ISO13485 - The correct standard for pharmaceutical packaging?

Hi,
Some advice please.
My company is currently accredited to ISO9001:2015 and we want to 'up our game' as far as demonstrating that we are taking the quality of our products seriously.
We manufacture polythene bags which ultimately contain pharmaceutical products and I was wondering if moving up to ISO13485 was a relevant move?

Thanks in advance

 

I'm not advocating one way or the other but just adopting a new standard won't improve quality. Doing so may lighten the burden for qualification and approval by your customers so there may well be a benefit. Just curious where you believe this would effect (quality) improvements?

As you may know, 13485 did not adopt the Annex SL structure so changing may actually be something of a step backwards (which is, of course, debatable but noted here to ensure you recognize the differences).

 

Hi, As Andy says, ISO9001 is a good start. For pharmaceutical packaging, I would suggest looking at either ISO15378 or PS9000 (Pharmaceutical packaging materials for medicinal products)

ISO15378 is heavily based on ISO13485 and tends to be more aimed at "combination devices" (eg inhalers, syringes, etc), and can be obtained from your usual standards provided, at a cost.

PS9000 is based on ISO9001 heavily focusses primary packaging (cartons, leaflets, foils, etc). It is available from https://www.pqg.org and is free to download.

Finding a body who will certify to either can be difficult. In UK some NB will include them within the scope of your 9001 certification. In Europe, other NBs will certify to ISO15378. It depends where you are and what you need. Simply using one of these as guidance for enhancing your quality will be a good start before you thinking of certification.

Finally I would talk to your key customers and see what they advise, some may have a preference for one over the other.

Chris

 

Hi Andy

Hi Andy,
Many thanks for the welcome and the clarification. The main reason for my question was that I wasn't sure whether ISO13485 was the way to go as it didn't seem to offer much more than ISO9001:2015 and didn't seem packaging specific.

To take your points as they come:

1. No, we are not being asked but are currently looking to increase our market presence and wanted to include a more rigorous standard as part of our marketing plan
2. Our present clients are not asking for anything more than ISO9001
3. If it is an investment and can generate additional sales then yes
4. Yes
5. Yes

 

Hi VG,
Thank you for taking the time to reply and offer alternatives. I will contact my clients and seek their opinion. I will also download PS9000 and pick the relevant clauses form that as a way forward short term.

 

Hi, Thanks for the very comprehensive answer. Following an earlier post I have looked into ISO15378 and that is the route we have chosen to go down. I am still waiting for feedback from a number of notified bodies reference certification, which is becoming a concern!