Many organizations preparing for ISO 9001 certification in Singapore often ask whether a Statement of Applicability (SoA) is required.Formally, the Statement of Applicability (SoA) is a mandatory document for ISO 27001, not ISO 9001. However, in practice, many ISO 9001 certified organizations maintain an “ISO 9001 Applicability Statement” to clearly document:
- Which clauses apply
- Which clauses do not apply
- The justification for exclusions
Auditors appreciate this document when it is prepared correctly, as it improves clarity, audit readiness, and compliance confidence.
What Is an ISO 9001 Applicability Statement?
An ISO 9001 Applicability Statement is a structured document that:
- Lists ISO 9001:2015 clauses (4–10)
- Identifies applicable and non-applicable requirements
- Justifies exclusions
- Links clauses to processes and responsibilities
This document supports:
- Internal audits
- Certification audits
- Management reviews
- Scope clarity
Six Steps to Develop Your ISO 9001 Applicability Statement
1. Define the Scope of Your Quality Management System (QMS)
Start by clearly defining the scope of your QMS, including:
- Products and services covered
- Business locations included
- Core business activities involved
Your applicability decisions must align with this scope.
If an activity is outside the scope, related ISO clauses may be considered non-applicable.
Output:
✔ A clear, documented QMS scope statement
2. List All ISO 9001:2015 Clauses
Create a table listing:
- Clauses 4 to 10
- Relevant sub-clauses (example: Design and development of products and services)
This table becomes the foundation of your ISO 9001 Applicability Statement.
Tip:
Clauses 4 to 7 (Context, Leadership, Planning, Support) are almost always applicable.
3. Identify Non-Applicable Requirements
ISO 9001 allows exclusions only if they do not affect product or service conformity.
The most common valid exclusion:
- Design and development of products and services
(Applicable to trading, distribution, or service-only organizations)
Important:
Customer satisfaction and product/service conformity cannot be excluded.
4. Justify Every Exclusion Clearly
For every non-applicable clause, clearly document:
- Why the clause does not apply
- How conformity is still ensured
Example justification:
Design and development of products and services is not applicable as the organization does not perform product design. All products are supplied based on customer-approved specifications.
Auditors focus heavily on clear and logical justification.
5. Document Responsibilities and Controls
For applicable clauses, briefly record:
- Related procedures or processes
- Responsible departments or roles
This demonstrates that your QMS is implemented and operational, not just documented.
- Shows ownership
- Improves audit confidence
- Strengthens internal accountability
6. Review, Approve, and Maintain the Document
Your ISO 9001 Applicability Statement should be:
- Approved by top management
- Version-controlled (date, version, owner)
- Reviewed during:
- Internal audits
- Management reviews
- Scope or process changes
This document should evolve as your business grows.
Why Auditors Like an ISO 9001 Applicability Statement
- Faster audit reviews
- Clear justification for exclusions
- Better traceability between clauses and processes
- Stronger compliance evidence
Need Help Preparing Your ISO 9001 Documentation?
If you need professional support for:
- ISO 9001 certification in Singapore
- Applicability statement preparation
- Internal audits
- ISO documentation & implementation
- bizSAFE or ISO upgrades
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