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
Frequently Asked Questions
ICS 11.020.01 is a classification code in the International Classification for Standards (ICS) system. It covers "Quality and environmental management in health care". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 55 standards classified under ICS 11.020.01 (Quality and environmental management in health care). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
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This document specifies the functions and quality evaluation of the specimen collection booth as part of pandemic response management for respiratory diseases. NOTE COVID-19 is an example of a disease for which such a specimen-collection booth is developed.
- Standard18 pagesEnglish languagesale 15% off
This document specifies requirements for the management of information related to response resources for a public health emergency (PHE) response, from the perspective of information and communication technology (ICT). This document provides: - an overview of response resource information management; - requirements for managing response resource information including: - information collection; - information storage; - information disposal; - information distribution. The requirements in this document can only be effectively applied, if information exchange described in REF Section_sec_5 \r \h Clause 5 08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E000000530065006300740069006F006E005F007300650063005F0035000000 is supported at both municipal and national levels.
- Standard8 pagesEnglish languagesale 15% off
This document provides recommendations for healthcare organizations on how to effectively manage and classifies patients who are infected with respiratory infectious diseases, especially during a pandemic. It covers various aspects of patient care, infection control and healthcare facility management to ensure the safety of both patients and healthcare workers in such situations.
- Technical specification10 pagesEnglish languagesale 15% off
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 languagee-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 languagee-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
SIGNIFICANCE AND USE
4.1 Application of the approach described within this practice applies the science-based, risk-based, and statistics-based concepts and principles introduced in Guides E3106 and E3219.
4.2 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the inspection of equipment for cleanliness in accordance with 21 CFR 211.67(b)(6) and is in accordance with FDA Process Validation Guidance Life Cycle approach.
4.3 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the visual inspection of equipment for cleanliness in accordance with European Medicines Agency (EMA) Annex 15.
4.4 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the visual inspection of equipment for cleanliness in accordance with the EMA’s Q&A Guidance (Q&A’s #7 and #8) (2).
4.5 Visual Inspection used as described in 4.4 should only be used in situations where there is a suitable safety margin between the VRL and MSSR and robust detectability at the VRL.
4.6 Application of the approach described within this practice applies the risk-based concepts and principles introduced in ICH Q9. As stated in ICH Q9, the level of effort, formality, and documentation for validation (including cleaning validation) should also be commensurate with the level of risk.
4.7 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for releasing manufacturing equipment and manufactured medical devices or cleanliness that is compatible with the U.S. FDA Guidance for Industry, PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance.
4.8 Key Concepts—This practice applies the following key concepts: (1) visual inspection, (2) quality risk management, (3) science-based appr...
SCOPE
1.1 This practice provides statistically valid procedures for determining the visual detection limit of residues and the qualification of inspectors to perform the visual inspection of pharmaceutical manufacturing equipment surfaces and medical devices for residues.
1.2 This practice applies to pharmaceuticals (including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies) and medical devices following all manufacturing and cleaning. This practice is also applicable to other health, cosmetics, and consumer products.
1.3 This practice applies to many types of chemical residues (including APIs, intermediates, cleaning agents, processing aids, machining oils, and so forth) that could remain on manufacturing equipment surfaces or medical devices that have undergone all manufacturing steps including cleaning.
1.4 This practice applies only to equipment or devices that have been justified through a Quality Risk Management program to have an acceptable hazard analysis, have cleaning processes that are repeatable and validated and where Visual Inspection can be relied upon to determine the cleanliness of the equipment at the residue limit justified by the HBEL.
1.5 The values stated in International System of Units (SI) units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommend...
- Standard21 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 languagee-Library read for1 day
- Amendment27 pagesEnglish languagee-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
SIGNIFICANCE AND USE
4.1 This guide provides minimum training guidelines for safe and efficient ambulance operations.
4.2 Ambulance providers and educators should follow this guide for the development of educational and training programs.
4.3 This guide is intended to promote safe and efficient ambulance operations and to reduce morbidity, mortality, and property loss associated with ambulance operations.
4.4 This guide is intended to assist those who are responsible for the development and implementation of policies and procedures for ambulance operations.
4.5 Topics or concepts listed in this guide are intended to serve as an outline of materials to be covered in the training of ambulance operators.
SCOPE
1.1 This guide provides minimum training standards for Emergency Medical Services (EMS) Ambulance Operators including legal aspects, operator qualifications and testing, history of EMS vehicle operations, vehicle types/equipment, safety, physical forces, mechanics, pre-run, operations, post-run, and special circumstances.
1.2 This guide promotes the safe and efficient delivery of the ambulance, equipment, crew, passengers, and patients, during all phases of the delivery of EMS involving the ambulance, at all times exercising the highest degree of care for the safety of the public. This guide may be applied to the driving of other EMS vehicles that do not necessarily provide patient transportation.
1.3 This guide shall be used as the basis for all programs relevant to the training of the emergency medical services operators.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Guide8 pagesEnglish languagesale 15% off
This document defines terms used in healthcare organization management.
- Standard11 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
5.1 Materials used in medical devices are selected in part for their biocompatibility, meaning that they have been demonstrated to have an acceptable biological response for the intended application. During manufacturing, most devices are exposed to a variety of processing steps and materials that have the potential to adversely affect the inherent biocompatibility of the device if they are not adequately removed prior to use.
Note 1: For a fine powder, depending upon application, a new biological risk assessment may be required.
5.2 In additive manufacturing, components are in most cases built layer-by-layer, allowing unprecedented freedom to design complex devices. This makes it possible to build devices that are very difficult to clean, such as topological optimized parts, small internal channels, lattice structures, and especially reticulated porous structures for bone ingrowth and fixation.
5.3 Powdered fusion AM presents additional challenges. Components come out of the build volume with residual powder filling all open spaces within the device. The majority of the excess powder is typically removed by a combination of vibratory shaking, blowing with compressed gas, vacuuming, and ultrasonic cleaning in a solvent. However, the particles are typically very small and can become lodged in internal features such as pores, making removal difficult. Furthermore, particles that were immediately adjacent to the component during manufacturing can be partially sintered to the surface. Those particles can be extremely difficult to remove, are indistinguishable from loose particles when observed by most techniques, and may be at risk of detaching during the intended use of the device.
5.4 This guide provides specific evaluation techniques for measuring the effectiveness of residue removal processes, as they should be able to yield consistent results that meet the respective performance and cleanliness criteria for the intended use.
SCOPE
1.1 This standard provides guidance for assessing the manufacturing material residues in medical devices fabricated using additive manufacturing (AM) techniques, specifically, from powder bed fusion AM technologies.
1.1.1 Some of the techniques discussed in this guide may be applicable to devices fabricated by other types of AM equipment (e.g., stereolithography). Given each AM technique’s characteristics and post-processing challenges, there could be additional risks or considerations associated with some AM techniques or materials that are not addressed by this guide.
1.2 This guide covers several qualitative and quantitative assessments of the presence and amount of residue remaining in or obtained by extraction in aqueous or organic solvents from powder bed fusion AM medical components.
1.2.1 This guide identifies techniques to qualitatively determine the presence of residue and a technique to quantitatively assess it. It does not set acceptance criteria or acceptable limits for residues remaining in built parts. These methods are not the only methods to determine the presence or quantity of residual material in additive manufactured medical components.
1.3 This guide pertains to devices in their finished state (after post-processing and subsequent manufacturing processes), as applicable. This guide may also be used to evaluate the effectiveness of cleaning processes between critical steps in the manufacturing process, to ensure minimal AM residue remains for cleaning processes downstream.
1.4 This guide is not intended to evaluate the residue level in medical components that have been cleaned for reuse.
1.5 Different cleaning methods, including high energy processes, can potentially damage small structures in AM parts. This guide does not address measurement or mitigation of this risk.
1.6 This guide does not address the manufacturing occupational health issues of working with small particles (e.g., breathing hazards).
1....
- Guide7 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
5.1 This standard guide may be used by medical device manufacturers as part of their design plan and implementation of the validation of the cleaning instructions of their reusable medical devices.
5.2 It may help medical device manufacturers identify the most inaccessible locations on their device for inoculation with clinically relevant, simulated-use test soil (see ASTM F3208), thereby allowing testing to evaluate whether or not the medical device can be adequately cleaned.
5.3 Methods described include pipetting, brushing, immersing, spraying, handling, and other techniques for applying soil.
5.4 Guidance is given as to how to identify the clinically relevant areas of the device to soil, the time allowed for the soil to dry, and other conditioning considerations based upon assessment of worst-case clinical conditions.
SCOPE
1.1 This guide provides methods and considerations for simulated soiling of reusable medical devices for the purpose of validating cleaning instructions. Techniques for application of soil, as well as incorporation of soil by various means (e.g., actuation of devices) will be described in order to assure worst-case contamination of the surface geometry of medical devices.
1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Guide4 pagesEnglish languagesale 15% off
CCMC - creation of a 2nd corrigendum as the instructions in the 1st corrigendum were incomplete and unclear
- Corrigendum9 pagesEnglish languagee-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 languagee-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 languagee-Library read for1 day
- Standard – translation127 pagesSlovenian and English languagee-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 languagee-Library read for1 day
- Standard – translation127 pagesSlovenian and English languagee-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.
- Standard68 pagesEnglish languagee-Library read for1 day
- Standard78 pagesGerman languagee-Library read for1 day
- Standard – translation131 pagesSlovenian and English languagee-Library read for1 day
This European Standard specifies requirements and recommendations for healthcare services provided by chiropractors.
- Standard35 pagesEnglish languagee-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 languagee-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 languagee-Library read for1 day
This document provides guidance on the maintenance management of medical devices that are under the supervision of healthcare delivery organizations. This document is not applicable to: a) modification, refurbishment or remanufacturing of medical devices; b) manufacturers that are responsible for installation, testing, maintenance, and servicing on medical devices that they have placed on the market; or c) implantable or single-use medical devices.
- Draft17 pagesEnglish languagesale 15% off
- Draft17 pagesEnglish languagesale 15% off
This document provides guidance and considerations for healthcare organizations to deliver diagnostic tests timely and accurately in a pandemic by leveraging innovative approaches to overcome the limitations of laboratory capacity as follows: – mitigating threats encountered in providing diagnostic services during a pandemic; – consideration for quality assurance of diagnostic service provision in a pandemic context; and – possible response measures to the surge in diagnostic demand. This document does not apply to the details for providing pandemic response medical tests such as the specimen collection protocols in the specimen collection units or screening stations (e.g., Walk-through or Drive-through), experiment procedures, and quality management systems of medical laboratories. Also, this document omits the pandemic responses related to the medical treatment of infected patients in the care units (e.g., emergency unit, in-patient unit) and transferring of confirmed patients in the healthcare organization during a pandemic.
- Draft15 pagesEnglish languagesale 15% off
- Draft15 pagesEnglish languagesale 15% off
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 languagee-Library read for1 day
- Standard – translation94 pagesSlovenian and English languagee-Library read for1 day
SIGNIFICANCE AND USE
This guide is intended to assist healthcare institutions in creating appropriate requests for proposals to be issued for medical transcription services.
This guide provides recommended guidelines for the essential elements to be included in requests for proposals issued to medical transcription services. The purpose of these requests is contracting for the production and delivery of transcribed patient care documentation for a healthcare institution.
This guide recognizes the necessity of a HIPAA Business Associate Agreement.
This guide recognizes the necessity of researching local, state, and federal requirements that may apply.
SCOPE
1.1 This guide covers recommended guidelines to healthcare institutions for the development and issuance of requests for proposals (RFPs), as well as guidelines for medical transcription service organizations (MTSOs) responding to requests for proposals. It does not purport to address all of the legal aspects of the RFP, if any, associated with its use. It is the responsibility of the user of this guide to establish appropriate legal guidelines prior to use.
1.2 It is appropriate for healthcare institutions to issue RFPs from time to time or at regular contractual intervals for the purpose of facilitating the process of contracting for medical transcription services.
1.3 It is anticipated that both a commercial contract for services and a HIPAA Business Associate Agreement will be based upon the responding proposals submitted to the RFP.
WITHDRAWN RATIONALE
This guide covers recommended guidelines to healthcare institutions for the development and issuance of requests for proposals (RFPs), as well as guidelines for medical transcription service organizations (MTSOs) responding to requests for proposals. It does not purport to address all of the legal aspects of the RFP, if any, associated with its use. It is the responsibility of the user of this guide to establish appropriate legal guidelines prior to use.
Formerly under the jurisdiction of Committee E31 on Healthcare Informatics, this guide was withdrawn in January 2020 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
- Guide8 pagesEnglish languagesale 15% off
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 languagee-Library read for1 day
- Corrigendum – translation5 pagesSlovenian languagee-Library read for1 day
ISO 15225:2016 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.
ISO 15225:2016 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.
ISO 15225:2016 does not include the nomenclature itself, which is provided as a separate data file.
- Standard21 pagesEnglish languagee-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 languagee-Library read for1 day
- Standard – translation94 pagesSlovenian and English languagee-Library read for1 day
ISO/TR 14969:2004 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. It 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 languagee-Library read for1 day
ISO 15225:2010 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.
ISO 15225:2010 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 ISO 15225:2010 are applicable to the development and maintenance of an international nomenclature for medical device identification.
ISO 15225:2010 does not include the nomenclature itself, which is provided as a data file.
- Standard28 pagesEnglish languagee-Library read for1 day
2012-04-27 EMA: CEN/CLC Corrigendum only for the Annex ZA (CLC PR = 24183).
- Corrigendum5 pagesEnglish languagee-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.
- Standard85 pagesEnglish languagee-Library read for1 day
IWA 1:2005 provides additional guidance for any health service organization involved in the management, delivery, or administration of health service products or services, including training and/or research, in the life continuum process for human beings, regardless of type, size and the product or service provided.
- Standard84 pagesEnglish languagesale 15% off
- Technical specification – translation148 pagesSlovenian and English languagee-Library read for1 day
This European Standard specifies requirements and recommendations for healthcare services provided by chiropractors.
- Standard30 pagesEnglish languagee-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 languagee-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 languagee-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 languagee-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 languagee-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 languagee-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 languagee-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 languagee-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 languagee-Library read for1 day
SCOPE
1.1 This guide establishes the minimum national standard for training the emergency medical technician (basic) in basic anatomy and physiology.
1.2 This guide is one of a series which together describe the minimum training standard for the emergency medical technician (basic).
WITHDRAWN RATIONALE
This guide establishes the minimum national standard for training the emergency medical technician (basic) in basic anatomy and physiology.
Formerly under the jurisdiction of Committee F30 on Emergency Medical Services, this guide was withdrawn in March 2006. This guide was withdrawn because it is no longer in line with the current national standards curriculum.
- Guide2 pagesEnglish languagesale 15% off