AS9100 vs IATF 16949 vs ISO 13485 vs ISO/IEC 17025: Which Standard Applies to You

AS9100, IATF 16949, ISO 13485 and ISO/IEC 17025 are not interchangeable. What each covers, which build on ISO 9001, why 17025 is accreditation not certification, and how to tell which applies to you.
A quality manager comparing certification standard documents with automotive, aerospace, medical device and lab calibration components on the desk
A quality manager comparing certification standard documents with automotive, aerospace, medical device and lab calibration components on the desk

AS9100, IATF 16949, ISO 13485 and ISO/IEC 17025 get grouped together as "quality standards", but they are not interchangeable, and holding the wrong one does not get you into the supply chain you are targeting. The quickest way to tell them apart is by what you make or do and who is asking for it. This guide sets out what each standard is for, how they relate, and how to work out which one actually applies to you.

The common ancestor: ISO 9001

Three of these four (AS9100, IATF 16949 and, more loosely, ISO 13485) trace back to ISO 9001, the generic quality management system standard usable by any industry. Each takes that base and adds requirements for a specific, high-stakes sector. ISO/IEC 17025 is the exception: it is a different kind of standard, which is exactly why it is so often confused with the others.

IATF 16949: automotive production

IATF 16949 is the automotive quality management standard, published by the International Automotive Task Force and built on top of ISO 9001. It adds the Core Tools (APQP, PPAP, FMEA, MSA and SPC), customer-specific requirements and a dedicated certification scheme. It applies to organisations manufacturing production or service parts for the vehicle supply chain, and most OEMs and Tier 1 suppliers require it as a condition of doing business.

AS9100: aerospace, space and defence

AS9100 is the equivalent for the aviation, space and defence industries. It also builds on ISO 9001 and adds sector requirements around safety, risk, configuration management, counterfeit-part prevention and traceability. It is maintained through the International Aerospace Quality Group, and certification is recorded in the industry's OASIS database. Primes such as the major airframers expect their suppliers to hold it.

ISO 13485: medical devices

ISO 13485 is the quality management standard for organisations that design and manufacture medical devices. It shares DNA with ISO 9001 but is deliberately run as a standalone standard, weighted towards regulatory compliance, risk management and traceability rather than continual improvement for its own sake. For many manufacturers it is a practical prerequisite for market access, underpinning routes such as CE marking in the EU and quality-system expectations in other regulated markets.

ISO/IEC 17025: testing and calibration laboratories

ISO/IEC 17025 is the odd one out, and the source of most of the confusion. It is not a QMS certification in the same sense as the other three. It sets the general requirements for the competence of testing and calibration laboratories, and laboratories are assessed against it and accredited by a national accreditation body (in the UK, UKAS), not certified by a certification body. Its focus is whether a lab produces technically valid results, not just whether it has a quality system on paper.

How to tell which one applies to you

  • You make parts for vehicles: IATF 16949.
  • You make parts or systems for aviation, space or defence: AS9100.
  • You make medical devices: ISO 13485.
  • You run a testing or calibration laboratory and issue results or certificates: ISO/IEC 17025.
  • You want a general quality management system and none of the above sectors apply: ISO 9001 on its own.

These are not mutually exclusive. A supplier serving both automotive and aerospace customers may hold IATF 16949 and AS9100 together, and a manufacturer with its own calibration lab may run ISO/IEC 17025 accreditation alongside its site QMS certification.

Frequently asked questions

Can one organisation hold more than one of these standards?

Yes. They cover different customers and outputs, so an organisation that supplies more than one regulated sector, or that runs its own lab, will often hold two or more. The systems overlap on the ISO 9001 base but are audited against their own sector requirements.

Is ISO/IEC 17025 a certification?

No. Laboratories are accredited to ISO/IEC 17025 by a national accreditation body, which assesses technical competence, rather than certified by a certification body. That distinction matters to customers relying on the lab's results.

Which of these is based on ISO 9001?

AS9100 and IATF 16949 are built directly on ISO 9001. ISO 13485 shares its heritage but is maintained as a separate, regulation-focused standard. ISO/IEC 17025 is a distinct standard for laboratory competence rather than an ISO 9001 derivative.

How REAS approaches this

Whichever of these standards applies, the problem is the same: dense, high-stakes requirements that an entire supply chain has to understand consistently, not just receive as a PDF. REAS's proven ground is automotive. The IATF 16949 channel we built and run for the International Automotive Oversight Bureau has grown to 12,000+ subscribers with 1,000+ videos in 12 languages, and our production runs on a BSI ISO 9001 certified process (FS 763439). The same approach applies to any standards or certification body that needs its requirements understood across a global audience.

For a closer look at the automotive standard, read what IATF 16949 is and how it differs from ISO 9001. See how REAS approaches video production for standards and certification bodies, or book a strategy call.

AS9100 vs IATF 16949 vs ISO 13485 vs ISO/IEC 17025: Which Standard Applies to You

AS9100, IATF 16949, ISO 13485 and ISO/IEC 17025 get grouped together as "quality standards", but they are not interchangeable, and holding the wrong one does not get you into the supply chain you are targeting. The quickest way to tell them apart is by what you make or do and who is asking for it. This guide sets out what each standard is for, how they relate, and how to work out which one actually applies to you.

The common ancestor: ISO 9001

Three of these four (AS9100, IATF 16949 and, more loosely, ISO 13485) trace back to ISO 9001, the generic quality management system standard usable by any industry. Each takes that base and adds requirements for a specific, high-stakes sector. ISO/IEC 17025 is the exception: it is a different kind of standard, which is exactly why it is so often confused with the others.

IATF 16949: automotive production

IATF 16949 is the automotive quality management standard, published by the International Automotive Task Force and built on top of ISO 9001. It adds the Core Tools (APQP, PPAP, FMEA, MSA and SPC), customer-specific requirements and a dedicated certification scheme. It applies to organisations manufacturing production or service parts for the vehicle supply chain, and most OEMs and Tier 1 suppliers require it as a condition of doing business.

AS9100: aerospace, space and defence

AS9100 is the equivalent for the aviation, space and defence industries. It also builds on ISO 9001 and adds sector requirements around safety, risk, configuration management, counterfeit-part prevention and traceability. It is maintained through the International Aerospace Quality Group, and certification is recorded in the industry's OASIS database. Primes such as the major airframers expect their suppliers to hold it.

ISO 13485: medical devices

ISO 13485 is the quality management standard for organisations that design and manufacture medical devices. It shares DNA with ISO 9001 but is deliberately run as a standalone standard, weighted towards regulatory compliance, risk management and traceability rather than continual improvement for its own sake. For many manufacturers it is a practical prerequisite for market access, underpinning routes such as CE marking in the EU and quality-system expectations in other regulated markets.

ISO/IEC 17025: testing and calibration laboratories

ISO/IEC 17025 is the odd one out, and the source of most of the confusion. It is not a QMS certification in the same sense as the other three. It sets the general requirements for the competence of testing and calibration laboratories, and laboratories are assessed against it and accredited by a national accreditation body (in the UK, UKAS), not certified by a certification body. Its focus is whether a lab produces technically valid results, not just whether it has a quality system on paper.

How to tell which one applies to you

  • You make parts for vehicles: IATF 16949.
  • You make parts or systems for aviation, space or defence: AS9100.
  • You make medical devices: ISO 13485.
  • You run a testing or calibration laboratory and issue results or certificates: ISO/IEC 17025.
  • You want a general quality management system and none of the above sectors apply: ISO 9001 on its own.

These are not mutually exclusive. A supplier serving both automotive and aerospace customers may hold IATF 16949 and AS9100 together, and a manufacturer with its own calibration lab may run ISO/IEC 17025 accreditation alongside its site QMS certification.

Frequently asked questions

Can one organisation hold more than one of these standards?

Yes. They cover different customers and outputs, so an organisation that supplies more than one regulated sector, or that runs its own lab, will often hold two or more. The systems overlap on the ISO 9001 base but are audited against their own sector requirements.

Is ISO/IEC 17025 a certification?

No. Laboratories are accredited to ISO/IEC 17025 by a national accreditation body, which assesses technical competence, rather than certified by a certification body. That distinction matters to customers relying on the lab's results.

Which of these is based on ISO 9001?

AS9100 and IATF 16949 are built directly on ISO 9001. ISO 13485 shares its heritage but is maintained as a separate, regulation-focused standard. ISO/IEC 17025 is a distinct standard for laboratory competence rather than an ISO 9001 derivative.

How REAS approaches this

Whichever of these standards applies, the problem is the same: dense, high-stakes requirements that an entire supply chain has to understand consistently, not just receive as a PDF. REAS's proven ground is automotive. The IATF 16949 channel we built and run for the International Automotive Oversight Bureau has grown to 12,000+ subscribers with 1,000+ videos in 12 languages, and our production runs on a BSI ISO 9001 certified process (FS 763439). The same approach applies to any standards or certification body that needs its requirements understood across a global audience.

For a closer look at the automotive standard, read what IATF 16949 is and how it differs from ISO 9001. See how REAS approaches video production for standards and certification bodies, or book a strategy call.