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How to comply with 7.1.5.3.1.d

You could investigate whether there is a standard regarding the calibration of load cells for international traceability.

If such a standard exists, you might be referred to the relevant instruction.

Regarding MSA, a GRR study is applicable to measuring instruments where operator influence is a factor—such as calipers, micrometers, and the like.

For instance, it is not typically a suitable method for precision balances. For such devices measuring instruments where operator influence is negligible, a stability study is conducted.

Variations in the equipment over time are monitored and reported using either Cg/Cgk or Cp/Cpk indices. The VDA 5 MSA manual references Cg/Cgk, whereas the AIAG MSA (Revision 4) manual references bias, stability, and linearity studies.

These analyses can be performed using software, or the results can be analyzed graphically using X-R charts.

Expired consumables and reagents

thnak you for this response. Following on from this, the lab in question is continuing to maintain that the tubes can be used. They have not done any validation , nor have they completed any documented justification. They are now attempting to rely on the result for the purposes of an anti doping test and sanction the person for the result. Who can we complain to about this conduct of the lab?

Templates: Technical Documentation for Medical Device & CER

Hello. Thank you for your inquiry. Here are my answers:

1. Regarding the CER - no, we do not provide sample wording. However, each of our documents includes guidelines and additional explanations on how to complete the relevant sections.

2. The “Technical Documentation for Medical Device” template should be understood mainly as a technical documentation index / summary file rather than a complete MDR Annex II and Annex III template.

It provides a useful high-level structure for collecting and referencing key elements of the technical documentation, such as device identification, intended purpose, Declaration of Conformity, GSPR, applicable standards, design and manufacturing information, materials, risk management, biocompatibility, pre-clinical data, stability, sterilization, software, usability, labelling, IFU, clinical evaluation and post-market surveillance.

Should you wish to review the document in more detail, we can organize an online meeting and go through the template together. During the meeting, we can clarify which sections are already covered by the template, which supporting documents need to be prepared separately, and what additional content would be required to make the technical documentation fully aligned with MDR Annex II and Annex III.

The validation of LIMS

You are correct that LIMS validation is not as straightforward as checking a spreadsheet, but it is also important to distinguish between a standard commercial LIMS package and laboratory-specific customisation.

For a commercial off-the-shelf LIMS, the laboratory would not normally be expected to validate the entire software package from first principles. However, the laboratory should be able to demonstrate that the system selected is suitable for its intended use, that the correct version is controlled, and that supplier information, access control, backup, recovery, support, and maintenance arrangements are in place.

The validation or verification effort should focus mainly on the parts of the LIMS that are configured or customised for the laboratory’s own use. This includes any areas where incorrect configuration or system failure could affect sample identity, result validity, calculations, reporting, confidentiality, traceability, or data integrity.

Key elements to consider include:

1. Intended use and scope
   Define which laboratory processes the LIMS supports, such as sample registration, result entry, calculations, review, authorisation, reporting, storage, or data transfer.
   
   
2. Configured workflows and user requirements
   Document laboratory-specific workflows, user roles, access levels, approval steps, report templates, test methods, units, limits, flags, and decision rules.
   
   
3. Risk assessment
   Identify where errors in configuration, customisation, data transfer, or user access could affect the validity or integrity of laboratory results.
4. Testing of customised or configured functions
   Test the LIMS using realistic laboratory scenarios, including sample login, result entry, amendments, review and approval, report generation, and retrieval of records.
   
   
5. Calculations and data transfers
   Verify any laboratory-specific calculations, rounding rules, unit conversions, reference ranges, specification limits, decision rules, instrument imports, exports, and interfaces.
   
   
6. Access control and audit trails
   Confirm that permissions are appropriate, unauthorised changes are prevented, and changes to data or configuration are traceable.
   
   
7. Backup, recovery and business continuity
   Confirm that records can be protected, restored, and accessed when needed.
   
   
8. Change control
   Ensure that software updates, configuration changes, new methods, calculation changes, report template changes, and interface changes are assessed, tested, approved, and recorded before use.

The evidence should therefore show that the laboratory has assessed the commercial LIMS as suitable for its intended use and has tested the laboratory-specific configuration, customisation, calculations, interfaces, reports, access controls, and data integrity controls before routine use.

Certification Scope

First, clearly describe what activities are planned outside the current certified scope. This can be documented as a planned scope extension, business decision, regulatory strategy, or change-control record. Then, perform a gap analysis and impact assessment to determine what new activities are required in terms of regulatory requirements, ISO 13485 clauses, competence, infrastructure, suppliers, records, risk management, validation, PMS, technical documentation, etc. According to the results of this GAP analysis, develop or revise procedures before implementation. The next step is to train relevant personnel, assign responsibilities, qualify suppliers if needed, establish records, and begin operating the new processes under controlled conditions.                                                                                                                                                                  Before asking the certification body to extend the certified scope, the new activities should be included in the internal audit programme and discussed in management review, at least to the extent that implementation and readiness can be demonstrated. Only after the QMS has been updated, implemented, and evidence exists, you can ask the certification body to assess and formally extend the certified scope.

The risks of losing the ISO 13485 Accreditation

Assuming SSD = Sterile Services Department, the hospital would be at potentially high risk, but the actual level depends on why ISO 13485 was lost.

Loss of certification does not automatically mean instruments are unsafe, but it removes an important independent assurance that the SSD’s QMS is controlled. Your hospital would likely be at medium risk if the loss was administrative, but high risk if it resulted from process-control failures. If the SSD cannot demonstrate validated sterilization, effective cleaning, controlled release, traceability, competent staff, maintained equipment, and effective CAPA, the risk becomes patient-safety critical, not merely a quality-system issue.

Quick question on constructing the technical documentation

Thank you for participating in the webinar and for your follow-up question. MDR Article 83(1) states that “for each device,” the manufacturer shall plan, establish, document, implement, maintain, and update a post-market surveillance system, proportionate to the risk class and appropriate for the type of device.                                                                                             

In addition, MDCG 2025-10, “Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices”, provides an explicit clarification. A PMS Plan may cover either a single device or a group of devices - devices with the same manufacturing process, design, and intended purpose, or devices within the same device family. In such cases, the PMS Plan should clearly state which devices are included within its scope.                                                                                                                                            

Therefore, when I referred to the PMS Plan as being device-specific, the intention was that it cannot be a purely generic QMS-level PMS procedure. The PMS Plan must define the device or group of devices covered, the PMS activities, data sources, methods, indicators, thresholds, frequency of monitoring, and rationale in a manner that is appropriate to the specific device or defined device family.                                                                              

Sensitive Data Issue - AI Meta & WhatsApp

Sadly, we do not cover these topics related to other data controllers. Please check our resources at https://advisera.com/eu-gdpr/

Expert perspective on ISO 9001:2026 transition – Sanity check on Gap Analysis and strategic shift

Thank you so much for your comment and  analysis! It is a truly great and accurate summary of the current situation.

I am really glad for this perspective—especially the point that it’s not about ‚less paperwork‘ but about better evidence, and the focus on building a more resilient QMS. You are also absolutely right with your warning at the end. It’s good to prepare, but I will definitely wait for the new standard to be officially published before making any final changes to our processes 

ISO 17025 - Traceability Questions

Hi you asked

We are planning on being a Testing & calibration laboratory (ISO17025) and would like to issue calibration certificates (for a set of calibration lenses) for use by others as part of the process above, what amendments need to be considered? (we will perform uncertainty budgets etc.)

You can issue traceable calibration certificates, to be used by testing laboratories provided you demonstrate full technical competence, control, and properly evaluated uncertainty in line with ISO 17025 for your metrology scope.

This includes, besides ensuring an unbroken traceability chain to NIST

• Defining your calibration capability (range and uncertainty) 
  Specify the lens power range covered and the uncertainty you can achieve
  
  
• Using validated or verified calibration methods
  Ensure the method is fit for purpose and performs consistently.
  
  
• Developing and reporting measurement uncertainty
  Establish an uncertainty budget (including standards, equipment, environment, and repeatability) and report it with results.
  
  
• Maintaining calibrated and controlled equipment
  Apply a calibration programme with periodic recalibration and checks.
  
  
• Implementing ongoing checks for the validity of results
  Use check standards or repeat measurements to confirm performance.
  
  
• Issuing compliant calibration certificates
  Here you will be guided by your accreditation body. Include results, uncertainty, traceability, and relevant conditions. to meet the requirements of ISO 17025 for reporting calibration results.