Handover of QMS Operations Even When the Responsible Person Changes

If You Receive a Folder but Find It Difficult to Start the Next Task

On the day the person responsible changes, shared folders and task lists were handed over.

However, when the next responsible person opens the files, evaluation materials are in various versions, and the email only contains a reply saying, ‘I have reviewed it.’

You need to ask again which materials were used for the assessment, whether the review has been completed for approval, and what materials still need to be received.

At this point, what is lacking is not the number of files, but the context of the tasks.

In medical device quality work, the relevant products and specifications, review records, and decision scopes must be interconnected to easily determine the next actions.

The handover is an opportunity to confirm whether this connection can be practically used by the next responsible person.

This text expands on the handover card from MedQraft's Instagram from a practical perspective.

The methods below are operational proposals from MedQraft and are not legal handover forms or an ISO 13485 full requirements checklist.

Please apply them in accordance with your company's procedures and approval authorities.

First, Define the Scope of Tasks to Handover

There is no need to explain all materials in the same depth.

First, distinguish tasks that require follow-up actions, such as ongoing evaluations, pending responses for change reviews, and unresolved corrective actions.

For regularly performed tasks, leave the next execution point and verification criteria.

The scope that the next person will take over should also be clear.

There may be different people collecting materials, reviewing technical content, and giving final approvals.

Ensure that changes in personnel do not automatically interpret as transfers of existing approval authorities.

The handover list should include the task name, current responsible person, handover recipient, roles in review and approval, and the scheduled next verification date.

For tasks that have yet to be assigned, decide who will assign them instead of leaving them as blanks.

Separate Completed and Pending Tasks in Progress Status

‘In progress’ merely indicates that a task exists; it cannot explain where it has stopped.

You need to distinguish between activities that have already been performed and those judgments that have not yet been completed.

For instance, stating 'Supplier evaluation in progress' doesn’t clarify the status as well as 'Received submitted materials, comparison with applicable component specifications incomplete, pending evaluation approval.'

Receiving materials is one thing, and judging them as sufficient is another.

Ambiguous Expression	Expression for the Next Responsible Person to Continue
Review completed	Record which materials were reviewed by whom and what opinions were left
Awaiting approval	Specify the scope for approval, the position of the approval request, and remaining preconditions
Awaiting vendor response	Link the questions asked, the date sent, and the items to review after the response
No issues	Specify the confirmed subjects, standards, results, and judgment range

For unresolved items, leave the next verification date and indicate who to consult if not resolved by that time.

If completion cannot be proven at the time of handover, do not forcefully label it as ‘complete,’ but distinguish between verified facts and additional confirmations needed.

Leave Judgment Basis with File Locations and Applicable Scope

Simply writing ‘Refer to shared folder’ requires the next responsible person to select the basis again.

It is better to narrow down to the documents and records actually used for judgment by task.

First, clarify the applicable products, models, or parts.

Then, link the reviewed specifications and the identifying information of documents, versions, and locations of those records.

Lastly, note what was decided based on those materials and what has not yet been decided.

The latest version may differ from the version used at that time for judgments.

Instead of retroactively correcting old judgment records to conform to the latest documents, it is necessary to maintain the version referenced at that time and check whether the review of subsequent changes is needed.

Specific management methods should follow the company's document and record management procedures.

While it may seem convenient to copy materials to one location, the original and copies can be updated separately.

First, consider linking to the original location managed by the company and checking if the handover recipient can actually access it.

Access permissions should be granted as needed, and avoid writing account passwords in handover notes.

Specify Next Actions with Confirmation Subjects and Decision Makers

Saying ‘Future review’ or ‘Responsible person confirmation’ relinquishes the responsibility for judgment to the next person.

The next responsible person should see what needs to be confirmed and what decisions they need to request.

For example, ‘Confirm vendor response’ can be specified as ‘Cross-check specifications provided by the vendor against applicable component specifications, and if there are differences, request impact review from the quality and development representatives.’

If the executor and reviewer are different, note both roles together.

Completion criteria are also necessary.

Does the work end with just sending an email, or is review records and approval also necessary? Confirm based on the company’s relevant procedures.

The handover notes themselves should not replace evaluation approvals or change approvals.

Hypothetical Case: If You Handover Supplier Evaluation

The following is a hypothetical situation for explanation.

It is not a real customer case or supplier approval standards.

At the time the quality person changes, let’s assume a new supplier evaluation is in progress, and vendor materials have been received, but cross-checking with applicable components and final judgments remain.

The existing notes read, ‘Evaluation of Company A in progress.
Materials are in the shared folder.
Progress upon receiving a response.’

The handover recipient must trace the reason for waiting for the response anew.

Organizing it as below can distinguish what has been completed and what remains.

Item	Example of Handover Notes
Task Scope	Evaluation of new supplier Company A's target parts. Does not include approval of other parts
Confirmed Facts	Receipt of vendor submitted materials. Confirmed submission list and storage location
Unresolved Issues	Comparison of applicable component specifications and submitted materials is incomplete. Awaiting answers to additional questions
Judgment Basis	Identification information and version of applicable part specifications, list of submitted materials, location of the email sent with questions
Next Actions	The purchasing representative should check the response schedule, and the quality and development representatives should compare the response and specifications.
Follow-up Decision	Organize evaluation results and remaining items, requesting review from the approving authority per company procedures.
Schedule Management	Agree on the next verification date at the time of handover and designate a person to consult if the response is delayed.
Handover Confirmation	The recipient explains unresolved items and their first actions after reviewing the materials.

Filling in the document numbers, responsible persons, and dates of actual work here will serve as a starting point.

However, there may be evaluation criteria not included in this table, and the supplier's eligibility should be judged separately based on the company's applicable standards.

Handover Confirmation Goes Beyond Merely Acknowledging Explanation

The handover simply hearing the explanation and the recipient responding ‘I have confirmed’ may not reveal issues with data access or interpretative differences.

We recommend a method where the handover person explains the actual work while the recipient engages with the materials.

1. The recipient directly finds original materials and related records.
2. They explain the范围 of completed sections and pending items in their own words.
3. They identify their first follow-up action and the persons to consult.
4. They organize parts of the material that are inaccessible or explanations that differ, and appoint a person responsible for supplementary explanations.

This process may reveal additional training or authority needed for the new responsible person.

Consider whether simply allowing access to files solves the problem, or if separate training and competency checks for carrying out the work are required, based on the company's procedures and roles.

In cases where the handover person is already absent, distinguish between confirmed facts verifiable from remaining records and unverified assumptions.

Do not invent judgments arbitrarily to fill in gaps; assign the responsibility for reviewing how unconfirmed aspects might affect current work.

Apply These Questions to One Ongoing Task

Try applying the following questions to one ongoing task.

These are not meant to create a new form for every item.

If you can find answers within existing managed task lists and records, simply link them.

• Can you identify the products, models, and parts handled by this task and what is excluded?
• Are completed activities and unfinished judgments distinctly separated?
• Can you find documents and versions used for judgments?
• Is it clear why decisions were made, and what remains unverified?
• Are next performers and review/approval roles specified?
• Are next verification dates and someone to consult in case of delay specified?
• Can the recipient open the materials and explain their first actions?

Any points where answers become unclear indicate actual maintenance tasks.

If data location is a problem, sort out connections and permissions, and if there is no basis for judgment, start reviewing verifiable records.

If responsibilities are unclear, agree on roles before expanding the form.

Recurring Issues in Handover Show the Scope of QMS Maintenance

If the same explanations are repeated from the start every time a responsible person changes, there may be tasks relying on a specific individual's memory.

Conversely, if ample records exist but work has stalled, it may be unclear with regard to approval authority or connections between tasks.

MedQraft supports building and maintaining quality systems by examining connections between documents and actual work.

If you let us know which tasks are currently stalling frequently during handovers and the processes being used, we can negotiate the review range and deliverables.

View Scope of QMS Consulting Support

The overall operation of quality systems can be further examined from whether procedures and actual work are connected.

Free Handover Checklist

We have prepared a three-page worksheet that can check the latest version, review status, and next tasks alongside actual materials.

Download the Checklist and Watch Introduction Video for Q-Atelier

Reference Scope and Confirmation Dates

ISO 13485 is a standard dealing with medical device quality management systems.

The background on the scope of the standard is found at ISO 13485:2016 Official Introduction.

The confirmation date is September 12, 2026.

The handover stages, memo examples, and verification questions included in the main text are practical suggestions from MedQraft and are not mandatory requirements quoted from standard provisions.

Actual operations require reviews based on applicable regulations, procedures, and task characteristics of the company.

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