When you search for an ISO 13485 quality management system certification body, you encounter two accreditation names repeatedly: IAS and ANAB. Both appear on registrar websites as proof of credibility.
Both claim international recognition. If you are not sure what the difference means for your medical device business, or whether it matters at all, this is the guide you need.
The answer is more practical than most buyers expect. IAS and ANAB are both signatories of the IAF Multilateral Recognition Arrangement, which means ISO 13485 certificates issued under either accreditation carry internationally recognized standing.
The difference that actually determines your outcome is how fast your registrar delivers your certificate, what it costs, and whether the audit disrupts your operations, not which accreditation body logo appears on the paperwork.
Quick Comparison: IAS-Accredited vs. ANAB-Accredited ISO 13485 Certification Bodies
Both accreditation bodies operate under the same international mutual recognition framework, but they differ in origin, regional footprint, and how certification bodies under each accreditation structure their audit delivery and pricing.
“ANAB confirmed its IAF MLA signatory status for ISO 13485 as a level 5 sub-scope.” (ANAB, "ANAB Expands IAF MLA Status")
What IAS Accreditation Means for Your ISO 13485 Certification
IAS accreditation under MSCB-207 confirms that a certification body meets the requirements of ISO/IEC 17021-1, the international standard governing management system certification bodies, and operates within the IAF Multilateral Recognition Arrangement for ISO 13485.
An ISO 13485 certificate issued by an IAS-accredited body carries the same international recognition as one issued by any other IAF MLA signatory, including ANAB-accredited registrars.
That is the answer most buyers never find in competitor content. Both bodies sit inside the same global framework.
The accreditation body name is not a quality ranking; it is a recognition pathway. What you are evaluating is the registrar behind that accreditation, not the accreditation body itself.
1. What IAS Accreditation Covers for Medical Device Certification
The International Accreditation Service issues management systems certification body accreditation under its MSCB program.
“The MSCB-207 scope covers the full range of management systems certification, which includes ISO 13485 medical device quality management systems.” (IAS, "Management System Certification Bodies")
The governing standard underneath IAS accreditation is ISO/IEC 17021-1. This is the same standard that ANAB-accredited certification bodies must conform to.
Both bodies require their accredited registrars to demonstrate competence, impartiality, and consistent audit processes against this standard. The accreditation pathway differs; the conformity requirement does not.
2. How KSQA Delivers ISO 13485 Certification Under IAS Accreditation
KSQA holds IAS Management Systems Certification Body Accreditation, MSCB-207, along with membership in the IAF Multilateral Recognition Arrangement and the International Aerospace Quality Group.
The accreditation is active and publicly displayed on the KSQA About Us page.
The audit process runs in four stages: gap analysis, Stage 1 documentation review, Stage 2 implementation audit, and certificate issuance.
Every audit is delivered virtually by default, which means no production downtime, no travel costs, and no scheduling delays tied to an auditor's physical availability.
Once the Stage 2 audit is complete, KSQA issues the certificate within 2-3 days.
The friction point most buyers hit with large registrars is not the audit itself; it is the gap between audit completion and the certificate in hand.
That window typically runs 30-45 days at large certification bodies. When an OEM is waiting on your supplier qualification documents, that gap costs you time on a contract. KSQA's 2-3 day issuance window closes that gap entirely.
Pricing is fixed. You know the full cost before the process begins, with no variable fees added at audit completion. An online client portal gives you real-time visibility into audit status, auditor credentials, and reports throughout the process.
KSQA brings more than 20 years of experience in ISO and AS9100 certification auditing and has completed hundreds of successful certifications across medical device design, manufacturing, and distribution businesses in the United States.
What ANAB-Accredited ISO 13485 Certification Bodies Offer
ANAB-accredited certification bodies for ISO 13485 include established registrars such as NQA and Perry Johnson Registrars (PJR), both of which carry IAF MLA recognition for this standard and operate across the United States.
They serve medical device manufacturers, distributors, and design firms, and their accreditation satisfies standard OEM supplier qualification requirements.
Their audit and certification timelines follow the industry standard of 30-45 days from audit completion to certificate issuance.
“ANAB is the largest multi-disciplinary accreditation body in North America and formally accredits certification bodies for ISO 13485 medical device quality management systems.” (Amtivo, "What Is ANAB Accreditation and What Are Its Benefits," January 2026)
What the Accreditation Difference Actually Means When Your Certificate Reaches a Procurement Desk
For most US medical device supply chain agreements, both IAS and ANAB accreditation satisfy the requirement for an accredited third-party certification body, because both operate under the same IAF MLA framework.
The decision that actually affects your qualification outcome is registrar turnaround time, pricing transparency, and audit delivery method.
OEM Supplier Qualification: Does Your Registrar's Accreditation Body Matter?
Most OEM supplier qualification requirements specify certification from an IAF MLA-accredited body. They do not specify IAS or ANAB by name.
“Both IAS and ANAB hold signatory status within the same international mutual recognition framework for ISO 13485, confirmed under the IAF level 5 sub-scope recognition structure.” (ANAB, "ANAB Expands IAF MLA Status"; IAF / Global ACI Launch)
This means an ISO 13485 certificate from KSQA, IAS-accredited under MSCB-207, satisfies the same OEM supplier qualification requirement as a certificate from an ANAB-accredited registrar.
One honest qualification: some procurement frameworks or government contracts may name a specific accreditation body in their supplier requirements.
Before you select a registrar, check your OEM's supplier qualification documentation directly.
In most cases, IAF MLA recognition is the stated requirement, and both IAS and ANAB meet it. But verifying your specific OEM's requirements before you begin is the step a qualified registrar will always recommend.
The Practical Factors That Determine Which Registrar to Choose
Once you confirm that both IAS and ANAB recognition satisfy your OEM's requirements, three factors determine which registrar actually serves your business:
Turnaround Time: If a contract is waiting on your certificate, 30-45 days is a risk. KSQA's 2-3 day certificate issuance removes that risk entirely.
Pricing Model: A fixed price means your budget is set before the process starts. Variable pricing means your final cost depends on audit complexity, scope changes, and additional fees, none of which are visible upfront.
Audit Logistics: A virtual-first audit eliminates production disruption and travel costs. In-person audits require scheduling, site access coordination, and production accommodation.
KSQA's IAS Management Systems Certification Body Accreditation, MSCB-207 underpins every ISO 13485 certification it issues. The accreditation is the foundation. The delivery model is what sets the outcome apart.
Which Option is Best For You?
1. ANAB-accredited registrar (e.g., NQA, PJR)
Best for: Medical device companies whose OEM or procurement contract explicitly names an ANAB-accredited body or larger organizations with extended internal timelines that are comfortable with the standard 30-45 day certificate issuance cycle.
2. KSQA, IAS-accredited under MSCB-207
Best for: U.S. medical device manufacturers, distributors, and design firms that need an IAS-accredited, IAF MLA-recognized ISO 13485 certificate issued within 2-3 days, at a fixed price, with no production disruption from a virtual-first audit.
Frequently Asked Questions (FAQs)
1. Is an IAS-accredited ISO 13485 certificate accepted by OEMs and procurement bodies?
Yes. IAS holds signatory status in the IAF Multilateral Recognition Arrangement for ISO 13485, which means certificates issued by IAS-accredited bodies, including KSQA, carry the same internationally recognized standing as those issued by ANAB-accredited registrars.
Most OEM supplier qualification requirements specify an IAF MLA-accredited certification body, not a named accreditation body. An ISO 13485 certificate from KSQA satisfies that requirement.
2. How long does it take to get ISO 13485 certified?
The industry standard for most large certification bodies is 30-45 days from audit completion to certificate issuance. KSQA issues ISO 13485 certificates within 2-3 days of a successful Stage 2 audit.
The full process, gap analysis, Stage 1 documentation review, and Stage 2 implementation audit run on a fixed timeline with virtual delivery, so no production time is lost waiting for an auditor to travel to your facility.
3. What is the difference between IAS and ANAB accreditation for ISO 13485 certification bodies?
IAS, International Accreditation Service, and ANAB, ANSI National Accreditation Board, are both accreditation bodies that authorize certification bodies to issue ISO 13485 certificates.
Both are IAF MLA signatories for this standard. IAS accredits KSQA under MSCB-207. ANAB accredits registrars such as NQA and PJR. The practical difference for buyers lies in which registrar they choose and how that registrar delivers the audit, not in the accreditation body name.
4. Does my OEM care whether my registrar is IAS-accredited or ANAB-accredited?
In most cases, no. Standard OEM and procurement supplier qualification requirements specify certification from an IAF MLA-accredited body, a framework that both IAS and ANAB satisfy for ISO 13485.
However, you should review your OEM's specific supplier documentation before selecting a registrar. If the requirement names an accreditation body specifically, confirm your registrar meets that requirement.
If it references IAF MLA recognition, both IAS and ANAB-accredited registrars qualify.
Your ISO 13485 Certificate with No Hidden Fees
The accreditation body behind your ISO 13485 quality management system certificate matters, but not in the way most buyers assume.
Both IAS and ANAB satisfy the international recognition standard that OEM supplier qualification requires. What separates registrars is how fast they deliver your certificate, what they charge, and whether the audit fits your operations.
KSQA is IAS-accredited under MSCB-207, operates with a fixed pricing model, and issues ISO 13485 certificates within 2-3 days of audit completion through a virtual-first process that requires no production downtime.
Request your ISO 13485 gap analysis from KSQA today.
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