ISO 13485 · Basic · 14 min lesson
Clause 7.5 - production and service provision, identification and traceability
ISO 13485:2016 clauses 7.5.1 to 7.5.5 and 7.5.8 to 7.5.11; EU MDR Article 27 and Annex VI (UDI); FDA QMSR and 21 CFR part 830 (UDI)
What you will learn
- Explain what clauses 7.5.1 to 7.5.5 require for controlled production, cleanliness, installation, servicing and sterile device records.
- Describe identification, status, UDI and traceability under clauses 7.5.8 and 7.5.9, including the extra rule for implantable devices.
- Build a batch record and a trace chain that an auditor can follow in both directions, and spot a weak one.
Key takeaways
- Clause 7.5.1: controlled production with a verified, approved record per device or batch stating quantities made and approved.
- Clause 7.5.2 sets cleanliness requirements; 7.5.3 and 7.5.4 cover installation and servicing; 7.5.5 ties sterilisation records to the batch.
- Clause 7.5.8 requires identification, status, returned device control and, where required, UDI (MDR Article 27; 21 CFR part 830).
- Clause 7.5.9 defines the extent of traceability; implants add components, materials, environment, distributor records and consignees.
- Clauses 7.5.10 and 7.5.11 protect customer property and preserve conformity of product through storage and distribution.
Free practice question
Halden's goods-in clerk receives a pallet of screws from a coating supplier. The pallet has a handwritten tag reading 'OK' with no date, no initials and no lot number. Production wants to start the next work order immediately.
What does clause 7.5.8 expect?
Accept the tag, because it says OK.
Not quite. Clause 7.5.8 requires status identification maintained by suitable means, and an unsigned, undated tag proves no inspection took place.
Hold the pallet in quarantine until the required checks are completed and the status is recorded with a lot identity.
Correct. Clause 7.5.8 requires status against monitoring and measurement requirements so only conforming product is used.
Remove the tag and ship the pallet to the customer.
Not quite. Shipping an unidentified pallet breaks clauses 7.5.8 and 7.5.9, and no release decision exists.
Wait for the next audit to decide.
Not quite. Clause 7.5.8 requires status control continuously, not after an audit, so waiting leaves nonconforming product at risk.
Key terms
- batch record: The record for each device or batch giving traceability and stating quantities manufactured and approved for distribution (ISO 13485 clause 7.5.1).
- traceability: Ability to trace the history, application or location of a device, to the extent defined by regulation and risk (ISO 13485 clause 7.5.9).
- UDI: Unique device identification: a device identifier plus a production identifier, required by regulation such as MDR Article 27 and 21 CFR part 830.
- product status: Identification of product as quarantined, in process, released or rejected against monitoring and measurement requirements (clause 7.5.8).
- implantable device: A device intended to remain in the body, for which clause 7.5.9.2 adds particular traceability records.
- consignee: The recipient named on a shipping package, whose name and address are recorded for implants (clause 7.5.9.2).
- customer property: Items owned by a customer and held by the organization, which must be identified, verified, protected and safeguarded (clause 7.5.10).
- preservation of product: Keeping product conforming through processing, storage, handling and distribution (clause 7.5.11).
Official sources
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- Regulation (EU) 2017/745 on medical devices (MDR), EUR-Lex
- FDA - Quality Management System Regulation (QMSR)
- FDA - Unique Device Identification System (UDI System)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.