ISO 13485 & EU MDR - Expert Advice Community

Getting ISO 13485

So to make a long story short, we are basically promised more work if we have ISO 13485 on our belt. In reading the standard I find that it really doesn’t apply to us. We do not do any sterilization, assembly, servicing, design, installation, particular requirements of implantable devices, CFR regulations, special labeling and traceability for medical devices. We do have a Clean Room where we mold medical products that has compliant procedures, risk assessments and so forth.

XYZ is a small rubber molding manufacturer (33 people) certified to ISO9001:2015 with the exclusion of Design. We manufacture for the Government, Aerospace, Military, Commercial and Medical fields. We manufacture small o-rings and core seals to medical manufacturer that typically ships in bulk with no major requirements such as CFA, FDA, labeling, etc.

So my question, is it a norm for a manufacturer to be ISO 9001 certified with an emphasis on ISO 13485? Getting ISO 13485 with so many exclusions or at least half of the standard doesn’t seem right.

Processes and records for CE purposes

• We designed this medical device together with an engineer of a foreign medical device production facility, which is already ISO13485 compliant.
• The product will only be produced for us, with our name on it. Some sort of Own Brand Labelling (OBL), but not completely the same.
• Based on the relevant risk classification rules, we classified the medical device in risk class IIa.
• We will have full access to all information and data needed to construct the technical file.

1. Are there any ISO13485 processes and records in the template kit that would not be necessary for CE purposes, or would all be necessary, taking into account risk class IIa?
2. How would an auditor exactly assess the implementation and operating effectiveness of these processes? I would guess according to the corresponding records, but how do they assess whether all records are in place for all cases that a record had to be registered?

Customer feedback

For class III medical devices, looking for guidance to understand what are the responsibilities of a distributor having a full process, from storage and delivery to clinical use activities such as user training and proctoring. this will help me to write a proper quality agreement.

QMS training

Hi, I'm having some doubts on ISO 13485, is it necessary to have QMS training once in 6 months, as per the standard?

ISO 13485:2016 vs 13485:2012

How to identify the new requirements of ISO 13485:2016 vs 13485:2012

ISO 13485 and Staff morale

How can ISO 13485 support and improve Staff morale?

Product complaints

Is there a deadline for handling product complaints?

Mould validation

How important is the mould validation documents?

Conformance with ISO 13485

Does 21 CFR 820 requires conformance with ISO 13485?

First qualified person

Qualification procedures need to be developed and implemented for a test or a certain manufacturing procedure. A test, OJT or validation should be included. However, who can be the "first" qualified person? For the validation of the qualification, there needs to be a person to compare. We are in the process of first developing the qualification procedure. Do we need to establish a procedure that specifies the first person to be qualified? Or can anyone or someone who had been doing the job become a first qualified person?