11.020.01 - Quality and environmental management in health care
ICS 11.020.01 Details
Quality and environmental management in health care
Management de la qualité et management environnemental dans le domaine de la santé
Vodenje kakovosti in ravnanje z okoljem v zdravstvu
General Information
e-Library Subscription
Create subscription and get permanent access to documents within 11.020.01 - Quality and environmental management in health care
Currently subscription includes documents marked with .We are working on making all documents available within the subscription.
This document provides guidance on essential social welfare services and medical support for socially vulnerable groups, who are likely to be in greater danger in the event of a respiratory epidemic disaster. This document applies to those: a) providing essential social welfare services for socially vulnerable groups in the event of a respiratory epidemic disaster; b) providing essential medical support for socially vulnerable groups in the event of a respiratory epidemic disaster.
- Technical specification11 pagesEnglish languagesale 15% off
This document provides guidelines to prevent cross-infections within a hospital, with a specific focus on the separate operation of wards dedicated to highly contagious respiratory infectious diseases, transportation of confirmed cases of highly contagious respiratory infectious diseases, disinfection, waste management, etc. This document applies to the following: a) separate operation of wards dedicated to highly contagious respiratory infectious diseases; b) transportation of confirmed cases of highly contagious respiratory infectious diseases and roles of the dedicated healthcare team in a ward dedicated to highly contagious respiratory infectious diseases; c) cleaning, disinfection, and waste management.
- Technical specification28 pagesEnglish languagesale 15% off
This document specifies the infection prevention and control (IPC) measures for cross-border workers. It is applicable only in the circumstance of novel infectious disease outbreak while valid vaccine or drug for treatment are not available. It can be used for the purpose of maintaining economic activities when a country that workers need to enter blocks its border due to a pandemic or epidemic (Annex A). This document provides information on the key aspects and details of the process requirements, procedures for selecting service providers, such as travel management company, and procedures for cross-border workers amidst a pandemic, encompassing the complete set of stages from ‘pre-departure’, ‘border crossing’, ‘quarantine and commute’, to ‘return’, and is addressed to all stakeholders involved in travel, whether from the public or private sector. NOTE Stakeholders are comprised of but not limited to health authority, healthcare organization and screening stations, accommodation services, transportation services, travel agencies, and private companies including their contractors and providers.
- Technical specification23 pagesEnglish languagesale 15% off
This document specifies hand hygiene training, compliance benchmarking, performance/feedback, and facility requirements for healthcare facilities that operate hand hygiene systems. This document covers facility readiness, hand hygiene education and training, monitoring, performance, promotion and identifying key issues that require attention for improvement. Procedures for surgical hand preparation are not addressed in this document. Furthermore, this document does not take into consideration, surface disinfection, instrument disinfection, ultraviolet irradiation (UV-C), heat sterilization, room fogging or electrostatic spraying devices and any other methods typically not designed or suitable for human hand hygiene purposes. Excluding surgical hand preparation, this document applies specifically to clinical healthcare workers, patients and visitors.
- Standard33 pagesEnglish languagesale 15% off
The purpose of this document is to provide organizations with requirements to deliver high-quality healthcare and specifies requirements for management systems for quality in healthcare organizations when an organization desires to: a) demonstrate its ability to consistently meet service user, stakeholder, and applicable statutory and regulatory requirements; b) enhance service user experience during the continuum of care and continually improve healthcare quality; and c) create and maintain processes that ensure timely, safe, effective, efficient, equitable, and people-centred care. The requirements of this document are based on recognized best practices and are intended to be applicable to any organization providing healthcare services, regardless of its type, size, or the services it provides.
- Standard35 pagesEnglish languagesale 15% off
This document provides processes that can be used to analyze the risks to the quality and safety of healthcare and continuity of care when telehealth services are used to support healthcare activities. Using risk management processes, quality objectives and procedures are derived which provide guidelines for the operations of telehealth services. These include but are not limited to the following domains:
— management of telehealth quality processes by the healthcare organization;
— strategic and operational process management relating to regulations, knowledge management (best practice) and guidelines;
— healthcare processes relating to people such as healthcare activities, planning, and responsibilities;
— management of financial resources to support telehealth services;
— management of information management and security used in telehealth services;
— processes related to the planning and provision of human resources, infrastructure, facilities and technology resources for use by telehealth services.
This document provides a set of example guidelines containing quality objectives and procedures for each domain. Organizations can apply the quality and risk management processes described in Clauses 5 and 6 to develop quality objectives and procedures appropriate to the telehealth services they provide.
This document does not provide guidance for the manufacture, assembly, configuration, interoperability or management of devices, products or technical systems.
Annex A provides procedures for the implementation of telehealth services by a large organization. Annex B provides use cases for the application of quality planning guidelines in different types of real-world telehealth services.
- Standard57 pagesEnglish languagesale 10% offe-Library read for1 day
This document provides processes that can be used to analyze the risks to the quality and safety of healthcare and continuity of care when telehealth services are used to support healthcare activities. Using risk management processes, quality objectives and procedures are derived which provide guidelines for the operations of telehealth services. These include but are not limited to the following domains:
— management of telehealth quality processes by the healthcare organization;
— strategic and operational process management relating to regulations, knowledge management (best practice) and guidelines;
— healthcare processes relating to people such as healthcare activities, planning, and responsibilities;
— management of financial resources to support telehealth services;
— management of information management and security used in telehealth services;
— processes related to the planning and provision of human resources, infrastructure, facilities and technology resources for use by telehealth services.
This document provides a set of example guidelines containing quality objectives and procedures for each domain. Organizations can apply the quality and risk management processes described in Clauses 5 and 6 to develop quality objectives and procedures appropriate to the telehealth services they provide.
This document does not provide guidance for the manufacture, assembly, configuration, interoperability or management of devices, products or technical systems.
Annex A provides procedures for the implementation of telehealth services by a large organization. Annex B provides use cases for the application of quality planning guidelines in different types of real-world telehealth services.
- Standard57 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the operation of a walk-through screening station (WTSS) for mass testing as part of pandemic response management. NOTE COVID-19 is an exemplary disease for which such a station is developed.
- Standard15 pagesEnglish languagesale 15% off
This document specifies the operation of a drive-through screening station (DTSS) for mass testing as part of pandemic response management. NOTE COVID-19 is an exemplary disease for which such a station is developed.
- Standard13 pagesEnglish languagesale 15% off
- Amendment27 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment27 pagesEnglish languagesale 10% offe-Library read for1 day
This document provides requirements for patient-centred staffing in healthcare settings. It is generic and applicable to any healthcare organization.
- Standard9 pagesEnglish languagesale 15% off
- Standard9 pagesEnglish languagesale 15% off
This document defines terms used in healthcare organization management.
- Standard11 pagesEnglish languagesale 15% off
- Standard11 pagesEnglish languagesale 15% off
CCMC - creation of a 2nd corrigendum as the instructions in the 1st corrigendum were incomplete and unclear
- Corrigendum9 pagesEnglish languagesale 10% offe-Library read for1 day
This Technical Report provides guidance on the relationship between the requirements in the European Regulations for Medical Device and In Vitro Diagnostic Medical Devices and EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.
- Technical report85 pagesEnglish languagesale 10% offe-Library read for1 day
This European Standard specifies requirements for a quality management system when a healthcare organization:
a) needs to demonstrate its ability to consistently provide healthcare product or service that meets 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 requirements, applicable statutory and regulatory requirements and requirements related to the quality characteristics; appropriate, correct care; availability; continuity of care; effectiveness; efficiency; equity; evidence/knowledge based care; patient centred care including physical, psychological and social integrity; patient involvement; patient safety and timelines/accessibility.
NOTE 1 Statutory and regulatory requirements can be expressed as legal requirements.
Requirements related to material outputs such as tissue, blood products, pharmaceuticals, cell culture products and medical devices have not been focused in the scope of this standard as they are regulated elsewhere.
This standard is focused on requirements for clinical processes. Organizations that also include research or education processes, or both in their quality management system could use the requirements in this standard where applicable.
This standard aims to adjust and specify the requirements, as well as the “product and service” concept and customer perspectives in EN ISO 9001:2015 to the specific conditions for healthcare providing mainly services and where customers are mainly patients.
- Standard83 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard – translation127 pagesSlovenian and English languagesale 10% offe-Library read for1 day
The standard specifies requirements for a quality management system in a healthcare organization
- Standard83 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard – translation127 pagesSlovenian and English languagesale 10% offe-Library read for1 day
EN ISO 13485 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). This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of this International Standard 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 this International Standard 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 this International Standard reflect any exclusion of design and development controls. If any requirement in Clauses 6, 7 or 8 of this International Standard 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.
- Standard68 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard78 pagesGerman languagesale 10% offe-Library read for1 day
- Standard – translation131 pagesSlovenian and English languagesale 10% offe-Library read for1 day
This European Standard specifies requirements and recommendations for healthcare services provided by chiropractors.
- Standard35 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard provides guidelines beyond the requirements given in ISO 9001 in order to consider both the effectiveness and efficiency of a quality management system, and consequently the potential for improvement of the performance of an organization. When compared to ISO 9001, the objectives of customer satisfaction and product quality are extended to include the satisfaction of interested parties and the performance of the organization.
This International Standard is applicable to the processes of the organization and consequently the quality management principles on which it is based can be deployed throughout the organization. The focus of this International Standard is the achievement of ongoing improvement, measured through the satisfaction of customers and other interested parties.
This International Standard consists of guidance and recommendations and is not intended for certification, regulatory or contractual use, nor as a guide to the implementation of ISO 9001.
This Technical Report provides assistance on how the EN ISO 9004:2000 guidelines may be applied to health services, without prescribing the activities that need to be done by the health service provider; the latter should use its own professional knowledge and/or follow guidelines and protocols established by relevant professional bodies.
Even though EN ISO 9004:2000 promotes a better understanding of the EN ISO 9001:2000 requirements, its scope goes further than that. It is a technical document for managers and process owners to monitor and improve organisation performance, minimise risks, reduce costs, satisfy customers and improve competitiveness.
To fulfil the requirements of processes that have impact on patient safety this Technical Report provides an approach for improvement of risk management in the organisation.
An important value of EN ISO 9004:2000 is that it can be used for self-assessment (see Annex A) comparing the performance of the organisation with the 290 in
- Technical report91 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard provides guidelines beyond the requirements given in ISO 9001 in order to consider both the effectiveness and efficiency of a quality management system, and consequently the potential for improvement of the performance of an organization. When compared to ISO 9001, the objectives of customer satisfaction and product quality are extended to include the satisfaction of interested parties and the performance of the organization.
This International Standard is applicable to the processes of the organization and consequently the quality management principles on which it is based can be deployed throughout the organization. The focus of this International Standard is the achievement of ongoing improvement, measured through the satisfaction of customers and other interested parties.
This International Standard consists of guidance and recommendations and is not intended for certification, regulatory or contractual use, nor as a guide to the implementation of ISO 9001.
This Technical Report provides assistance on how the EN ISO 9004:2000 guidelines may be applied to health services, without prescribing the activities that need to be done by the health service provider; the latter should use its own professional knowledge and/or follow guidelines and protocols established by relevant professional bodies.
Even though EN ISO 9004:2000 promotes a better understanding of the EN ISO 9001:2000 requirements, its scope goes further than that. It is a technical document for managers and process owners to monitor and improve organisation performance, minimise risks, reduce costs, satisfy customers and improve competitiveness.
To fulfil the requirements of processes that have impact on patient safety this Technical Report provides an approach for improvement of risk management in the organisation.
An important value of EN ISO 9004:2000 is that it can be used for self-assessment (see Annex A) comparing the performance of the organisation with the 290 in
- Technical report91 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Corrigendum4 pagesEnglish languagesale 10% offe-Library read for1 day
- Corrigendum – translation5 pagesSlovenian languagesale 10% offe-Library read for1 day
This International Standard specifies rules and guidelines for a medical device nomenclature data
structure, in order to facilitate cooperation and exchange of data used by regulatory bodies on an
international level between interested parties, e.g. regulatory authorities, manufacturers, suppliers,
healthcare providers and end users.
This International Standard includes guidelines for a minimum data set and its structure. These
guidelines are provided for system designers setting up databases that utilize the nomenclature system
described herein.
The requirements contained in this International Standard are applicable to the development and
maintenance of an international nomenclature for medical device identification.
This International Standard does not include the nomenclature itself, which is provided as a separate
data file.
- Standard21 pagesEnglish languagesale 10% offe-Library read for1 day
This European standard specifies requirements for a quality management system where an organization:
a) needs to demonstrate its ability to consistently provide health care services that meet requirements from customers as well as applicable statutory and regulatory requirements, and professional standards
b) aims to enhance customer satisfaction through the effective application of the system, including continual improvement of the management system, the clinical processes and the assurance of conformity to requirements related to the quality characteristics ; appropriate, correct care; availability; continuity of care; effectiveness; efficiency; equity; evidence/knowledge based care; patient centred care including physical, psychological and social integrity; patient involvement; patient safety and timelines/accessibility. Material products such as tissue, blood products, pharmaceuticals, cell culture products and medical devices have not been focused in the scope of the standard as they are regulated elsewhere. This European Standard is focused on requirements for clinical processes. Organizations that also include research or education processes, or both in their quality management system could use the requirements in this European Standard where applicable. This European Standard aims to adjust and specify the requirements, as well as the “product” concept and customer perspectives in EN ISO 9001:2008 to the specific conditions for health care where products are mainly services and customers are mainly patients. The focus of this European Standard is the clinical processes and their risk management in order to promote good quality health care.
- Standard64 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard – translation94 pagesSlovenian and English languagesale 10% offe-Library read for1 day
1.1 General
This European standard specifies requirements for a quality management system where an organization:
a) needs to demonstrate its ability to consistently provide health care services that meet requirements from customers as well as applicable statutory and regulatory requirements, and professional standards
b) aims to enhance customer satisfaction through the effective application of the system, including continual improvement of the management system, the clinical processes and the assurance of conformity to requirements related to the quality characteristics ; appropriate, correct care; availability; continuity of care; effectiveness; efficiency; equity; evidence/knowledge based care; patient centred care including physical and psychological integrity; patient involvement; patient safety and timelines/accessibility.
Material products such as tissue, blood products, pharmaceuticals, cell culture products and medical devices have not been focused in the scope of the standard as they are regulated elsewhere.
This European Standard is focused on requirements for clinical processes. Organizations that also include research or education processes, or both in their quality management system could use the requirements in this European Standard where applicable.
This European Standard aims to adjust and specify the requirements, as well as the “product” concept and customer perspectives in EN ISO 9001:2008 to the specific conditions for health care where products are mainly services and customers are mainly patients.
The focus of this European Standard is the clinical processes and their risk management in order to promote good quality health care.
1.2 Application
This European Standard
a) gives requirements for systematic approaches for the organization’s ability to produce good quality health care.
b) can be used by management at all levels in the health care organization to implement and maintain a quality management system or by internal and external parties, including certification bodies, to assess the organization’s ability to meet patients’ needs and expectations as well those from other customers.
c) is applicable to health care organizations, regardless of structure, organization, owner, size or type of health care services provided.
d) is applicable to e.g. primary health care, pre-hospital and hospital care, tertiary care, nursing homes, hospices, preventive health care, mental health services, dental services, physiotherapy, occupational health services and pharmacies.
e) is focused on requirements for clinical processes. Organizations that also include research or education processes, in the scope of their quality management system could use the requirements in this standard where applicable.
Where any requirement(s) of this European Standard cannot be applied due to the nature of a health care organization and its product (including services), this can be considered for exclusion.
Where exclusions are made, claims of conformity to this European Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the health care organization’s ability, or responsibility, to provide products (including services) that meets customer and applicable statutory and regulatory requirements.
- Standard64 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard – translation94 pagesSlovenian and English languagesale 10% offe-Library read for1 day
This Technical Report provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. This Technical Report does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. This guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.
- Technical report84 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard provides rules and guidelines for a medical device nomenclature data structure, in order to facilitate cooperation and exchange of data used by regulatory bodies on an international level between interested parties, e.g. regulatory authorities, manufacturers, suppliers, health care providers and end users. This International Standard includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases that utilize the nomenclature system described herein. The requirements contained in this International Standard are applicable to the development and maintenance of an international nomenclature for medical device identification.
- Standard28 pagesEnglish languagesale 10% offe-Library read for1 day
2012-04-27 EMA: CEN/CLC Corrigendum only for the Annex ZA (CLC PR = 24183).
- Corrigendum5 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard 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 requirements and regulatory requirements applicable to medical devices and related services. The primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 (see Annex B).
- Standard85 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard provides guidelines beyond the requirements given in ISO 9001 in order to consider both the effectiveness and efficiency of a quality management system, and consequently the potential for improvement of the performance of an organization. When compared to ISO 9001, the objectives of customer satisfaction and product quality are extended to include the satisfaction of interested parties and the performance of the organization. This International Standard is applicable to the processes of the organization and consequently the quality management principles on which it is based can be deployed throughout the organization. The focus of this International Standard is the achievement of ongoing improvement, measured through the satisfaction of customers and other interested parties. This International Standard consists of guidance and recommendations and is not intended for certification, regulatory or contractual use, nor as a guide to the implementation of ISO 9001.
- Standard84 pagesEnglish languagesale 15% off
- Technical specification – translation148 pagesSlovenian and English languagesale 10% offe-Library read for1 day
This European Standard specifies requirements and recommendations for healthcare services provided by chiropractors.
- Standard30 pagesEnglish languagesale 10% offe-Library read for1 day
A quality management system is a management system to direct and control an organisation with regard to quality (ISO 9000:2000).
The guide is generally applicable to the health services sector and will complement national legislation. Furthermore other national requirements, sector specific requirements and standards may complement the guide or be used in parallel.
The main target groups for this guide are strategic decision-makers at all levels in the health services sector and all staff who are involved in the development, implementation and assessment of a quality management system in a health care organisation, including the stakeholders.
This guide is generally applicable to all health care organisations regardless of structure, organisation, owner, size, type of service provided, locally used approaches or location. When using and adapting this guide every organisation needs to consider the nature, culture, complexity, legislation, regulation, etc. of their organisation and further specify their own requirements and use complementary national and local information.
The guide also applies to the requirements of patient organisations, owners, users, insurers, inspectorates and to relevant legislation. In this manner the guide provides a basis for national requirements on health services, e.g. Provisions and Recommendations, for purchasers of health services, for contracts and agreements, and for supervision, audit, certification and accreditation in the health services sector.
- Technical specification64 pagesEnglish languagesale 10% offe-Library read for1 day
A quality management system is a management system to direct and control an organisation with regard to quality (ISO 9000:2000).
The guide is generally applicable to the health services sector and will complement national legislation. Furthermore other national requirements, sector specific requirements and standards may complement the guide or be used in parallel.
The main target groups for this guide are strategic decision-makers at all levels in the health services sector and all staff who are involved in the development, implementation and assessment of a quality management system in a health care organisation, including the stakeholders.
This guide is generally applicable to all health care organisations regardless of structure, organisation, owner, size, type of service provided, locally used approaches or location. When using and adapting this guide every organisation needs to consider the nature, culture, complexity, legislation, regulation, etc. of their organisation and further specify their own requirements and use complementary national and local information.
The guide also applies to the requirements of patient organisations, owners, users, insurers, inspectorates and to relevant legislation. In this manner the guide provides a basis for national requirements on health services, e.g. Provisions and Recommendations, for purchasers of health services, for contracts and agreements, and for supervision, audit, certification and accreditation in the health services sector.
- Technical specification64 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard 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 requirements and regulatory requirements applicable to medical devices and related services. The primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 (see Annex B).
- Corrigendum7 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 13485:2003 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 requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
If 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 regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.
If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.
The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.
- Standard62 pagesEnglish languagesale 10% offe-Library read for1 day
ISO/IEC Guide 63:2012 provides guidance to standards writers on how to include safety aspects in the development of medical device safety standards intended to be used within the risk management framework established in ISO 14971. It expands on the concepts developed in ISO/IEC Guide 51 to include safety-related performance and usability. ISO/IEC Guide 63:2012 is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.
- Guide21 pagesEnglish languagesale 15% off
- Guide12 pagesRussian languagesale 15% off
TC - BT decision, withdrawal of EN 46003:1999 and subsequent modifications regarding Module E
20061212 - Corrects EN ISO 13485:2003 and withdraws EN 46003:1999
- Corrigendum10 pagesEnglish, French and German languagesale 10% offe-Library read for1 day
This European Standard specifies, in conjunction with EN ISO 9003 : 1994, the quality system requirements for the final inspection and test of medical devices excluding in vitro diagnostic medical devices and active implantable medical devices, and is applicable when a medical device supplier's quality system is assessed in accordance with regulatory requirements. NOTE: For sterile medical devices the relevant particular clauses inEN 46002 : 1996 apply as this standard alone is not sufficient for manufacturers of sterile medical devices seeking to comply with regulatory requirements. As part of an assessment by a third party for the purpose of regulatory requirements, the supplier may be required to provide access to confidential data in order to demonstrate compliance with this standard. The supplier may be required to exhibit these data but is not obliged to provide copies for retention.
- Standard9 pagesEnglish languagesale 10% offe-Library read for1 day
This European Standard specifies, in conjunction with EN ISO 9002, the quality system requirements for the production, and where relevant, installation of medical devices. The field of application of EN ISO 9002 applies. In addition, this European Standard, in conjunction with EN ISO 9002, is applicable when a medical device supplier's quality system is assessed in accordance with regulatory requirements. As part of an assessment by a third party for the purpose of regulatory requirements, the supplier may be required to provide access to confidential data in order to demonstrate compliance with this standard. The supplier may be required to exhibit these data but is not obliged to provide copies for retention.
- Standard12 pagesEnglish languagesale 10% offe-Library read for1 day
This European Standard specifies, in conjunction with EN ISO 9001, the quality system requirements for the design/development, production, and where relevant, installation and servicing of medical devices. The field of application of EN ISO 9001 applies. In addition, this European Standard, in conjunction with EN ISO 9001, is applicable when a medical device supplier's quality system is assessed in accordance with regulatory requirements. As part of an assessment by a third party for the purpose of regulatory requirements, the supplier may be required to provide access to confidential data in order to demonstrate compliance with this standard. The supplier may be required to exhibit these data but is not obliged to provide copies for retention.
- Standard12 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 day