ISO 9001:2015 (Design and Manufacturing)

ISO 9001:2015 (Design and Manufacturing).

UR5 ROBOT AND STAND.

ISO 9001 is managed by the International Organisation for Standardization (ISO) in Geneva, Switzerland. ISO is an independent membership organisation and the world’s largest developer of voluntary international standards. ISO 9001:2015 was developed by the ISO / TC 176 / SC 2 –Quality Systems Technical Committee.

However, ISO does not provide certification or conformity assessment. This is performed by accredited certification bodies. These are establishments that evaluate an organisation’s management system and certify them with respect to the published standards.

Note: A new version of ISO 9001 appears about every seven years. It was first issued in 1987: at that time, you had to describe in detail what your business did. What applied in the 1994 version, was ‘say what you do and do what you say’. In the 2000 version, you had to focus on proper processes in order to continually improve and thereby increase your customer satisfaction. There was nothing added in 2008, but it was more precise about the interpretation of the standard. 
ISO 9001:2015 was published on 23 September 2015. is cover for design and manufacturing of automated machinery and metal machining services.


* Design and Development

1.a Purpose.
To document the design and development process for project sales as established within the organization.

1.b Terminology
MSL : Material Shortage List (for Assy Production and Purchasing)
JO : Job Order
BOM : Bill of Material
PM : Project Management
PRO : Production Order
CAR : Corrective Action Report
PAR : Preventive Action Report
DHF : Design History File

1c. Procedure Outline
* Responsibility and action.

1.1 (Receive JO)
Design Manager & Snr Design Engineer receive JO from Project Management.

1.2 (Sales Kick-off Meeting)
Design Manager and Sr. Design Engineer attend Sales Kick-off meeting. Check with Sales if there is any changes from Proposal Concept and get required information from Customer.

1.3 (Receive Project Schedule, PDA)
Design Manager & Design Engineer receive Project Schedule and PDA number from PM and update information internally.

1.4 (Design Requirements, Mech. and Elec.)
Design Manager & Design Engineer design Kick-Off Meeting internally for the design requirements and Project Schedule. Product level risk management shall be started & continued throughout the whole design process. Prepare necessary tasks to meet with customer.

1.5 (Kick-off meeting with Customer)

Design Manager & Design Engineer kick-Off Meeting with customer and verify required information in the meeting. Out-put of risk management, if necessary, can be discussed.

1.6 (Proceed Mech./ Elec.Design).

Design Engineer (Mech. and Elec.) proceed with Mechanical/Electrical design. Update Product Risk Management Report.

1.7 (Design Review)

Design Manager & Design Engineer design Review internally and arrange to meet with Customer to have design approval. Review shall include Product Risk Management out-put. Record review result in meeting minutes under designated project folder.

1.8 (Design Output)
Design Engineer (Mech. and Elec.) Update 3D Design if required changes by customer and do Detailing. Update Product Risk Management Report Using CAD tool determine the output.

Remarks: Design out put are 3D drawings & 2D drawings Design out put will be reviewed and Approved.

1.9 (Design Verification)
Design Manager, Design Engineer (Mech. and Elec.) Get Drawing approval from Manager. Release BOM List and PDF drawings to PM Group for issuing of MSL. Send product risk management report to project management for their reference.

Remarks: Customer specification is regarded as acceptance criteria for verification. Design review meeting with customer to confirm that output meet the design input requirement.

1.10 (Prepare Machine Manual, Support FAT)

Design Engineer (Mech. and Elec.) Prepare Assembly Drawing (with Balloon) and update BOM. Prepare Machine Manual. (SSME Mech./Elect portion - for HP project) Support Assembly and FAT.

1.11 (Engineering Change and update)

If machining part design change needed while the part is in production stage, Design Engineer has to fill up part I of ECN form as per new requirement then submit it together with updated drawing to follow up with production planner. Risk management shall be conducted. Production planner will then put ECN number as a remark on Production Order. If machining part design change needed after the part has been collected from logistics, the project leader has to update the drawing as per requirement and fill up the new revised drawing number in respective PDA and submit the drawing together with approved drawing to QA Document Control who, in turn, will replace current drawing with new update to production planner for production modification.

1.12 (UAI request, if any)

Design Engineer Receive UAI request from production planner. Sign on UAI logbook if accept the request. Risk management shall be conducted.

1.13 (Store Data Files)

Design Engineer Store all required data under Engineering Design Folder. (Soft and Hard Copy).

1.14 (Update machine manual, Support Verification & Validation of Machine).

Design Engineer Update machine manual to PM. Support project management on verification & validation of machine when called upon. Activities can include : -Dismantling for shipping -Site Installation -SAT(Site acceptance Test) Remarks : Validation acceptance criteria are in SAT. SAT data show design meets the predetermined user needs and intended use.


1.d Process Flow Chart (summary).

Process Flow Chart.

1.f Link for reference.

a. International Organization for Standardization (ISO)

b. The ISO 9001 Design Process Explained.

c. Important differences between ISO 9001:2015 and ISO 9001:2008