How to Transition from ISO 9001:2015 When the Next Revision Arrives

Last updated: April 1, 2026

ISO 9001:2026 is at the FDIS — Final Draft International Standard — stage as of April 2026. That means the text is essentially locked. Publication is targeted for September 2026, and the revision TC 176 has been developing is best described as evolution, not a revolution. The clause structure is unchanged, the Harmonized Structure is retained, and the foundational requirements of the 2015 version remain intact. What's new are targeted additions that address a decade of auditing experience: a stronger leadership accountability thread, explicit quality culture and ethical behavior requirements, cleaner separation of risk and opportunity, and acknowledgment that modern organizations run on digital tools that need validation.

If you're trying to understand how to transition from ISO 9001:2015 to the next revision, this guide gives you the full picture: what's actually changing clause by clause, what you should be doing right now (including one amendment that's already been in effect since February 2024), a practical gap assessment methodology, a step-by-step transition roadmap, and the most common mistakes that will cost you time and audit findings in 2028 and 2029.

One structural note before we begin: the International Accreditation Forum (IAF) ceased operations on January 1, 2026. It has been replaced by Global Accreditation Cooperation Incorporated (GACI). When you see references to "IAF transition mandates" in older guidance documents, understand that GACI now holds that responsibility. Formal transition period confirmation for ISO 9001:2026 will come from GACI after publication.

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Where the Standard Stands Right Now

ISO standards revisions follow a defined sequence of stages. As of April 2026, ISO 9001:2026 is at the FDIS stage — the final step before publication. Here's what that means in practice:

• The technical content is finalized. FDIS-stage changes are editorial, not substantive.
• FDIS approval requires a two-thirds majority among ISO member bodies. Given the strong approval the standard received at earlier stages, publication in September 2026 is highly probable.
• Major certification bodies — DNV, NQA, TUV, DQS — have already published preliminary transition guidance based on the confirmed changes. Their auditors are being trained now.

The practical implication: you don't need to wait for publication to start preparation. The changes are confirmed. You can build your gap assessment and preliminary remediation plan against what's known today.

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What's Changing: Clause by Clause

Here is a precise accounting of every confirmed change in ISO 9001:2026. This is not a summary of general themes — it's a working reference you can use directly in a gap assessment.

Clause 4: Climate Change Now Explicitly Required

The climate change consideration that was added as a standalone amendment in February 2024 (ISO 9001:2015/Amd 1:2024) is fully absorbed into the body of ISO 9001:2026. The requirement lands in Clause 4, the context analysis section:

• Clause 4.1: Organizations must consider whether climate change is a relevant external issue when determining organizational context.
• Clause 4.2: Organizations must determine whether any interested parties have requirements related to climate change.

This was always where the amendment was headed — the 2024 addition was a bridge to the 2026 revision. But the significance of it being in the primary standard body (rather than an amendment) is that it will receive standard audit attention on every audit cycle going forward. It's not optional and it can no longer be overlooked.

Additionally, the Quality Policy under ISO 9001:2026 must take into account the organization's context and support its strategic direction — a tightening of the linkage between Clause 4 analysis and Clause 5 policy outputs.

Clause 5: Leadership, Quality Culture, and Ethical Behavior

This is the most operationally significant change in the entire revision. ISO 9001:2026 adds explicit requirements for top management under Clause 5.1:

• Top management must demonstrate leadership in promoting ethical behavior within the organization.
• Top management must demonstrate leadership in promoting a quality culture — not just maintaining a quality management system.
• There is a new requirement for top management to ensure that opportunities for improvement are reported to appropriate levels of management. This closes a gap where improvement opportunities were identified but buried at department level and never surfaced to leadership.

None of these are documentation requirements. They require demonstrable, auditable leadership behavior. What auditors will look for:

• Management review records that reflect genuine engagement with quality culture health, not just KPI scorecards
• Evidence of ethical behavior standards being communicated, reinforced, and enforced — not just written in a policy
• Mechanisms by which improvement opportunities flow upward and result in leadership-level decisions

Organizations where quality is treated as a back-office function managed entirely by the quality manager will face real work here. A policy signed by the CEO is not evidence of leadership promotion. Demonstrated behavior is.

Clause 6: Cleaner Separation of Risk and Opportunity

ISO 9001:2015 Clause 6.1 combined risk and opportunity planning in a single clause. ISO 9001:2026 provides a clearer structural separation:

• General requirements for addressing risks and opportunities remain.
• Actions to address risks are now explicitly separated from actions to address opportunities.

For organizations that already run mature risk management processes with distinct risk and opportunity registers, this is largely structural — a documentation alignment. For organizations that merged risks and opportunities into a single combined table (a common shortcut), this will require genuinely separating the two and ensuring each has its own action planning logic. The intent matters: risks are managed or mitigated; opportunities are pursued or exploited. Conflating them in a single register suggests the organization hasn't thought clearly about either.

Clause 7.3: Quality Culture and Ethical Behavior Awareness

Clause 7.3, which governs employee awareness, is expanded to explicitly include awareness of quality culture and ethical behavior. This creates a direct, auditable connection:

• Top management promotes quality culture and ethical behavior (Clause 5.1).
• Employees are demonstrably aware of both (Clause 7.3).

If your current onboarding and training programs cover product quality requirements, conformance criteria, and QMS procedures — but say nothing about organizational values or ethical expectations — you have a gap. Onboarding materials, periodic awareness training, and internal communications that reference quality culture and ethics all become relevant audit evidence under this requirement.

Clause 9: Internal Audits Simplified

ISO 9001:2026 removes the requirement that internal audits confirm conformity with both the organization's own QMS requirements and the requirements of ISO 9001 itself. Going forward, internal audits must confirm conformity with the organization's QMS requirements only.

This is a welcome simplification. The old dual standard — audit against your system and against the standard — created confusion about the purpose of first-party audits and sometimes led to internal audit programs that were more about ISO compliance theater than genuine system evaluation. First-party audits should answer the question: is your QMS working as designed? Third-party certification audits answer the question: does your QMS conform to ISO 9001? Each has its proper place.

The practical implication for your internal audit program: your audit scope should be built around your own processes, procedures, and quality objectives. Mapping every finding to an ISO clause is no longer required — though many organizations will continue to do it for internal reference purposes.

Clause 10: Leadership's Role in Continual Improvement Made Explicit

ISO 9001:2026 makes leadership's role in continual improvement more explicit in Clause 10. This mirrors the Clause 5.1 additions — improvement is not just a system function that quality managers administer. It requires active leadership engagement.

Management review outputs under the 2026 version must demonstrate a clear, documented connection between review findings and assigned continual improvement actions. A management review that produces no improvement actions — or produces action items that get recorded but never followed up — is a finding under ISO 9001:2026 in a way it wasn't always enforced under the 2015 version.

Technology, AI Oversight, and Digital Tool Validation

ISO 9001:2026 acknowledges the reality that modern organizations use software — ERP systems, digital inspection tools, AI-assisted quality processes, automated SPC platforms — as integral parts of their QMS. New requirements address the oversight and validation of these tools.

This doesn't mean every ISO 9001-certified manufacturer needs to implement full pharmaceutical-grade computer system validation. It means organizations must demonstrate:

• That they understand what their digital quality tools are designed to do
• That the tools are configured correctly for their application
• That outputs from those tools can be relied upon as quality records
• That AI-assisted quality decisions have appropriate human oversight and validation mechanisms

For most manufacturers, this translates to: document the intended use of each digital quality tool in use, maintain version control records, and demonstrate periodic verification that configurations remain fit for purpose. For organizations using AI tools in quality decision-making — defect detection, risk scoring, SOP gap analysis — the oversight requirement carries additional weight.

New Annex A: 15 Pages of Guidance Material

ISO 9001:2026 adds a new Annex A — approximately 15 pages of guidance material for applying the standard's requirements. Every quality manager and ISO consultant working with this standard needs to read it carefully. Annex A will be the interpretive reference that shapes how auditors apply ambiguous requirements. What's in the annex matters as much as what's in the body of the standard when it comes to preparing for audit.

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The Amendment Already in Effect: Act Now

Before planning your 2026 transition, address an obligation that has been in effect since February 2024.

ISO 9001:2015/Amd 1:2024 added two requirements to the existing standard with no transition period. These are not future requirements — they are current requirements, and your certification body's auditors should be checking them at every surveillance audit:

• Clause 4.1: The organization shall determine whether climate change is a relevant issue.
• Clause 4.2: The organization shall determine whether interested parties have requirements related to climate change.

Two sentences. But many certified organizations — particularly those that haven't had a major audit since early 2024 — have not addressed them. Here's what you should do this week:

1. Open your current Clause 4.1 context analysis document. Add an explicit entry evaluating whether climate change is a relevant external issue for your organization. For manufacturing organizations, common dimensions include supply chain risk (raw material availability, logistics disruptions), physical operational risk (flooding, extreme weather at facilities), and regulatory trajectory (carbon pricing, emissions requirements). Even if you conclude it's not currently a major issue, document that determination.
2. Open your Clause 4.2 interested party register. Add an entry for each relevant interested party that addresses whether they have made climate-related requirements of your organization — customer sustainability questionnaires, investor ESG reporting requirements, regulatory disclosure obligations.
3. Document the review date so you have a clear record if your next surveillance audit raises this.

This isn't about writing a climate strategy. It's about demonstrating that your organization considered climate change as a factor in your context analysis. That's all the amendment requires.

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Gap Assessment Methodology

A gap assessment is the foundation of any successful transition. Done well, it tells you exactly what needs to change, how much effort each change requires, and who owns it. Done poorly, it gives you a false sense of readiness that surfaces as nonconformances at your transition audit.

Step 1: Map Confirmed Changes to Your Current QMS

Build a table that captures every confirmed change against your current QMS posture:

ISO 9001:2026 Clause	New or Changed Requirement	Current QMS Status	Gap Description
4.1 / 4.2	Climate change consideration required	Not addressed / Addressed	Context analysis lacks explicit climate entry
5 (Policy)	Quality Policy must reflect context and support strategy	Partially addressed	Policy exists but doesn't explicitly reference context analysis outputs
5.1	Top management promotes ethical behavior and quality culture	Not addressed	No demonstrable leadership behavior evidence; policy only
5.1	Improvement opportunities reported to top management	Not addressed	Improvement ideas captured at department level; no escalation mechanism
6.1	Risks and opportunities explicitly separated	Partially addressed	Single combined table; needs split into distinct risk and opportunity registers
7.3	Employee awareness includes quality culture and ethics	Not addressed	Training covers QMS requirements only; no cultural or ethical content
8	Digital tool validation and AI oversight	Not addressed	ERP and inspection software used without validation records
9 (Internal Audit)	Audits confirm QMS conformity only (not ISO 9001 itself)	Change (simplification)	Update audit scope template; not a gap but a program change
10	Leadership role in continual improvement explicit	Partially addressed	Management review minutes record discussions; no assigned improvement actions

Step 2: Rate Each Gap by Severity

Assign each gap a severity rating to drive prioritization:

• Critical: Likely to produce a major nonconformance at transition audit. These require immediate action and verification before your transition audit is scheduled.
• Significant: Likely to produce a minor nonconformance or observation. These must be resolved before transition audit but are more manageable.
• Cosmetic: Documentation or formatting update only. Handle in a single document revision cycle.

Under this framework, the Clause 5.1 leadership behavior requirements and the digital tool validation gap typically rate as Critical for most organizations. The Clause 6.1 structural separation and internal audit scope change typically rate as Cosmetic.

Step 3: Assign Owners and Deadlines Before Leaving the Room

Every gap needs a named individual owner and a target completion date. The quality manager cannot own every item. The Clause 5.1 leadership behavior gap belongs to the CEO or executive team — not to quality. The Clause 7.3 training gap belongs to HR and quality jointly. The digital tool validation gap may belong to IT and quality together.

A gap assessment without ownership assignments is a document, not a plan. Before the gap assessment meeting ends, every row should have a name and a date in the owner and deadline columns.

Step 4: Verify Effectiveness — Don't Just Check the Box

After each remediation action is completed, verify that the change actually closed the gap. The test is simple: if an auditor walked in tomorrow and reviewed this area, would they find objective evidence of conformance? If you can't answer yes with evidence in hand, verification isn't complete.

Document the verification — date, method, result, verifier. This becomes your internal evidence that the transition work was done properly, which you may need if an auditor questions an area during your transition audit.

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Step-by-Step Transition Roadmap

The transition window opens at publication (September 2026) and closes approximately three years later (September 2029), pending formal GACI confirmation. Here is a milestone-based roadmap that builds adequate buffer into every phase:

Phase 1: Pre-Publication (Now)

You don't have to wait for the standard to be published to start. The changes are confirmed at FDIS stage. Right now you should:

• Address the Amd 1:2024 climate change requirement in Clauses 4.1 and 4.2 if you haven't already — this is overdue for many organizations.
• Review the Quality Policy for linkage to organizational context and strategic direction.
• Conduct an informal leadership conversation about the Clause 5.1 requirements — not to create documents, but to assess whether leadership is prepared to demonstrably promote quality culture and ethical behavior.
• Identify which digital quality tools are in use and whether any validation records exist.
• Begin following GACI guidance as it emerges; watch for official transition period confirmation post-publication.

Phase 2: Standard Publication — Q3 2026

When ISO 9001:2026 is published in September 2026:

• Obtain the published standard and Annex A immediately. Read Annex A in full — this is not optional.
• Brief your certification body. Understand their specific transition requirements, audit approach, and any documentation they'll need from you at the transition audit.
• Confirm the formal transition period terms from GACI once published.

Phase 3: Formal Gap Assessment — Q4 2026 to Q1 2027

Conduct your structured gap assessment against the published final standard within the first six months of publication. Key outputs:

• Completed gap table with every confirmed change assessed against your current QMS
• Severity ratings for each gap
• Named owners and target completion dates for all Critical and Significant gaps
• Estimated effort and resource requirements for remediation

Phase 4: Remediation and Implementation — 2027

Execute against the gap assessment. Key activities by area:

Leadership and culture (Clause 5.1 / Clause 7.3): Work with executive leadership to establish visible, recurring behaviors that demonstrate quality culture promotion — communication cadences, recognition practices, improvement opportunity reporting channels. Update employee awareness training to include quality culture and ethics content. This phase takes longer than most organizations expect because behavioral change is harder than document change.

Documentation updates: Revise context analysis, interested party register, Quality Policy, risk and opportunity registers, internal audit scope, management review templates. These are relatively straightforward if you've done the leadership work first.

Digital tool validation: Inventory all software used in QMS-relevant processes. Document intended use, configuration baseline, and verification approach for each. Prioritize tools where outputs are used as quality records or feed into compliance decisions.

Customer satisfaction channels (if applicable): If you currently rely on a single annual survey, add at least one additional channel — complaint trend analysis, customer scorecard data, field feedback mechanisms, direct account review data.

Phase 5: Internal Audit and Management Review — Q1 2028

Complete at least one full internal audit cycle and one management review under ISO 9001:2026 requirements before your transition audit. These are your dress rehearsal:

• Internal audits should use your updated scope — conformity with your QMS, not with ISO 9001 directly.
• Management review should produce specific, assigned improvement actions with documented ownership and timelines — not just observations.
• Any nonconformances found should have corrective actions initiated, not just recorded.

Problems found here are self-correctable. Problems found by a third-party auditor become formal nonconformances on your record.

Phase 6: Schedule and Complete Transition Audit — Q2–Q3 2028

Schedule your transition audit with your certification body no later than Q2 2028. This is not the deadline — this is the target. Here's why the timing matters:

• Certification bodies will face capacity constraints in 2028 and 2029. The same pattern occurred in 2017 and 2018 during the 2015 transition. Organizations that waited until the last 12 months found limited scheduling availability and premium pricing.
• Building in buffer before September 2029 protects against a major nonconformance that requires a follow-up visit, an auditor availability problem, or an unexpected business disruption.
• Organizations that complete transition by early 2029 have a clear margin. Those planning to finish in September 2029 have no margin at all.

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Lessons from the 2015 Transition

The 2008 to 2015 transition ran exactly three years — September 2015 to September 2018. It's a useful reference point for what to expect and what to avoid.

What went wrong:

• A large portion of the certification community waited until 2017 and 2018. Certification body capacity got tight. Audit slot availability dropped. Prices rose. Organizations that waited had fewer options.
• Risk-based thinking (new to the 2015 version) was widely implemented as a paper exercise. Risk registers that sat on a network drive and had no operational connection were a top nonconformance for years after transition.
• Context analysis (entirely new in 2015) was treated as a one-time transition task rather than a living input to the QMS. Auditors found organizations still carrying 2015 context analyses unchanged in 2022.
• Consultants recycled 2008-era templates with superficial updates. Organizations that used them ended up with non-conformances at transition audits.

What went right:

Organizations that used the transition as a forcing function to genuinely improve their QMS — not just update documents — came out better positioned. They eliminated procedures nobody used, tightened the connection between quality objectives and business strategy, and got real value from certification in the years that followed.

The 2026 transition offers the same opportunity. The changes around quality culture, leadership accountability, and improvement reporting aren't bureaucratic additions. They're areas where a well-run QMS should already be strong. If they're not, the transition is your chance to make them so.

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Common Transition Mistakes to Avoid

Delegating the Clause 5.1 requirements to quality. The promotion of quality culture and ethical behavior is a leadership obligation. The quality manager can facilitate — they cannot substitute for executive leadership. If the CEO and executive team aren't engaged with these requirements, no documentation will satisfy a competent auditor.

Treating the improvement reporting requirement as a suggestion box. The new Clause 5.1 requirement that improvement opportunities be reported to top management means a formal mechanism must exist and be used. A generic "submit ideas here" email address doesn't cut it. The mechanism must demonstrably result in opportunities reaching appropriate leadership levels and being acted upon or consciously declined.

Conflating digital tool validation with computer system validation. ISO 9001:2026 does not require pharmaceutical-grade CSV for every software tool. It requires that you can demonstrate digital tools produce reliable, trustworthy outputs for their intended use. The scope of validation should be proportionate to the risk — a simple spreadsheet used for tracking training records needs less rigor than an AI-assisted defect detection system used to make release decisions.

Using the internal audit change as justification to reduce audit rigor. Removing the dual-standard requirement from internal audits (you no longer need to audit against ISO 9001 directly) doesn't mean internal audits should be less thorough. Your QMS requirements should already embody the standard's requirements. Auditing against your own QMS should be equally rigorous.

Waiting for the final GACI transition terms to start work. GACI will issue formal guidance after publication. But the changes are known now. Waiting for official transition terms before beginning gap assessment is waiting for a reason to delay action you already have enough information to take.

Not reading Annex A. This is the interpretive guidance that auditors will use. Organizations that haven't read it are operating with incomplete information about what conformance looks like in practice.

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Milestone Timeline

Milestone	Target Date	Key Actions
Address Amd 1:2024 climate change requirement	Immediately (overdue if not done)	Update Clauses 4.1 and 4.2 in current QMS documentation
Pre-publication gap review	Q2 2026 (now)	Informal assessment against confirmed FDIS changes; identify critical gaps
ISO 9001:2026 published	September 2026	Obtain final standard; read Annex A; brief certification body; monitor GACI for transition terms
Formal gap assessment complete	Q1 2027	Full clause-by-clause gap analysis; severity ratings; owners and deadlines assigned
Leadership engagement on Clause 5.1	Q1–Q2 2027	Executive briefing; quality culture and ethics promotion mechanisms defined
Documentation updates complete	Q3 2027	Context analysis, Quality Policy, risk/opportunity registers, audit scope, management review templates
Digital tool validation complete	Q3 2027	Inventory, documentation of intended use, configuration baseline, verification records
Employee awareness training rollout	Q4 2027	Clause 7.3-aligned training including quality culture and ethical behavior content
First internal audit under ISO 9001:2026	Q1 2028	Full internal audit cycle using updated scope and requirements; findings and CAPAs initiated
Management review under ISO 9001:2026	Q1–Q2 2028	Management review with outputs explicitly linked to assigned continual improvement actions
Transition audit scheduled	Q2 2028 at the latest	Book early — capacity will be constrained in late 2028 and 2029
Transition audit	Q3 2028 (target)	Third-party transition audit; nonconformances addressed within certification body timeframe
ISO 9001:2026 certificate issued	Q4 2028 / Q1 2029	Confirmed compliance; full buffer before September 2029 deadline
Industry deadline	September 2029	ISO 9001:2015 certificates no longer valid; all certified organizations must hold ISO 9001:2026 certificate

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Frequently Asked Questions

When will ISO 9001:2026 be published?

September 2026 is the target publication date. The standard is currently at FDIS stage as of April 2026 — the final formal step before publication. FDIS-stage changes are editorial only; the technical content is fixed. Publication is highly probable on the September 2026 timeline.

Does the revision change the clause structure?

No. The Harmonized Structure (formerly Annex SL) is retained. Clause numbering is unchanged. ISO 9001:2026 is evolutionary — targeted additions and clarifications within existing clauses, plus a new 15-page Annex A. Organizations familiar with ISO 9001:2015 will find the 2026 version immediately recognizable.

What happened to the IAF — who manages transition now?

The International Accreditation Forum (IAF) ceased operations on January 1, 2026. It has been replaced by Global Accreditation Cooperation Incorporated (GACI). GACI will issue formal transition period confirmation and any mandatory requirements for certification bodies after ISO 9001:2026 is published. References to "IAF mandates" in older guidance documents now fall under GACI's authority.

How long is the transition period?

Three years is expected, consistent with the 2008 to 2015 transition. Formal confirmation will come from GACI after publication. Plan for a September 2026 to September 2029 window. Don't wait for the official announcement to start preparation — the changes are known and the work can begin now.

What does the internal audit change in Clause 9 actually mean?

ISO 9001:2026 removes the requirement that internal audits confirm conformity with both your QMS and with ISO 9001 itself. Internal audits must still confirm conformity with your own QMS requirements — the change removes the dual standard. In practice, update your internal audit scope template to reference your QMS requirements rather than the ISO 9001 standard directly. This is a simplification, not a reduction in rigor.

What is the quality culture requirement actually asking for?

Clause 5.1 requires top management to demonstrably promote a quality culture — meaning auditable evidence that leadership actively fosters quality values, not just signs a policy. Examples of evidence: executive participation in quality reviews, internal communications that reinforce quality priorities, visible leadership response when quality concerns are raised, formal channels through which improvement opportunities flow upward and receive leadership attention.

Which certification bodies have published transition guidance already?

DNV, NQA, TUV, and DQS have all published preliminary transition guidance based on the FDIS changes. If you're certified through one of these bodies, review their published materials now. Your certification body's specific transition requirements — including any additional documentation or audit structure requirements — may supplement the GACI mandates, and understanding those specifics early gives you a more accurate picture of what your transition audit will actually look like.

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Start Now — The Window Is Already Open

ISO 9001:2026 is at FDIS stage. The changes are confirmed. The transition window opens at publication in September 2026 and closes in September 2029. That's three years — which sounds like enough time until you consider that every other certified organization faces the same deadline, certification body capacity will compress in 2028 and 2029, and the most impactful changes (leadership behavior, quality culture, digital tool validation) take longer to implement than documentation changes.

The organizations that navigate this transition well are the ones that treat it as what it is: an opportunity to make their QMS more rigorous, more operationally connected, and more defensible under audit. The ones that treat it as a compliance hurdle to clear at the last possible moment will face the same problems their predecessors faced in 2017 and 2018.

If you haven't addressed the Amd 1:2024 climate change requirement, do that this week. Then pull the FDIS text, work through the confirmed changes against your current QMS, and build a preliminary gap profile. That work can start today.

At Certify Consulting, we help organizations move through ISO 9001 transitions from initial gap assessment through certification audit. Every organization's gap profile is different. If you want a structured assessment of where your QMS stands against the confirmed ISO 9001:2026 changes — and a clear plan for getting there without running out of runway — schedule a consultation and we'll build that picture together.

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Written by Jared Clark, JD, MBA, PMP, CMQ-OE, CPGP, CFSQA, RAC — Principal Consultant, Certify Consulting. Jared has led ISO 9001 implementations across 200+ organizations with a 100% first-time audit pass rate.

Last updated: April 1, 2026