ISO Regulations
Setting the standard for standard-setting
Founded in 1947, the Geneva, Switzerland-based International Organization for Standardization (ISO) is a non-governmental, independent consortium of 165 member countries working toward a common set of goals:
- Developing voluntary international standards covering a gamut of industry sectors including (among others):
- Technology
- Manufacturing
- Agriculture
- Food Safety
- Healthcare
- Facilitating global trade by providing common standards among nations
- Facilitating creation of quality products and services that are safe and reliable
- Helping businesses increase productivity and operational efficiency
- Encouraging fair global trade
- Protecting end-users by certifying that products/services conform to established international standards
ISO's work, including its publishing of more than 22,000 standards to date, influences a range of areas where international standardization helps clear up potential confusion and advance the organization’s stated goals, such as:
- Units of measurement
- Alphabetization and translation
- Specifications for materials, tools, parts, processes and testing methods
- Formats in which specifications are presented
Each of ISO's 165 members is recognized as the entity "most representative of standardization in its country." This can be a private organization — such as the American National Standards Institute (ANSI) or the British Standards Institution (BSI) — or a governmental organization, as it is in most ISO member nations.
References
"Public-Private Partnerships in Healthcare - HealthManagement.Org." HealthManagement, https://healthmanagement.org/c/it/issuearticle/public-private-partnerships-in-healthcare.Helping researchers and labs maintain compliance with standards
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行业标准与法规要求
- USP<643>
- IVDR 2022 is a marathon, not a sprint. We’ll help you go the distance.
- 21 CFR Part 11 - Data Integrity
- Maintaining Data Integrity: Understanding ALCOA Guidance
- Overview of European Pharmacopoeia (Ph. Eur.) chapter 2.2.44
- EU GMP Annex 1
- EU GMP Annex 11
- ISO 14644 cleanroom recovery testing explained
- ISO 21501
- ISO Regulations
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IVD-Regulation (IVDR)
- IVDR compliant instruments*
- IVDR compliant software*
- IVDR compliant reagents
- E-book
- In-house IVD FCM panel or not: it depends
- Building IVDR compliant panels for haematological disorders
- Laboratory Developed Test (LDT) vs IVD Validation Workflow
- Potential Impacts of EU IVD-Regulation on the Clinical Flow Cytometry Lab
- IVD-R Annex I Global Safety and Performances Requirements (GSPR). A New Set of Requirements for Clinical Laboratories Performing Laboratory Developed Tests
- Key Considerations to Validate a Flow Cytometry Assay According to ISO 15189 Requirements
- Regulatory Entities: Separation with Cooperation
- USP 1046
- USP 1047
- USP <788>, <787> and EP2.9.19
- USP <790>
- ISO 11171
- USP 787