Standards Development Methodology (ASF-GOV-001)

Version History

1. Purpose

1.1This document establishes the methodology by which Accréditation Sans Frontières (ASF) develops, consults upon, approves, publishes, monitors, revises, and, where necessary, withdraws healthcare accreditation standards. The methodology is designed to ensure that all ASF standards are evidence-informed, stakeholder-tested, independently reviewed, transparently governed, and subject to continuous improvement.

1.2This methodology applies to: (a) development of new accreditation standards for any healthcare facility type; (b) major revision of existing standards (defined in §9); (c) minor revision and editorial maintenance; and (d) suspension or withdrawal of standards no longer in use.

1.3This methodology is aligned with the requirements of the ISQua International Accreditation Programme (IAP) — External Evaluation Association (EEA) Principles for Standards, 6th Edition, and in particular with Principles 1 (Evidence), 2 (Stakeholder Engagement), 3 (Transparency), and 5 (Review). It is read alongside the ASF ISQua EEA Crosswalk (ASF-EV-004).

2. Scope

This methodology governs all ASF healthcare accreditation standards currently in development or active use, including the Hospital, Ambulatory Clinic, Long-Term Care, Primary Health Clinic, and Fitness and Wellness standards. It does not cover assessment tools or surveyor training materials (governed by ASF-OPS-002 and ASF-OPS-009 respectively).

3. Governance and Responsibilities

3.1Overall accountability for ASF standards development rests with the ASF Standards Development Committee (SDC), which operates under formally approved Terms of Reference (ASF-GOV-002).

3.3All persons involved in standards development are required to declare any conflict of interest in accordance with ASF-GOV-003. Any person with a declared conflict is excluded from decisions on the relevant standards or clauses.

4. Standards Development Lifecycle

4.1ASF applies a defined nine-stage lifecycle to all standards development activities. Each stage is documented and retained as controlled information to ensure a full audit trail from initial concept to published standard:

1. 1. Stage 1 — Needs Identification and Scoping
2. 2. Stage 2 — Evidence and Benchmark Review
3. 3. Stage 3 — Draft Development
4. 4. Stage 4 — Stakeholder Consultation
5. 5. Stage 5 — Technical and Independent Expert Review
6. 6. Stage 6 — Pilot Testing or Field Validation
7. 7. Stage 7 — Formal Approval and Publication
8. 8. Stage 8 — Post-Implementation Monitoring
9. 9. Stage 9 — Scheduled Periodic Review

5. Evidence-Informed Approach (Stages 1–2)

5.1 Needs Identification and Scoping

5.1.1The first stage is a formal needs assessment leading to a documented Scoping Brief approved by the SDC, defining: the healthcare facility type and population; the regulatory and policy context; the patient safety rationale; an assessment of existing international standards; the relationship to existing ASF standards; and the proposed timeline.

5.2 Evidence and Benchmark Review

5.2.1ASF draws on six source categories: (a) international accreditation standards (ISQua member bodies, JCI, Accreditation Canada, ACHS); (b) peer-reviewed scientific and clinical literature (PubMed/MEDLINE, Cochrane Library, WHO institutional repository); (c) WHO normative guidance; (d) ISQua guidance documents, including the EEA Principles 6th Edition; (e) applicable regulatory requirements; and (f) documented expert consensus where peer-reviewed evidence is limited, flagged for prioritised future review.

5.2.2The evidence review produces an updated Standards Evidence Bibliography (ASF-EV-001) recording, for each standards domain: the principal evidence sources; quality of evidence; and any evidence gaps.

6. Draft Development (Stage 3)

6.1Draft standards follow ASF’s document architecture: numbered chapters; numbered criteria using the verb “shall”; criteria classified into four tiers; guidance notes presented separately from normative requirements; and a cross-reference table linking each criterion to its principal evidence source in ASF-EV-001.

6.2ASF criteria classification system:

7. Stakeholder Consultation (Stage 4)

7.1Stakeholder consultation is mandatory in every new standards development cycle and every major revision. ASF engages: (a) healthcare facility managers and quality officers; (b) clinical professionals; (c) patient and family representatives; (d) healthcare regulatory bodies; (e) academic and research experts; (f) ASF surveyors; and (g) peer accreditation bodies.

7.3The formal consultation period is open for a minimum of 28 calendar days.

7.5All consultation responses are recorded in a Comment Matrix capturing: the stakeholder category; the criterion number; the comment text; ASF’s decision (accepted / accepted with modification / rejected); and the rationale. The matrix is summarised in the Stakeholder Consultation Summary (ASF-EV-002), published on france-asf.fr.

8. Expert Review and Pilot Testing (Stages 5–6)

8.1.1Following consultation, the revised draft is submitted for independent expert review by at least one expert not involved in drafting and with no conflict of interest, evaluating: clinical accuracy; clarity and measurability; feasibility; completeness; consistency; and alignment with international standards.

8.2.1Where practicable, ASF conducts a structured pilot or field validation exercise involving a minimum of three participating facilities selected to represent the range of types, sizes, and resource settings. Findings are published in ASF-EV-003.

9. Approval, Version Control, and Publication (Stage 7)

9.1Final SDC submission requires: the final draft; summary of changes; updated ASF-EV-001; the completed Comment Matrix and ASF-EV-002; expert review findings; pilot outcomes (ASF-EV-003); and a statement of alignment with ISQua EEA Principles cross-referenced to ASF-EV-004.

9.4Revision types: Major revision — any change affecting intent, scope, number, or measurable content of criteria; increments from V1.x to V2.0; requires full lifecycle review. Minor revision — editorial corrections and clarifications without change to requirement; approved by SDC Chair; increments as V1.1, V1.2.

10. Post-Implementation Monitoring (Stage 8)

Following publication, ASF actively monitors: survey findings data (score distributions by criterion); structured surveyor debrief; accredited organisation feedback; incident and complaint data from the risk register (ASF-QMS-003); and external signals including new WHO guidance and updates to international accreditation standards. Findings are reviewed by the SDC at least annually.

11. Scheduled Periodic Review (Stage 9)

11.1All ASF accreditation standards are reviewed at intervals not exceeding five years. A review is initiated earlier if triggered by: significant regulatory change; a new edition of a major international reference standard; new WHO guidance; systematic post-implementation issues; an SDC formal request; or a material gap identified in the annual ISQua EEA crosswalk review.

11.3This Standards Development Methodology is itself reviewed on the same five-year cycle. Next scheduled review: September 2031.

12. Document Control and Transparency

All controlled documents carry a unique code, version number, effective date, and approval signature. Superseded versions are archived and retained for a minimum of ten years. All published ASF governance documents and accreditation standards are accessible without charge on france-asf.fr. ASF accreditation standards are the intellectual property of Accréditation Sans Frontières; use by any external assessment organisation requires a formal written agreement.

13. References

Document code: ASF-GOV-001  ·  Version: V3.0  ·  Effective: 2026-09-30  ·  Next review: September 2031  · 
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ASF-GOV-001 — Standards Development Methodology · Version V4.0

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