QMS: ISO 9001, AS 9100, ISO 13485, TL 9000 compared

Hugues Orgitello updated 7 Oct 2026 14 min read

Four quality management system standards cover most electronics supply chains: ISO 9001 as the generic baseline, AS 9100 for aviation, space and defence, ISO 13485 for medical devices and TL 9000 for information and communication technology (ICT). Two of them changed status in 2026. ISO 9001:2026 was published on September 16, 2026, which starts a three-year certificate transition, and the US QMSR made ISO 13485:2016 part of 21 CFR Part 820 on February 2, 2026. This page sets out the current editions, the dates that follow from them and what each sector overlay adds, from the primary texts: the ISO committee, the accreditation transition document, the Federal Register, the EU Official Journal, IAQG and TIA QuEST Forum.

The four standards at a glance

Standard	Current edition (October 7, 2026)	Owner	Relation to ISO 9001	Who asks for it
ISO 9001	ISO 9001:2026 (published September 16, 2026); ISO 9001:2015 + Amd 1:2024 still certifiable during transition	ISO/TC 176/SC 2	The baseline	Customers, tenders
AS 9100	AS9100D (2016); next revision will be IA9100	IAQG (published by SAE in the Americas, regional equivalents EN 9100 and JISQ 9100)	ISO 9001:2015 text plus aerospace requirements in bold italics	Aviation, space and defence primes
ISO 13485	ISO 13485:2016; EN ISO 13485:2016/A11:2021 in the EU	ISO/TC 210	Stand-alone, does not contain the ISO 9001 text	Regulators (EU MDR/IVDR harmonised standard, US QMSR, MDSAP) and customers
TL 9000	Requirements Handbook R6.3 (effective October 1, 2021), Measurements Handbook R5.7 (effective June 30, 2020), Category Tables R5.9	TIA QuEST Forum	All of ISO 9001:2015 plus ICT requirements and measurements	ICT network operators and their suppliers

AS 9100 and TL 9000 are built on the ISO 9001:2015 text. ISO 13485 is not: since its first edition in 1996 as a supplement to ISO 9001, it has become a stand-alone standard (the FDA preamble to the QMSR describes this history). Its 2016 structure is closer to ISO 9001:2008 than to the Annex SL high-level structure.

Dated changes, 2024 to 2029

Date	Event	Source
February 2, 2024	FDA publishes the QMSR final rule, 89 FR 7496	Federal Register
February 22 and 23, 2024	IAF/ISO communiqué; climate change amendments (ISO 9001:2015/Amd 1:2024 and other management system standards) published on February 23	IAF/ISO joint communiqué
April 17, 2024	NASA reports the IA9100 publication estimate moved to the fourth quarter of 2026	NASA OSMA
November 19, 2025	ISO/DIS 9001 public comment stage closes (approved with 97%)	ISO/TC 176/SC 2 news
February 2, 2026	QMSR takes effect: Part 820 incorporates ISO 13485:2016 and clause 3 of ISO 9000:2015	Federal Register, eCFR
July 9, 2026	ISO/FDIS 9001 ballot closes; approval announced August 7, 2026	ISO/TC 176/SC 2 news
September 16, 2026	ISO 9001:2026 (sixth edition) published	ISO/TC 176/SC 2 news, Global ACI
March 31, 2027	Accreditation bodies ready to assess ISO 9001:2026	Global ACI TECH-3-TR
June 30, 2027	Certification bodies submit their transition declaration	Global ACI TECH-3-TR
September 30, 2027	Accreditation body transition decisions completed	Global ACI TECH-3-TR
March 31, 2028	New and initial accredited certifications only to ISO 9001:2026	Global ACI TECH-3-TR
September 30, 2029	End of transition for ISO 9001:2015 certificates	Global ACI TECH-3-TR

ISO 9001: the generic baseline

ISO 9001 is maintained by ISO/TC 176/SC 2. Since 2015 it follows Annex SL, the common structure of ISO management system standards (clauses 4 to 10: context, leadership, planning, support, operation, performance evaluation, improvement), which is why it integrates easily with ISO 14001, ISO 45001 or ISO/IEC 27001 in one integrated management system (IMS).

ISO 9001:2015 with Amd 1:2024

On February 23, 2024 ISO published climate action amendments to its management system standards, including ISO 9001:2015/Amd 1:2024. Two sentences were added. Clause 4.1: "The organization shall determine whether climate change is a relevant issue." Clause 4.2, a note: relevant interested parties can have requirements related to climate change. The IAF/ISO communiqué states that the overall intent of 4.1 and 4.2 is unchanged and that a quality management system audit should not become a disproportionate climate audit.

ISO 9001:2026: what changed

The Global ACI transition document lists the key changes and calls the overall changes minimal:

Clause in ISO 9001:2026	Change (Global ACI TECH-3-TR, section 3.1)
Whole document	Alignment with Annex SL and ISO TMB resolution 16/2025; terms aligned with the harmonized structure; ISO 9000 remains the normative reference for quality terms
Documented information	New phrase for documented information; "documented information shall be available" clarified
5.1.1	Items a to k reorganised; new item i, promoting quality culture and ethical behaviour; "continual improvement" instead of "improvement"; new NOTE 2 on quality culture
5.2.1	Elements moved into item e, so the policy takes into account the context and supports strategic direction
6.1	Split into 6.1.1 determining risks and opportunities, 6.1.2 actions to address risks, 6.1.3 actions to address opportunities
6.3	Planning of changes adds monitoring of effectiveness, communication of the changes and review of results
7.3	Awareness now includes organizational quality culture and ethical behaviour
9.3.2	Management review inputs "shall include"; new input on changes in the needs and expectations of interested parties
Annexes	Annex A (informative) rewritten to clarify requirements; Annex B removed

Certification and transition

ISO 9001 certificates are issued by certification bodies accredited to ISO/IEC 17021-1 by national accreditation bodies (COFRAC in France, UKAS in the UK, DAkkS in Germany, ANAB in the US and others). The transition rules for ISO 9001:2026 are set by Global ACI (Global Accreditation Cooperation Incorporated), whose document states it is mandatory for its multilateral recognition arrangement signatories and the certification bodies they accredit. The transition period is three years, with the dates in the table above. The transition can take place at a scheduled surveillance or recertification audit, or in a separate transition audit.

Global ACI also notes that ISO 9001 is the base of several sector schemes (AS/EN/JISQ/IA 91XX, TL 9000, IATF 16949, ISO 22163, ISO 29001), so the sector owners have to follow with their own revisions.

AS 9100: aviation, space and defence

The 9100 standard is owned by the IAQG (International Aerospace Quality Group) and published regionally as AS9100 (SAE, Americas), EN 9100 (Europe) and JISQ 9100 (Japan). The current revision is D (AS9100D, 2016). As NASA describes it, AS9100 is the copyrighted ISO 9001 text with additional text in bold italics for the aerospace industry, so the IAQG has to stay aligned with ISO 9001 revisions.

IA9100, the next revision

In 2022 the IAQG signed a publication and distribution agreement with SAE International; new IAQG documents and revisions take the prefix IA, so the next 9100 becomes IA9100. According to NASA, the revision started in the third quarter of 2021, the first draft was released in November 2023 (388 consolidated comments), and the publication estimate moved to the fourth quarter of 2026 to follow ISO 9001. The fourteen themes listed for the revision include product safety, human factors, cyber and data security, counterfeit terminology, culture and ethics, foreign object debris, sub-tier supplier control and transfer of work. Until IA9100 is published with its transition rules, AS9100D is the edition being certified; check the IAQG and your certification body before planning a transition.

What AS9100D adds to ISO 9001:2015

AS9100D clause	Aerospace requirement
8.1.1	Operational risk management
8.1.2	Configuration management
8.1.3	Product safety
8.1.4	Prevention of counterfeit parts
8.5.1.2	Validation and control of special processes
8.5.1.3	Production process verification (first article inspection, commonly to 9102)
8.5.1	Prevention, detection and removal of foreign objects (FOD) among the controlled conditions

The table lists the best-known additions; the full set is in the bold italic text of the standard.

ICOP, OASIS and auditors

AS 9100 certification runs under the IAQG ICOP scheme (Industry Controlled Other Party). The 9104 series sets the rules: 9104/1 for certification programmes (being replaced by IA9104/1 according to the resolutions log) and 9104/3 for auditor competence and authentication. The IAQG resolutions log requires auditor authentication bodies to check completion of the IAQG sanctioned AATT (Aerospace Auditor Transition Training).

Certificates live in OASIS (Online Aerospace Supplier Information System). An IAQG resolution states that certification bodies shall not issue a valid certificate to the certified organisation until the audit and certification data are uploaded and published in OASIS, and that if a new certificate is not published within six months of the expiry date, the organisation has to apply for a new initial certification. A paper certificate that is not in OASIS is therefore not evidence.

ISO 13485:2016: medical devices

ISO 13485:2016 is published by ISO/TC 210 and is the current edition. In the EU, EN ISO 13485:2016 and its European amendment EN ISO 13485:2016/A11:2021 are cited as harmonised standards: under the MDR by Commission Implementing Decision (EU) 2022/6 of January 4, 2022 (entry 10), and under the IVDR by Decision (EU) 2022/15 of January 6, 2022 (entry 7). A11 adds annexes linking clauses to the MDR and IVDR requirements; it does not change the ISO text.

QMSR: ISO 13485 inside 21 CFR Part 820

The FDA final rule (89 FR 7496) took effect on February 2, 2026. Part 820 is now the Quality Management System Regulation. Section 820.7 incorporates by reference ISO 13485:2016 and clause 3 of ISO 9000:2015 (terms and definitions). FDA did not incorporate ISO 14971 or other standards referenced by ISO 13485. What FDA kept on top of the standard:

QMSR section	ISO 13485 clause	FDA addition
820.10(a)	Whole standard	Document a QMS that complies with ISO 13485 and the rest of Part 820
820.10(b)(1)	7.5.8 Identification	Unique device identification per Part 830
820.10(b)(2)	7.5.9.1 Traceability	Traceability per Part 821 where applicable
820.10(b)(3)	8.2.3 Reporting to regulatory authorities	Medical device reporting per Part 803
820.10(b)(4)	7.2.3, 8.2.3, 8.3.3	Advisory notices handled per Part 806 (corrections and removals)
820.10(c)	7.3 Design and development	Mandatory for class II and III devices and listed class I devices, including those automated with software
820.10(d)	7.5.9.2 Implantable devices	Applies to devices that support or sustain life
820.35(a)	8.2.2 Complaint handling	Minimum content of complaint records (device name, date, UDI or UPC, complainant, nature, corrective action, reply)
820.35(b)	7.5.4 Servicing	Minimum content of servicing records
820.35(c)	7.5.1, 7.5.8, 7.5.9	UDI recorded for each device or batch
820.45	(FDA section, uses ISO 13485 terms)	Device labelling and packaging controls

MDSAP

MDSAP (Medical Device Single Audit Program) lets one audit by an authorised auditing organisation cover ISO 13485 plus the requirements of five regulators: TGA (Australia), ANVISA (Brazil), Health Canada, MHLW and PMDA (Japan) and the US FDA. The QMSR preamble records that IMDRF developed MDSAP in 2012 and that FDA may accept MDSAP audit reports in place of routine surveillance inspections; participation is voluntary for FDA-regulated manufacturers. Health Canada ended CMDCAS on January 1, 2019: from that date, Class II, III and IV medical device licence applications with CMDCAS certificates are not accepted, and licence holders needed a certificate from an MDSAP auditing organisation.

See MDR for the EU regime and FDA 510(k), De Novo, PMA for the US premarket routes.

TL 9000: ICT sector

TL 9000 was developed in 1998 by QuEST Forum, which merged with the Telecommunications Industry Association (merger announced September 19, 2017); the programme is now run by TIA QuEST Forum. According to its overview, certified organisations must comply with all requirement clauses of ISO 9001:2015, the ICT-specific requirements for their registration (hardware, software, services) and the industry measurements for their product category.

Document	Current version	Status (TL 9000 handbook status page)
Requirements Handbook	R6.3, effective October 1, 2021	Active; upgrade to R6.3 is mandatory (one new requirement in section 9.3); no revision under way
Measurements Handbook	R5.7, effective June 30, 2020	Active; R5.7 replaced the SPR measures with eSPR; no revision under way
Product Category Tables	R5.9	Active; changes collected for a next release

The measurements

The Measurements Handbook defines the following measurement families (Measurements Handbook outline):

Family	Measurements
Common	NPR (number of problem reports), FRT (problem report fix response time), OFR (overdue fix responsiveness), OTD (on-time delivery)
Outage	SO (system outage), NEO (network element outage), SSO (support service caused outage), plus MTRS and GSI for end-customer service providers
Hardware	ERI (early return), YRR (one-year return), LTR (long-term return), NYR (normalised one-year return), BRR (basic return rate) for some categories
Software	SFQ (software fix quality), eSPR (early software problem reports)
Service quality	SQ, plus CCRR (end-customer complaint report rate) and IRR (incident restore rate) for network operators

Registrations submit their data every month, no later than seven weeks after the end of the month (UTC clock), to the TL 9000 measurements repository; data submitted in error must be corrected and resubmitted for up to two years back. The product category tables define approximately 160 product categories. Information Alert 25-001A (2025) clarified that data must cover the whole customer base providing the necessary data, not a selected subset.

Stacking standards

Sector	Typical set
Generic electronics	ISO 9001, often with ISO 14001 and ISO 45001 in an IMS
Aerospace electronics	AS9100D (includes ISO 9001:2015), plus customer special-process approvals
Medical electronics	ISO 13485:2016 with ISO 14971 risk management, IEC 62304 software and IEC 60601-1 safety, MDSAP where the market requires it
Automotive electronics	ISO 9001 plus IATF 16949 (see IATF 16949)
ICT equipment	TL 9000 (includes ISO 9001:2015) and the monthly measurements

ISO 9001, ISO 14001, ISO 45001 and ISO/IEC 27001 share the Annex SL structure. ISO 13485:2016 does not, so a combined medical and non-medical system needs a clause mapping. The 2026 ISO 9001 adds a second timing problem: AS9100D and TL 9000 R6.3 still embed ISO 9001:2015, so a site holding both ISO 9001 and a sector certificate will see the ISO 9001 transition before the sector standards follow.

Claims the texts contradict

Claim	What the text says
"ISO 9001:2015 remains the current edition in 2026; the revision is still a working draft." (made by the earlier version of this page)	ISO 9001:2026 was published on September 16, 2026, after the FDIS ballot closed on July 9, 2026 (ISO/TC 176/SC 2).
"Once published, the transition is typically three years."	The ISO 9001:2026 transition is fixed: new certifications only to the 2026 edition from March 31, 2028, end of transition September 30, 2029 (Global ACI TECH-3-TR).
"The 2026 revision will add climate change."	Climate change was added to ISO 9001:2015 by Amd 1:2024 on February 23, 2024. The 2026 changes are about quality culture, ethics, risks and opportunities, change planning and management review.
"TL 9000 QMS-R Release 6.3 (2023), QMS-M Release 5.5." (made by the earlier version of this page)	R6.3 has been effective since October 1, 2021; the active Measurements Handbook is R5.7, effective June 30, 2020.
"FRT means Field Replacements per Thousand, the return rate." (made by the earlier version of this page)	FRT is problem report fix response time. Returns are measured by ERI, YRR, LTR, NYR or BRR.
"TL 9000 product categories are numbered 1.x to 8.x."	The handbook outline counts approximately 160 product categories in the Category Tables (current release R5.9); we did not find a 1.x to 8.x rule in the TIA QuEST Forum material.
"The QMSR requires ISO 13485 certification" or "the regulator requires ISO 13485 through the QMSR".	The QMSR requires compliance with ISO 13485 plus Part 820. FDA states it will not require ISO 13485 certification and will not accept a certificate in place of an inspection.
"The QMSR retains definitions, labelling, complaint files and UDI" as a vague list.	The FDA additions are specific: 820.10(b) links ISO 13485 clauses to Parts 803, 806, 821 and 830; 820.35 sets complaint, servicing and UDI record content; 820.45 covers labelling and packaging.
"ISO 13485:2016 was reviewed and confirmed in 2025 without modification." (made by the earlier version of this page)	We could not confirm this from an ISO source; we only state that ISO 13485:2016 is the current edition.
"Notified bodies expect a QMS aligned with ISO 13485" (as if it were not a harmonised standard).	EN ISO 13485:2016 with A11:2021 is a harmonised standard under both MDR (Decision 2022/6) and IVDR (Decision 2022/15).
"AATT means Aerospace Auditor Training and Transition." (made by the earlier version of this page)	IAQG resolutions call it Aerospace Auditor Transition Training.
"An AS 9100 major finding must be closed within 60 days." (made by the earlier version of this page)	We found no such figure in the IAQG material we could access; the timelines are set in 9101 and the CB contract. We removed it.
"Customer-furnished property is an aerospace addition." (made by the earlier version of this page)	Property belonging to customers or external providers is ISO 9001:2015 clause 8.5.3, not an AS 9100 addition.
"Rev E is in development."	The next 9100 revision will be named IA9100, following the 2022 IAQG and SAE agreement.

Common pitfalls

Pitfall	Consequence
Waiting for the ISO 9001:2015 certificate expiry to plan the 2026 transition	All 2015 certificates must transition by September 30, 2029, and no new 2015 certifications after March 31, 2028
Taking an AS 9100 supplier certificate on paper without OASIS	Under IAQG resolutions a certificate is not valid until published in OASIS
Treating ISO 9001 design and development (8.3) as not applicable in a medical context	Under the QMSR, design controls (ISO 13485 clause 7.3) are mandatory for class II and III devices and software-automated class I devices
Relying on an ISO 13485 certificate for FDA	FDA does not accept certificates in place of inspections; only MDSAP audit reports can replace routine surveillance
Missing the TL 9000 monthly submission deadline	The handbook requires data each month within seven weeks; late or erroneous data has to be fixed
Selling Class II to IV devices in Canada with a plain ISO 13485 certificate	Health Canada requires a certificate from an MDSAP auditing organisation since January 1, 2019

How to choose

1. Who are your customers? Aerospace and defence primes ask for AS 9100 (check in OASIS). Medical regulators ask for an ISO 13485 QMS, MDSAP where Canada is in scope. ICT network operators may ask for TL 9000. Generic customers usually accept ISO 9001.
2. Do you design the product? Design and development is the largest step from ISO 9001 to ISO 13485 or AS 9100. Under the QMSR it is mandatory for most devices.
3. When does your ISO 9001 certificate cycle fall? Plan the move to ISO 9001:2026 into a surveillance or recertification audit before September 30, 2029.

Further reading

• IATF 16949 automotive quality: automotive supplement to ISO 9001:2015
• MDR medical device regulation: EU framework where EN ISO 13485 is harmonised
• FDA 510(k), De Novo, PMA: US medical routes, with the QMSR
• Harmonised standards and presumption of conformity: what a citation in the Official Journal does
• Glossary: definitions of ISO 9001, AS 9100, ISO 13485, TL 9000, MDSAP, QMSR, IAQG, OASIS

See also

• IATF 16949: automotive quality management
• Risk management: ISO 14971, IEC 31010, FMEA, FTA, HAZOP
• MDR: the EU Medical Device Regulation (2017/745)
• MDR class IIb and III: UDI, EUDAMED, NB, surveillance
• IVDR: in vitro diagnostic medical devices

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Sources & references

1. ISO 9001:2026 has been released (ISO/TC 176/SC 2 news, September 28, 2026), ISO/TC 176/SC 2 committee.iso.org/sites/tc176sc2/home/news/content-left-area/news-and-updates/news-2.html
2. Global ACI-TECH-3-TR 2029-09-30 (M), Transition requirements for ISO 9001:2026, Global Accreditation Cooperation Incorporated sys.global-aci.org/uploads/documents/TECH-3-TR_2029-09-30_(M)_ISO_9001_2026_Transition_v1_03.pdf
3. ISO 9001:2015 Quality management systems requirements, International Organization for Standardization www.iso.org/standard/62085.html
4. IAF/ISO joint communiqué on climate change amendments to management system standards (February 22, 2024), IAF and ISO iaf.nu/iaf_system/uploads/documents/Joint_ISO-IAF_Communique_re_Climate_Change_Amds_to_ISO_MSS_Feb_2024_Final.pdf
5. Annex SL high-level structure for management system standards, International Organization for Standardization www.iso.org/sites/directives/current/consolidated/index.xhtml
6. ISO 13485:2016 Medical devices quality management systems, International Organization for Standardization www.iso.org/standard/59752.html
7. Commission Implementing Decision (EU) 2022/6 (MDR harmonised standards, adds EN ISO 13485:2016/A11:2021), European Commission eur-lex.europa.eu/eli/dec_impl/2022/6/oj
8. Commission Implementing Decision (EU) 2022/15 (IVDR harmonised standards, adds EN ISO 13485:2016/A11:2021), European Commission eur-lex.europa.eu/eli/dec_impl/2022/15/oj
9. FDA QMSR Final Rule, 89 FR 7496 (February 2, 2024, effective February 2, 2026), US Food and Drug Administration www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments
10. 21 CFR Part 820, Quality Management System Regulation (eCFR), US Government Publishing Office www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820
11. MDSAP Medical Device Single Audit Program, US Food and Drug Administration www.fda.gov/medical-devices/cdrh-international-affairs/medical-device-single-audit-program-mdsap
12. Notice: MDSAP transition plan, frequently asked questions, Health Canada www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/notice-transition-plan-medical-device-audit-program.html
13. Status of the development of IA9100 (April 17, 2024), NASA Office of Safety and Mission Assurance sma.nasa.gov/news/articles/newsitem/2024/04/17/status-of-the-development-of-ia9100-quality-management-systems-requirements-for-aviation-space-and-defense-organizations
14. IAQG ICOP certification scheme resolutions log (February 12, 2026), International Aerospace Quality Group iaqg.org/wp-content/uploads/2026/02/ICOT-Resolutions-Log-Master-12-February-2026.pdf
15. IAQG OASIS database of AS 9100 certified suppliers, International Aerospace Quality Group www.iaqg.org/oasis/
16. TL 9000 handbook status, TIA QuEST Forum tl9000.org/handbooks/status.html
17. TL 9000 Measurements Handbook outline, TIA QuEST Forum tl9000.org/handbooks/mh_outline.html
18. TL 9000 data submissions and due dates, TIA QuEST Forum tl9000.org/alerts/data_submissions.html
19. TIA and QuEST Forum announce merger (September 19, 2017), Telecommunications Industry Association tiaonline.org/press-release/tia-and-quest-forum-announce-merger/
20. TL 9000 Quality Management System (QuEST Forum / TIA), Telecommunications Industry Association www.tiaonline.org/what-we-do/quest-forum/