We have a very strict checklist for all new suppliers to ensure our policy "Look for the Q" allows our clinical and manufacturing partners to trust that both materials, tools and equipment comply with the latest custom made medical device requirments. 

The Q Quality control system is based on the 12 Point checklist below:

Below are the criteria reflect the expectations for supplier control under ISO 13485:2016 Clause 7.4 and risk-based purchasing control for medical device components.

ISO 13485 Supplier Evaluation Criteria for Qaadir (Orthotics & Prosthetics Materials)

1. Quality Management System (QMS) Requirements

Evaluate whether the supplier operates a controlled and documented quality system.

Minimum Criteria

• ISO 13485 certification (preferred)

• OR ISO 9001 certification (acceptable with additional controls)

• Documented QMS procedures for:

  • incoming material inspection

  • lot traceability

  • nonconforming product control

  • calibration of measuring equipment

Evidence to Request

• Copy of valid certificate

• Latest audit summary or certificate scope

• Quality manual or QMS overview

2. Regulatory Compliance & Medical-Grade Material Standards

Since Qaadir materials are used for medical devices (orthoses, prosthetic sockets, workshop production), the supplier must comply with:

Criteria

• Compliance with REACH, RoHS, and applicable chemical regulations

• Material safety data sheets (MSDS) available

• Biocompatibility documentation (ISO 10993), if applicable to patient-contact materials

• FDA/CE compliance, if relevant

• Declaration of Conformity for medical-grade materials (e.g., copolymer, carbon fiber, EVA, PU resins)

Evidence

• DoC

• MSDS

• Test reports

• Material specifications

3. Product Specifications & Consistency

For O&P, consistency is critical (e.g., EVA hardness, resin viscosity, carbon weave weight).

Criteria

• Ability to meet required technical specifications

• Lot-to-lot consistency demonstrated through:

  • certificates of analysis (CoA)

  • process control documentation

• Defined tolerances for dimensions, density, hardness, viscosity, thickness, etc.

Evidence

• Technical data sheets

• CoA samples

• Dimensional tolerance declarations

4. Traceability & Lot Identification

ISO 13485 requires the ability to trace defective O&P materials back to the source.

Criteria

• Unique batch/lot identification

• Traceability system from raw material → finished product

• Ability to support product recalls

Evidence

• Sample labels

• Traceability procedure

• Recall capability documentation

5. Risk Management Integration (ISO 14971 Alignment)

Suppliers must understand the risk impact of their materials on device safety.

Criteria

• Supplier’s materials do not introduce unacceptable risks

• Hazard controls in place (e.g., contamination prevention)

• Change notification system (for formulation or process changes)

Evidence

• Change control policy

• Risk assessment input (if available)

• Manufacturing environment controls

6. Manufacturing Capability & Process Controls

Evaluate whether the supplier can reliably achieve your manufacturing requirements.

Criteria

• Defined and controlled manufacturing processes

• Preventive maintenance systems

• Calibration of measuring and testing equipment

• Capability to scale production as Qaadir grows

Evidence

• Process flow chart

• Maintenance plan

• Calibration certificates

7. Environmental & Storage Controls

This is critical for:

• resins

• adhesives

• EVA

• thermoplastics

• prepregs

• carbon fiber

Criteria

• Defined storage conditions (temperature, humidity, shelf-life)

• Controlled packaging methods to prevent contamination or damage

• First-expiry-first-out (FEFO) system

Evidence

• Storage specifications

• Shelf-life reports

• Packaging specifications

8. Delivery Performance Standards

For O&P operations, consistent delivery timelines are crucial.

Criteria

• On-time delivery performance

• Ability to deliver to GCC, India, Africa

• Lead time transparency

• Capability to manage urgent orders

Evidence

• Logistics capability statement

• Shipping SOP

• Past performance (if any)

9. Financial Stability & Business Continuity

Suppliers should be reliable long-term partners.

Criteria

• Financial stability

• Business continuity and disaster recovery plans

• No history of major supply disruptions

Evidence

• Business license

• Company profile

• Continuity plan summary

10. Communication, Customer Service & Technical Support

Especially important for specialised O&P materials (resins, prepreg, carbon, thermoplastics).

Criteria

• Responsiveness

• Technical expertise available

• Ability to support troubleshooting

• Stability of key account manager

Evidence

• Support responsiveness test

• Training or technical data availability

11. Cost, Value, and Commercial Terms

While not part of compliance, ISO 13485 expects purchasing decisions to be justifiable.

Criteria

• Competitive pricing

• Clear pricing structure

• Reasonable MOQs

• Payment terms

• Warranty & return policies

12. Ethical, Social & Environmental Responsibility

Increasingly important for global supply chains.

Criteria

• No child labour, forced labour, or unethical practices

• Environmental responsibility (ISO 14001 is a plus)

• Proper waste handling

Evidence

• Declaration of compliance

• ESG/CSR policy