The Hidden Time Sink in Audit Planning
Every audit plan must identify which clauses of the applicable standard are not relevant to the client's scope. For ISO 9001, Clause 4.3 requires the organization to determine the boundaries and applicability of the management system, including any clauses that are not applicable. The auditor must verify and document these exclusions.
This sounds straightforward, but in practice, determining non-applicable clauses is one of the most time-consuming aspects of audit planning. The auditor must:
- 1. Understand the client's scope, products, services, and processes in detail.
- 2. Review every clause of the applicable standard.
- 3. Assess whether each clause is relevant to the client's specific operations.
- 4. Document the justification for excluding any clause.
- 5. Verify that the exclusion does not affect the organization's ability to meet customer or regulatory requirements.
For a straightforward single-standard audit, this process might take an hour. For a multi-standard audit with a complex scope, it can take several hours. Across hundreds of audits per year, non-applicable clause determination represents a significant investment of auditor time.
Why Manual Cross-Referencing Is Problematic
Beyond the time investment, manual non-applicable clause determination introduces several risks:
Inconsistency: Different auditors may reach different conclusions about clause applicability for similar scopes. Without a systematic approach, exclusion decisions depend on individual interpretation, creating inconsistency across the CB's audit programme.
Errors of Omission: An auditor might overlook a clause that should be excluded, planning to audit a requirement that is genuinely not applicable to the client. This wastes audit time and can create confusion during the audit.
Errors of Inclusion: More seriously, an auditor might exclude a clause that is actually applicable. This means the audit will not cover a relevant requirement, potentially leading to an incomplete assessment and a flawed certification decision.
Documentation Gaps: Even when the exclusion decision is correct, the justification may not be adequately documented. Accreditation assessors expect clear rationale for every excluded clause.
How AI Non-Applicable Clause Generation Works
Certiva uses AI to analyze the client's scope and generate a preliminary list of non-applicable clauses with justifications. Here is how the process works:
Input Data: The AI uses information already in the system about the client:
- •The formal scope statement
- •The products and services offered
- •The processes involved
- •The applicable standard(s)
- •The EA code(s)
- •Any previous audit records and exclusion decisions
Analysis: The AI cross-references the client's characteristics against every clause of the applicable standard. It considers:
- •Which clauses relate to activities the client does not perform (e.g., design and development for a distribution company)
- •Which clauses relate to functions that are not present in the client's operations
- •Which standard-specific exclusion rules apply (e.g., ISO 9001 Clause 8.3 may not be applicable if the organization does not design products)
Output: The AI generates a list of potentially non-applicable clauses, each with:
- •The clause reference
- •A brief description of the clause requirement
- •The rationale for non-applicability based on the client's scope
- •A confidence level indicator
Auditor Review: The generated list is presented to the auditor for review. The auditor examines each proposed exclusion, confirms or rejects it based on their professional judgment, and adds any additional exclusions or modifications.
What This Means in Practice
Consider a practical example: a logistics company seeking ISO 9001 certification. Their operations involve warehousing, transportation, and distribution. They do not design products, do not manufacture goods, and do not perform calibration.
Manually, the auditor would review all clauses of ISO 9001, identify that Clause 8.3 (Design and Development) is likely not applicable, assess each sub-clause, and document the justification. They would also consider whether other clauses or sub-clauses might not apply.
With Certiva's AI, the system analyzes the scope and immediately identifies:
- •Clause 8.3 as non-applicable (the organization does not design products or services)
- •Specific sub-clauses that may not apply based on the nature of logistics operations
- •Clauses that might initially seem non-applicable but actually are relevant (the AI flags these for auditor attention)
The auditor reviews the AI's analysis, confirms the exclusions, and the audit plan is updated accordingly. What previously took an hour takes minutes.
Multi-Standard Complexity
The value of AI non-applicable clause generation increases significantly for multi-standard audits. When a client is being audited against ISO 9001, ISO 14001, and ISO 45001 simultaneously, the number of clauses to evaluate is tripled. The interactions between standards add further complexity.
Certiva's AI handles multi-standard analysis by considering each standard independently while also identifying common exclusions that apply across standards.
Standard-Specific Intelligence
Different standards have different exclusion rules and conventions:
- •ISO 9001:2015 allows exclusion of requirements within Clause 8 (Operation) if they are not applicable, provided the exclusions do not affect the organization's ability or responsibility to ensure conformity.
- •ISO 14001:2015 does not use the concept of exclusions in the same way as ISO 9001.
- •ISO 27001:2022 uses a Statement of Applicability to document which controls are applicable and which are not, with justification for each decision.
Certiva's AI understands these differences and generates exclusion analyses appropriate to each standard's requirements and conventions.
Accreditation Benefits
AI-generated non-applicable clause lists provide several benefits during accreditation assessments:
- •Documented Rationale: Every exclusion has a documented justification, satisfying the assessor's expectation for clear reasoning.
- •Consistency: The AI applies the same analytical framework to every audit, demonstrating systematic and consistent practice.
- •Completeness: The AI considers every clause, reducing the risk that an exclusion was overlooked or undocumented.
The Auditor's Role Remains Central
It is important to emphasize that AI non-applicable clause generation does not remove the auditor from the process. The AI provides a starting point that the auditor validates using their professional knowledge and judgment. The auditor may:
- •Confirm the AI's proposed exclusions
- •Add exclusions the AI did not identify
- •Override AI suggestions based on information not captured in the system
- •Modify the justification language to reflect their specific assessment
The final exclusion list is the auditor's decision, informed and accelerated by AI analysis.
Time and Quality Impact
The impact on audit planning efficiency is significant:
- •Time Savings: Non-applicable clause determination time is reduced by 60 to 80 percent.
- •Consistency: Exclusion decisions across auditors are more uniform.
- •Documentation Quality: Every exclusion is documented with clear rationale.
- •Error Reduction: The systematic analysis reduces the risk of both over-exclusion and under-exclusion.
Ready to eliminate hours of manual clause cross-referencing?
Book a demo at getcertiva.com and see how Certiva's AI generates non-applicable clause lists that your auditors can review and confirm in minutes.