Medical Devices and Healthcare Technologies
Proposed technical area; title and scope under review.
International Standardization Infrastructure
Codema Global Rating is an international standardization initiative developing innovative methodologies, technical guidelines and auditable Rating Protocols across a wide range of technical and industrial sectors.
Its standardization activities are coordinated by the Codema Technical Secretariat and organized through Technical Committees and Working Groups, in accordance with principles of openness, transparency, stakeholder participation and consensus.
The Codema Global Rating Association, based in Geneva, Switzerland, provides the institutional framework for stakeholder participation in standardization activities.
Membership in the Association enables individuals, technical experts, companies, institutions and consumers to participate in Technical Committees and Working Groups. Individual membership is free of charge, while organizations participating through designated representatives are subject to the applicable membership conditions.
A core element of the Codema Global Rating methodology is the integration of standardization with information systems. Rating Protocols are structured into auditable technical matrices incorporating defined requirements, assessment criteria, rating metrics and documented evidence.
These matrices are designed for integration with digital platforms, enterprise information systems and AI-enabled applications, enabling the execution, management and traceability of assessment and auditing processes within existing technological environments.
This approach, developed through the Audit as a Layer methodology, supports the application of standards through both traditional independent auditing and digitally integrated assessment processes.
The Codema Global Rating General Guidelines constitute the methodological and procedural framework governing the development, application and continuous evolution of the Codema standardization system.
Each General Guideline defines specific aspects of the methodology, including technical governance, the organization of standardization activities, the development of Rating Protocols, assessment and auditing procedures, stakeholder participation, and integration with information systems.
The Codema Technical Secretariat is responsible for the development, revision and maintenance of the General Guidelines, ensuring the consistency and coherence of the overall standardization methodology.
Members of the Codema Global Rating Association may contribute observations, comments and proposals concerning the General Guidelines. The Codema Technical Secretariat reviews these contributions and may incorporate them into subsequent revisions, supporting an open and participatory process of methodological development.
The General Guidelines are subject to continuous review and development. Existing documents are periodically updated to reflect methodological improvements, technological developments and experience gained through practical application. New General Guidelines are progressively introduced as the Codema standardization system evolves.
The following catalogue provides access to the General Guidelines and their respective versions and revisions.
Governance, responsibilities and procedures for Codema technical work.
Rating Protocol rules, evaluation criteria, ratings and assessment reports.
Development, revision, consensus and evolution of Rating Protocols.
Guidelines for the application of Rating Protocols in auditing activities.
Procedure for initiating and managing new technical work dossiers.
Organization of the stakeholder ecosystem and technical notification process.
Procedure for industry-originated proposals and sponsorship of new Rating Protocol development.
Framework for institutional support of technical programmes in areas of shared stakeholder interest.
Integration of auditable matrices, controls, evidence and traceability with information systems.
Document descriptions are editorial summaries. Official versions and publication links will be added after verification by the Codema Technical Secretariat. Expert onboarding documentation is managed separately through the Association.
The Codema Ecosystem & Notification System establishes a structured framework for identifying and informing stakeholders with an interest in Codema Global Rating standardization activities.
Its operation is governed by GG120 – Codema Ecosystem and Notification System, which defines the framework for stakeholder mapping, notification and circulation of information relating to technical work.
The system is organized by Technical Committee. Each Technical Committee has a corresponding ecosystem covering its Technical Area and, within the same structure, ecosystems associated with individual Rating Protocols.
Ecosystems may include associations, professional bodies, institutions, regulatory observers, standardization organizations, technical experts and other relevant stakeholders. Their composition is reviewed and updated as technical activities and subjects evolve.
Identification within an ecosystem indicates relevance for information and notification purposes. Active participation in technical work is organized separately through the Working Groups and the Codema Global Rating Association.
Select a Technical Committee to view the structure of its ecosystem and the related Rating Protocol ecosystems. Published documents and lists can be added as they are approved for publication.
Technical Committee definition and ecosystem documentation under development.
Ecosystem documentation for the pharmaceutical quality and compliance Technical Area will be incorporated following review.
A preliminary mapping of invited associations, clusters, institutions and regulatory observers exists for TC21. It covers relevant global and regional organizations and is intended for continuous updating.
The following protocol families are identified in TC21's preliminary technical programme. Individual ecosystem listings will be introduced here when available and approved.
Protocol names are abbreviated here for navigation. The full titles and versions belong in the Rating Protocols catalogue.
Ecosystem structure to be populated following confirmation of the Technical Committee scope and related protocols.
Technical Committee ecosystem and related protocol ecosystems to be included following editorial verification.
Technical Committee ecosystem and related protocol ecosystems to be included following editorial verification.
Proposed cross-sector Technical Area concerning matters with a direct impact on consumers; scope and ecosystem to be defined.
Technical Committee ecosystem and related protocol ecosystems to be added following verification.
Technical Committee ecosystem and related protocol ecosystems to be added following verification.
Codema Global Rating organizes its standardization activities through Technical Committees (TCs), each covering a defined Technical Area, which may correspond to a specific industrial or service sector or extend across multiple sectors and fields of activity.
Each Technical Committee provides the organizational and technical framework for a number of Working Groups (WGs), established to address specific standardization subjects within its Technical Area.
Working Groups undertake the development, review and evolution of Rating Protocols in accordance with the applicable Codema General Guidelines.
Technical Committees provide continuity and coordination across related standardization subjects, allowing new Working Groups and Rating Protocols to be established as technical developments, sectoral requirements and stakeholder needs evolve.
Technical activities are coordinated by the Codema Technical Secretariat and conducted according to principles of openness, transparency, stakeholder participation and consensus.
Participation in standardization activities takes place through the Working Groups, within the institutional framework of the Codema Global Rating Association. Participation is open to all interested stakeholders, including industry representatives, technical experts, researchers, institutions, professional organizations and consumers.
Proposed technical area; title and scope under review.
Pharmaceutical quality assurance, quality control and regulatory compliance. Protocol catalogue under consolidation.
Cloud technologies, distributed ledger technologies, tokenisation and digital assets. Technical programme documented.
Technical programme and official title to be confirmed.
AI performance, reliability, behaviour and anomaly assessment.
Applications of artificial intelligence in sectoral processes and workflows.
Proposed cross-sector technical area concerning direct consumer impact; scope and title under review.
Working title; technical scope to be confirmed.
Sustainability and ESG-related technical activities; scope to be confirmed.
Titles and scopes marked as proposed or under review will be confirmed by the Codema Technical Secretariat before official publication.
Under Development
The catalogue of Rating Protocols is being prepared.
The Codema Global Rating Association, based in Geneva, Switzerland, provides the institutional framework for the governance, development and international participation of Codema standardization activities.
The Association brings together individuals, technical experts, companies, professional organizations, academic institutions, standardization bodies, consumer representatives and other stakeholders interested in contributing to the development of technical standards and evaluation methodologies.
Its activities are based on the principles of openness, transparency, impartiality, stakeholder participation and consensus, in alignment with internationally recognized principles of standardization.
The Association provides a framework for stakeholder representation and participation in the development and evolution of the Codema standardization system.
Its governance structure supports the involvement of different technical, industrial, scientific and institutional interests, contributing to the independence, continuity and international development of standardization activities.
The Codema Technical Secretariat is responsible for the coordination of technical activities and the application of the Codema General Guidelines.
Participation in Codema standardization activities takes place through Working Groups established within the Technical Committees.
Membership in the Codema Global Rating Association provides the institutional basis for participation in these Working Groups.
Association members may participate in multiple Working Groups according to their interests and fields of expertise, contributing to the development, review and continuous evolution of Rating Protocols.
Participation is open to all interested stakeholders, including individuals whose professional knowledge or direct experience is relevant to the subject of standardization.
The Association provides different forms of membership according to the capacity in which stakeholders participate.
Open and free of charge to individuals participating in a personal capacity, including technical experts, researchers, professionals and consumers.
Organizations may join the Association and designate qualified representatives to participate as experts in Codema Working Groups. Corporate membership is subject to the applicable membership contribution.
Standardization organizations, academic institutions, public bodies, professional associations and other institutions may participate through designated representatives, according to the applicable institutional membership arrangements.
The Association supports broad international participation across technical disciplines, industrial sectors and areas of public interest.
Through a common institutional framework, stakeholders contribute their technical knowledge, professional expertise and practical experience to the development of standards addressing evolving technological, economic and societal requirements.
Under Development
This section is being prepared.