Quality Management System Exclusions API Spec Q1

[유문종]

Quality Management System Exclusions API Spec Q1 limits the sections of the standard applicable for exclusion (refer to Section 1.2.1). 

For eligibility of these exclusions, the Applicant or Licensed Organization shall provide a written justification for the exclusion(s), identifying the exclusion(s) in your Quality Manual.

 Even if the activities of the proposed excluded sections are performed through outsourcing (refer to Section 4.1), the Applicant or Licensed Organization must ensure that appropriate controls are being maintained both in the outsourced organization’s management system and in their own management system for periodic verification of the controls being outsourced. 

With this, such activities are not eligible for exclusion. 

NOTE: 

The Applicant or Licensed Organization shall be required to provide evidence (during audits) that controls are adequately implemented and maintained for any activity that may be outsourced. 

 Examples If no customer-supplied property (either finished product, raw material, or intellectual documentation) is allowed within the manufacturing/servicing process of the Applicant or Licensed Organization, then API Spec Q1, Section 7.5.4, may be declared as an applicable exclusion.

 However, if this Organization provides threading, heat treatment or inspection services of finished product its clients, Section 7.5.4 is not eligible for exclusion. 

Similarly, if this Organization receives proprietary designs of products for of manufacturing, Section 7.5.4 is not eligible for exclusion. If processes that require validation as prescribed by the respective product specification(s) are not applicable (e.g., welding, NDE and heat treating), then API Spec Q1, Section 7.5.2 may be declared as an applicable exclusion. 

However, if an Organization is required to perform such processes and chooses to outsource them, Section 7.5.2 is not eligible for exclusion. 

If no product design is performed by nature of the defined activities within the management system (e.g., threading, servicing, machining), then API Spec Q1, Section 7.3 may be declared as an applicable exclusion.

 However, if an Organization must satisfy specific product design requirements from applicable standards or if the design is outsourced to third party designers or to other divisions within the Organization (e.g., a corporate design center), Section 7.3 is not eligible for exclusion, and all elements of this part of the standard must be addressed within the quality management system. 

Furthermore, the Organization must develop and maintain Design Package(s) (applicable documentation) to demonstrate compliance with design and development requirements.