Need to combine AS9100 / ISO/IEC17025 into one Quality Manual

[Scotty Rogers]

I have recently been tasked to work with two companies that are going to transition into one entity at the end of the year. One company is AS9100 and the other is ISO17025 Calibration Lab. I was wanting to know if anyone has created a quality manual with both accreditations and if so what an outline would look like for this. I am hoping to make the quality manual a condensed version as the core scope of work for the AS9100 company is service based no production.
thanks in advance.

 

[ChrisM]

"I have recently been tasked to work with two companies...." In what capacity? As a consultant, or they will both be new suppliers to the organization that you work for, or something else..... ?

 

[Cristiann]

I have seen many combined handbooks until now, my suggestion out of my experiences can be that you can use bold, italic or underlined sections for specific requirements for one of that standard and the common ones you can use the same formatting.

 

[v9991]

I have recently been tasked to work with two companies that are going to transition into one entity at the end of the year. One company is AS9100 and the other is ISO17025 Calibration Lab. I was wanting to know if anyone has created a quality manual with both accreditations and if so what an outline would look like for this. I am hoping to make the quality manual a condensed version as the core scope of work for the AS9100 company is service based no production.
thanks in advance.

on the QMS side, what is the down side of handling site-specific QMS; and aligning one with other;
versus
in other words, what is the advantage of harmonizing it; unless this extends to cover the core processes and systems;

its feasible, as both the units are operating in "service mode"; with respective units holding corresponding procedures/processes/metrics
[a dose of GPT ]

Section (AS9100/ISO Clause)	Content Focus (Condensed)	Key Integration Points
0. Introduction	Quality Policy Statement, Scope of the QMS (Clearly define the combined entity, stating the inclusion of AS9100-registered service activities and ISO/IEC 17025-accredited calibration activities), Exclusions (if any, with justification).	Scope: Explicitly cite both standards. The scope is what ties the two certifications together.
1. Normative References	List of applicable standards (AS9100, ISO 17025, ISO 9001, relevant regulatory/statutory requirements).	References: Critical to show compliance with both sets of rules.
2. Terms and Definitions	Definitions unique to Aerospace/AS9100 (e.g., Critical Items, Product Safety, Counterfeit Parts) and unique to Calibration/17025 (e.g., Impartiality, Measurement Traceability, Measurement Uncertainty).	Clarity: Ensures a common understanding across the merged teams.
3. Context of the Organization
4.1 Understanding the Organization & its Context	Internal/External Issues relevant to both service delivery (AS9100) and laboratory operations (17025).	Risk/Opportunity: Address the risks common to both entities (e.g., personnel competence, loss of accreditation/certification).
4.2 Needs & Expectations of Interested Parties	Identify parties like Customers (Aerospace & Calibration), Regulatory Bodies (e.g., FAA, accreditation bodies), and accreditation bodies (e.g., A2LA, ANAB).	Regulatory: Recognize the distinct compliance requirements for each certification.
4.3 Scope of the QMS (Formal)	Formal documented scope statement for the Integrated QMS.	Single Document, Dual Scopes: Defines the boundaries for both the QMS and the lab's technical activities.
4.4 Quality Management System	General QMS processes and their interactions.
5. Leadership
5.1 Leadership & Commitment	Top Management's commitment to both the service quality (AS9100) and the technical competence/impartiality of the lab (17025).	Commitment: Must satisfy the top management requirements of both standards.
6. Planning
6.1 Actions to Address Risks & Opportunities	Risk Management approach (FMEAs for service, Risk-Based Thinking for QMS, and Specific Impartiality Risk for the lab).	Risk: Detail the specific risk management for Impartiality as required by ISO 17025.
6.2 Quality Objectives & Planning	Objectives for service performance (on-time delivery, customer satisfaction) and lab performance (turnaround time, measurement uncertainty targets).	Measurement: Objectives must cover both sides of the business.
7. Support
7.1 Resources** & Personnel	Personnel Competence: Unified system for training, qualification, and competency specific to job function (including the unique technical requirements of 17025 personnel). Infrastructure: Description of the facilities, including the specific laboratory environment/conditions (17025 requirement).	Resource Integration: The lab's specific technical resources (equipment, reference materials) are critical 17025 details that must be fully integrated here.
7.1.5 Monitoring & Measuring Resources	Calibration & Traceability: This entire section is where the ISO 17025 metrological traceability and calibration program must be fully detailed (or referenced to a procedure).	Metrology: This is where the 17025 depth is mandatory.
7.5 Documented Information	Control of documentation for QMS Procedures (AS9100) and Technical Records / Measurement Data (17025).	Documentation: Address the control of the Quality Manual, SOPs, and the specific Technical Records (e.g., raw data, calibration certificates).
8. Operation
8.1 Operational Planning & Control	Integrated process flow for receiving customer orders, planning service work, and scheduling calibration work.	Process Alignment: Show how the service company's request for calibration becomes the lab's input.
8.2 Requirements for Products & Services	Contract Review: Ensuring the lab can meet measurement requirements (17025) and the service company can meet delivery/regulatory requirements (AS9100).	Customer Focus: Address the distinct requirements for quoting a service job vs. quoting a calibration job.
8.5 Control of External Providers	Supplier Approval: Supplier selection for both aerospace-related suppliers (AS9100 emphasis on risk/counterfeit) and subcontracted calibration services (17025 requirement).	Supplier: The unique 17025 need to control subcontracted lab work must be in this section.
8.6 Release of Products & Services	Product Release (AS9100 service completion) and Reporting Results (ISO 17025 calibration certificate/report contents).	Output: Crucially, this section addresses the specific 17025 requirements for the content of the calibration report (e.g., measurement uncertainty, conformity statements).
9. Performance Evaluation
9.1 Monitoring, Measurement, Analysis, & Evaluation	Audits, Measurement Uncertainty calculation and monitoring (17025), Process efficiency (AS9100), and Customer Satisfaction surveys.	Data Validity: The lab's specific technical data validation processes belong here (e.g., use of reference materials, inter-laboratory comparisons).
9.3 Management Review	Review Inputs: Must include data on aerospace service performance and lab technical performance (e.g., impartiality, validity of results, resource adequacy).	Review: Ensure the review addresses both standards completely.
10. Improvement
10.2 Nonconformity & Corrective Action	Unified process for Nonconforming Service/Product (AS9100) and Nonconforming Work (17025).	CARs: Use a single, integrated CAR system that addresses both QMS nonconformities and technical nonconforming lab work.