Exclusion to 8.3

As ISO 45001 does not include clause 8.3, you only need to be concerned for clause 8.3 in ISO 9001. Design and development of products and services. If your organization does not do design and development, then all you need to do is list this as an exclusion when writing your scope for the QMS. This is also how you would do so for any other management systems, such as the ISO 45001 OHSMS, by documenting what is not included in the scope. This can be simply done by listing exclusions within your scope statement.

Remember, you are only allowed to exclude activities or sections of the standard if doing so does not hinder the intend of the management system; so for the QMS, for instance, you can’t exclude anything that affects your ability to provide products and services that meet customer needs and improve customer satisfaction as this is the intent of the QMS. So, this being said you can’t exclude design if you actually do design just because you don’t want to include it.

You can read more about QMS scope and exclusions in the articles: How to define the scope of the QMS according to ISO 9001:2015, https://advisera.com/9001academy/blog/2015/10/13/how-to-define-the-scope-of-the-qms-according-to-iso-90012015/ and What clauses can be excluded in ISO 9001:2015?, https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/

Thank you very much sir for your information.

The exclusion has been written in our IMS however the Auditor comments is

-Quote1-

9001 There is a concern whether appropriate justification exists for requirements of clause 8.3 and sub-clause 8.3.1 to 8.3.6 not to apply since Design and Development of “Management Services of Crew management/deployment, maintenance and operation for Cargo ship “ is believed to be existed.

4.3 of IMM, Exclusion says; Due to the nature of the service management, requirements specified under Design and Development of Products and Services (Clause 8.3 and sub-clause 8.3.1 to 8.3.6) is not applicable.

-Unquote1-

-Quote2-

45001 We understand scope of the OH&S management includes all management activities. it is needed word out "boundaries"in IMS for management activities in order to clarify sub-contractor work in work shop, shipyard, crewing agent etc.

-Unquote2-

Exclusion must need justification. Could you help me regarding this one sir?

Thank you very much!

To address your first quote, it is necessary to justify why a certain section is not applicable, so all you will need to do here is explain why design and development does not apply.  The auditor has indicated that they thing you do in fact design the “management services of crew management/deployment, maintenance and operation for cargo ships”, so you need to explain why you do not believe this to be a design activity. If you do, in fact, design this service then you will not be able to exclude clause 8.3 as the standard does not allow you to exclude any activities you do that affect meeting customer needs or improving customer satisfaction.

As for your second quote, it sounds like your current scope does not include the assessment of safety for sub-contractor work. You would need to change your scope statement to include this. Remember, the scope of the OHSMS is intended to identify where your OH&S rules apply, so if this area is not covered you will need to update.

Thank you so much sir, We tried to remove the exclusion but the auditor comment:

Quote

1.   The organization erased the description of “Exclusion for Clause 8.3” from IMS Manual. This does abandon the current certification scheme which had been designed that the organization did not apply 8.3 requirements of ISO9001 to the management system. 

2.   Additionally, It is needed word out ”boundaries” in IMS for management activities in order to clarify sub-contractor work in work shop, shipyard, crewing agent etc.

Unquote

thank you very much in advance sir for your answer.

Your certification auditor is correct. By removing the exclusion rather than explaining why it is relevant you have changed the scope of your management system, and therefore the scope of your certification. You now need to not only have the processes in place to do this activity, but the certification auditors also need to fully audit these new processes before they can change the scope of your certification. As they said, you have abandoned the current certification scope, so need to recertify to the new scope.

As for your second point, I don’t fully understand the wording of “needed word out boundaries” and you should follow up with the auditors exactly what they are asking, but as I said before it sounds like your current scope does not include the assessment of safety for sub-contractor work. You would need to change your scope statement to include this. Remember, the scope of the OHSMS is intended to identify where your OH&S rules apply, so if this area is not covered you will need to update.

thank you very much, Sir. This information is very helpful.