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Healthcare

The most common mistake in healthcare is treating three entirely separate activities as one: delivering healthcare, manufacturing medical devices and operating a laboratory. All three fall into different record classes.

The questions we ask before producing a result

  1. Do you deliver healthcare, manufacture devices or operate a laboratory?
  2. If you manufacture devices, what is the risk class and intended use?
  3. Are you the manufacturer, the importer or the distributor?
  4. Which market are you placing on?
  5. Is hazardous biological material handled?

Candidate ISO standards 16

ISO 90012015
Quality Management System

For organisations in any sector seeking to standardise processes and manage customer expectations systematically.

ISO 100122026
Measurement Management System

For organisations that demonstrate product or service conformity on the basis of measurement results.

ISO 223012019
Business Continuity Management System

For organisations where service interruption is critical, or that are multi-site or critical suppliers.

ISO/IEC 270012022
Information Security Management System

For organisations that process data, access customer systems or provide cloud services.

ISO/IEC 277012025
Privacy Information Management System

For organisations processing personally identifiable information within an ISO 27001 scope.

ISO 303012019
Management System for Records

For organisations and groups of organisations establishing corporate governance over records.

ISO 373012021
Compliance Management System

For organisations carrying a broad inventory of regulatory obligations.

ISO 410012018
Facility Management System

For organisations providing facility services or managing large property portfolios.

ISO/IEC 420012023
Artificial Intelligence Management System

For organisations that develop, provide or use artificial intelligence in high-impact contexts.

ISO 450012018
Occupational Health and Safety Management System

For businesses seeking to address employee, site and operational risks systematically.

ISO 500012018
Energy Management System

For organisations with measurable energy consumption and energy performance targets.

ISO 71012023
Quality Management for Healthcare Organisations

A quality management system for organisations delivering healthcare services.

ISO 134852016
Medical Devices Quality Management System

For organisations that design, manufacture, install or service medical devices.

ISO 153782017
Primary Packaging Materials for Medicinal Products

For businesses producing and supplying primary packaging materials for medicinal products.

ISO 9001 sector application
ISO 16000-402019
Indoor Air Quality Management System

For organisations managing air quality in building and facility interiors.

ISO 350012019
Biorisk Management System

For laboratories and organisations working with hazardous biological materials.

Most commonly confused in this field

ISO 15189 and ISO/IEC 17025 are accreditation, not certification

Medical laboratory and testing/calibration laboratory competence is classified as accreditation, and is not described as an ordinary business ISO certificate.

ISO 13485 does not substitute for CE/MDR conformity

The medical device quality management system is one thing and product conformity another. Device class, target market and economic operator role are mandatory questions.

CE is not a "certificate"

It is product conformity for placing on the EU market, with a notified body involved where required. It is not shown in the same class as an ISO certificate.

Non-ISO programmes common in this field

These are not ISO standards; each has its own scheme owner, issuing body and rules. Whether they are candidates is decided by activity and buyer requirement.

  • CE / MDR / IVDR conformity
  • Notified body assessment

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This page is for information only; it is not legal advice. A record appearing here does not mean it is required for your business. This library does not issue certificates.

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