Regulatory Open Forum

Dear Community,

I reached out to you to advise on the requirement for ISO 13485 clause 5.5.1 Responsibility and authority stating the below
 * Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization.
 * Top management shall document the interrelation of all personnel who manage, perform and verify work affecting quality and shall ensure the independence and authority necessary to perform these tasks

Should the management delegates and their titles be clearly defined within a QMS referenced document just like Managements representative appointment?

We received a non conformance during a recent audit due to the fact that the country manager is not clearly appointed within a QMS document as a delegate for the general manager for the greater region and entitled to attend management reviews.

Although we presented the communication stating clearly the country manager's appointment, the auditor insisted to have the matter documented in the QMS system and the management review procedure stating clearly that the country manager can attend management reviews instead of general manager.

To what extend the use of wording can be considered a non conformance to the guidance?

Thank you

Hi Youmna

First with the QMS documents you need to have an organization chart with the roles identified for each function  - design and development, manufacturing, quality control, sales, marketing, customer support and others. -
Then as per the clause 5.5.1 - for each of the functional role their responsibilities and authorities (R&A) are to be  - this is to be done by the Top Management.

In this particular instant of Country Manager role identified within your organization - the responsibilities and authorities of this role to be defined. 

Though in the audit they would have identified only one role - country manager in your case - due to sampling method of audit - you need to define the responsibilities and authorities for each of the roles in your organization as per the chart

Appointment of a country manager is not an evidence of having defined R&A

Regards

Sriram

Dear Community,

I reached out to you to advise on the requirement for ISO 13485 clause 5.5.1 Responsibility and authority stating the below
 * Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization.
 * Top management shall document the interrelation of all personnel who manage, perform and verify work affecting quality and shall ensure the independence and authority necessary to perform these tasks

Should the management delegates and their titles be clearly defined within a QMS referenced document just like Managements representative appointment?

We received a non conformance during a recent audit due to the fact that the country manager is not clearly appointed within a QMS document as a delegate for the general manager for the greater region and entitled to attend management reviews.

Although we presented the communication stating clearly the country manager's appointment, the auditor insisted to have the matter documented in the QMS system and the management review procedure stating clearly that the country manager can attend management reviews instead of general manager.

To what extend the use of wording can be considered a non conformance to the guidance?

Thank you

Hello Sriram,

We did show an organization chart with the roles identified for each function and well as job description.

Thanks

Hi Youmna

First with the QMS documents you need to have an organization chart with the roles identified for each function  - design and development, manufacturing, quality control, sales, marketing, customer support and others. -
Then as per the clause 5.5.1 - for each of the functional role their responsibilities and authorities (R&A) are to be  - this is to be done by the Top Management.

In this particular instant of Country Manager role identified within your organization - the responsibilities and authorities of this role to be defined. 

Though in the audit they would have identified only one role - country manager in your case - due to sampling method of audit - you need to define the responsibilities and authorities for each of the roles in your organization as per the chart

Appointment of a country manager is not an evidence of having defined R&A

Regards

Sriram

Dear Community,

I reached out to you to advise on the requirement for ISO 13485 clause 5.5.1 Responsibility and authority stating the below
 * Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization.
 * Top management shall document the interrelation of all personnel who manage, perform and verify work affecting quality and shall ensure the independence and authority necessary to perform these tasks

Should the management delegates and their titles be clearly defined within a QMS referenced document just like Managements representative appointment?

We received a non conformance during a recent audit due to the fact that the country manager is not clearly appointed within a QMS document as a delegate for the general manager for the greater region and entitled to attend management reviews.

Although we presented the communication stating clearly the country manager's appointment, the auditor insisted to have the matter documented in the QMS system and the management review procedure stating clearly that the country manager can attend management reviews instead of general manager.

To what extend the use of wording can be considered a non conformance to the guidance?

Thank you

Hello Sriram,

We did show an organization chart with the roles identified for each function and well as job description.

Thanks

Hi Youmna

First with the QMS documents you need to have an organization chart with the roles identified for each function  - design and development, manufacturing, quality control, sales, marketing, customer support and others. -
Then as per the clause 5.5.1 - for each of the functional role their responsibilities and authorities (R&A) are to be  - this is to be done by the Top Management.

In this particular instant of Country Manager role identified within your organization - the responsibilities and authorities of this role to be defined. 

Though in the audit they would have identified only one role - country manager in your case - due to sampling method of audit - you need to define the responsibilities and authorities for each of the roles in your organization as per the chart

Appointment of a country manager is not an evidence of having defined R&A

Regards

Sriram

Dear Community,

I reached out to you to advise on the requirement for ISO 13485 clause 5.5.1 Responsibility and authority stating the below
 * Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization.
 * Top management shall document the interrelation of all personnel who manage, perform and verify work affecting quality and shall ensure the independence and authority necessary to perform these tasks

Should the management delegates and their titles be clearly defined within a QMS referenced document just like Managements representative appointment?

We received a non conformance during a recent audit due to the fact that the country manager is not clearly appointed within a QMS document as a delegate for the general manager for the greater region and entitled to attend management reviews.

Although we presented the communication stating clearly the country manager's appointment, the auditor insisted to have the matter documented in the QMS system and the management review procedure stating clearly that the country manager can attend management reviews instead of general manager.

To what extend the use of wording can be considered a non conformance to the guidance?

Thank you

Hello Youmna,

Seems a bit nit-picky to me personally because in a quality system this is defined by the organisation.  Section 5.5.1 of ISO 13485 provides information for how top management is defined in the organisation, but is up to the company to define their top management, responsibilities, and roles.  Concerning the Country Manager, I could probably only comment after seeing how your organisation is established and the different roles.  When defining delegates in a quality system for roles and responsibilities this does indeed get tricky because some persons what to see this clearly defined - whereas others are fine with only statements or a document defining delegate(s).  Personally I would push against the nonconformance because the standard needs to have top management defined, but does not speak or require anything about delegates.  Is it best practice? Yes.  But required? No.

Hello Sriram,

We did show an organization chart with the roles identified for each function and well as job description.

Thanks

Hi Youmna

First with the QMS documents you need to have an organization chart with the roles identified for each function  - design and development, manufacturing, quality control, sales, marketing, customer support and others. -
Then as per the clause 5.5.1 - for each of the functional role their responsibilities and authorities (R&A) are to be  - this is to be done by the Top Management.

In this particular instant of Country Manager role identified within your organization - the responsibilities and authorities of this role to be defined. 

Though in the audit they would have identified only one role - country manager in your case - due to sampling method of audit - you need to define the responsibilities and authorities for each of the roles in your organization as per the chart

Appointment of a country manager is not an evidence of having defined R&A

Regards

Sriram

Dear Community,

I reached out to you to advise on the requirement for ISO 13485 clause 5.5.1 Responsibility and authority stating the below
 * Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization.
 * Top management shall document the interrelation of all personnel who manage, perform and verify work affecting quality and shall ensure the independence and authority necessary to perform these tasks

Should the management delegates and their titles be clearly defined within a QMS referenced document just like Managements representative appointment?

We received a non conformance during a recent audit due to the fact that the country manager is not clearly appointed within a QMS document as a delegate for the general manager for the greater region and entitled to attend management reviews.

Although we presented the communication stating clearly the country manager's appointment, the auditor insisted to have the matter documented in the QMS system and the management review procedure stating clearly that the country manager can attend management reviews instead of general manager.

To what extend the use of wording can be considered a non conformance to the guidance?

Thank you

I am sorry Richard, your statement "Section 5.5.1 of ISO 13485 provides information for how top management is defined in the organisation, but is up to the company to define their top management, responsibilities, and roles" is Not Correct.

The Standard in this clause very clearly says "Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization" - As you can see very clearly that it is not "how top management is defined" rather Top Management has to define responsibilities and authorities  - for whom? Not to them, but to all personnel in the organisation.

The Guidance document for ISO 13485:2016 - which is ISO/TC 210 clearly articulates this with the definition including the inputs to consider for the Responsibilities and authorities

Hello Youmna,

Seems a bit nit-picky to me personally because in a quality system this is defined by the organisation.  Section 5.5.1 of ISO 13485 provides information for how top management is defined in the organisation, but is up to the company to define their top management, responsibilities, and roles.  Concerning the Country Manager, I could probably only comment after seeing how your organisation is established and the different roles.  When defining delegates in a quality system for roles and responsibilities this does indeed get tricky because some persons what to see this clearly defined - whereas others are fine with only statements or a document defining delegate(s).  Personally I would push against the nonconformance because the standard needs to have top management defined, but does not speak or require anything about delegates.  Is it best practice? Yes.  But required? No.

Hello Sriram,

We did show an organization chart with the roles identified for each function and well as job description.

Thanks

Hi Youmna

First with the QMS documents you need to have an organization chart with the roles identified for each function  - design and development, manufacturing, quality control, sales, marketing, customer support and others. -
Then as per the clause 5.5.1 - for each of the functional role their responsibilities and authorities (R&A) are to be  - this is to be done by the Top Management.

In this particular instant of Country Manager role identified within your organization - the responsibilities and authorities of this role to be defined. 

Though in the audit they would have identified only one role - country manager in your case - due to sampling method of audit - you need to define the responsibilities and authorities for each of the roles in your organization as per the chart

Appointment of a country manager is not an evidence of having defined R&A

Regards

Sriram

Dear Community,

I reached out to you to advise on the requirement for ISO 13485 clause 5.5.1 Responsibility and authority stating the below
 * Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization.
 * Top management shall document the interrelation of all personnel who manage, perform and verify work affecting quality and shall ensure the independence and authority necessary to perform these tasks

Should the management delegates and their titles be clearly defined within a QMS referenced document just like Managements representative appointment?

We received a non conformance during a recent audit due to the fact that the country manager is not clearly appointed within a QMS document as a delegate for the general manager for the greater region and entitled to attend management reviews.

Although we presented the communication stating clearly the country manager's appointment, the auditor insisted to have the matter documented in the QMS system and the management review procedure stating clearly that the country manager can attend management reviews instead of general manager.

To what extend the use of wording can be considered a non conformance to the guidance?

Thank you