Regulatory Open Forum

Hi everyone,

I am wondering if one of you has a template he can share of a SOP related to communication with external parties (authorities, customers) ? Thanks in advance.

For the context of ISO 13485:2016 clause 7.2.3 first paragraph requiring that we "plan and document arrangements for" (I view that to be different than "document procedures for") communicating with customers in various ways, and regarding clause 7.2.3 second paragraph requiring that we "communicate with" (I again view that to be different than "document procedures for") regulatory authorities, I have our clients simply use the corresponding section of the Quality Manual to document the organization's corresponding policy promises plus therewith to reference the corresponding documented procedures where such procedures are required elsewhere by ISO 13485 (i.e., the clause 8.2.1 feedback procedure; the clause 8.2.2 complaint handling procedure; the clause 8.3.3 advisory notice procedure; and the clause 8.2.3 procedure for reporting to regulatory authorities).  And for the parts of clause 7.2.3 that don't require us to "document procedures" (i.e., regarding customer communication about product information, enquiries, and contracts or order handling, including amendments, and regarding regulatory authority communication other than reporting, such as regarding periodic facility registration or regarding agency inspections), I have our clients reference their corresponding voluntary documented procedures if they exist or else write a corresponding narrative in the Quality Manual that at least assigns responsibilities and gives a brief explanation of how the organization communicates with customers and regulatory authorities about those topics.  This has always been a successful approach when clients were audited by external auditors.

Hi everyone,

I am wondering if one of you has a template he can share of a SOP related to communication with external parties (authorities, customers) ? Thanks in advance.

Thank you Kevin,

This is not a ISO 13485 but a MDR 2017/745 requirements on art.10 :

(j) handling communication with competent authorities, notified bodies, other economic operators, customers and/or
other stakeholders;

Anyway my question was not how to fullfill with the requirement but if someone has a template or know where to find a template :)

Thanks in advance,

For the context of ISO 13485:2016 clause 7.2.3 first paragraph requiring that we "plan and document arrangements for" (I view that to be different than "document procedures for") communicating with customers in various ways, and regarding clause 7.2.3 second paragraph requiring that we "communicate with" (I again view that to be different than "document procedures for") regulatory authorities, I have our clients simply use the corresponding section of the Quality Manual to document the organization's corresponding policy promises plus therewith to reference the corresponding documented procedures where such procedures are required elsewhere by ISO 13485 (i.e., the clause 8.2.1 feedback procedure; the clause 8.2.2 complaint handling procedure; the clause 8.3.3 advisory notice procedure; and the clause 8.2.3 procedure for reporting to regulatory authorities).  And for the parts of clause 7.2.3 that don't require us to "document procedures" (i.e., regarding customer communication about product information, enquiries, and contracts or order handling, including amendments, and regarding regulatory authority communication other than reporting, such as regarding periodic facility registration or regarding agency inspections), I have our clients reference their corresponding voluntary documented procedures if they exist or else write a corresponding narrative in the Quality Manual that at least assigns responsibilities and gives a brief explanation of how the organization communicates with customers and regulatory authorities about those topics.  This has always been a successful approach when clients were audited by external auditors.

Hi everyone,

I am wondering if one of you has a template he can share of a SOP related to communication with external parties (authorities, customers) ? Thanks in advance.

Hello Quang,

Maybe someone at a company participating in the forums here would have a procedure which could be shared.  Often procedures and templates are considered intellectual property especially to consulting firms, so you might need to engage with one of them to help develop a procedure for your quality system.  Indeed, under Article 10 there is this "communication" requirement with various parties and stakeholders.  And yes, it is asked for and also something we ask for as part of an EU MDR quality system assessment because ... it is asked for by Notified Body auditors.  Typically you could have one over-arching procedure which is "Communicating with Stakeholders" where this procedure could have separate sections addressing the types of communication, who you communicate, what you communicate, and when you communicate.  Depending on how many products/product families there are or the size of the company, this procedure is appropriate (for single products and small companies).

For larger organisations, we still generate an over-arching communication procedure, but this procedure is an "index" which references than individual procedures related to a stakeholder.  As an example, there is a "Communicating with Notified Bodies" procedure which has various items such as audit planning, Technical Documentation review, notification of changes, notification of serious incidents, notification of FSCA, etc. etc.  This procedure then references the individual quality system procedures where this is managed, e.g. change control or Vigilance procedure.  Just as above, the procedure describes when, who, what, why, and the circumstances around communicating with Notified Bodies.  Then there are individual procedures for the different stakeholders which then provide references to the various procedures managing the processes.  Is this too much?  Probably.  But then so are the expectations auditors and reviewers are demanding under EU MDR.  There is the requirement in Article 10 for handling communications, so this could probably be simply done with a procedure, but really depends on the organisation and all of those interactions outside of the company.

Thank you Kevin,

This is not a ISO 13485 but a MDR 2017/745 requirements on art.10 :

(j) handling communication with competent authorities, notified bodies, other economic operators, customers and/or
other stakeholders;

Anyway my question was not how to fullfill with the requirement but if someone has a template or know where to find a template :)

Thanks in advance,

For the context of ISO 13485:2016 clause 7.2.3 first paragraph requiring that we "plan and document arrangements for" (I view that to be different than "document procedures for") communicating with customers in various ways, and regarding clause 7.2.3 second paragraph requiring that we "communicate with" (I again view that to be different than "document procedures for") regulatory authorities, I have our clients simply use the corresponding section of the Quality Manual to document the organization's corresponding policy promises plus therewith to reference the corresponding documented procedures where such procedures are required elsewhere by ISO 13485 (i.e., the clause 8.2.1 feedback procedure; the clause 8.2.2 complaint handling procedure; the clause 8.3.3 advisory notice procedure; and the clause 8.2.3 procedure for reporting to regulatory authorities).  And for the parts of clause 7.2.3 that don't require us to "document procedures" (i.e., regarding customer communication about product information, enquiries, and contracts or order handling, including amendments, and regarding regulatory authority communication other than reporting, such as regarding periodic facility registration or regarding agency inspections), I have our clients reference their corresponding voluntary documented procedures if they exist or else write a corresponding narrative in the Quality Manual that at least assigns responsibilities and gives a brief explanation of how the organization communicates with customers and regulatory authorities about those topics.  This has always been a successful approach when clients were audited by external auditors.

Hi everyone,

I am wondering if one of you has a template he can share of a SOP related to communication with external parties (authorities, customers) ? Thanks in advance.

Thank you Kevin,

This is not a ISO 13485 but a MDR 2017/745 requirements on art.10 :

(j) handling communication with competent authorities, notified bodies, other economic operators, customers and/or
other stakeholders;

Anyway my question was not how to fullfill with the requirement but if someone has a template or know where to find a template :)

Thanks in advance,

For the context of ISO 13485:2016 clause 7.2.3 first paragraph requiring that we "plan and document arrangements for" (I view that to be different than "document procedures for") communicating with customers in various ways, and regarding clause 7.2.3 second paragraph requiring that we "communicate with" (I again view that to be different than "document procedures for") regulatory authorities, I have our clients simply use the corresponding section of the Quality Manual to document the organization's corresponding policy promises plus therewith to reference the corresponding documented procedures where such procedures are required elsewhere by ISO 13485 (i.e., the clause 8.2.1 feedback procedure; the clause 8.2.2 complaint handling procedure; the clause 8.3.3 advisory notice procedure; and the clause 8.2.3 procedure for reporting to regulatory authorities).  And for the parts of clause 7.2.3 that don't require us to "document procedures" (i.e., regarding customer communication about product information, enquiries, and contracts or order handling, including amendments, and regarding regulatory authority communication other than reporting, such as regarding periodic facility registration or regarding agency inspections), I have our clients reference their corresponding voluntary documented procedures if they exist or else write a corresponding narrative in the Quality Manual that at least assigns responsibilities and gives a brief explanation of how the organization communicates with customers and regulatory authorities about those topics.  This has always been a successful approach when clients were audited by external auditors.

Hi everyone,

I am wondering if one of you has a template he can share of a SOP related to communication with external parties (authorities, customers) ? Thanks in advance.