Quality - SOP - External Audits

External Audits are conducted by your company of all product or service providers that are identified as “Critical” Suppliers, other non-critical suppliers or for cause (as defined in Supplier Qualification).

This procedure applies to the:

• Selection, evaluation and ongoing qualification of both critical product and critical service suppliers to your company.
• All suppliers of products, materials, goods, and services impacting product quality, and conformity to product and service requirements.
• Contract manufacturers and test vendors who are going to be used in the Verification and Validation and Design Transfer phase.
• Current critical suppliers, other than contract manufacturers, will be audited at least once every 3 (or as per Company policy) years, where practical. Critical contract manufacturers (including of components and final devices) will be audited at least annually. Where an actual visit is not practical then a remote audit (desk audit) will be carried out. Where there have been issues raised with a critical supplier, audits may be scheduled more frequently.
• Supplier Qualification recommends on-site audits for potential new suppliers of critical products or services. The site visits for your company supplier qualifications should, where practical, be carried out as supplier audits. A supplier audit must be conducted prior to approval of new critical suppliers. However, critical suppliers which have been “inherited” by your company are exempt from this requirement but will undergo supplier audits as part of their ongoing qualification.