You will get a Quality Management System that is Audit Ready
You will get a Quality Management System that is Audit Ready
GAP analysis
Compare existing documents against requirements, delivering a report of needs
- Delivery Time 5 days
- Number of Revisions 1
- Number of Words 2500
- Number of Technical Illustrations 1
- Consultation
- Proofreading & Editing
- Additional Research
- References & Citations
5 days
delivery —
Oct 9, 2024
Revisions may occur after this date.
Upwork Payment Protection
Fund the project upfront. Brian gets paid once you are satisfied with the work.
Project details
A complete Turn Key Ready QMS and Audit Results that will escalate your company to certification status in the shortest amount of time.
Offering not only the documentation, but also embedded ERP/QMS Software available for companies that need additional support.
I work closely with a software team that can develop custom software for your QMS and ERP needs and can include our documentation as part of the package.
Advanced systems include the software at no extra charge and no commitment required.
Regular systems are those that already have basic documents and processes, but need an professional review prior to certification.
Intermediate are those systems only needing a review or audit to complete their pre-certification. Includes guidance on improvement as part of the purchase.
Offering not only the documentation, but also embedded ERP/QMS Software available for companies that need additional support.
I work closely with a software team that can develop custom software for your QMS and ERP needs and can include our documentation as part of the package.
Advanced systems include the software at no extra charge and no commitment required.
Regular systems are those that already have basic documents and processes, but need an professional review prior to certification.
Intermediate are those systems only needing a review or audit to complete their pre-certification. Includes guidance on improvement as part of the purchase.
Document Type
DocumentationTopic
ManufacturingLanguage
English, BengaliWhat's included
| Service Tiers |
Starter
$4,500
|
Standard
$10,000
|
Advanced
$50,000
|
|---|---|---|---|
| Delivery Time | 5 days | 20 days | 70 days |
Number of Revisions | 1 | 3 | 5 |
Number of Words | 2500 | ||
Number of Technical Illustrations | 1 | 1 | |
Consultation | |||
Proofreading & Editing | |||
Additional Research | |||
References & Citations | |||
Formatted Style Guide | - |
Optional add-ons
You can add these on the next page.
Fast Delivery
+$1,500 - $5,000
Additional Revision
+$1,500
Quality Manual
(+ 2 Days)
+$1,200About Brian
Quality Management Systems Consulting
Pocatello, United States - 1:06 am local time
Create all controlled documentation and safeguards for FDA, FAA, CASA, AS9100, AS9110, AS9103, AS9115, AS9145, AS5553, ISO9001, MDSAP, and ISO13485.
Lead and train employees in appropriate procedures and processes within the Quality Management System to drive Improvement.
Liaison for outside Auditors and work closely with customers for Auditing and Risk assessment in Aerospace and Medical Device Regulations.
Assess and write Procedures based on relevant standards and regulatory requirements to verify compliance with regulatory and statutory bodies, perform quarterly audits as lead auditor as well as internal auditor, and approval of all documents.
Using Customer requirements, Regulatory and Statutory requirements, keep records of testing such as Cpk verification, communicate with customers as to the validity of the machining process and updates to process controls. Write project specific procedures for customers as required, to verify compliance for regulatory bodies.
Using Approved Data, completion of AS9102 as evidence of First Article Conformity, In Process and Final Conformity of aerospace products
Verification of Drawings, Documentation, and Articles to approve for APMA submission to CASA
Completion of Form 1 ARC for CASA and 8130-3 FAA conformity Documents
Works with outside institutions such as DCMA, FDA, FAA, and Certification Bodies to verify compliance to standards during external audits as a Certified Lead Auditor for AS9100 and ISO13485. Also, using ISO9001:2015 specifications, able to train and lead a team of internal auditors to verify compliance to standards.
Specific focus on employee development and Quality Functions throughout the workplace as it relates to improvement and quality system requirements.
Update and maintain Quality Management Systems to comply with current standards, creates Procedures, Work Instructions, Corrective Actions, Continual Improvement, Root Cause Analysis, Action Plans, updates to FDA and other regulatory body requirements in accordance with AS9100/ISO13485/FDA requirements.
Write and submit documentation for regulatory bodies as needed, while building relationships with those interested parties to better improve processes.
Write and investigate non-conformities using various Root Cause Analysis techniques and reports to regulatory bodies as required.
Understanding of ITAR, FDA, ANVISA, EU MDD-93-42-EEC, ARGMD, and FAA regulations and how they pertain to the industry.
Steps for completing your project
After purchasing the project, send requirements so Brian can start the project.
Delivery time starts when Brian receives requirements from you.
Brian works on your project following the steps below.
Revisions may occur after the delivery date.
Creating and Implementing BMS/QMS by selected project
Developing the BMS (Context) Leadership Planning QMS Support Operations Performance Evaluation Improvement Link for Business to submit for Link for Meetings Customer Complaints Tracking KPIs Dashboard