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McCullochRegulatory Compliance
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ISO Management System Audits

Independent audits and certification readiness assessments against ISO management system standards, for organisations in any sector.

Most regulatory work is sector specific. ISO management system audits are not. Whatever the industry, the discipline is the same: assess a management system against a recognised standard, find where practice and evidence fall short, and give the organisation a clear, prioritised route to conformity.

What we do

We carry out independent audits and certification readiness assessments against ISO management system standards. That covers internal (first party) audits, supplier and vendor (second party) audits, and pre certification gap assessments ahead of a certification body visit. Each engagement produces an objective, evidence based report with findings graded by significance and practical corrective actions.

Standards we audit against

  • ISO 9001 (Quality management)
  • ISO 13485 (Medical devices, quality management)
  • ISO 14971 (Medical device risk management)
  • ISO 27001 (Information security management)
  • ISO 14001 (Environmental management)
  • ISO 45001 (Occupational health and safety)
  • ISO 22301 (Business continuity management)
  • ISO/IEC 17025 (Testing and calibration laboratories)

Our approach

We follow the principles of ISO 19011 for auditing management systems: risk based, impartial, and grounded in objective evidence. Audits are scoped to your context, conducted against the clauses of the relevant standard, and reported in a way that satisfies certification bodies while remaining genuinely useful to the teams who have to act on the findings.

Because the method is standard agnostic, the same advisory team can support a single site seeking its first certificate or a multi site group harmonising several management systems at once.

Discuss iso management system audits

Tell us about your product or programme and we will come back to you promptly.