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Accréditation Sans Frontières

International Accreditation of Healthcare Facilities

ISO Standards We Cover · by ASF

ASF’s ISO management-system standards coverage — not just 9001 and 15189.

Accréditation Sans Frontières consults, runs GAP analyses, and prepares organisations for readiness across a curated range of ISO and management-system standards — quality, health & laboratory, food safety, and environment & safety. This page is ASF’s overview of that coverage.

Important: ASF provides consulting, gap-analysis and readiness preparation across every standard listed on this page. ASF does not issue certificates — certification audits are performed by an independent accredited certification body. This applies to all standards below, not only ISO 9001 and ISO 15189.

Note: this page covers ISO management-system standards — international, voluntary standards organisations certify against (ISO 9001, ISO 15189, and others). It is separate from ASF’s own accreditation standards, the health-facility accreditation criteria ASF itself develops and uses for its accreditation programme.

Honesty rule: a “document pack” or fixed-price link below means ASF already has a complete, ready-to-use library for that standard. Every other standard routes to a free GAP-analysis / quote request — ASF never claims a pack or a fixed price that doesn’t exist.

Why cover ten standards, not one?

Organisations rarely need just a single standard. A hospital pursuing ISO 9001 usually also needs ISO 45001 for staff safety; a lab building ISO 15189 often needs ISO 17025 alongside it; a hotel with a kitchen needs ISO 22000 or HACCP on top of general quality management. Juggling a separate consultant per standard means separate contracts, separate audits, and documentation that doesn’t talk to itself.

ASF’s cross-standard GAP-analysis capability means one point of contact scopes your organisation against every relevant standard at once, flags where requirements overlap so you document them once instead of twice, and coordinates the resulting readiness programme as a single engagement — not a stack of disconnected consulting relationships.

Category 1 of 4

Quality & Management Systems

The foundational management-system standards most organisations start with — general quality management, medical-device-specific quality requirements, and information security.

Stack of paper documents and file folders on an office table, representing quality management system documentationPhoto: Wesley Tingey / Unsplash

ISO 9001:2015

Pack available

Quality management systems — the general-purpose international standard for consistently providing products and services that meet customer and regulatory requirements.

Sector: Any organisation, any size, any sectorExplore the ISO 9001 Ready pack →

ISO 13485:2016

GAP analysis

Quality management systems specific to the medical device industry — design, development, production, installation and servicing, with strong regulatory-compliance requirements.

Sector: Medical device manufacturers & distributorsRequest a GAP Analysis →

ISO/IEC 27001

GAP analysis

Information security management systems — a risk-based framework for protecting the confidentiality, integrity and availability of an organisation’s information assets.

Sector: Any organisation handling sensitive dataRequest a GAP Analysis →

Category 2 of 4

Health & Laboratory

Standards for medical laboratories, testing and calibration facilities, and the business-continuity planning that underpins crisis-ready healthcare and humanitarian operations.

White microscope on a laboratory bench, representing medical laboratory testing equipmentPhoto: Ousa Chea / Unsplash

ISO 15189

Pack available

Medical laboratories — particular requirements for quality and competence, covering both the management system and the technical competence of laboratory testing.

Sector: Medical & clinical laboratoriesExplore the ISO 15189 Ready pack →

ISO/IEC 17025:2017

GAP analysis

General requirements for the competence of testing and calibration laboratories — applies to any lab issuing test, measurement or calibration results, medical or otherwise.

Sector: Testing & calibration laboratoriesRequest a GAP Analysis →

ISO 22301

GAP analysis

Business continuity management systems — requirements to plan for, respond to, and recover from disruptive incidents. Directly relevant to ASF’s humanitarian and crisis-readiness focus.

Sector: Healthcare & humanitarian operationsRequest a GAP Analysis →

Category 3 of 4

Food Safety

Directly relevant to the food & beverage component of ASF’s Hospitality ISO 9001 Ready pack — hotels, restaurants and catering operations that handle food need these standards alongside general quality management.

Empty commercial kitchen with stainless steel equipment and counters, representing food-preparation hygienePhoto: Ricardo Gomez Angel / Unsplash

ISO 22000:2018

GAP analysis

Food safety management systems — requirements for any organisation in the food chain to demonstrate its ability to control food safety hazards and consistently deliver safe products.

Sector: Hotels, restaurants, catering & food producersRequest a GAP Analysis →

HACCP

GAP analysis

Hazard Analysis & Critical Control Points — the foundational, systematic preventive methodology for identifying biological, chemical and physical hazards in food production and controlling them at critical points.

Sector: Any food-handling operationRequest a GAP Analysis →

Category 4 of 4

Environment & Safety

Environmental responsibility and occupational safety — increasingly required by clients, tenders and regulators alongside quality certification.

White hard hat resting on top of solar panels, representing environmental and workplace safety managementPhoto: Evgeniy Alyoshin / Unsplash

ISO 14001:2015

GAP analysis

Environmental management systems — a structured framework for managing environmental responsibilities, reducing environmental impact, and complying with environmental legislation.

Sector: Any organisation with an environmental footprintRequest a GAP Analysis →

ISO 45001:2018

GAP analysis

Occupational health and safety management systems — reduces workplace risk and improves employee safety and wellbeing. Replaces the older OHSAS 18001 standard.

Sector: Any employer, any sectorRequest a GAP Analysis →

Don’t see your standard?

Every management-system standard shares the same ISO High-Level Structure. Whatever standard your organisation needs, ASF can scope a GAP analysis and readiness programme for it.

Request a GAP Analysis →

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