Common ISO 9001 Nonconformities — And How to Prevent Them Before Your Audit
- wilkshireconsulting
- 4 minutes ago
- 5 min read
At Wilkshire Consulting, one of the most common things we hear after an ISO 9001 audit is:
We didn’t expect those findings.”
The reality is that most ISO 9001 nonconformities are predictable and preventable. Certification bodies see the same issues repeatedly across industries — from manufacturing and construction to service providers and IT organizations.
Understanding where companies typically fail gives you a powerful advantage. In this article, we’ll walk through the most common ISO 9001 nonconformities, explain why they occur, and show you how to prevent them before your audit.
1. Ineffective or Meaningless Management Reviews
Why it’s a common nonconformity
Management review is one of the most frequently cited findings because many organizations treat it as a formality rather than a strategic tool.
Common issues include:
Reviews conducted irregularly or not at all
Missing required inputs (e.g., audit results, risks, supplier performance)
No evidence of decisions or actions taken
Leadership attendance not documented
Reviews that focus on operations but ignore the QMS
How to prevent it
Ensure management reviews:
Follow a documented agenda aligned to ISO 9001 Clause 9.3
Include measurable data and performance trends
Produce clear outputs (decisions, actions, resource needs)
Are attended or endorsed by top management
Are documented thoroughly (minutes, action items, follow-ups)
Auditors want to see leadership using the QMS to drive decisions, not just ticking a box.
2. Poor Control of Documented Information
Why it’s a common nonconformity
Document control often fails because:
Obsolete procedures are still in use
Employees use uncontrolled templates or personal files
Document changes aren’t approved or communicated
Records are missing, incomplete, or inconsistent
Electronic systems lack access control or version tracking
How to prevent it
Implement a controlled system that:
Clearly identifies current vs obsolete documents
Assigns ownership for document approval and updates
Ensures documents are accessible at the point of use
Protects records from alteration or loss
Tracks revision history
Auditors will often test this by asking multiple employees for the same procedure — inconsistency is a red flag.
3. Weak Internal Audit Programs
Why it’s a common nonconformity
Internal audits are often under-resourced or rushed shortly before the certification audit. Typical failures include:
Incomplete audit schedules
Audits that only confirm compliance instead of effectiveness
Auditors auditing their own work
Findings not followed up
Corrective actions never verified for effectiveness
How to prevent it
Strengthen your internal audit program by:
Covering all ISO clauses and all processes
Using trained, independent auditors
Writing meaningful audit findings
Tracking corrective actions to closure
Verifying effectiveness, not just completion
Auditors expect your internal audit program to identify issues before they do.
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4. Inadequate Risk-Based Thinking
Why it’s a common nonconformity
Many organizations claim they use risk-based thinking but cannot show evidence beyond a one-time risk register.
Common gaps include:
Risks identified but never reviewed
No link between risks and operational controls
Opportunities ignored entirely
Leadership unaware of key quality risks
Risks not considered during changes
How to prevent it
Integrate risk-based thinking into:
Strategic planning
Process design and changes
Supplier management
Corrective actions
Management review
Risk should be dynamic and ongoing, not static documentation.
5. Ineffective Corrective Action Processes
Why it’s a common nonconformity
Organizations often respond to issues without addressing root cause. Typical problems:
Jumping straight to fixes without analysis
Repeating the same problems
No evidence of root cause methods
Actions not tracked or closed
No verification of effectiveness
How to prevent it
Build a structured corrective action process:
Use root cause analysis tools (5 Whys, Fishbone, etc.)
Identify systemic causes, not symptoms
Assign ownership and deadlines
Verify effectiveness after implementation
Trend corrective actions to identify patterns
Auditors look for learning and improvement, not just problem-solving.
6. Lack of Employee Awareness and Competence
Why it’s a common nonconformity
ISO 9001 requires employees to understand:
The quality policy
Relevant quality objectives
Their role in the QMS
The consequences of nonconformance
Auditors commonly find:
Employees unaware of the quality policy
Training records missing or outdated
Competence never evaluated
New hires not trained on QMS requirements
How to prevent it
Establish a clear competence and awareness program:
Define required competencies by role
Provide training and evaluate effectiveness
Communicate the quality policy regularly
Integrate QMS awareness into onboarding
Keep training records current
If employees can’t explain quality basics, auditors will question leadership commitment.
7. Poor Supplier Evaluation and Control
Why it’s a common nonconformity
Supplier issues arise when organizations:
Fail to evaluate suppliers consistently
Don’t define evaluation criteria
Ignore supplier performance data
Use unapproved suppliers
Keep outdated supplier lists
How to prevent it
Implement a supplier management process that:
Establishes evaluation and re-evaluation criteria
Monitors supplier performance (quality, delivery, issues)
Maintains an approved supplier list
Includes corrective actions for poor performance
Considers supplier risk during selection
Auditors want to see that suppliers are controlled — not just chosen on cost.
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8. Misalignment Between Procedures and Actual Practice
Why it’s a common nonconformity
Auditors often say: “Your procedure says one thing, but your people do another.”
Common causes:
Procedures written by consultants without employee input
Processes that changed but documents weren’t updated
Overly complex or unrealistic procedures
Employees unaware of changes
How to prevent it
Ensure procedures:
Reflect actual workflows
Are written with employee input
Are reviewed after process changes
Are easy to understand and practical
Are communicated clearly
The best defense is simple: write what you do, and do what you write.
9. Failure to Track Quality Objectives Effectively
Why it’s a common nonconformity
Quality objectives often fail when:
They’re too vague or unrealistic
No measurements are tracked
Progress isn’t reviewed
Objectives don’t align with strategy
Employees don’t know them
How to prevent it
Create quality objectives that are:
Specific and measurable
Relevant to customer satisfaction
Reviewed regularly
Aligned to the quality policy
Communicated across the organization
Auditors want to see progress — not perfection.
10. Not Being “Audit Ready” Day to Day
Why it’s a common nonconformity
Organizations prepare intensely right before audits but struggle during surprise questions. This leads to:
Missing records
Conflicting answers from employees
Panic under pressure
Leadership unavailable during audits
How to prevent it
Maintain continuous audit readiness:
Keep records current
Train employees on audit interaction
Perform mock audits
Review common auditor questions
Ensure leadership availability
ISO 9001 rewards consistency, not last-minute preparation.
How Wilkshire Consulting Helps Prevent ISO 9001 Nonconformities
At Wilkshire Consulting, we help organizations:
Identify gaps before auditors do
Strengthen internal audits and management reviews
Simplify documentation without losing control
Build risk-based thinking into daily operations
Train teams for long-term compliance
Our approach ensures your ISO 9001 system is audit-ready, effective, and sustainable.
Final Thoughts
ISO 9001 audits don’t fail because of bad intentions — they fail because of overlooked details and weak systems.
By understanding common nonconformities and addressing them proactively, your organization can approach audits with confidence instead of stress.
With the right structure, ISO 9001 becomes more than a certificate — it becomes a powerful tool for operational excellence.
Need to get ISO certified? We got your back!
Click on the link below for a free 30-minute consultation today!
Wilkshire Consulting Downloadable Documents:
ISO 9001:2015 Quality Management System Documentation Template Package
ISO 14001:2015 Environmental Management System Documentation Template Package
45001:2018 Occupational Health and Safety Documentation Template Package
ISO 9001 | ISO 14001 MS Integrated Documentation Template Package
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