ISO 7101:2023 is the international baseline standard for healthcare quality management systems, applicable across every healthcare segment regardless of which other accreditation you hold. ARC's deepest automated coverage runs on ISO 7101's seven-clause Annex SL structure; related standards like ISO 9001 and ISO 15189 extend the same discipline to non-healthcare and laboratory scopes.
ISO 7101 follows the Annex SL high-level structure shared by modern ISO management-system standards, adapted specifically for healthcare delivery organisations.
Understanding your organisation, its patients and stakeholders, and the scope of the quality management system.
Top management commitment, a quality policy, and clearly assigned roles and responsibilities.
Risk and opportunity assessment, quality objectives, and planning for change.
Resources, competence, awareness, communication and documented information.
Operational planning and control of clinical and non-clinical processes, patient safety culture included.
Monitoring, measurement, internal audit and management review held on a fixed cadence.
Nonconformity and corrective action, and continual improvement of the quality management system.
ARC benchmarks your current processes against the target ISO standard's full clause set.
Quality manual, process maps and procedures drafted to match how your teams actually work.
Role-specific QMS training so every team member can demonstrate compliance on audit day.
A genuine internal-audit cycle that surfaces real non-conformities before the certifier does.
Our consultants are present through the Stage 1 and Stage 2 certification audits.
Ongoing internal audit and management-review support through annual surveillance visits.