We were having a discussion about Safety Data Sheets. As you are aware, the format of the SDS was changed a couple of years ago. Therefore, are SDS now fair game in ISO9001 and/or AS9100 audits? I have two situations: A plastics AS9100 injection molding company who purchases the resin and processes it to make parts for the customer. The material is specified by the customer. SDS are received with the plastic resin.
The other is ceramic dielecric powder company (ISO9001) who designs product for the customer. This company does provide SDS with the shipments.
Will the auditor be reviewing SDS during the audit based on "statutory and regulatory requirements"?
This is something that has two answers, and they are the same for AS9100 Rev D and ISO 9001:2015.
First when it comes to having SDSs for the chemicals and materials that are used within the company comes under “Environment for operation of processes” (Clause 7.1.4). If these SDSs are required in your country to have in order to use the chemicals you must therefore have them to perform your processes. This was also previously the case in the last standard under clause 6.4 for “work environment”. If you needed to have these in place to perform your process then it is a resource that you needed to have and was therefore auditable.
Secondly, if you are creating a chemical that requires an SDS to be sent with it, then this is a requirement of your product. Therefore, it falls under the standard in clause 8.2.2 “Determining the requirements for products and services”. If there is a requirement that you need to meet and are not doing so this could be an audit nonconformance. Again, in the previous version of the standards this was also a requirement in clause 7.2.1 “Determination of requirements related to the product” where it also stated that you shall determine statutory and regulatory requirements applicable to the product.
So, this has really not changed. The auditors could have reviewed SDS during an audit against these requirements. That being said, just because an auditor can look at one aspect of a process does not meant hat they will.