to type certificated products are mandated by regulations; however, these same concepts are also required in defence and space applications per contractual requirements.
Where there are changes to items which the organization does not have design input or is not permitted to make any changes to the design [e.g. build to print, Technical Standard Order (TSO) articles] then change requests are to be formally submitted to the customer and approved via the customer’s change request process.
[...]
- Standard38 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements for the effective control of non-deliverable software. This document can be used during the design, development, test, production, release, use, maintenance, and retirement of non-deliverable software. This can include non-deliverable software procured from external suppliers and utilized in the design, production, evaluation, test, acceptance, or calibration of a deliverable product.
This document focuses solely on the unique requirements of the operational processes that pertain to non-deliverable software as identified below:
This document applies to non-deliverable software (including firmware) that affects a deliverable product or service. Following are several applications and supporting examples of non-deliverable software that is within the scope of this document:
— design and development: modelling, simulation, virtual reality, virtual machine, computer-aided design (CAD), three-dimensional (3D) modelling and analysis tools, software compiler, and code generators;
— manufacturing: additive manufacturing, computer numerical controlled (CNC) programs, robotics, factory automation, tools that load deliverable software, software used in special process (e.g. heat treat, shot peen, sonic wall inspection), and automated manufacturing software (i.e. pick and place);
— verification, validation and maintenance: coordinate measuring machine (CMM) programs, hardware or software qualification, code coverage, test scripts, analysis tools, acceptance test, production acceptance, calibration (inspection, test or calibration), simulator, emulator, and software used in post-delivery service provisions.
The following types of software are not within scope of this document:
— deliverable software (refer to EN 9115);
— manufacturing and measuring equipment embedded software (e.g. operating system, drivers);
— enterprise or office software (e.g. MS Office, word processing or spreadsheet applications, Teams, network software, email, employee management system).
Operational processes not covered in this document are addressed by the respective organization’s quality management system (QMS), based on the EN 9100-series (i.e. EN 9100, EN 9110, EN 9120) and/or ISO 9001 standards.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
1 Scope
1.1 General
The aviation, space, and defence industries rely on the development and manufacture of complex products comprised of multiple systems, subsystems, and components each designed by individual designers (design activities) at various levels within the supply chain. Each design or manufacturing activity controls various aspects of the configuration and specifications related to the product. When a change to design or process is requested or required, the change is typically required to be evaluated against the impacts to the entire system.
Proposed changes to design data/information that the design activity identifies to be minor and have no effect on the product requirements or specifications, have the potential to be implemented and approved, where authorized to do so, but requires notification. Changes that affect customer mandated requirements or specifications shall be approved prior to implementation. In many cases, the design activity is not conducted by the DAH or design authority. The design activity may be several layers below the design approval. Irrespective of where the design activity is conducted in the supply chain, notification is required. The typical change notification flow is presented in Figure 1.
[Figure 1]
Submitting NOC data either electronically or conventionally on paper is subject to the terms and conditions of the customer’s contract. This also includes, where applicable, data access under the regulations of export control.
The process of exchanging, coordinating, and approving NOC data varies with the multiple relationships and agreements among all organizations concerned. An 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). A sample form can be found in the Supply Chain Management Handbook (SCMH).
If all or part of this document is contractually invoked, design organizations and design holders (i.e. the organization responsible for the product end item design) that have responsibility for change management of products used on other higher-level designs shall use the information and processes defined in this document for submitting change notifications.
1.2 Application
This document defines the common NOC requirements for aviation, space, and defence organizations. The requirements that a design organization are to use when submitting a NOC to the customer for either change authorization or notification are included herein. A NOC informs the customer of physical or functional (e.g. design, material, software, maintenance) changes or any associated process changes to an established baseline configuration.
Retention of the NOC establishes a means of configuration control and captures the evolution of the part. This requirement is of utmost importance in commercial/civil aviation products where changes to type certificated products are mandated by regulations; however, these same concepts are also required in defence and space applications per contractual requirements.
Where there are changes to items which the organization does not have design input or is not permitted to make any changes to the design [e.g. build to print, Technical Standard Order (TSO) articles] then change requests are to be formally submitted to the customer and approved via the customer’s change request process.
[...]
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This document gives guidance on the selection and application of tools that can be used in a quality management system to:
a) characterize a process or a variable;
b) facilitate problem solving;
c) highlight areas for improvement;
d) improve effectiveness.
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This document gives guidance on the selection and application of tools that can be used in a quality management system to: a) characterize a process or a variable; b) facilitate problem solving; c) highlight areas for improvement; d) improve effectiveness.
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This document provides guidance to anatomic pathology (AP) laboratories on implementing a management system to meet requirements for quality and competence of ISO 15189. NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification31 pagesEnglish languagesale 15% off
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This document 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 document 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 document, 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 document specifies the requirements for a railway quality management system (RQMS)
— applicable throughout the whole supply chain of the railway sector related to industrial products and services,
— providing continual improvement, emphasizing defect prevention and defect reduction in the supply chain, and
— enhancing and sustaining product quality, including its safety aspects.
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1.1 General
This document establishes the requirements for performing and documenting FAI. It is emphasized the requirements specified in this document are complementary (not alternative) to customer and applicable statutory and regulatory requirements.
1.2 Purpose
The primary purpose of FAI is to verify and validate product realization processes are capable of producing characteristics that meet engineering and design requirements. A well-planned and executed FAI by a multi-disciplinary team (e.g. members from responsible functions) provides objective evidence the manufacturer’s processes can produce compliant product; having effectively understood and incorporated the associated requirements.
NOTE A FAI is not a product acceptance document. While interrelated, FAI and product acceptance are separate activities. The focus of FAI is verification of production processes via assessment of product. FAI and supporting documentation do not provide assurance regarding conformance for product acceptance purposes; neither does the lack of a FAI necessarily imply product is nonconforming to engineering and design requirements.
FAI will:
- provide confidence, through objective evidence, the product realization processes are capable of producing conforming product;
- demonstrate the manufacturers and processors of the product have an understanding of the associated requirements;
- provide assurance of product conformance at the start of production and after changes, as outlined in this document.
A FAI is intended to:
- mitigate risks associated with production startup and process changes;
- reduce future escapes;
- help ensure product safety;
- improve quality, delivery, and customer satisfaction;
- reduce costs and production delays associated with product nonconformances;
- identify product realization processes not capable of producing conforming characteristics and initiate and/or validate associated corrective actions.
-
1.3 Application
This document applies to organizations and their suppliers responsible for product realization processes that produce the design characteristics of the product. The organization shall flow down the requirements of this document to suppliers who produce design characteristics.
This document also applies to suppliers performing special process(es). A certificate of conformance (CoC) provided by processors attests to satisfying the requirements. External suppliers providing special process(es) can satisfy this document's requirements by either:
- documenting the design characteristics and associated results on a first article inspection report (FAIR); or
- documenting the design characteristics and associated results on a detailed CoC.
This document applies to assemblies, sub-assemblies, and detail parts including castings, forgings, and modifications to standard catalogue or commercial-off-the-shelf (COTS) items. Each of these items have a separate FAI.
Unless contractually required, this document does not apply to:
- development and prototype parts that are not considered as part of the first production run;
- procured standard catalogue item, COTS, or deliverable software. When these items are included in an assembly, they shall be documented in the index of part numbers in an assembly FAIR.
1.4 Informative
If there is a conflict between the requirements of this document, and customer or applicable statutory/regulatory requirements, the latter takes precedence.
In this document, the following verbal forms are used:
- "shall" indicates a requirement;
- "should" indicates a recommendation;
- "may" indicates a permission;
- "can" indicates a possibility or a capability.
Information marked as "NOTE" is for guidance in understanding or clarifying the associated requirement .
- Standard28 pagesEnglish languagesale 10% offe-Library read for1 day
1.1 General
This document establishes the requirements for performing and documenting FAI. It is emphasized the requirements specified in this document are complementary (not alternative) to customer and applicable statutory and regulatory requirements.
1.2 Purpose
The primary purpose of FAI is to verify and validate product realization processes are capable of producing characteristics that meet engineering and design requirements. A well-planned and executed FAI by a multi-disciplinary team (e.g. members from responsible functions) provides objective evidence the manufacturer’s processes can produce compliant product; having effectively understood and incorporated the associated requirements.
NOTE A FAI is not a product acceptance document. While interrelated, FAI and product acceptance are separate activities. The focus of FAI is verification of production processes via assessment of product. FAI and supporting documentation do not provide assurance regarding conformance for product acceptance purposes; neither does the lack of a FAI necessarily imply product is nonconforming to engineering and design requirements.
FAI will:
- provide confidence, through objective evidence, the product realization processes are capable of producing conforming product;
- demonstrate the manufacturers and processors of the product have an understanding of the associated requirements;
- provide assurance of product conformance at the start of production and after changes, as outlined in this document.
A FAI is intended to:
- mitigate risks associated with production startup and process changes;
- reduce future escapes;
- help ensure product safety;
- improve quality, delivery, and customer satisfaction;
- reduce costs and production delays associated with product nonconformances;
- identify product realization processes not capable of producing conforming characteristics and initiate and/or validate associated corrective actions.
-
1.3 Application
This document applies to organizations and their suppliers responsible for product realization processes that produce the design characteristics of the product. The organization shall flow down the requirements of this document to suppliers who produce design characteristics.
This document also applies to suppliers performing special process(es). A certificate of conformance (CoC) provided by processors attests to satisfying the requirements. External suppliers providing special process(es) can satisfy this document's requirements by either:
- documenting the design characteristics and associated results on a first article inspection report (FAIR); or
- documenting the design characteristics and associated results on a detailed CoC.
This document applies to assemblies, sub-assemblies, and detail parts including castings, forgings, and modifications to standard catalogue or commercial-off-the-shelf (COTS) items. Each of these items have a separate FAI.
Unless contractually required, this document does not apply to:
- development and prototype parts that are not considered as part of the first production run;
- procured standard catalogue item, COTS, or deliverable software. When these items are included in an assembly, they shall be documented in the index of part numbers in an assembly FAIR.
1.4 Informative
If there is a conflict between the requirements of this document, and customer or applicable statutory/regulatory requirements, the latter takes precedence.
In this document, the following verbal forms are used:
- "shall" indicates a requirement;
- "should" indicates a recommendation;
- "may" indicates a permission;
- "can" indicates a possibility or a capability.
Information marked as "NOTE" is for guidance in understanding or clarifying the associated requirement .
- Standard28 pagesEnglish languagesale 10% offe-Library read for1 day
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This document defines the minimum requirements for auditors, CBs, auditor authentication bodies (AABs), training provider approval bodies (TPABs), and training providers (TPs) who participate in the IAQG industry controlled other party (ICOP) scheme. The requirements in this document supplement those defined within the EN 9104-001, EN 9104-002, EN ISO/IEC 17021-1, and EN ISO/IEC 17021-3 standards.
Data protection for the parties subject to this document and other relevant requirements of the ICOP scheme are managed via bi-lateral contracts between the joint controllers of the data.
- Standard28 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines the industry-accepted requirements for the ICOP scheme, which provides confidence to ASD customers, that organizations with certification of their QMS, issued by accredited CBs, meet applicable AQMS standard requirements. The requirements in this document are applicable to all participants in the ICOP scheme. If there is a conflict between the requirements of this document, and customer or applicable statutory/regulatory requirements, the latter takes precedence.
- Standard50 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment4 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment4 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines the industry-accepted requirements for the ICOP scheme, which provides confidence to ASD customers, that organizations with certification of their QMS, issued by accredited CBs, meet applicable AQMS standard requirements. The requirements in this document are applicable to all participants in the ICOP scheme. If there is a conflict between the requirements of this document, and customer or applicable statutory/regulatory requirements, the latter takes precedence.
- Standard50 pagesEnglish languagesale 10% offe-Library read for1 day
1.1 General
This document defines requirements for the preparation and execution of the audit process. In addition, it defines the content and composition for the audit reporting of conformity and process effectiveness to the EN 9100-series standards, the organization’s QMS documentation, and customer and statutory/regulatory requirements.
The requirements in this document are additions or represent changes to the requirements and guidelines in the standards for conformity assessment, auditing, and certification as published by ISO/IEC (i.e. ISO/IEC 17000:2020, ISO/IEC 17021 1). When there is conflict with these standards, the requirements of this document take precedence.
NOTE 1 In this document, the term “EN 9100-series standards” comprises the EN 9100, EN 9110, and EN 9120 standards; developed by the IAQG and published by various national standards bodies.
NOTE 2 In addition to this document, the IAQG publishes deployment support material on the IAQG website (see http://www.iaqg.org) that can be used by audit teams, when executing the audit process.
1.2 Application
This document is intended to be used for audits of EN 9100-series standards by Certification Bodies (CBs) for certification of organizations, under the auspices of the ASD industry certification scheme [also known as the Industry Controlled Other Party (ICOP) scheme]. The ICOP scheme requirements are defined in the EN 9104-series standards (i.e. FprEN 9104-1, prEN 9104-2, EN 9104 3).
NOTE Relevant parts of this document can also be used by an organization in support of internal audits (1st party) and external audits at suppliers (2nd party).
- Standard30 pagesEnglish languagesale 10% offe-Library read for1 day
1.1 General
This document is primarily intended to apply to new parts and products intended to be produced in an on-going production phase but can also be applied to parts currently in production (e.g., manufacturing, maintenance). This document is applicable to all production processes that influence the variation of KCs, as well as maintenance and service processes in which KCs are identified. It applies to organizations for assemblies and all levels of parts within an assembly, down to the basic materials including castings and forgings, and to organizations that are responsible for producing the design characteristics of the product.
The variation control process begins with product definition, typically stated in the design documentation (e.g., digital model, engineering drawing, specification) which identifies KCs, and leads to a variation management process for those KCs. This process may also be used for producer-identified KCs (e.g., process KCs, additional/substitute product KCs).
Producers and their subcontractors are responsible for flow down of the standard requirements to those external providers, who produce design characteristics and provide production and service provisions, to ensure that KCs conform to the customer’s requirements.
1.2 Purpose
This document is designed to drive the improvement of manufacturing and maintenance processes through adequate planning and effective management of KC variation. This focus is intended to improve uniformity (less variation or minimum variation of product KCs) and acceptance probability of the end-product.
NOTE Control of a product or process KC per this document does not constitute, nor imply acceptance of the resulting product. If variation management, under this document, is to be part of an acceptance decision, the requirements need to be specified in the applicable product acceptance plan or contract.
1.3 Convention
The following conventions are used in this document:
- "shall" indicates a requirement;
- "should" indicates a recommendation;
- "may" indicates a permission; and
- "can" indicates a possibility or a capability.
- Standard34 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines the minimum requirements for auditors, CBs, auditor authentication bodies (AABs), training provider approval bodies (TPABs), and training providers (TPs) who participate in the IAQG industry controlled other party (ICOP) scheme. The requirements in this document supplement those defined within the EN 9104-001, EN 9104-002, EN ISO/IEC 17021-1, and EN ISO/IEC 17021-3 standards.
Data protection for the parties subject to this document and other relevant requirements of the ICOP scheme are managed via bi-lateral contracts between the joint controllers of the data.
- Standard28 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment4 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment4 pagesEnglish languagesale 10% offe-Library read for1 day
1.1 General
This document is primarily intended to apply to new parts and products intended to be produced in an on-going production phase but can also be applied to parts currently in production (e.g., manufacturing, maintenance). This document is applicable to all production processes that influence the variation of KCs, as well as maintenance and service processes in which KCs are identified. It applies to organizations for assemblies and all levels of parts within an assembly, down to the basic materials including castings and forgings, and to organizations that are responsible for producing the design characteristics of the product.
The variation control process begins with product definition, typically stated in the design documentation (e.g., digital model, engineering drawing, specification) which identifies KCs, and leads to a variation management process for those KCs. This process may also be used for producer-identified KCs (e.g., process KCs, additional/substitute product KCs).
Producers and their subcontractors are responsible for flow down of the standard requirements to those external providers, who produce design characteristics and provide production and service provisions, to ensure that KCs conform to the customer’s requirements.
1.2 Purpose
This document is designed to drive the improvement of manufacturing and maintenance processes through adequate planning and effective management of KC variation. This focus is intended to improve uniformity (less variation or minimum variation of product KCs) and acceptance probability of the end-product.
NOTE Control of a product or process KC per this document does not constitute, nor imply acceptance of the resulting product. If variation management, under this document, is to be part of an acceptance decision, the requirements need to be specified in the applicable product acceptance plan or contract.
1.3 Convention
The following conventions are used in this document:
- "shall" indicates a requirement;
- "should" indicates a recommendation;
- "may" indicates a permission; and
- "can" indicates a possibility or a capability.
- Standard34 pagesEnglish languagesale 10% offe-Library read for1 day
1.1 General
This document defines requirements for the preparation and execution of the audit process. In addition, it defines the content and composition for the audit reporting of conformity and process effectiveness to the EN 9100-series standards, the organization’s QMS documentation, and customer and statutory/regulatory requirements.
The requirements in this document are additions or represent changes to the requirements and guidelines in the standards for conformity assessment, auditing, and certification as published by ISO/IEC (i.e. ISO/IEC 17000:2020, ISO/IEC 17021 1). When there is conflict with these standards, the requirements of this document take precedence.
NOTE 1 In this document, the term “EN 9100-series standards” comprises the EN 9100, EN 9110, and EN 9120 standards; developed by the IAQG and published by various national standards bodies.
NOTE 2 In addition to this document, the IAQG publishes deployment support material on the IAQG website (see http://www.iaqg.org) that can be used by audit teams, when executing the audit process.
1.2 Application
This document is intended to be used for audits of EN 9100-series standards by Certification Bodies (CBs) for certification of organizations, under the auspices of the ASD industry certification scheme [also known as the Industry Controlled Other Party (ICOP) scheme]. The ICOP scheme requirements are defined in the EN 9104-series standards (i.e. FprEN 9104-1, prEN 9104-2, EN 9104 3).
NOTE Relevant parts of this document can also be used by an organization in support of internal audits (1st party) and external audits at suppliers (2nd party).
- Standard30 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard72 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard – translation102 pagesSlovenian and English languagesale 10% offe-Library read for1 day
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”.
- Standard11 pagesEnglish languagesale 10% offe-Library read for1 day
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”.
- Standard11 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard72 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard – translation102 pagesSlovenian and English languagesale 10% offe-Library read for1 day
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.
- Standard69 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard62 pagesEnglish languagesale 15% off
- Standard66 pagesFrench languagesale 15% off
- Standard66 pagesFrench languagesale 15% off
- Standard66 pagesFrench languagesale 15% off
- Standard64 pagesEnglish, Spanish and Russian languagesale 15% off
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.
- Technical report65 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Technical specification47 pagesEnglish languagesale 10% offe-Library read for1 day
- Technical specification41 pagesEnglish languagesale 15% off
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.
- Technical report65 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard40 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard33 pagesEnglish languagesale 15% off
- Standard35 pagesFrench languagesale 15% off
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
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard17 pagesEnglish languagesale 15% off
- Standard18 pagesFrench languagesale 15% off
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.
- Technical specification47 pagesEnglish languagesale 10% offe-Library read for1 day
- Technical specification41 pagesEnglish languagesale 15% off
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
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
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- Standard18 pagesFrench languagesale 15% off
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.
- Standard59 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard43 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard24 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard40 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard33 pagesEnglish languagesale 15% off
- Standard35 pagesFrench languagesale 15% off