ISO 15378 certification - Has anyone experience with ISO 15378?

Ajit Basrur

Staff member
Admin
#1
Hi,

Our management has decided to go in for the ISO 15378 certification. Has anyone experience with this standard ?

How many procedures / records are required - does any one have this information ?

:thanx:
 
Elsmar Forum Sponsor
G

Gert Sorensen

#2
Re: ISO 15378 certification

Can't help there :(

Have you made a GAP analysis? Perhaps you should contact your Notifying Body and have them assist you? :bigwave:
 

Ajit Basrur

Staff member
Admin
#3
Re: ISO 15378 certification

Can't help there :(

Have you made a GAP analysis? Perhaps you should contact your Notifying Body and have them assist you? :bigwave:
Thanks Gert.

Have just prepared a template for doing gap analysis. Btw, our Notifying Body in Hong Kong is also new to this standard and they are contacting their corporate office for more details. In between all this time consuming exercise, I was thinking of getting help from cove. ;)
 
G

Gert Sorensen

#4
Re: ISO 15378 certification

Let's hope someone from Pharma will pop by today and give their :2cents:
 

chris1price

Trusted Information Resource
#5
Re: ISO 15378 certification

This is interesting, we provide packaging materials to many pharma companies, but have never been asked about this standard, never mind certification. I'll have to get a copy and see what I'm missing.
 
Thread starter Similar threads Forum Replies Date
K Comparison wanted: ISO 15378:2018 vs. PS9000:2016 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
P ISO 15378 2015 to 2017 Comparison wanted General Auditing Discussions 4
P Is the next revision of ISO 15378 following the High Level Structure? Other ISO and International Standards and European Regulations 5
I ISO 9000 series, 13485:2003, 15378:2006 - Small Compounding Pharmacy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Ajit Basrur Scope for ISO 13485 vs. ISO 15378 - Molding Parts for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
C ISO 15378 - Gap Analysis With PS 9000:2001- Pharmaceutical Packaging Materials Various Other Specifications, Standards, and related Requirements 5
Sidney Vianna ISO 15378:2006, Primary packaging materials for medicinal products Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 4
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
B ISO 17025:2017 risk management Risk Management Principles and Generic Guidelines 0
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 2768-mk print call out Other ISO and International Standards and European Regulations 11
T ISO 17024, clauses 4.3.8. and 5.1.1. Other ISO and International Standards and European Regulations 4
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet ISO 26262 ISO 26262 - Road vehicles – Functional safety 3
Marc ISO 26262- Road vehicles – Functional safety ISO 26262 - Road vehicles – Functional safety 0
John C. Abnet ISO 26262 IATF 16949 - Automotive Quality Systems Standard 0
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
K PDCA cycle and ISO processes alternative model Quality Management System (QMS) Manuals 14
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
D Which ISO Standard to purchase? ISO 13485:2016 - Medical Device Quality Management Systems 7
V ISO 10360-5: 2020 Gap analysis and Action plan Excel .xls Spreadsheet Templates and Tools 1
Q ISO 9001 - Reseller Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 45001 6.1.2.1 Hazard Identification Occupational Health & Safety Management Standards 1
T The difference between ISO 14644-3:2005 and ISO 14644:2019 Other Medical Device Related Standards 2
S Any ISO standards around Artificial Intelligence and Machine Learning? Medical Information Technology, Medical Software and Health Informatics 4
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
N ISO 9001 - Training business with fewer than 5 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 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
J Opportunity in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3

Similar threads

Top Bottom