Maintaining a Quality System: Connecting Procedures with Actual Work

Verify the Flow of One Task Rather Than the Number of Documents

While procedures may be organized, the responsible parties might work in different ways.

Conversely, even if work is conducted, there may be no records indicating the criteria used for judgment.

ISO 13485:2016 addresses the requirements of a quality management system that consistently satisfies customer and applicable regulatory requirements related to medical devices and associated services.

This is why it is essential to examine both document retention and actual operations together.

Official Introduction to ISO 13485:2016

Below is MedQraft's practical suggestion for examining operational status, not a complete compliance audit checklist.

Choose One Recent Change Task

For an imaginary case, let’s assume that we changed the supplier for production parts.

Related materials may be scattered among purchase emails, meeting minutes, test results, and revised documents.

Step	Verification Questions
Change Request	Who wanted to change what for what reason?
Impact Review	Did you consider the impact on specifications, risk management, and existing evaluation materials?
Decision	Who approved the change within what scope?
Execution	From what model and time was the new part used?
Confirmation	Are the results of planned verification activities connected with remaining actions?
Document Reflection	Do the site standards and training materials match the changes?

The review scope will vary depending on the type of change.

This does not mean that the same depth of review or the same format should be applied to all changes.

Dividing Issues into Three Reveals the Maintenance Scope

Issues with Standards: Procedures do not align with the current organization or approval authority is unclear.

After verifying the responsible parties and judgment points, procedures need to be updated.

Implementation Issues: Standards exist, but they are not followed.

You need to determine if it is due to lack of training, schedules, tools, or authority.

Simply revising documents cannot be considered a resolution.

Issues with Records: Evidence exists, but it is hard to find or the version connection is broken.

You can start by improving how document numbers, change numbers, applicable models, and record locations are connected.

Without this distinction, operational issues can easily be resolved only by adding documents or organizing necessary procedures into file sorting.

Specify Items to Be Maintained First

Rather than fixing all documents simultaneously, it is advisable to prioritize based on factors such as impact on safety and quality, frequency of occurrences, and degree of lack of evidence.

The inspection results should include current status, necessary actions, responsible parties, and completion criteria.

Instead of "improving change management," write actionable steps like "connect the supplier change with the applicable model and evaluation results and complete pending reviews."

Examining Connections with a Single Supplier Change

The following is a hypothetical example of maintenance rather than a real customer case.

Let’s assume that we applied parts from a new supplier, but the purchasing team has approval emails, the quality team has inspection results, and the production team retains work standards from before the revision.

Simply confirming the existence of each file may seem normal, but the application point and criteria are not connected.

Confirmed Status	Required Follow-up Review	Example Evidence for Completion
No model specified in approval email	Confirm the approval scope and target model	Records confirming the approval scope
Inspection results reference previous specifications	Confirm the criteria used for evaluation and impact of changes	Review results and required follow-up evaluations
On-site standards are previous version	Confirm the distribution status and impact scope	Verification of application of the latest standards and related actions
Hard to find the starting point of use	Trace the scope of application through purchase and production records	Records linked to application point and target

Avoid retroactively filling in missing past records as if they were created at the time.

Distinguish between currently verifiable facts and parts that cannot be verified, and record discovered issues and follow-up reviews at the actual time of completion.

Transitioning Problems Discovered in Internal Audits to Operational Improvements

If document number errors and repeating approval omissions are treated as issues of the same level, the maintenance prioritization will become unclear.

Review the impact and repetition of discovered issues and handle them according to the applicable procedures.

It is helpful to separate content that needs to be corrected immediately from content that requires further review of causes and prevention of recurrence.

For example, even if the reason for an approval omission is recorded as "carelessness of the responsible party," it could actually be that they lack substitute approval authority or that the approval stage is skipped due to scheduling.

After confirming the actual work of the relevant responsible parties, measures should be determined.

Distinguish between the fact of having conducted training and the judgment that the issue has been resolved.

Five Points to Confirm in a Maintenance Meeting

• Which tasks are disconnected at which points?
• What products, records, and ongoing tasks may be affected?
• What needs immediate attention and what requires further review?
• Who determines the completion status and based on what evidence?
• How will the same issues be monitored to ensure they do not recur in follow-up confirmations?

These questions are not aimed at increasing new formats.

If answers can be found in existing records, then begin by organizing those connections.

If issues of repetition or decisions regarding resources/authority are needed, it is best to compile that information to be utilized in management decisions.

Prepare for Audits While Observing Daily Operations

QMS maintenance is about ensuring that audit materials and on-site operations are linked together.

Organizations targeting the U.S. market must also confirm compliance with the QMSR implemented on February 2, 2026.

Holding ISO certification does not allow one to assume meeting regulatory requirements for all markets.

FDA QMSR Guide

MedQraft discusses the necessary range and deliverables for QMS building, operation maintenance, and audit preparation by examining existing procedures and work records together.

This example does not substitute for a complete review of requirements according to the standard text.