Top 10 ISO 9001 Audit Non-Conformities & How to Avoid Them

The Issue: Often, lack of control over documentation is noted during an audit. For example, some problems are found in old operating procedures (SOPs), instructions that are not authorized, procedures that have not been updated and documents that have no revision record and are still used.

How to Avoid it:

• Make sure to have a centrally maintained system (on paper or digitally) that records previous and present edits.
• Assign clear ownership for document approvals and updates.
• Restrict editing permissions and ensure only current versions are accessible to users.
• Review documents periodically to keep them relevant and aligned with operational practices.

The issue: Though it is necessary to undertake internal audits for compliance, many businesses do not do them correctly. Auditing often goes wrong because planners don’t do their job well, reports aren’t finishes as expected and actions to improve processes are missing

How to Avoid it:

• Train internal auditors on ISO 9001 requirements and auditing techniques.
• Set up an audit timetable that covers all operations.
• apply findings to improve your operation.

The issue: Top management is required by ISO 9001 to use formal reviews to assess the performance of the QMS. Typically, groups have trouble because agendas are missing, meetings are not recorded, and no one follows up.

How to Avoid it:

• Organize management review meetings once a year as a minimum but meet in this way more frequently if the situation calls for it.
• Go through topics that the standard mandates, for example, audit findings, customer opinions, process performance, issues found and upcoming improvements.
• Take meeting notes, delegate authority and log actions that lead to the closure of issues.

The issue: It is vital to employees to be trained, but organizations frequently neglect to record their progress, what they can do or how well they perform.

How to Avoid it:

• Establish a comprehensive training matrix, mapping employee roles to necessary competencies.
• Maintain detailed records of all training of all training sessions, including sign-in sheets and evaluation results.
• Conduct periodic skill assessments to ensure ongoing competency improvements.

The issue: Many times, record keeping for product or progress issues, customer complaints and internal matters is not organized, so concerns are hard to sort out or spot.

How to Avoid it:

• Use a method for reporting errors that involves noting the concern, grouping it and identifying the main source of the problem.
• Roles and timelines should be assigned for the correction of beliefs and actions.
• Look into logs often to hunt for problems that come up often and areas for improvement.

The issue: A poorly handled corrective action process often leaves problems open and unresolved, causing these problems to come back. Not many businesses carry out root cause analysis, register all the actions needed or check how well they are working.

How to Avoid it:

• Utilize root cause analysis tools like the 5 Whys, Fishbone Diagram, or Pareto Analysis.
• Document corrective actions with deadlines and assigned personnel.
• Conduct effectiveness reviews to confirm resolutions before closing corrective actions.

The issue: ISO 9001 doesn’t require strict risk management (as ISO 31000 does), but organizations should apply risk thinking. Frequently, important risk and mitigation plans are missing from organizations.

How to Avoid it:

• Make sure to ensure risks and opportunities are identified at every stage of planning, product development and change management.
• You can use free tools like risk registers or matrices to assess impact and likelihood.
• Take into account risk whenever you design processes, purchase resources or serve customers.
• Check risks on a regular basis and revise the way you handle them if necessary.

The issue: If you do not observe, analyse, and address what customers say, your QMS suffers, and the satisfaction of customers decrease.

How to Avoid it:

• Receiving customer feedback through surveys, reviews and broken communication records.
• Conduct trend analysis to identify recurring issues and opportunities for improvement.
• Taking action against common issues based on feedback to enhance the experience for customers.

The issue: Unclear, indistinct or impossible-to-measure quality objectives are regularly problems during audits. Goals that do not make sense or are not checked op on are mostly worthless.

How to Avoid it:

• Set up SMART (Specific, Measurable, Attainable, Relevant, Time-bound) targets that support your organization’s strategy.
• Inform all employees about what needs to be accomplished and make sure they get the message.
• Watch progress closely and make necessary changes to reach the targets.
• Objective performance evaluation should be part of the management review.

The issue: Without Key Performance Indicators (KPIs) or monitoring mechanisms, organizations struggle to measure process performance and identify inefficiencies.

How to Avoid it:

• Establish performance metrics for each process within the QMS.
• Conduct regular performance reviews to assess trends and take corrective actions.
• Utilize real-time data visualization tools for better monitoring.