Neev International

ISO 13485:2016 Audit

A good audit finds real gaps early, gives them a priority, and leaves you with a plan you can act on. That is how we approach ISO 13485:2016 Audit. Medical Devices Quality Management audit.

What ISO 13485:2016 Audit covers

  • Audit planning with scope, criteria, sampling approach and schedule agreed in advance.
  • Document and record review against the relevant standard, regulation, contract or internal procedure.
  • Onsite or remote interviews and observation of how work is actually performed.
  • Evidence-based findings classified by severity, with objective evidence recorded for each.
  • Root-cause discussion and practical corrective-action suggestions.
  • Closing meeting that walks management through results before the report is issued.

How ISO 13485:2016 Audit works

  1. Scope and criteria. We confirm the standard or criteria, the sites and processes in scope, and the audit team and dates.
  2. Document review. Procedures, records and prior findings are reviewed to focus the audit on higher-risk areas.
  3. Audit execution. We interview staff, sample records and observe operations, remotely or onsite as scoped.
  4. Findings and closing meeting. Findings are discussed with management so facts are agreed before reporting.
  5. Report and follow-up. The report lists findings and recommendations, and follow-up checks can be scheduled.

Deliverables

  • Closing meeting summary
  • Follow-up verification note when scoped
  • Audit plan and checklist
  • Findings register with severity and evidence
  • Written audit report with executive summary

Who needs ISO 13485:2016 Audit

ISO 13485:2016 Audit is most often requested by manufacturers, contractors, laboratories, hospitals, government departments, developers and any organisation that must demonstrate compliance. PMCEPC (NEEV INTERNATIONAL) works with clients in India, the USA, Canada, Australia, the UAE, Malaysia, the United Kingdom, Europe, Russia, China, Japan, Hong Kong and Singapore, and serves other locations on request.

To get an accurate quotation for ISO 13485:2016 Audit, send the project location, the purpose of the work, any drawings or documents you already have, the deadline and the format you want the results in.

ISO 13485:2016 Audit pricing

The indicative professional range for ISO 13485:2016 Audit is shown below in US dollars. It is a guide, not a fixed quotation, because scope, location, team size, duration and data requirements change the final fee.

ServiceUS$ indicative rateEnquiry
ISO 13485:2016 Audit$130 – $300 / dayASK NOW
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ISO 13485:2016 Audit: frequently asked questions

How much does ISO 13485:2016 Audit cost?

PMCEPC publishes an indicative rate of $130 – $300 / day for ISO 13485:2016 Audit. The final fee depends on scope, location, complexity, deliverables and timeline, and is confirmed in a written quotation before work starts.

Does ISO 13485:2016 Audit lead to certification?

Our audit is an independent assessment and readiness review. Certification itself must be issued by an accredited certification body or the relevant authority, and we can prepare you for that audit.

How long does an audit take?

Small sites are often completed in one to three audit days plus reporting. Larger or multi-site audits need more time. Daily rates and the number of audit days are stated in the quotation.

Can ISO 13485:2016 Audit be delivered remotely or onsite?

PMCEPC delivers remotely, in hybrid mode or onsite depending on the assignment. Desk work such as review, analysis, drafting and reporting is usually remote, while site measurement, inspection and meetings are arranged onsite where location and permissions allow. Travel and living costs are quoted separately.

Browse the complete services catalogue, EPC services and rates, or read our guide: ISO 9001:2015 Audit Preparation Checklist.

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