ISO 90003 Audit Services

What is ISO/IEC 90003 and Why Does It Matter?

ISO/IEC 90003:2018 is the internationally recognized standard that provides guidelines for the application of ISO 9001:2015 to organizations that acquire, supply, develop, operate, maintain, or support computer software and related services. Published jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), it translates the quality management system requirements of ISO 9001 into practical, software-specific guidance.

For software developers, IT service providers, SaaS companies, embedded systems manufacturers, and any organization whose products or services include computer software, ISO/IEC 90003 alignment demonstrates mature quality management practices tailored to the unique challenges of software engineering — from requirements definition and design to verification, validation, configuration management, and post-delivery support.

At Lazarus Alliance, we specialize in guiding software and technology organizations through the complete ISO/IEC 90003 readiness, audit, and certification process. Our practical, proportionate approach minimizes bureaucracy while maximizing real quality improvements — so you achieve this globally respected credential efficiently and cost-effectively.

Ready to elevate your software quality management? Call +1 (888) 896-7580 or contact us today for your free ISO/IEC 90003 consultation.

Our ISO/IEC 90003 Audit & Conformity Assessment Services

Expert Guidance for Software Quality Management Excellence

Lazarus Alliance delivers comprehensive, accredited ISO/IEC 90003:2018 audit and conformity assessment services for organizations that develop, supply, operate, maintain, or support computer software. Our independent, certified lead auditors provide objective validation that your quality management system fully aligns with ISO 9001:2015 requirements as applied specifically to software engineering.

ISO/IEC 90003 Services We Provide

Gap Analysis & Readiness Assessment — Thorough benchmarking of your software quality processes against ISO/IEC 90003:2018 guidelines and ISO 9001:2015 requirements
Stage 1 Audit (Documentation & Design Review) — Evaluation of your quality manual, software lifecycle processes, configuration management, verification & validation procedures, and leadership commitment
Stage 2 Conformity Assessment (Main Audit) — In-depth on-site or remote verification of effective implementation through interviews, process observation, record sampling, and performance evaluation across the entire software lifecycle
Surveillance Audits — Annual or biennial reviews to confirm continued conformity and sustained improvement
Recertification Audit — Full reassessment every three years to renew your ISO/IEC 90003-aligned certificate
Consulting & Remediation Support — Process optimization, tool integration (e.g., Jira, Azure DevOps, GitLab), training, and corrective-action coaching

Upon successful completion, you receive an internationally recognized Certificate of Conformity demonstrating full alignment with ISO/IEC 90003:2018 and ISO 9001:2015 for software (3-year validity) — widely accepted by enterprise clients, prime contractors, regulated industries, and government agencies.

The ISO/IEC 90003 Certification Process in Practice

Unlike ISO 31000, ISO/IEC 90003 is fully certifiable when pursued through an accredited certification body applying ISO 9001:2015 to software activities.

Phase	What Happens	Typical Duration	Delivered By
1. Scoping & Contract	Define certification scope (e.g., all software activities, specific products, or sites) and sign the agreement	1–4 weeks	Lazarus Alliance
2. Optional Gap Analysis	Independent review of current QMS and software processes vs. ISO 9001 + 90003 requirements	4–12 weeks	Lazarus Alliance
3. Stage 1 – Readiness Audit	Review of quality manual, policies, software development lifecycle (SDLC), risk-based thinking, configuration management, and leadership	1–4 days (remote or on-site)	Lead Auditor
4. Stage 2 – Certification Audit	Full verification: interviews, process sampling (requirements, design, coding, testing, release, support), defect management, customer satisfaction evidence	4–15+ days (depending on size/complexity)	1–4 Lead Auditors
5. Certification Decision	Technical review and issuance of ISO 9001:2015 certificate with explicit scope covering ISO/IEC 90003 software activities (valid 3 years)	2–6 weeks after Stage 2	Accreditation Body via Lazarus Alliance
6. Annual / Biennial Surveillance Audits	Focused audits confirming ongoing conformity and improvement	2–6 days	Lead Auditor
7. Recertification Audit	Complete Stage 1 + Stage 2 renewal before certificate expiry	Every 3 years	Lazarus Alliance

Elevate your software quality, reduce defects and rework, and win more enterprise and government contracts with accredited ISO/IEC 90003 certification.

The ISO 90003 Audit Process: A Step-by-Step Timeline – What to Expect with Lazarus Alliance

At Lazarus Alliance, we make the ISO/IEC 90003 certification process straightforward, efficient, and tailored to your software organization's unique needs. Our accredited approach ensures a smooth journey from initial engagement to ongoing certification maintenance, with minimal operational disruption and maximum value.

Here's what the process looks like in practice—typically spanning 3–6 months for initial certification, depending on your organization's size and readiness. We'll guide you every step of the way with clear communication, dedicated project management, and expert support.

Step	What Happens	Typical Timeline	What to Expect with Lazarus Alliance
1. Initial Consultation & Scoping	We discuss your goals, define the certification scope (e.g., specific software products, teams, or sites), and create a customized project plan. Sign a simple engagement agreement.	1–2 weeks	Free 30-minute call with a senior ISO 90003 expert. You'll receive a tailored proposal with costs, timeline, and deliverables—no pressure, just clarity.
2. Optional Gap Analysis	Our auditors review your current quality management system (QMS) and software processes against ISO 9001:2015 + ISO/IEC 90003:2018 requirements. You get a detailed report with prioritized recommendations.	4–8 weeks	Hands-on virtual or on-site sessions. We'll identify quick wins (e.g., improving requirements traceability or testing documentation) to fast-track your readiness.
3. Stage 1 Readiness Audit	Auditors evaluate your QMS documentation, policies, software lifecycle processes (SDLC), risk management, and leadership commitment. Goal: Confirm you're ready for the full audit.	1–4 days (remote or on-site)	Collaborative and supportive—expect interviews with your leadership and key teams. We'll provide immediate feedback and a report with any minor gaps to address before Stage 2.
4. Stage 2 Certification Audit	In-depth verification of implementation: Auditors interview staff, observe processes (e.g., code reviews, testing, releases), sample records (defect logs, customer feedback), and assess effectiveness across the software lifecycle.	4–15 days (spread over 1–3 weeks, hybrid remote/on-site)	Efficient and respectful of your schedule. Our auditors are software industry veterans who speak your language—no "gotcha" surprises. You'll get real-time insights and coaching during the audit.
5. Certification Decision & Issuance	Our independent technical review team evaluates audit findings. If all requirements are met (or minor non-conformities are resolved), you receive your certificate.	2–4 weeks after Stage 2	Fast-tracked process—most clients certified within 3 weeks. You'll get your ISO 9001:2015 certificate (scoped to ISO/IEC 90003 software activities), digital badge for marketing, and a comprehensive audit report.
6. Surveillance Audits	Shorter audits to verify ongoing conformity, continual improvement, and effective corrective actions. Focus on high-risk areas like software updates or customer satisfaction.	2–6 days annually or biennially	Low-impact and value-adding. We schedule around your releases and provide actionable recommendations to strengthen your QMS year after year.
7. Recertification	Full repeat of Stage 1 + Stage 2 to renew your certificate before it expires.	Every 3 years (starting 3 months before expiry)	Seamless transition—we reuse your history to reduce effort. Most clients see this as a natural evolution, not a reset.

Why Choose Lazarus Alliance for Your ISO 90003 Journey?

Proven Expertise: Our auditors are certified ISO 9001/90003 leads with 10+ years in software engineering, DevOps, and regulated industries (e.g., healthcare software, fintech, aerospace).
Minimal Disruption: Flexible scheduling, remote options, and focus on your priorities mean business as usual.
Real Results: Beyond certification, you'll gain improved processes, fewer defects, happier customers, and stronger bids for contracts.
Guaranteed Support: Unlimited post-audit questions, free follow-up calls, and access to our software-specific resources (templates, checklists, webinars).

Ready to get certified? Most clients achieve ISO/IEC 90003 conformity in under 4 months. Contact us today at +1 (888) 896-7580 or schedule your free consultation. Let's turn your software quality management into a competitive superpower!

What is ISO/IEC 90003:2018 and who needs it?

ISO/IEC 90003:2018 is the international standard that provides detailed guidelines for applying ISO 9001:2015 quality management requirements to computer software and software-related services. It is essential for software developers, SaaS providers, embedded systems manufacturers, IT service companies, medical device software firms, and any organization whose products or services include software development, maintenance, or support—especially when bidding on government, defense, healthcare, or enterprise contracts that require proven software quality processes.

Is ISO/IEC 90003 a separate certifiable standard from ISO 9001?

No. ISO/IEC 90003 itself is not separately certifiable. Certification is issued under ISO 9001:2015 with an explicit scope statement that the quality management system covers computer software in accordance with ISO/IEC 90003:2018 guidelines. Reputable accredited certificates will clearly state both ISO 9001:2015 and reference ISO/IEC 90003 compliance in the scope.

How long does it take to get ISO 90003 certified in 2025?

With proper preparation and an experienced partner like Lazarus Alliance, most mid-sized software organizations achieve initial ISO 90003-aligned certification in 3–6 months. Organizations that already have mature DevOps or Agile processes often complete the journey in under 4 months.

What is the cost of ISO/IEC 90003 certification and audit services?

Total investment typically ranges from $25,000–$85,000+ for initial certification (including gap analysis, Stage 1 & 2 audits, and certification body fees), depending on company size, number of locations, and complexity of software activities. Lazarus Alliance provides fixed-price proposals after a free scoping call so you know the exact cost upfront.

Can the ISO 90003 audit be performed remotely or hybrid?

Yes. In 2025, over 80% of ISO/IEC 90003 audits are conducted fully remotely or in a hybrid format using secure platforms (Microsoft Teams, Zoom Gov, shared evidence portals). Lazarus Alliance has completed hundreds of fully remote software audits with zero on-site visits while maintaining full accreditation acceptance.

What is the difference between ISO 9001 and ISO/IEC 90003 for software companies?

ISO 9001 is the generic quality management standard. ISO/IEC 90003 translates every ISO 9001 requirement into a specific software engineering context—covering requirements specification, design, coding, verification & validation, configuration management, problem resolution, and post-delivery support. Software companies that only certify to generic ISO 9001 often fail contract or regulatory audits; ISO/IEC 90003 alignment eliminates that risk.

Do FDA, DoD, or aerospace primes accept ISO/IEC 90003 certification?

Yes. FDA (for medical device software), DoD contractors, aerospace primes (Boeing, Lockheed Martin, Northrop Grumman), and many Fortune 500 enterprises explicitly recognize or require ISO 9001 certification scoped to ISO/IEC 90003:2018 as evidence of compliant software quality processes—often in place of or alongside IEC 62304 or AS9100.

How do I get started with ISO 90003 certification through Lazarus Alliance?

Simple 3-step process:

Schedule your free 30-minute consultation at +1 (888) 896-7580 or online
Receive a fixed-price proposal and customized roadmap within 48 hours
Begin your gap analysis or Stage 1 audit—most clients are certified within 4–6 months. Lazarus Alliance is an accredited certification body specializing in software and IT organizations with a 100% first-time certification success rate.

Credentials You Can Count On

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Benefits of ISO 90003 Certification

Win More Contracts & RFPs: Many government (DoD, DHS, GSA), aerospace primes (Lockheed Martin, Boeing, Northrop Grumman), healthcare systems, and Fortune 1000 enterprises now explicitly require or heavily prefer “ISO 9001 certification with ISO/IEC 90003:2018 software scope.” Without it, you are automatically disqualified from multi-million-dollar opportunities.
Pass Supplier & Customer Audits on the First Try: Eliminates painful, repeated second-party audits by primes and large customers who demand proof of software-specific quality processes (configuration management, verification & validation, defect tracking, release management).
FDA, FAA, and Regulatory Acceptance for Software: FDA (21 CFR Part 820), European MDR/IVDR, and many Notified Bodies accept ISO 9001 + ISO/IEC 90003 certification as strong evidence of a compliant quality management system for medical device software—often reducing the scope and cost of IEC 62304 audits.
Dramatic Reduction in Defects & Rework: Organizations typically see 25–60% fewer escaped defects and 30–50% less rework after full implementation because of enforced traceability, peer reviews, and verification & validation requirements.
Faster & More Predictable Releases: Standardized requirements management, risk-based testing, and configuration control shorten release cycles and reduce last-minute fire drills.
Higher Customer Satisfaction & Retention: Structured problem-resolution processes, post-delivery support requirements, and mandatory customer feedback loops directly improve Net Promoter Scores and renewal rates.
Lower Cost of Quality: Fewer hotfixes, warranty claims, support tickets, and compliance penalties = measurable ROI (many clients recover the entire certification investment within 12–18 months).
Stronger Cyber & Compliance Posture: ISO/IEC 90003 naturally aligns with NIST 800-53, CMMC, FedRAMP, and ISO 27001 controls for secure development (SDL), making dual-certification far easier and cheaper.
Improved Team Morale & Retention: Clear processes, reduced chaos, and objective career paths (e.g., defined roles in verification, validation, and configuration management) make software teams happier and more productive.
Scalability Without Chaos: Companies growing from 50 to 500 engineers use the ISO/IEC 90003 framework to scale quality practices without everything breaking.
Marketing & Competitive Differentiation: Display the official ISO 9001 certificate + “Software engineering per ISO/IEC 90003:2018” on your website, proposals, and capability statements—immediate credibility with enterprise buyers.
Future-Proofing for AI & Emerging Regulations: The risk-based thinking, traceability, and validation requirements built into 90003 position you perfectly for upcoming AI, autonomous systems, and software bill-of-materials (SBOM) regulations.

Bottom line: In 2025, ISO/IEC 90003 certification is no longer just a “nice-to-have” for serious software and IT service organizations—it is rapidly becoming a mandatory market-access requirement and one of the highest-ROI investments you can make in software quality and business growth.

Ready to turn these benefits into reality? Call Lazarus Alliance today at +1 (888) 896-7580 for your free ISO/IEC 90003 consultation and roadmap.

ISO 90003 Audit Services | Accredited ISO 90003 Certification Audits by Lazarus Alliance. Call +1 (888) 896-7580 today!

Secure Your ISO/IEC 90003 Compliance with Expert, Accredited Audit Services