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This message was posted by a user wishing to remain anonymous

Does anyone have an example of a process-based model illustration (compliance to MDSAP), that can provide guidance for how the interaction of processes are linked within their organization?

Dear Anonymous,

I cannot provide such an overview, but maybe the linkages from the MDSAP audit model might help you to gain a better understanding of how the processes are linked.
You can download the MDSAP audit model here: https://www.fda.gov/media/87544/download 

The audit model outlines expected links at the end of different tasks.

Kind regards

------------------------------
Lukas Losigkeit
CEO & Principal Consultant
Hamburg
Germany
------------------------------

Original Message:
Sent: 10-Feb-2021 17:04
From: Anonymous Member
Subject: MDSAP Process Based Model

This message was posted by a user wishing to remain anonymous

Does anyone have an example of a process-based model illustration (compliance to MDSAP), that can provide guidance for how the interaction of processes are linked within their organization?

Lukas,

Thank you for the information. 

For me, your link did not work, perhaps this one will for others

------------------------------
Scott Bishop
Houston TX
United States
------------------------------

Original Message:
Sent: 11-Feb-2021 02:44
From: Lukas Losigkeit
Subject: MDSAP Process Based Model

Dear Anonymous,

I cannot provide such an overview, but maybe the linkages from the MDSAP audit model might help you to gain a better understanding of how the processes are linked.
You can download the MDSAP audit model here: https://www.fda.gov/media/87544/a

The audit model outlines expected links at the end of different tasks.

Kind regards

------------------------------
Lukas Losigkeit
CEO & Principal Consultant
Hamburg
Germany

Original Message:
Sent: 10-Feb-2021 17:04
From: Anonymous Member
Subject: MDSAP Process Based Model

This message was posted by a user wishing to remain anonymous

Does anyone have an example of a process-based model illustration (compliance to MDSAP), that can provide guidance for how the interaction of processes are linked within their organization?

Thank you for the information, Scott. You´re right, the link was broken. I corrected it.

In case you have further questions regarding MDSAP, feel free to let me know.

------------------------------
Lukas Losigkeit
CEO & Principal Consultant
Hamburg
Germany
------------------------------

Original Message:
Sent: 11-Feb-2021 09:57
From: Scott Bishop
Subject: MDSAP Process Based Model

Lukas,

Thank you for the information.

For me, your link did not work, perhaps this one will for others

------------------------------
Scott Bishop
Houston TX
United States

Original Message:
Sent: 11-Feb-2021 02:44
From: Lukas Losigkeit
Subject: MDSAP Process Based Model

Dear Anonymous,

I cannot provide such an overview, but maybe the linkages from the MDSAP audit model might help you to gain a better understanding of how the processes are linked.
You can download the MDSAP audit model here: https://www.fda.gov/media/87544/a

The audit model outlines expected links at the end of different tasks.

Kind regards

------------------------------
Lukas Losigkeit
CEO & Principal Consultant
Hamburg
Germany

Original Message:
Sent: 10-Feb-2021 17:04
From: Anonymous Member
Subject: MDSAP Process Based Model

This message was posted by a user wishing to remain anonymous

Does anyone have an example of a process-based model illustration (compliance to MDSAP), that can provide guidance for how the interaction of processes are linked within their organization?

The MDSAP audit model explains its approach to process-based auditing.  But to my knowledge, it doesn't clearly explain how an organization will illustrate the sequence and interaction of its quality management system (QMS) processes.

The MDSAP audit approach is aimed (among other things) at assessing conformity with ISO 13485:2016. That standard's clause 0.3 demands that the organization define its QMS "process approach".  Similarly, its clause 4.1.2 requires determination of the sequence and interaction of the QMS processes.  ISO 13485:2016's process approach grew out of its predecessor, ISO 13485:2003 clause 0.2, which itself was a medical-device industry adaptation of the ISO 9001:2000 process approach.

This means that we need to understand ISO's principles on processes, and on the "process approach".  A good illustration (literally) of that can be found in ISO 13485:2003's guidance document (ISO 14969) as well as in ISO 9001:2000.  I still rely on the guts of that illustrative model even today under ISO 13485:2016, as I don't believe the process-based approach has changed much, save perhaps for greater emphasis on the integration of a risk-based approach.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 10-Feb-2021 17:04
From: Anonymous Member
Subject: MDSAP Process Based Model

This message was posted by a user wishing to remain anonymous

Does anyone have an example of a process-based model illustration (compliance to MDSAP), that can provide guidance for how the interaction of processes are linked within their organization?

I guess that I would take the shorter route. ISO 13485:2016 has the normative reference to ISO 9000:2015 to describe the process approach. The diagram that is provided in ISO 9001:2015 (section 0.3) is the pictorial representation of this process approach. This is the current state of the art with regard to process approach that doesn't require you to use a document that has been withdrawn (14969).

You will also find this connection to ISO 9001:2015 in the ISO Guidebook on ISO 13485:2016 that you could purchase here. FYI, member price is $96.

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States
------------------------------

Original Message:
Sent: 10-Feb-2021 17:04
From: Anonymous Member
Subject: MDSAP Process Based Model

This message was posted by a user wishing to remain anonymous

Does anyone have an example of a process-based model illustration (compliance to MDSAP), that can provide guidance for how the interaction of processes are linked within their organization?

When correlating ISO 13485:2016 to ISO 9001, it needs to be accurately conveyed that ISO 13485:2016 is based on ISO 9001:2008, rather than ISO 9001:2015.  This is an important factor, as ISO 9001:2015 represents an example of ISO's latest management system standard paradigm, called the High-Level Structure (HLS).

In the context of the medical device industry, I personally would refrain from categorizing the HLS as the latest state of the art.  Persons with a working knowledge of ISO 9001:2015 and its HLS can attest to the fundamental differences between it as contrasted with ISO 9001:2008 and ISO 13485:2016.  This is in fact a reason that ISO/TC 210 is leery about ISO's aim of revising ISO 13485 to adopt the HLS.  During informal correspondence with Joe Lewelling (current ISO/TC 210 Committee Manager), he told me that ISO/TC 210 views that the HLS raises enormous problems in the context of ISO 13485.

Accordingly, until ISO 13485 is aligned with the ISO 9001:2015 HLS (hopefully that will be never), my recommendation is to interpret ISO 13485:2016 and its process approach within the applicable ISO paradigm, which officially is from ISO 9001:2008 and ISO 13485:2003.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 12-Feb-2021 08:55
From: Mark Swanson
Subject: MDSAP Process Based Model

I guess that I would take the shorter route. ISO 13485:2016 has the normative reference to ISO 9000:2015 to describe the process approach. The diagram that is provided in ISO 9001:2015 (section 0.3) is the pictorial representation of this process approach. This is the current state of the art with regard to process approach that doesn't require you to use a document that has been withdrawn (14969).

You will also find this connection to ISO 9001:2015 in the ISO Guidebook on ISO 13485:2016 that you could purchase here. FYI, member price is $96.

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States

Original Message:
Sent: 10-Feb-2021 17:04
From: Anonymous Member
Subject: MDSAP Process Based Model

This message was posted by a user wishing to remain anonymous

Does anyone have an example of a process-based model illustration (compliance to MDSAP), that can provide guidance for how the interaction of processes are linked within their organization?

Note that ISO 9001:2008 also contains the aforesaid process approach illustration.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 12-Feb-2021 09:47
From: Kevin Randall
Subject: MDSAP Process Based Model

When correlating ISO 13485:2016 to ISO 9001, it needs to be accurately conveyed that ISO 13485:2016 is based on ISO 9001:2008, rather than ISO 9001:2015.  This is an important factor, as ISO 9001:2015 represents an example of ISO's latest management system standard paradigm, called the High-Level Structure (HLS).

In the context of the medical device industry, I personally would refrain from categorizing the HLS as the latest state of the art.  Persons with a working knowledge of ISO 9001:2015 and its HLS can attest to the fundamental differences between it as contrasted with ISO 9001:2008 and ISO 13485:2016.  This is in fact a reason that ISO/TC 210 is leery about ISO's aim of revising ISO 13485 to adopt the HLS.  During informal correspondence with Joe Lewelling (current ISO/TC 210 Committee Manager), he told me that ISO/TC 210 views that the HLS raises enormous problems in the context of ISO 13485.

Accordingly, until ISO 13485 is aligned with the ISO 9001:2015 HLS (hopefully that will be never), my recommendation is to interpret ISO 13485:2016 and its process approach within the applicable ISO paradigm, which officially is from ISO 9001:2008 and ISO 13485:2003.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 12-Feb-2021 08:55
From: Mark Swanson
Subject: MDSAP Process Based Model

I guess that I would take the shorter route. ISO 13485:2016 has the normative reference to ISO 9000:2015 to describe the process approach. The diagram that is provided in ISO 9001:2015 (section 0.3) is the pictorial representation of this process approach. This is the current state of the art with regard to process approach that doesn't require you to use a document that has been withdrawn (14969).

You will also find this connection to ISO 9001:2015 in the ISO Guidebook on ISO 13485:2016 that you could purchase here. FYI, member price is $96.

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States

Original Message:
Sent: 10-Feb-2021 17:04
From: Anonymous Member
Subject: MDSAP Process Based Model

This message was posted by a user wishing to remain anonymous

Does anyone have an example of a process-based model illustration (compliance to MDSAP), that can provide guidance for how the interaction of processes are linked within their organization?