API Q1 10th Edition Consulting
Unmatched Expertise for Your 10th Edition Transition
Implement the 10th Edition with our API experts at your side.
Management system experts to guide you through the extensive, nuanced changes of API Spec Q1, 10th Edition.
At QSI, we view the API 10th Edition changes from a unique perspective:
- We’re involved in the API standards development process and participate on the Quality and Supply Chain Management Subcommittees (since 1990)
- We develop and implement quality management and integrated management systems
- We have consulted, trained, and audited internationally in more than 30 countries
Our expert consultants are well-positioned to step in where needed to ensure a smooth transition for you and your team.
Readiness Reviews
Examining your implementation plan to determine gaps prior to an internal audit or management review.
Internal Audits
Auditing your management system against specified criteria prior to a management review.
Quality Manual & Procedures Reviews
Analyzing your quality documentation to uncover weaknesses and improvements.
Complex Clause Consulting
- Interpreting and applying the new requirements for risk
- Assisting with the development of a risk assessment model that will satisfy Q1 clause 5.3 (Risk Management) and clause 5.5 (Purchasing Control), including the other Q1 clauses where risk requirements are identified
- Integrating risk management processes with purchasing and supply chain activities
- Enabling proactive identification and mitigation of risks beyond product delivery and quality
Personnel Training to API Spec Q1, 10th Edition – Learn How To Master Complex Requirements
- Understanding how many mandatory documented procedures and records are required throughout the 10th Edition
- Documenting risk assessments and contingency plans when they are required
- Documenting gap analyses to the expanded requirements for “Control and Use of External Documents”
- Understanding how the word “critical” is used throughout the specification
- Identifying supplier evaluation methodologies for critical and non-critical purchases
- Understanding what “identified risk” means as it relates to supply chain evaluations
- Determining suppliers’ level of risk and performing supplier evaluations commensurate with the level of risk assessed
- Determining when a management of change is required and when required, learning how to document it
- Understanding the implications of Externally Owned Property