Supplier Qualification Questionnaire (SQQ)

Note for supplier: For every question marked Yes, the supplier must:

Provide supporting documentation
Provide reference document number and revision
Specify applicable standards
Describe implementation method (not just policy statement)
Attach sample records where requested

Responses such as "Available upon request" or "Yes, we comply" without evidence will be considered incomplete.

Supplier Information

Company Name

Registered Address

Key Contacts

Role	Name	Phone	Email
CEO / Owner
Quality Head
Project Manager
Commercial Contact
Escalation Contact

Type of Business (Manufacturer / Distributor / Service Provider)

Products / Services Offered

Experience in manufacturing pharmaceutical/regulated-industry equipment with the similar scope

Additional Services Offered (if any)

Design & Engineering Automation & Software Validation Support Project Management Installation & Commissioning Maintenance Contracts Spare Parts Supply Retrofit / Upgrades Other (Specify)

Legal & Tax Information

Company/business registration/license No:
Tax Registration No:
VAT / GST No:
Import/Export License No:
Chamber of Commerce Registration:
Country of Incorporation:
Years in Operation:
Attach copies (mandatory) *	Attach supporting registration and legal documents.

Quality System Overview

Regulatory Compliance *

Certification Type	Certificate No.	Issuing Authority	Issue Date	Expiry Date	Scope Covered	Copy Attached (Y/N)	Verified with Authority (Y/N)
Certification Details & Verification:
ISO 9001
ISO 14001
ISO 45001
GMP
ASME U Stamp
National Board (NB)
CE Marking
Other (Specify)

Technical and Manufacturing Capability

List equipment categories manufactured and applications.
Do you provide design documentation (P&ID, GA drawings, BoM).	YesNo — Details:
Are materials of construction certified (e.g., SS316L, PTFE, Hastelloy)?	YesNo — Details:
Do you provide FAT, SAT support scope & documentation?	YesNo — Details:
Do you provide Installation Qualification (DQ/IQ/OQ/PQ) support scope?	YesNo — Details:

Software and Automation (if applicable)

Control platform.	YesNo — Details:
Is software FDA 21 CFR Part 11 compliant for automation?	YesNo — Details:

Calibration, Maintenance, and Servicing

Are instruments calibrated to national/international standards?	YesNo — Details:
Do you provide calibration certificates and intervals.	YesNo — Details:
Do you provide Preventive maintenance procedures/plan.	YesNo — Details:
Are service engineers trained and qualified?	YesNo — Details:

After-Sales Support

Packaging, Transportation, and Storage

Describe packaging methods to prevent transport damage.
Are packaging materials compliant with safety regulations?	YesNo — Details:
Provide recommended transport and storage conditions.

Commercial & Cost Structure

Commercial Terms & Conditions

Supporting Documentation Required

Client Name	Country	Equipment Supplied	Project Scope	Year	Contact Reference	Regulatory Inspection Involved (Y/N)
Pharmaceutical / Regulated Industry Project Experience (Last 5 Years)

At least three (3) relevant pharmaceutical or regulated industry references are required.
Tax certificate (attach copies)	YesNo Attach documents and add notes if required.
Bank account details confirmed by the bank (attach copies)	YesNo Attach documents and add notes if required.
Audited financial statements for the past three (3) years (attach copies)	YesNo Attach documents and add notes if required.
Other Documents attached	YesNo Attach documents and add notes if required.

Supplier Declaration

The supplier hereby confirms that the information provided above is accurate and correct at the time of declaration, unless otherwise stated in the Details section.
Authorized Representative Name:
Designation:
Email address:
Date:

Have you been inspected by regulatory authorities (e.g., US FDA, EMA)?	YesNo — Details:
Do you provide NRTL (UL/FM/CSA) Certificates for Electrical & control compliance	YesNo — Details:
Do you have deviation and non-conformance management process.	YesNo — Details:
Traceability controls for materials and components.	YesNo — Details:
Do you perform Supplier qualification for sub-suppliers	YesNo — Details:
Do you provide Material Safety Data Sheets (MSDS) for lubricants, cleaning agents, etc. (if applicable)	YesNoN/A
Do you provide Leak test and weld inspection reports (NDT / radiography)	YesNo — Details:
Do you perform and document a design-level risk assessment (covering safety, contamination, and utility interactions) appropriate to the equipment type	YesNo — Details:

Warranty period for equipment/components
Commitment to bear all costs associated with warranty repair or replacement of equipment/components?	YesNo — Details:
Availability of spare parts and consumables	YesNo — Details:
Response time for service calls
Training provided for operators and maintenance staff	YesNo — Details:
Supplier confirms support to Installation supervision and commissioning	YesNo — Details:
Is local service representation available within the United States?	YesNo Details (provide company name, location, contact person, phone, email):
Escalation contacts and communication matrix provided	YesNo — Details:

Is the price validity period clearly defined	YesNo — Details:
Are the price terms specified?	Ex-WorksFOBCIFOther - Specify:
The quote must clearly mention payment terms (PO, delivery, installation, acceptance, retention % and period)?	YesNo — Details:
Is advance payment required?	YesNo — If yes, percentage and justification:
Ability to provide an advance payment guarantee?	YesNo — Details:
Consent to provide a performance guarantee?	YesNo — Details:

General Terms & Conditions attached?	YesNo
Governing Law:
Jurisdiction:
Limitation of Liability clause included?	YesNo
Liquidated Damages applicable?	YesNo — Details:
Insurance coverage (Type & Limit):
Force Majeure clause included?	YesNo
Confidentiality agreement required?	YesNo

Do you have a certified Quality Management System?	YesNo — Details:
Do you have Change Control and CAPA systems.	YesNo — Details:
Do you perform internal audits? Frequency?	YesNo — Details:
Supplier provides Quality Policy and Manual	YesNo — Details:
Do you have document control and record retention practices	YesNo — Details:
Agreement to retain records for inspection. Define the record retention period.	YesNo — Details:

Quality Policy and Manual (attach copies)	YesNo Attach documents and add notes if required.
Organizational chart (attach copies)	YesNo Attach documents and add notes if required.
Sample FAT/SAT/Qualification documentation (attach copies)	YesNo Attach documents and add notes if required.
User manuals, SOPs, maintenance instructions (attach copies)	YesNo Attach documents and add notes if required.
Client reference / trade reference list (attach copies)	YesNo Attach documents and add notes if required.