SBS - The best value in QMS software

Scope of ISO 13485 Certificate for Multiple Devices

N

Nidhi V

#1
Hello Forum members!

I am looking for some urgent help on finalizing the scope of my ISO 13485 certification application. I am dealing with 2 products- a medical device and a combination product (a prefilled, mutiple use, non- refillable, mechanical (no external source of energy, no springs) drug delivery system).

I'd appreciate guidance on whether or not a prefilled, mutiple use, non- refillable, mechanical drug delivery system can be included in an ISO 13485 certification and how it would be included in the scope of the audit and the certificate, in my application. I'd appreciate it if someone could provide the phrases to be used to cover the activities listed below in the scope!

My organization is responsible for design control, incoming testing of sub assemblies and final assembly and release with a drug filled reservoir. The sub- assembly manufacturer holds an ISO 13485 certificate.

Appreciate your help!
:agree:

Regards,

Nidhi
 
Elsmar Forum Sponsor

sreenu927

Quite Involved in Discussions
#2
Re: Scope of ISO 13485 certificate

Hi Nidhi,

I am not clear of your role " design control and incoming testing of sub assemblies and final assembly and release with a drug filled reservoir."

Are you a contract manufacturer or manufacturer of finished goods?

I assume, this is the first time that you are going for ISO 13485 certification!

Both are medical devices and fall under the scope of ISO 13485.

The scope of the ISO cert depends on how your Organization would like to have keeping in view of future.Some want to be specific by listing the products; some to be general covering the broad category of products.

You can google for sample scopes. A few as below:

1. Design, development assemble, manufacture, distribute and service of lifescience instruments

2. Design, assemble/manufacture, sales & service of medical instruments used in cardiology including ECG Recorders, Bedside monitors

3. Design, development, manufacture, distribute and repair of medical device instruments intended to use in genetic analysis such as DNA Amplifiers, Genetic Analyzers, etc.

In summary, the scope should be as follows:
The (design and development), manufacture, (installation, service) [ACTIVITY] of (in-vitro diagnostic analyzers/software, in-vitro diagnostic medical devices, in-vitro diagnostic reagents, in-vitro diagnostic test kits) [PRODUCTS/PRODUCT CATEGORY] used in the (diagnosis, management, detection) [PURPOSE] of (autoimmune status, blood analytes, blood components, blood gases, blood grouping, cancer, cardiac markers, coagulation, compatibility testing, disease status, donor screening, drugs of abuse, endocrine disorders, fertility testing, genetic testing, immune status, pregnancy testing, prenatal screening, protein metabolism, sexually transmissible agents, tissue typing, transmissible agents, immunological typing, therapeutic drug monitoring, other... ) [APPLICATION] including (home use, near patient/point of care) in-vitro diagnostic devices.

You can think of your product to fit into the above SAMPLE, that suits to your Organization, may or may not be exactly as above.

Hope this helps!

Regards,
Sreenu
 
N

Nidhi V

#3
Re: Scope of ISO 13485 certificate

Dear Sreenu,

Thank you so much! We are a manufacturer of finished product.

We are doing this for the first time but what we're facing is a difference of approach by- the Indian office of the NB Vs European HQ of NB.

From what I understand- mentioning "drug delivery systems" as the product family would cover both, a reusable and disposable drug delivery system.

Thanks once again!

Cheers

Nidhi
 

sreenu927

Quite Involved in Discussions
#4
Re: Scope of ISO 13485 certificate

If you want to vote for "drug delivery systems", you can justify that in future that you may want to add in for disposable as well. So make it general.

If the discussion is between your NB -India and EUHQ, let them settle and let u know the outcome and then you decide whether to go for it or not.

Sometimes, it also depends on where you intend to market your product.

Regards,
Sreenu
 
Thread starter Similar threads Forum Replies Date
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 8
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
K Restricted Scope of ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 7
R Scope of ISO 13485 certification ISO 13485:2016 - Medical Device Quality Management Systems 6
P Dropping ISO 9001 limits the scope of the ISO 13485 audit? ISO 13485:2016 - Medical Device Quality Management Systems 6
S ISO 13485 scope of certification - We are a virtual manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
K MDSAP scope vs ISO 13485 Scope Canada Medical Device Regulations 4
R Scope of Certification for a Design Organization with Outsourced Mfg. - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 10
M OEM-OBL ISO 13485 Certification - Devices mentioned in the product scope ISO 13485:2016 - Medical Device Quality Management Systems 4
chris1price What are the Scope Numbers on ISO 13485 Certificates ISO 13485:2016 - Medical Device Quality Management Systems 2
R ISO 13485 Certificate Scope modified by Notified Body EU Medical Device Regulations 9
S What is the scope of EN ISO 13485 and ISO 13485 ? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Scope of ISO 13485 Registration and Component Makers ISO 13485:2016 - Medical Device Quality Management Systems 7
D Scope of ISO 13485 Certification needs the word Production. ISO 13485:2016 - Medical Device Quality Management Systems 9
V ISO 13485 certification scope in Spanish ISO 13485:2016 - Medical Device Quality Management Systems 5
B Class IIb Medical Device using Annex II route - Need to Update ISO 13485 Scope? ISO 13485:2016 - Medical Device Quality Management Systems 2
L Non-medical device is in the ISO 13485 audit scope? ISO 13485:2016 - Medical Device Quality Management Systems 11
Ajit Basrur Scope for ISO 13485 vs. ISO 15378 - Molding Parts for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
Q The scope of ISO 21534 Other Medical Device Related Standards 0
K Medical Device Repairs and ISO Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
K Software Updates in the Field and ISO scope ISO 13485:2016 - Medical Device Quality Management Systems 2
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D ISO 9001:2015 4.3 Determining the Scope of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Scope of Combined ISO 9001 and IATF 16949 QMS - Non-automotive customers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M ISO 27001 ISMS scope for companies with subsidiaries IEC 27001 - Information Security Management Systems (ISMS) 0
L Dying a slow SCOPE death - NEW ISO APG Paper on Scope and Applicability May 2020. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
P ISO 80369-7 standard - Interpreting which Parts should be in scope Other Medical Device Related Standards 7
I Sales Documents in scope for ISO-9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
qualprod ISO 9001:2015 8.5.1 f - Scope with customer special process requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S ISO 9001:2015 - Scope of Registration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 35
N ISO 9001 certification with limited scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q ISO 9001, section 4.3 Determining the scope of our QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q ISO 9001:2015 - Extent of Policy and Scope with Context and Interested Parties ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K ISO 9001:2015 clause 9.2.2 a. - Define the audit criteria and scope Internal Auditing 2
B ISO 14001:2015 4.3 - How to make the scope of the EMS available to interested parties ISO 14001:2015 Specific Discussions 4
F ISO 9001:2015 4.3 - Determining the scope of the quality management system ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J ISO 17025, Laboratory Scope and Certifications Requests ISO 17025 related Discussions 4
G How to define the scope of QMS as per ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
Anerol C IATF or ISO TS 16949 rules about Scope of QMS IATF 16949 - Automotive Quality Systems Standard 7
M Taking on a job outside of our ISO Scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I ISO 9001 Scope - Exclusion of Design in an engineered solutions company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
T Does your Quality Dept Control Procedures Outside the Scope of ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S ISO 9001:2008 Certification Scope does not mention "manufacturing" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
F ISO/TS 16949 internal audit scope and annual plan Internal Auditing 2
F What is the scope for "Total Numbers of Employees on site" per ISO/TS 16949 ? IATF 16949 - Automotive Quality Systems Standard 4
R Changing ISO 9001 Certification Scope Quality Manager and Management Related Issues 4

Similar threads

Top Bottom