ISO 13485 - List of required / needed procedures and records attached

C

CaliCate

#41
Joylc - Thanks so much for posting your list of docs for ISO 13485:2016! It will be very helpful as not only do I/we need to get ready for our re-certification audit to current 2003 regulation later this year but also need to see where the gaps are with the 2016 update now rather than later. 3 years seems like plenty of time to become compliant but being part of a very small company where I and others have multiple responsibilities and never enough hours in the day to complete regular tasks let alone the "hidden" tasks like preparing for NB audit I need as much time as I can get.

A perfect example of why The Cove is by far the best resource for us Quality/Regulatory Compliance/Doc. Control folks bar none!

A million Thank You's to you and all The Covers! :applause::thanks:

Best Regards CaliCate :cool::smokin:
 
Elsmar Forum Sponsor

howste

Thaumaturge
Super Moderator
#43
Hi there,

Does any one have an updated version of required SOPs list for ISO 13485:2016?

Thanks.
There's one two posts up that was in answer to your last post in July 2016. The standard hasn't changed since then.

Here is the list I came up with:
4.1.6 Computer software for QMS validation
4.2.4 Document control
4.2.5 Control of records
5.6.1 Management review
6.4.1 Monitor/control of work environment
7.3.1 Design & development
7.3.8 Design transfer
7.3.9 Design change control
7.4.1 Purchasing
7.5.1 Production control
7.5.4 Servicing
7.5.6 Process validation (process software validation)
7.5.7 Sterilization validation
7.5.8 Identification
7.5.9.1 Traceability
7.5.11 Preservation of product
7.6 Monitoring & measurement (calibration, computer software for monitoring & measurement validation)
8.2.1 Feedback
8.2.2 Customer complaints
8.2.3 Regulatory reporting
8.2.4 Internal audits
8.2.6 Monitoring & measurement of product
8.3.1 Nonconforming product
8.3.3 Advisory notices
8.3.4 Rework
8.4 Analysis of data
8.5.2 Corrective action
8.5.3 Preventive action

A couple of sections call out the need for multiple procedures which is what the (comments) are showing. I am planning to lump all software validations into the process validation procedure.
 

Mark Meer

Trusted Information Resource
#44
I am planning to lump all software validations into the process validation procedure.
While I realize that software validation is in 7.5.6 (process validation) of the standard, it is also in 7.6 (control of monitoring and measuring equipment).

In my opinion it makes much more sense to include software validation procedures as part of a general "Equipment and Software Control" SOP, rather than in a process validation SOP.

This way the same general process can be used regardless of whether the software is used in production or not.

Just a suggestion...
MM
 

Sam Lazzara

Trusted Information Resource
#45
Thanks for sharing that perspective, Mark.

Side Note - Software validation also shows up in clause 4.1.6, with regard to the validation of the application of computer software used in the QMS.

I have decided to log all QMS software into my Equipment Log (per my Equipment SOP), even if it is standalone software. However, I have so far included QMS process software validation, whether applied to production processes, measuring/monitoring processes or any other QMS process, in my Process Validation SOP. I have amended my Equipment SOP to ensure that each piece of equipment is classified as hardware only, software only, or hardware+software. And I have a link to the Process Validation SOP to cover software validation for equipment with embedded software or "equipment" that is standalone software.

I guess it is not that critical "how" we cover it, as long as we somehow address it from each of the 3 software validation angles described in 13485:2016.
 

Marcelo

Inactive Registered Visitor
#46
We would only have this software validation requirement in 4.1.6, instead of having two more duplicate requirements which make no sense, if people would follow my suggestion :notme:
 

Sam Lazzara

Trusted Information Resource
#47
Hi there,

Does any one have an updated version of required SOPs list for ISO 13485:2016?

Thanks.
I have attached what I came up with when I searched for the appearance of "documented procedure" in ISO 13485:2016.

One thing I always tell my clients, which I hope everyone realizes....just because the standard requires 32 (or whatever number of) things to have documented procedures, that does not mean that you need 32 procedures. For example, I cover all of 13485:2016 and every other med device QMS regulation/standard in the world with a Quality Manual and 21 SOPs.
 

Attachments

Marcelo

Inactive Registered Visitor
#48
One thing I always tell my clients, which I hope everyone realizes....just because the standard requires 32 (or whatever number of) things to have documented procedures, that does not mean that you need 32 procedures. For example, I cover all of 13485:2016 and every other med device QMS regulation/standard in the world with a Quality Manual and 21 SOPs.
One thing I always tell my clients, and unfortunately most people don't realize because they are too focused on "passing the audit" instead of doing the right thing, is that documented procedures formally required by ISO 13485 usually pale in numbers in comparison with the documented procedures that the organization has to create due to their own processes and activities (most people do not understand what 4.2.1 d) means)

Anyway, in practice you can include all formally required "documented procedures" in one document only, so instead of 32, 21 or whatever, you can have only one BIGSOP! :p
 
Thread starter Similar threads Forum Replies Date
E List of Sales Procedures required for ISO 13485 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V List of Required Procedures as per ISO 13485 & MDD EU Medical Device Regulations 8
T AVL (Approved Vendor List) Supplier Listing - ISO 13485 Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
I Is there a list of ISO 13485 registered firms? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Approved Supplier List ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 43
H Simple Effective Internal Audit ISO 13485 Audit Check List needed Internal Auditing 3
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

Similar threads

Top Bottom