Regulatory Open Forum

​​Does anyone have recommendations for a resource to consult on quality agreements for in-country representatives? We have an MDSAP audit finding that requires us to improve our quality agreements for MDSAP jurisdictions but would also like these agreements to be applicable for all our global representatives.
Thanks!

------------------------------
Maria V. Vrabie
Director of Regulatory Affairs
Hu-Friedy Mfg. Co., LLC
Chicago, IL
------------------------------

While I don't have specific recommendations for in-country representatives, I do have quality agreement recommendations that would apply in that case.

First, note that, except in one case, quality agreements are not a regulatory requirement. Except for the exception, I usually recommend against them. Instead describe the relationship in the "purchasing data" (to use the QSR term).

In ISO 13485:2016, 4.1.5 an outsourced process requires a supplier covered by 7.4 which includes evaluation, selection, and controls. Clause 4.1.5 says that the controls for an outsourced process must include a quality agreement. Unfortunately, the standard doesn't describe or define a quality agreement. However, the handbook does provide some additional information.

To set the stage, you have a process that your QMS requires, but you have decided that a party outside your QMS should provide the output of the process. (See ISO 13485:2016, clause 3.16.)

Your QMS provides process inputs and the outsourced process provides the outputs. The handbook says, "[ISO 13485:2016] requires that there is a written quality agreement that defines the responsibilities of each party."

My recommendation is to start with a SIPOC diagram to help define the inputs and outputs. In this case, your QMS is both the supplier and customer. However, you may decide to identify organizational elements instead of your whole company.

Once done, you know the "responsibilities of each party". They will be in the format "we provide xxx, you apply your process, and provide yyy to us". It is now easy to write the quality agreement. Do not make it complicated. In most cases, if you have more than one page, the quality agreement is too long. You could also incorporate the SIPOC diagram.

I recommend making the quality agreement an attachment to the purchase order or contract, not a separate document.

------------------------------
Dan O'Leary
Swanzey NH
United States
------------------------------

Original Message:
Sent: 18-Apr-2018 13:18
From: Maria Vrabie
Subject: MDSAP

​​Does anyone have recommendations for a resource to consult on quality agreements for in-country representatives? We have an MDSAP audit finding that requires us to improve our quality agreements for MDSAP jurisdictions but would also like these agreements to be applicable for all our global representatives.
Thanks!

------------------------------
Maria V. Vrabie
Director of Regulatory Affairs
Hu-Friedy Mfg. Co., LLC
Chicago, IL
------------------------------

I generally agree with Dan here on this. In writing this requirement, the discussion was that a written quality agreement is whatever the organization defines. The intent was not to create excessive burden, but that organizations must define the requirements when they outsource and that requires a written agreement.

I would add that your organization should also define what arrangements are outsourced (vs. purchased). An outsource relationship is different than a purchasing relationship and requires that higher level of control. With this, you should also apply a risk-based approach in this requirements. The higher risk may require more information in the quality agreement, lower risk less. Good luck!

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

Original Message:
Sent: 19-Apr-2018 09:35
From: Dan O'Leary
Subject: MDSAP

While I don't have specific recommendations for in-country representatives, I do have quality agreement recommendations that would apply in that case.

First, note that, except in one case, quality agreements are not a regulatory requirement. Except for the exception, I usually recommend against them. Instead describe the relationship in the "purchasing data" (to use the QSR term).

In ISO 13485:2016, 4.1.5 an outsourced process requires a supplier covered by 7.4 which includes evaluation, selection, and controls. Clause 4.1.5 says that the controls for an outsourced process must include a quality agreement. Unfortunately, the standard doesn't describe or define a quality agreement. However, the handbook does provide some additional information.

To set the stage, you have a process that your QMS requires, but you have decided that a party outside your QMS should provide the output of the process. (See ISO 13485:2016, clause 3.16.)

Your QMS provides process inputs and the outsourced process provides the outputs. The handbook says, "[ISO 13485:2016] requires that there is a written quality agreement that defines the responsibilities of each party."

My recommendation is to start with a SIPOC diagram to help define the inputs and outputs. In this case, your QMS is both the supplier and customer. However, you may decide to identify organizational elements instead of your whole company.

Once done, you know the "responsibilities of each party". They will be in the format "we provide xxx, you apply your process, and provide yyy to us". It is now easy to write the quality agreement. Do not make it complicated. In most cases, if you have more than one page, the quality agreement is too long. You could also incorporate the SIPOC diagram.

I recommend making the quality agreement an attachment to the purchase order or contract, not a separate document.

------------------------------
Dan O'Leary
Swanzey NH
United States

Original Message:
Sent: 18-Apr-2018 13:18
From: Maria Vrabie
Subject: MDSAP

​​Does anyone have recommendations for a resource to consult on quality agreements for in-country representatives? We have an MDSAP audit finding that requires us to improve our quality agreements for MDSAP jurisdictions but would also like these agreements to be applicable for all our global representatives.
Thanks!

------------------------------
Maria V. Vrabie
Director of Regulatory Affairs
Hu-Friedy Mfg. Co., LLC
Chicago, IL
------------------------------

​Thanks Dan and Mark! I appreciate the additional insight into requirement for quality agreement. We are definitely trying to take the least burdensome approach and had drafted a fairly simple "agreement" as a supplement to any existing distribution terms in place with the in-county reps. This document covered responsibilities for post-market surveillance, vigilance, record keeping, etc.. but the MDSAP AO was looking for the country specific requirements to be cited. A checklist or something similar which breaks down the responsibilities between in-country rep and manufacturer, specific to each MDSAP country is what I am looking for.

------------------------------
Maria V. Vrabie
Director of Regulatory Affairs
Hu-Friedy Mfg. Co., LLC
Chicago, IL
------------------------------

Original Message:
Sent: 19-Apr-2018 09:35
From: Dan O'Leary
Subject: MDSAP

While I don't have specific recommendations for in-country representatives, I do have quality agreement recommendations that would apply in that case.

First, note that, except in one case, quality agreements are not a regulatory requirement. Except for the exception, I usually recommend against them. Instead describe the relationship in the "purchasing data" (to use the QSR term).

In ISO 13485:2016, 4.1.5 an outsourced process requires a supplier covered by 7.4 which includes evaluation, selection, and controls. Clause 4.1.5 says that the controls for an outsourced process must include a quality agreement. Unfortunately, the standard doesn't describe or define a quality agreement. However, the handbook does provide some additional information.

To set the stage, you have a process that your QMS requires, but you have decided that a party outside your QMS should provide the output of the process. (See ISO 13485:2016, clause 3.16.)

Your QMS provides process inputs and the outsourced process provides the outputs. The handbook says, "[ISO 13485:2016] requires that there is a written quality agreement that defines the responsibilities of each party."

My recommendation is to start with a SIPOC diagram to help define the inputs and outputs. In this case, your QMS is both the supplier and customer. However, you may decide to identify organizational elements instead of your whole company.

Once done, you know the "responsibilities of each party". They will be in the format "we provide xxx, you apply your process, and provide yyy to us". It is now easy to write the quality agreement. Do not make it complicated. In most cases, if you have more than one page, the quality agreement is too long. You could also incorporate the SIPOC diagram.

I recommend making the quality agreement an attachment to the purchase order or contract, not a separate document.

------------------------------
Dan O'Leary
Swanzey NH
United States

Original Message:
Sent: 18-Apr-2018 13:18
From: Maria Vrabie
Subject: MDSAP

​​Does anyone have recommendations for a resource to consult on quality agreements for in-country representatives? We have an MDSAP audit finding that requires us to improve our quality agreements for MDSAP jurisdictions but would also like these agreements to be applicable for all our global representatives.
Thanks!

------------------------------
Maria V. Vrabie
Director of Regulatory Affairs
Hu-Friedy Mfg. Co., LLC
Chicago, IL
------------------------------

Hi Maria

with regards to your AO request drop me an email might have something done that would help the specific checklist specifies the nuances for each jurisdiction for product being sold to in line with both the regulatory and companion document stated links etc 

Kind regards,

------------------------------
Ivan Whelan
Director
mobile: +447453318474
email: ivan@meddevsolutions.co.uk
Web: www.meddevsolutions.co.uk
------------------------------

Original Message:
Sent: 20-Apr-2018 08:46
From: Maria Vrabie
Subject: MDSAP

​Thanks Dan and Mark! I appreciate the additional insight into requirement for quality agreement. We are definitely trying to take the least burdensome approach and had drafted a fairly simple "agreement" as a supplement to any existing distribution terms in place with the in-county reps. This document covered responsibilities for post-market surveillance, vigilance, record keeping, etc.. but the MDSAP AO was looking for the country specific requirements to be cited. A checklist or something similar which breaks down the responsibilities between in-country rep and manufacturer, specific to each MDSAP country is what I am looking for.

------------------------------
Maria V. Vrabie
Director of Regulatory Affairs
Hu-Friedy Mfg. Co., LLC
Chicago, IL

Original Message:
Sent: 19-Apr-2018 09:35
From: Dan O'Leary
Subject: MDSAP

While I don't have specific recommendations for in-country representatives, I do have quality agreement recommendations that would apply in that case.

First, note that, except in one case, quality agreements are not a regulatory requirement. Except for the exception, I usually recommend against them. Instead describe the relationship in the "purchasing data" (to use the QSR term).

In ISO 13485:2016, 4.1.5 an outsourced process requires a supplier covered by 7.4 which includes evaluation, selection, and controls. Clause 4.1.5 says that the controls for an outsourced process must include a quality agreement. Unfortunately, the standard doesn't describe or define a quality agreement. However, the handbook does provide some additional information.

To set the stage, you have a process that your QMS requires, but you have decided that a party outside your QMS should provide the output of the process. (See ISO 13485:2016, clause 3.16.)

Your QMS provides process inputs and the outsourced process provides the outputs. The handbook says, "[ISO 13485:2016] requires that there is a written quality agreement that defines the responsibilities of each party."

My recommendation is to start with a SIPOC diagram to help define the inputs and outputs. In this case, your QMS is both the supplier and customer. However, you may decide to identify organizational elements instead of your whole company.

Once done, you know the "responsibilities of each party". They will be in the format "we provide xxx, you apply your process, and provide yyy to us". It is now easy to write the quality agreement. Do not make it complicated. In most cases, if you have more than one page, the quality agreement is too long. You could also incorporate the SIPOC diagram.

I recommend making the quality agreement an attachment to the purchase order or contract, not a separate document.

------------------------------
Dan O'Leary
Swanzey NH
United States

Original Message:
Sent: 18-Apr-2018 13:18
From: Maria Vrabie
Subject: MDSAP

​​Does anyone have recommendations for a resource to consult on quality agreements for in-country representatives? We have an MDSAP audit finding that requires us to improve our quality agreements for MDSAP jurisdictions but would also like these agreements to be applicable for all our global representatives.
Thanks!

------------------------------
Maria V. Vrabie
Director of Regulatory Affairs
Hu-Friedy Mfg. Co., LLC
Chicago, IL
------------------------------

​Thanks Ivan for the great checklist, much appreciated!

------------------------------
Maria V. Vrabie
Director of Regulatory Affairs
Hu-Friedy Mfg. Co., LLC
Chicago, IL
------------------------------

Original Message:
Sent: 21-Apr-2018 03:03
From: Ivan Whelan
Subject: MDSAP

Hi Maria

with regards to your AO request drop me an email might have something done that would help the specific checklist specifies the nuances for each jurisdiction for product being sold to in line with both the regulatory and companion document stated links etc

Kind regards,

------------------------------
Ivan Whelan
Director
mobile: +447453318474
email: ivan@meddevsolutions.co.uk
Web: www.meddevsolutions.co.uk

Original Message:
Sent: 20-Apr-2018 08:46
From: Maria Vrabie
Subject: MDSAP

​Thanks Dan and Mark! I appreciate the additional insight into requirement for quality agreement. We are definitely trying to take the least burdensome approach and had drafted a fairly simple "agreement" as a supplement to any existing distribution terms in place with the in-county reps. This document covered responsibilities for post-market surveillance, vigilance, record keeping, etc.. but the MDSAP AO was looking for the country specific requirements to be cited. A checklist or something similar which breaks down the responsibilities between in-country rep and manufacturer, specific to each MDSAP country is what I am looking for.

------------------------------
Maria V. Vrabie
Director of Regulatory Affairs
Hu-Friedy Mfg. Co., LLC
Chicago, IL

Original Message:
Sent: 19-Apr-2018 09:35
From: Dan O'Leary
Subject: MDSAP

While I don't have specific recommendations for in-country representatives, I do have quality agreement recommendations that would apply in that case.

First, note that, except in one case, quality agreements are not a regulatory requirement. Except for the exception, I usually recommend against them. Instead describe the relationship in the "purchasing data" (to use the QSR term).

In ISO 13485:2016, 4.1.5 an outsourced process requires a supplier covered by 7.4 which includes evaluation, selection, and controls. Clause 4.1.5 says that the controls for an outsourced process must include a quality agreement. Unfortunately, the standard doesn't describe or define a quality agreement. However, the handbook does provide some additional information.

To set the stage, you have a process that your QMS requires, but you have decided that a party outside your QMS should provide the output of the process. (See ISO 13485:2016, clause 3.16.)

Your QMS provides process inputs and the outsourced process provides the outputs. The handbook says, "[ISO 13485:2016] requires that there is a written quality agreement that defines the responsibilities of each party."

My recommendation is to start with a SIPOC diagram to help define the inputs and outputs. In this case, your QMS is both the supplier and customer. However, you may decide to identify organizational elements instead of your whole company.

Once done, you know the "responsibilities of each party". They will be in the format "we provide xxx, you apply your process, and provide yyy to us". It is now easy to write the quality agreement. Do not make it complicated. In most cases, if you have more than one page, the quality agreement is too long. You could also incorporate the SIPOC diagram.

I recommend making the quality agreement an attachment to the purchase order or contract, not a separate document.

------------------------------
Dan O'Leary
Swanzey NH
United States

Original Message:
Sent: 18-Apr-2018 13:18
From: Maria Vrabie
Subject: MDSAP

​​Does anyone have recommendations for a resource to consult on quality agreements for in-country representatives? We have an MDSAP audit finding that requires us to improve our quality agreements for MDSAP jurisdictions but would also like these agreements to be applicable for all our global representatives.
Thanks!

------------------------------
Maria V. Vrabie
Director of Regulatory Affairs
Hu-Friedy Mfg. Co., LLC
Chicago, IL
------------------------------

Hi Maria,

We took the approach to have a single contract with the roles and responsibilities defined based on the MDSAP companion document. Our AO went through it and did not have any comments.

------------------------------
Stacie-Ann Creighton
Indianapolis IN
United States
------------------------------

Original Message:
Sent: 20-Apr-2018 08:46
From: Maria Vrabie
Subject: MDSAP

​Thanks Dan and Mark! I appreciate the additional insight into requirement for quality agreement. We are definitely trying to take the least burdensome approach and had drafted a fairly simple "agreement" as a supplement to any existing distribution terms in place with the in-county reps. This document covered responsibilities for post-market surveillance, vigilance, record keeping, etc.. but the MDSAP AO was looking for the country specific requirements to be cited. A checklist or something similar which breaks down the responsibilities between in-country rep and manufacturer, specific to each MDSAP country is what I am looking for.

------------------------------
Maria V. Vrabie
Director of Regulatory Affairs
Hu-Friedy Mfg. Co., LLC
Chicago, IL

Original Message:
Sent: 19-Apr-2018 09:35
From: Dan O'Leary
Subject: MDSAP

While I don't have specific recommendations for in-country representatives, I do have quality agreement recommendations that would apply in that case.

First, note that, except in one case, quality agreements are not a regulatory requirement. Except for the exception, I usually recommend against them. Instead describe the relationship in the "purchasing data" (to use the QSR term).

In ISO 13485:2016, 4.1.5 an outsourced process requires a supplier covered by 7.4 which includes evaluation, selection, and controls. Clause 4.1.5 says that the controls for an outsourced process must include a quality agreement. Unfortunately, the standard doesn't describe or define a quality agreement. However, the handbook does provide some additional information.

To set the stage, you have a process that your QMS requires, but you have decided that a party outside your QMS should provide the output of the process. (See ISO 13485:2016, clause 3.16.)

Your QMS provides process inputs and the outsourced process provides the outputs. The handbook says, "[ISO 13485:2016] requires that there is a written quality agreement that defines the responsibilities of each party."

My recommendation is to start with a SIPOC diagram to help define the inputs and outputs. In this case, your QMS is both the supplier and customer. However, you may decide to identify organizational elements instead of your whole company.

Once done, you know the "responsibilities of each party". They will be in the format "we provide xxx, you apply your process, and provide yyy to us". It is now easy to write the quality agreement. Do not make it complicated. In most cases, if you have more than one page, the quality agreement is too long. You could also incorporate the SIPOC diagram.

I recommend making the quality agreement an attachment to the purchase order or contract, not a separate document.

------------------------------
Dan O'Leary
Swanzey NH
United States

Original Message:
Sent: 18-Apr-2018 13:18
From: Maria Vrabie
Subject: MDSAP

​​Does anyone have recommendations for a resource to consult on quality agreements for in-country representatives? We have an MDSAP audit finding that requires us to improve our quality agreements for MDSAP jurisdictions but would also like these agreements to be applicable for all our global representatives.
Thanks!

------------------------------
Maria V. Vrabie
Director of Regulatory Affairs
Hu-Friedy Mfg. Co., LLC
Chicago, IL
------------------------------

I would say the same thing here. In Chapter 2 of the Companion Document (Audit Model), there is an outline for each of the 5 MDSAP countries. The audit criteria is also listed here. There are some very specific items for a couple of the countries (like the Australia requirement for the license holder address to be on the package). You will likely find that you representative in those countries will be the best source to outline what their process consists of after they receive the product. Do not forget that you have the regulatory responsibility to ensure they have the appropriate documentation as well (you probably want copies of everything they do). I would also advise that you have the product registration numbers and your manufacturer/facility number to be able to search the regulators website for information to verify everything.

Good Luck!!

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

Original Message:
Sent: 21-Apr-2018 16:33
From: Stacie-Ann Creighton
Subject: MDSAP

Hi Maria,

We took the approach to have a single contract with the roles and responsibilities defined based on the MDSAP companion document. Our AO went through it and did not have any comments.

------------------------------
Stacie-Ann Creighton
Indianapolis IN
United States

Original Message:
Sent: 20-Apr-2018 08:46
From: Maria Vrabie
Subject: MDSAP

​Thanks Dan and Mark! I appreciate the additional insight into requirement for quality agreement. We are definitely trying to take the least burdensome approach and had drafted a fairly simple "agreement" as a supplement to any existing distribution terms in place with the in-county reps. This document covered responsibilities for post-market surveillance, vigilance, record keeping, etc.. but the MDSAP AO was looking for the country specific requirements to be cited. A checklist or something similar which breaks down the responsibilities between in-country rep and manufacturer, specific to each MDSAP country is what I am looking for.

------------------------------
Maria V. Vrabie
Director of Regulatory Affairs
Hu-Friedy Mfg. Co., LLC
Chicago, IL

Original Message:
Sent: 19-Apr-2018 09:35
From: Dan O'Leary
Subject: MDSAP

While I don't have specific recommendations for in-country representatives, I do have quality agreement recommendations that would apply in that case.

First, note that, except in one case, quality agreements are not a regulatory requirement. Except for the exception, I usually recommend against them. Instead describe the relationship in the "purchasing data" (to use the QSR term).

In ISO 13485:2016, 4.1.5 an outsourced process requires a supplier covered by 7.4 which includes evaluation, selection, and controls. Clause 4.1.5 says that the controls for an outsourced process must include a quality agreement. Unfortunately, the standard doesn't describe or define a quality agreement. However, the handbook does provide some additional information.

To set the stage, you have a process that your QMS requires, but you have decided that a party outside your QMS should provide the output of the process. (See ISO 13485:2016, clause 3.16.)

Your QMS provides process inputs and the outsourced process provides the outputs. The handbook says, "[ISO 13485:2016] requires that there is a written quality agreement that defines the responsibilities of each party."

My recommendation is to start with a SIPOC diagram to help define the inputs and outputs. In this case, your QMS is both the supplier and customer. However, you may decide to identify organizational elements instead of your whole company.

Once done, you know the "responsibilities of each party". They will be in the format "we provide xxx, you apply your process, and provide yyy to us". It is now easy to write the quality agreement. Do not make it complicated. In most cases, if you have more than one page, the quality agreement is too long. You could also incorporate the SIPOC diagram.

I recommend making the quality agreement an attachment to the purchase order or contract, not a separate document.

------------------------------
Dan O'Leary
Swanzey NH
United States

Original Message:
Sent: 18-Apr-2018 13:18
From: Maria Vrabie
Subject: MDSAP

​​Does anyone have recommendations for a resource to consult on quality agreements for in-country representatives? We have an MDSAP audit finding that requires us to improve our quality agreements for MDSAP jurisdictions but would also like these agreements to be applicable for all our global representatives.
Thanks!

------------------------------
Maria V. Vrabie
Director of Regulatory Affairs
Hu-Friedy Mfg. Co., LLC
Chicago, IL
------------------------------

​Thanks everyone for the MDSAP Companion Document references and recommendations!

------------------------------
Maria V. Vrabie
Director of Regulatory Affairs
Hu-Friedy Mfg. Co., LLC
Chicago, IL
------------------------------

Original Message:
Sent: 22-Apr-2018 10:02
From: Mark Swanson
Subject: MDSAP

I would say the same thing here. In Chapter 2 of the Companion Document (Audit Model), there is an outline for each of the 5 MDSAP countries. The audit criteria is also listed here. There are some very specific items for a couple of the countries (like the Australia requirement for the license holder address to be on the package). You will likely find that you representative in those countries will be the best source to outline what their process consists of after they receive the product. Do not forget that you have the regulatory responsibility to ensure they have the appropriate documentation as well (you probably want copies of everything they do). I would also advise that you have the product registration numbers and your manufacturer/facility number to be able to search the regulators website for information to verify everything.

Good Luck!!

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

Original Message:
Sent: 21-Apr-2018 16:33
From: Stacie-Ann Creighton
Subject: MDSAP

Hi Maria,

We took the approach to have a single contract with the roles and responsibilities defined based on the MDSAP companion document. Our AO went through it and did not have any comments.

------------------------------
Stacie-Ann Creighton
Indianapolis IN
United States

Original Message:
Sent: 20-Apr-2018 08:46
From: Maria Vrabie
Subject: MDSAP

​Thanks Dan and Mark! I appreciate the additional insight into requirement for quality agreement. We are definitely trying to take the least burdensome approach and had drafted a fairly simple "agreement" as a supplement to any existing distribution terms in place with the in-county reps. This document covered responsibilities for post-market surveillance, vigilance, record keeping, etc.. but the MDSAP AO was looking for the country specific requirements to be cited. A checklist or something similar which breaks down the responsibilities between in-country rep and manufacturer, specific to each MDSAP country is what I am looking for.

------------------------------
Maria V. Vrabie
Director of Regulatory Affairs
Hu-Friedy Mfg. Co., LLC
Chicago, IL

Original Message:
Sent: 19-Apr-2018 09:35
From: Dan O'Leary
Subject: MDSAP

While I don't have specific recommendations for in-country representatives, I do have quality agreement recommendations that would apply in that case.

First, note that, except in one case, quality agreements are not a regulatory requirement. Except for the exception, I usually recommend against them. Instead describe the relationship in the "purchasing data" (to use the QSR term).

In ISO 13485:2016, 4.1.5 an outsourced process requires a supplier covered by 7.4 which includes evaluation, selection, and controls. Clause 4.1.5 says that the controls for an outsourced process must include a quality agreement. Unfortunately, the standard doesn't describe or define a quality agreement. However, the handbook does provide some additional information.

To set the stage, you have a process that your QMS requires, but you have decided that a party outside your QMS should provide the output of the process. (See ISO 13485:2016, clause 3.16.)

Your QMS provides process inputs and the outsourced process provides the outputs. The handbook says, "[ISO 13485:2016] requires that there is a written quality agreement that defines the responsibilities of each party."

My recommendation is to start with a SIPOC diagram to help define the inputs and outputs. In this case, your QMS is both the supplier and customer. However, you may decide to identify organizational elements instead of your whole company.

Once done, you know the "responsibilities of each party". They will be in the format "we provide xxx, you apply your process, and provide yyy to us". It is now easy to write the quality agreement. Do not make it complicated. In most cases, if you have more than one page, the quality agreement is too long. You could also incorporate the SIPOC diagram.

I recommend making the quality agreement an attachment to the purchase order or contract, not a separate document.

------------------------------
Dan O'Leary
Swanzey NH
United States

Original Message:
Sent: 18-Apr-2018 13:18
From: Maria Vrabie
Subject: MDSAP

​​Does anyone have recommendations for a resource to consult on quality agreements for in-country representatives? We have an MDSAP audit finding that requires us to improve our quality agreements for MDSAP jurisdictions but would also like these agreements to be applicable for all our global representatives.
Thanks!

------------------------------
Maria V. Vrabie
Director of Regulatory Affairs
Hu-Friedy Mfg. Co., LLC
Chicago, IL
------------------------------
​