Incorporating SOP Into ISO 9001 Procedures - 7.5.3 Identification and traceability

S

Stapuff

#1
I already have SOP's created over time that cover most of ISO requirements. Can I incorporate them into ISO simply by creating the link and as long as they meet the requirements (see below)? Is the format of all the Procedures required to be the same?


7.5.3 Identification and traceability
7.5.3.1 Traceability: Traceability is maintained at the supplier when required by applicable laws and regulations, or when specified internally to facilitate corrective actions. Traceability is based on identifying the finished products, or batches, with lot numbers. Activities related to maintaining and recording traceability are addressed in Operational Procedures QOP-753-01 SOP for Production Facilities Section 5.7


You thoughts.....

As always - I appreciate all your help and guidance.

Kurt
 
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Helmut Jilling

Auditor / Consultant
#2
Stapuff said:
I already have SOP's created over time that cover most of ISO requirements. Can I incorporate them into ISO simply by creating the link and as long as they meet the requirements (see below)? Is the format of all the Procedures required to be the same?


7.5.3 Identification and traceability
7.5.3.1 Traceability: Traceability is maintained at the supplier when required by applicable laws and regulations, or when specified internally to facilitate corrective actions. Traceability is based on identifying the finished products, or batches, with lot numbers. Activities related to maintaining and recording traceability are addressed in Operational Procedures QOP-753-01 SOP for Production Facilities Section 5.7


You thoughts.....

As always - I appreciate all your help and guidance.

Kurt


Yes, you can do that. ISO does not define any particular formats. You may select anything that works for you. You will need a quality manual, and the manual generally describes how you defined your system. And there are certain procedures or SOPs that are required (see cl 4.2.1.c and 4.2.1.d).
 
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