ISO 13485 - Supply Chain Requirements

M

Matthies

#1
Dear all,

Our company sells computers to hospitals and our company wants to be ISO 13485 certified.
The design of the computers is done elsewhere in a factory with ISO 13485, but we only add/change hard drive or RAM memory or wifi modules, but opening the device is necessary to perform this task.
Our computer systems (touch screen panel PC or Tablet like systems) are used in hospitals for basic use, but some are used in surgery operationg room and display heart rate and blood pressure.


My questions is:
Is there anything Supply Chain should do or know to comply with ISO 13485?


Please help and thanks in advance!
 
Elsmar Forum Sponsor
M

Matthies

#3
Dear Yodon,

Thanks for your reply.
We already have a copy of the ISO standard, but as vague as it sometimes can be, i would like to know if there are any examples of what's different from ISO 9001, because we already comply with that ISO standard
 

Ajit Basrur

Staff member
Admin
#4
Dear Yodon,

Thanks for your reply.
We already have a copy of the ISO standard, but as vague as it sometimes can be, i would like to know if there are any examples of what's different from ISO 9001, because we already comply with that ISO standard
Refer our existing threads -

ISO 13485 Sec 7.4 - Supplier Selection, Evaluation and Re-evaluation

Purchasing Process Map for ISO 9001 and ISO 13485 - Example wanted

You can also take a look at this article -
Supplier Controls in a ISO 13485:2003 Environment
 
J

Jeff Frost

#5
Dear Yodon,

Thanks for your reply.
We already have a copy of the ISO standard, but as vague as it sometimes can be, i would like to know if there are any examples of what's different from ISO 9001, because we already comply with that ISO standard
I am working with a company implementing ISO 13485 and the very first activity we performed was to sit down with a copy of 13485 and 9001 and highlighted the actual differences between the two standards. Medical device additional requirements are in blue text but in many cases the change was only minor. A good example is the Purchasing Process, Clause 7.4.1. The only additional requirement for this clause is the addition of the requirement to have a documented procedure.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
I am working with a company implementing ISO 13485 and the very first activity we performed was to sit down with a copy of 13485 and 9001 and highlighted the actual differences between the two standards. Medical device additional requirements are in blue text but in many cases the change was only minor. A good example is the Purchasing Process, Clause 7.4.1. The only additional requirement for this clause is the addition of the requirement to have a documented procedure.
2 comments:

1. Even more user-friendly than the blue Italics, is ISO 13485:2003 annex B, which tabulates / discusses the differences.

2. Adding a requirement to have a documented procedure is not "minor" IMO. Where such a requirement is absent, it suffices to demonstrate that the existing process / practice is generally aligned with the standard's requirements; while a requirement for a documented procedure forces the organization to be much more systematic and consistent + it allows much closer audit scrutiny.

Cheers,
Ronen.
 
J

Jeff Frost

#7
Ronen E

Though you may not like the word minor, most changes to ISO 13485 are business operation based and are usually present within the organizations. One must remember that under 9001 the organization must establish process methods such as purchasing. Everyone performing the process (purchasing in this case) must understand the company’s method for meeting Standards requirement and must adhere to established process methods when performing the function. If employees are not following the established process method, then there is a finding of nonconformity. So in the case of my example the assessment of the purchasing process per 13485 becomes (1) has the business established a process for purchasing product, (2) is it documented in a procedure and (3) are the employees performing this process following the established and documented methods.
 
Thread starter Similar threads Forum Replies Date
B ISO 13485 Management Review - What should be presented by Supply Chain Management Quality Manager and Management Related Issues 1
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
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
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
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 Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
T ISO 13485 - Assembly instructions written vs. online ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
N 93/42/EEC certification without ISO 13485 EU Medical Device Regulations 3
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 5
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9
S Qualification question - ISO 13485 - Setting up a small lab Reliability Analysis - Predictions, Testing and Standards 2
K ISO 13485 clause 8.5.2 'Any necessary CA shall be taken without undue delay' ISO 13485:2016 - Medical Device Quality Management Systems 11
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
D ISO 13485 8.2.1 and 8.2.2 - Customer Feedback and Customer Complaints ISO 13485:2016 - Medical Device Quality Management Systems 5
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
M Getting started in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 31
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
C SOP Template needed for ISO 13485 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 9
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11

Similar threads

Top Bottom