SBS - The best value in QMS software

Scope for ISO 13485 vs. ISO 15378 - Molding Parts for Medical Devices

Ajit Basrur

Staff member
Admin
#1
Hi all,

Need advise - we have been molding parts for medical devices for a long time and most of our customers are happy with our quality management systems aligned as per ISO 13485.

Now, we are having a new cusotmer for whom, we will be molding parts for a vaginal applicator and he has told us to get certified as per ISO 15378 standard.

I checked the scope for ISO 15378 and it states - This International Standard identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products, while

ISO 13485 scope states - This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.

In the past, we have been producing some inhalers, plastic containers for Tablets etc but no customer insisted on this ISO 15378.

If thats the case, would all devices containing any medication fall under the scope of ISO 15378 ? Any guidance highly appreciated. :thanks:
 
Elsmar Forum Sponsor
G

Gert Sorensen

#2
Now, we are having a new cusotmer for whom, we will be molding parts for a vaginal applicator and he has told us to get certified as per ISO 15378 standard.

In the past, we have been producing some inhalers, plastic containers for Tablets etc but no customer insisted on this ISO 15378.

If thats the case, would all devices containing any medication fall under the scope of ISO 15378 ? Any guidance highly appreciated. :thanks:
Hi Qualityalways,

The thing is that you have probably mostly produced secondary or tertiary packaging in the past, or packaging for medical devices. Now you are being met with the requirements for primary packaging for pharmaceutical production.

I think you would be well advised to make a gap analysis of your system compared to the 15378, probably you will find that you already cover most of it in your existing system.

Whether or not your company should then pursue certification is an economic and a management consideration. It does cost to acquire and maintain a certification, but the upside is that you can expand your activities into this area.

From the SQS website:
  • The standard specifies the requirements for a quality management system as well as the applications for design, manufacture and supply of primary packaging materials for medicinal products.
  • As a consequence of the direct contact of the product with the packaging (contamination risk), the implementation of GMP in production and the control of primary packaging materials are of high importance for the security of the patients.
  • The application of GMP for pharmaceutical packaging materials guarantees that the legal requirements and the standards of the pharmaceutical industry for medical devices are met.
  • The certification of a company according to ISO 15378 confirms that the GMP rules are applied and that the company operates based on an effective and efficient management system.

Best of luck
 

Ajit Basrur

Staff member
Admin
#3
Thanks Gert, but I was wondering would the molding of the vaginal applicator be applicable under ISO 13485 or ISO 15378 ?

The tablet applicator is a Class I medical device under Sec. 884.4520 Obstetric-gynecologic general manual instrument, with Product Classification code as HGD.

Basically, I am trying to correlate if this device falls under the scope of ISO 15378 or ISO 13485. :confused:
 
G

Gert Sorensen

#4
This is not my field of use - or expertise - so I am guessing here (aided by my RA department). If the applicator goes inside the female body then it is a device under 13485. If it does not, then it is a container under 15378. :bigwave:
 
S

sharadmshukla

#5
Dear Mr. Basrur,

Greetings of the day!

Your product 'vaginal applicator' comes under definition of medical device as per MDD 93/42/EEC. Also you have verified that it is categorized as medical device in FDA database.

There is no question that this product is medical device and it is not combination product i.e. device+medicinal.

Probably since this product is used to apply medicines/ tablets in vaginal part may be your customer is bit confused.

You may discuss in detail with your customer about the relevence of the standard applicable. Mr. Sorensen has also suggested you the right way to do gap analysis.

Certification to this standard is not difficult as it's almost similar to ISO 13485 carrying additional requirement of GMP.

Best Regards-
Sharad Mi. Shukla
 
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
N Scope of ISO 13485 Certificate for Multiple Devices EU Medical Device Regulations 3
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
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