Supplier evaluation

Answer
It is your company that has the authority to decide if all raw material manufacturers need to be audited or not. ISO 9001:2015 does not oblige to use audits to qualify suppliers.

“Manufacturer have an ISO 9001-2015 standard is this enough? (please do consider that: raw material provider has a ISO 9001-2015 standard and also we perform initial laboratory control all provided raw material).”
Answer
Again, it is your company that has the authority to decide the initial qualification criteria for suppliers.

“According to ISO 9001:2008 clause 7.4.1, it was required to keep records of the criteria for selection, evaluation and re-evaluation of the suppliers but this requirement was ch anged ISO 9001-2015 and wide is expanded. In ISO 9001:2008, the organization needed to ensure the purchased product met specified purchase requirements. In ISO 9001:2015, the verification needs to ensure "the externally provided processes, products and services meet requirements. (is this mean every provider shall be in site audit?)”
Answer
It means that organizations should decide which products, services or subcontracting are relevant enough to the conformity or products or services provided by the organization. For those considered to be relevant, organizations should plan how they will control if specified purchase requirements are being met. Site audit is just one of the possibilities, others are internal lab quality control, supplier quality control, third party quality control

The following material will provide you information about purchasing:
- ISO 9001 – How to evaluate supplier performance according to ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/10/27/how-to-evaluate-supplier-performance-according-to-iso-90012015/
- free online training ISO 9001:2015 Lead Auditor Course - https://advisera.com/training/iso-9001-lead-auditor-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/