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ISO 13485:2016 Section 5.5.3

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#1
Does a process require an SOP? we have a requirement in our QMS and ISO 13485 to communicate the effectiveness of the QMS at least monthly to management. We conduct weekly management meetings without formal documentation. Reviewing data from the last several years these meetings have occurred and the requirements are being met weekly.

Further -
0.3 Process approach
This International Standard is based on a process approach to quality management. Any activity that
receives input and converts it to output can be considered as a process. Often the output from one
process directly forms the input to the next process.
For an organization to function effectively, it needs to identify and manage numerous linked processes.
The application of a system of processes within an organization, together with the identification and
interactions of these processes, and their management to produce the desired outcome, can be referred
to as the “process approach.”
When used within a quality management system, such an approach emphasizes the importance of:
a) understanding and meeting requirements;
WE ARE

b) considering processes in terms of added value;
An SOP adds no value

c) obtaining results of process performance and effectiveness;
MINUTES OF MEETINGS ARE RECORDED AND DEMONSTRATE EFFECTIVENESS.

d) improving processes based on objective measurement.
OBJECTIVE DATA SHOWS THIS IS BEING MET.

Is this acceptable?
 
Elsmar Forum Sponsor

William55401

Quite Involved in Discussions
#2
I would say it depends. The key word is effectiveness. What, in detail, do you review? Is it a metric based meeting that drives follow up and closure of issues within the QMS? Do the minutes tell that same story? Is the meeting a true engine for improvement and action? Or, is it more of a status or communication meeting?

Ed, if you stopped these meetings would anyone care? Do these meetings compete with your formal mgmt review process where you must make a QMS effectiveness decision?

If these are truly effective meetings that support QMS effectiveness, I would definitely create an SOP (for you, this would just be a section in your mgmt review sop). If not, I would just position them as communication Meetings and remove any reference to them in the QMS.
 

somashekar

Staff member
Super Moderator
#3
Does a process require an SOP? we have a requirement in our QMS and ISO 13485 to communicate the effectiveness of the QMS at least monthly to management. We conduct weekly management meetings without formal documentation. Reviewing data from the last several years these meetings have occurred and the requirements are being met weekly.

Further -
0.3 Process approach
This International Standard is based on a process approach to quality management. Any activity that
receives input and converts it to output can be considered as a process. Often the output from one
process directly forms the input to the next process.
For an organization to function effectively, it needs to identify and manage numerous linked processes.
The application of a system of processes within an organization, together with the identification and
interactions of these processes, and their management to produce the desired outcome, can be referred
to as the “process approach.”
When used within a quality management system, such an approach emphasizes the importance of:
a) understanding and meeting requirements;
WE ARE

b) considering processes in terms of added value;
An SOP adds no value

c) obtaining results of process performance and effectiveness;
MINUTES OF MEETINGS ARE RECORDED AND DEMONSTRATE EFFECTIVENESS.

d) improving processes based on objective measurement.
OBJECTIVE DATA SHOWS THIS IS BEING MET.

Is this acceptable?
5.5.3 is about Internal communication and here a SOP not required by the standard. All that is required is communication proceses are established, and effectiveness of the quality management system is communicated.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#4
I would say it depends. The key word is effectiveness. What, in detail, do you review?

The review varies to current activity from our group. CAPA, audits, DHR, DHF, Suppliers. Basically, what the group did last week, what we are doing this week, and long-term projects are discussed.


Is it a metric-based meeting that drives follow up and closure of issues within the QMS?
Depends on the topic but it can be metric-related.

Do the minutes tell that same story? Is the meeting a true engine for improvement and action? Or, is it more of a status or communication meeting?

Its both. Because all key stakeholders are present its effective at obtaining consensus on the spot since the CEO has direct feedback and direction to other leaders. I relay some metrics around complaints or training and DHR readiness. Some more informal such as the news from the FDA or MDD MDR news. I have an xls template with headings like FDA/13485/CAPA/training/Postmarket surv/ support/ change notices/ and a misc header

Ed, if you stopped these meetings would anyone care? Do these meetings compete with your formal mgmt review process where you must make a QMS effectiveness decision?

We have had these meetings every Monday for the past 10 years. If these were to stop they would be noticed at our annual mgmt review or earlier by internal audits, external audit. These meetings have met the recent 13485 auditors' expectations. I am hesitant to create an SOP at this point as it would add a risk. We hired a consultant who made this a minor finding so here I am. I am justifying that an SOP would not add value as these are a standard business occurence.

If these are truly effective meetings that support QMS effectiveness, I would definitely create an SOP (for you, this would just be a section in your mgmt review sop). If not, I would just position them as communication Meetings and remove any reference to them in the QMS.
Maybe I can just release the template as a reference document in the QMS?

Thanks!

Ed
 
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