Implementing an AS9100 Aerospace Quality System

S

sasiengineer

#1
Dear Experts,

I am work for startup company and we plan to implement EN AS 9100 and currently we dont have any ISO certification in place.

1.Is the Gap Analaysis necessary for a start up company?

2. If anyone you have Gap Analysis checklist for EN AS 9100 please kindly share with me .

Thanks in Advance.
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Re: Seeking Gap Analysis Checklist for EN AS9100

What is the status of your startup company? Does your startup company have any procedures or systems in place yet? Is it at the place where you are actually producing anything?
 
S

sasiengineer

#3
Re: Seeking Gap Analysis Checklist for EN AS9100

Marc said:
What is the status of your startup company? Does your startup company have any procedures or systems in place yet? Is it at the place where you are actually producing anything?
My company in 3 months old company and we are in the process of developing procedures. I believe there is no need of Gap Analysis for a startup company. But still I would like to confirm if there is any check list is available to startup and implement the quality standards

Yes we are involved in structural design and development activities for Tier2 aerospace suppliers and we don’t have production facilities. So we are mainly involved in Drawings and Stress Analysis


Thanks
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
Re: Seeking Gap Analysis Checklist for EN AS9100

Have you outlined your existing and intended systems?

I suggest you don't need a Gap Analysis. All a Gap Analysis is is essentially an Audit Check List which lists the line items of requirements.

You need to take a copy of the standard, read it, understand what it requires, and figure out what systems and documentation are required in addition to those you have already planned. At this point in your system development if you do not do this, you will not understand what you are putting together.

Is this structural design and development of buildings or what? What, exactly, do you design and develop?
 
S

sasiengineer

#5
Re: Seeking Gap Analysis Checklist for EN AS9100

Marc said:
Have you outlined your existing and intended systems?

I suggest you don't need a Gap Analysis. All a Gap Analysis is is essentially an Audit Check List which lists the line items of requirements.

You need to take a copy of the standard, read it, understand what it requires, and figure out what systems and documentation are required in addition to those you have already planned. At this point in your system development if you do not do this, you will not understand what you are putting together.

Is this structural design and development of buildings or what? What, exactly, do you design and develop?

Thanks for your great suggestions. I am Having ISO 9001:2000 / SAE AS9100 Rev. B Audit Checklist.I am following the standards avaialble in the checklist.

The Key areas we focus on are
Design & development-aero structures (e.g. wings, fuselages)
Interior Refurbishment designs
Wiring Harness
Avionics related structural services
And FE Analysis, Structural Dynamics and Fatigue and Fracture Analysis

My company not involved in Production (ie. Manufacturing) can I exclude any clause from (7.5) the AS 9100 standard?

Thanks Again
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
Re: Implementing a Quality System in a Startup Company - AS9100

I retitled this thread to Implementing a Quality System in a Startup Company - AS9100 because that appears to be what the real issue is.

Are you already supplying customers?
 
S

sasiengineer

#7
Re: Implementing a Quality System in a Startup Company - AS9100

Yes we already started supporting customers on design and analysis.

Today’s most successful companies know the importance of having a proven Quality Management System in place. Our Company is working on becoming AS 9100 Registered.

I Hope, By implementing a Quality Management System that complies with AS 9100 we will be able to make our company run more efficiently, increase our customers’ satisfaction and communicate to potential customers.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#8
Re: Implementing a Quality System in a Startup Company - AS9100

sasiengineer said:
Yes we already started supporting customers on design and analysis.

Today’s most successful companies know the importance of having a proven Quality Management System in place. Our Company is working on becoming AS 9100 Registered.

I Hope, By implementing a Quality Management System that complies with AS 9100 we will be able to make our company run more efficiently, increase our customers’ satisfaction and communicate to potential customers.

May I suggest that you start by flow charting your design and support processes. Discuss with each person how they perform their jobs, determine your customer requirements (AS9100) review the standard as Marc suggested. Develop Company policy, delvelop procedures and send them for review to your Management team for their review and input. Develop an Internal Audit System, set training guidelines with who ever will be responsible for training, and develop a basic training session with all of the employees to give them a basic understanding of AS9100 and your company's policy's and procedures.

I hope this will get you started, but there is an advantage to not having any policies or procedures in place, because you and your support group will be able to define your business.

It will take you at least 1 year (in my opinion) to establish the system, perform internal audits and so forth, but if there is a lack of a lot of experience in developing and designing a QMS it could take longer.

Take it step by step.
 
Last edited:
S

sasiengineer

#9
Re: Implementing a Quality System in a Startup Company - AS9100

Thanks Mr.Coury Ferguson.

I am sure your valuable point will help me lot to develop the system.

We do only design and development (aero structures) & Analysis activities and not involve in any manufacturing. Is there is any exclusion in any AS 9100clause?
 

CarolX

Super Moderator
Super Moderator
#10
Re: Implementing a Quality System in a Startup Company - AS9100

sasiengineer said:
Thanks Mr.Coury Ferguson.

I am sure your valuable point will help me lot to develop the system.

We do only design and development (aero structures) & Analysis activities and not involve in any manufacturing. Is there is any exclusion in any AS 9100clause?
Please review badgerman's answer to your similar question in this thread.

EN AS 9100 Permissible Exclusion and Provision - Aerospace design and development

He can certainly guide you, but more information is needed.
 
Last edited:
Thread starter Similar threads Forum Replies Date
A Implementing an AS9100 Aerospace Quality System AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
S Implementing TS16949 from AS9100 and NADCAP Other ISO and International Standards and European Regulations 7
K Implementing AS9100 Rev C - Electrical Harnesses and Cable Assemblies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
G Implementing Dual Standards in a Company - ISO 9001 & AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Implementing an AS9100 Quality System - Stage 1 Audit for AS9100 is Oct 2012 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 22
M Difficulties associated with implementing a QMS - AS9100 Startup AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
K Risk Management Compliance - Implementing AS9100:2009 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 50
N What is the Best Way to Structure my Approach to Implementing AS9100? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
H Implementing ISO22301 on a Limited Scope Business Continuity & Resiliency Planning (BCRP) 2
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
L Implementing the PRRC role in a company EU Medical Device Regulations 7
A Implementing ISO 20000-1 - Where to start Other ISO and International Standards and European Regulations 2
B Lessons Learned Implementing ISO 50001 (Chemical Engineering Progress) Other ISO and International Standards and European Regulations 0
C How medical device manufacturers are implementing standards like GDPR and HIPAA Other ISO and International Standards and European Regulations 5
M Informational EU – Commission Implementing Decision (EU) as regards the designation of expert panels in the field of medical devices Medical Device and FDA Regulations and Standards News 0
R Implementing Design History Documents/ Technical Documents in the QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
tnorton Lessons learned from implementing Customer Complaints Customer Complaints 1
M Informational Update – MDR and IVDR implementing measures rolling plan – 2 more NBs designated under the new regulations Medical Device and FDA Regulations and Standards News 0
S Implementing a 45001 Health & Safety standard - Internal audit plan wanted Internal Auditing 1
M Informational Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Medical Device and FDA Regulations and Standards News 0
J Implementing Machine Replacement Part Reverse engineering technology Manufacturing and Related Processes 3
Q Does anyone have experience implementing a QMS without ISO certification? Quality Manager and Management Related Issues 2
M Informational EU – April 2019 update of the MDR and IVDR implementing measures rolling plan Medical Device and FDA Regulations and Standards News 0
I First Time Implementing Document Control for ISO-9001 - how far back do you go? Document Control Systems, Procedures, Forms and Templates 15
M Medical Device News Last update of the MDR and IVDR implementing measures rolling plan – December 2018 Medical Device and FDA Regulations and Standards News 0
J Implementing EN 62304:2006 on existing and proven medical devices IEC 62304 - Medical Device Software Life Cycle Processes 6
M Medical Device News MDR and IVDR implementing measures rolling plan EU Medical Device Regulations 0
B Implementing an Escalation Process and Andon system Supplier Quality Assurance and other Supplier Issues 1
K EQMS question - Implementing an electronic QMS to support ISO 13485:2016 Quality Assurance and Compliance Software Tools and Solutions 4
T Is there any requirement to be compliant with IEC 62304 while implementing ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
A Compliance Obligations - Implementing 6.1.1 and 6.1.3 NOTE - Determine risks and... ISO 14001:2015 Specific Discussions 1
G Heavy Civil Construction Company Implementing ISO 9001:2015 for Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
K Implementing ISO13485:2016 in the Middle of a New Device Project ISO 13485:2016 - Medical Device Quality Management Systems 1
D Implementing 5S for Multiple Shop Floor Layout Workstations Lean in Manufacturing and Service Industries 2
N FDA Guidelines for implementing Continuous Improvement Process US Food and Drug Administration (FDA) 5
Q Easy Way of "Implementing" Risk in ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
N Implementing ISO 17025 in a Calibration Laboratory ISO 17025 related Discussions 8
E Does anyone have experience implementing a Tiered QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L Implementing ISO 9001 in small Trading Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C Implementing a set of bore gages at a machine Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
A Implementing Risk Management in a Medical Device "Distributor Only" company ISO 13485:2016 - Medical Device Quality Management Systems 2
T Implementing a Suspect Counterfeit Identification Program Quality Manager and Management Related Issues 3
O Implementing Lean Intranet Sharepoint Lean in Manufacturing and Service Industries 6
F Implementing ISO 9001:2008 in a new Food Processing company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J ISO 22301 - Implementing a Business Continuity Management System Business Continuity & Resiliency Planning (BCRP) 15
M Does anyone here have experience implementing PCI DSS (Data Security Standard) IEC 27001 - Information Security Management Systems (ISMS) 10
L Implementing a new quality management system for a new engineering company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Implementing ISO 9001 in an Assembly Plant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D Understanding and implementing ISO 17025 ISO 17025 related Discussions 9

Similar threads

Top Bottom