API Spec Q1 (Clause 4.1.2): Understanding the Quality Policy

As per ISO 9000:2015, generally Quality Policy is consistent with the overall policy of the organization, aligned with the organization’s vision and mission and provides a framework for the setting of the quality objectives. As a part of its commitment to quality, top management shall establish, document, and approve the quality policy. [...]

By |December 27th, 2022|

Design Package requirements for API Monogram Licensing

Design Package API Monogram Certification Program requires manufactures to maintain the Design Package(s) conforming to the latest edition of the applicable API Product Specification(s). During API Monogram Certification Audits, these design packages are reviewed and audited under clause 5.4 of API Spec Q1. The purpose of the implementation of the API [...]

By |May 7th, 2020|

API Spec Q1 (Clause 5.10): Control of Non-Conforming Product

There is a common question asked by our clients, Does every product non-conformity closure requires a root cause analysis and corrective action? The answer to this query is ‘No’, supported with below explanation. Interpretation / Explanation As per API Spec Q1 (clause 5.10.2) *the organization shall address nonconforming product by performing one [...]

By |April 28th, 2020|

API Spec Q1 (Clause 5.11): MOC (Management of Change); for changes to Management System Procedures

API Spec Q1 (clause 5.11.2 d) specify that; the organization shall use the MOC (Management of Change) process when changes to the management system procedures are made, including changes resulting from corrective and preventive actions (see 6.4). Does that mean a complete MOC process need to completed, when organisation is making [...]

By |January 17th, 2020|