AS9120B 8.5.1 Control of Production and Service Provision

wbrand

Starting to get Involved
#1
Hi All,

As a AS9120B aerospace distributor of hardware, how does 8.5.1 Control Of Production and Services Provision apply to us if we do not dimensional inspect hardware nor mfg any hardware as well? Or can I just take exception to that? Thank you in advance.
 
Elsmar Forum Sponsor

dsanabria

Quite Involved in Discussions
#2
If you do not do any measurements to the product and do not have equipment that requires calibration - yes, you can apply the N/A to only thos lines from 8.5.1 but you still need to comply with the rest.
 

Kronos147

Trusted Information Resource
#3
AS9100 Rev. D 8.5.1 has a lot more to control of service than measurement.

Such as:
the availability of documented information
the appointment of competent persons
the implementation of actions to prevent human error;
the establishment of criteria for workmanship
the accountability for all products
the control and monitoring of identified critical items, including key characteristics, in accordance with established processes;
the provision for the prevention, detection, and removal of foreign objects;

Is AS9120 that different?
 
Thread starter Similar threads Forum Replies Date
P AS9120B Control of External Providers for Franchised Distribution AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
E AS9120B 8.4.2a Ensuring external providers remain within control of the QMS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
F AS9120B - Exclusions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S AS9120B - 8.5.2 Delivering Split Product AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Q AS9120B flow down to external providers: Records Retention AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Q AS9120B - ESD monitoring devices part of 7.1.5 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
W AS9120B - How to meet clause 7 Support that covers 7.1., 7.1.1, 7.1.2, & 7.1.3? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
A Failed the AS9120B Exam Twice.....Need Help AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
C Are zero defect sampling plans relevant to AS9120B Distributor AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Q AS9120B Clause 8.4.1.1 External Providers Scope of Approval AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q Customer Requirements - AS9120B Audit Finding AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
W AS9120B QMS and its process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
E Online training for an internal auditor to AS9120B AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
W AS9120B 8.4.3 Information for External Providers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
W AS9120A to AS9120B transition AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D AS9100D vs AS9120B differences AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
K ASME, ANSI, ASTM and similar specifications and their requirements for document control. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
Z Software for design control ISO 13485:2016 - Medical Device Quality Management Systems 3
K Quality Control/Assurance in the Metal Industry Quality Tools, Improvement and Analysis 10
K Defining risk control measures IEC 62304 - Medical Device Software Life Cycle Processes 14
J Warehouse temperature and humidity control EU Medical Device Regulations 7
Jimmy123 IATF16949 Control Plan FMEA and Control Plans 1
D Control Number for Class III and IV devices Canada Medical Device Regulations 0
J Document Control Metrics Document Control Systems, Procedures, Forms and Templates 3
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
C UDI Questions on Control Units Other US Medical Device Regulations 6
A Quality Control Datasheets Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
M Control-self assessment Internal Auditing 5
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 0
A Prototype control plan FMEA and Control Plans 2
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 3
W FMEA - Current control and occurrence rating FMEA and Control Plans 3
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
G Control Plan & PFMEA Review Procedure? FMEA and Control Plans 1
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
A Fabric roll inspection - What type of Control Chart to use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
C Monitoring and Control Instruments RoHS, REACH, ELV, IMDS and Restricted Substances 3
M ISO14971:2019 - Verification of implementation and effectiveness of risk control ISO 14971 - Medical Device Risk Management 3
T Risks arising from control measures vs. ineffective control measures ISO 14971 - Medical Device Risk Management 11
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
P IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems. Qualification and Validation (including 21 CFR Part 11) 0
R Risk control measures as per ISO 14971 ISO 14971 - Medical Device Risk Management 6
T Linking Control Plans and PFMEA's FMEA and Control Plans 3
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 3
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5

Similar threads

Top Bottom