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Quality Leadership Without the Full-Time Overhead

Helping Hardware Companies Scale From Prototype to Production

Lean6QMS provides fractional Quality leadership, Quality Management System consulting and manufacturing Quality support to growing hardware, technology and manufacturing companies.

Whether you're preparing to ship your first commercial product, scaling outsourced manufacturing, implementing ISO 9001 or ISO 13485, or struggling with supplier and production Quality issues, we help build the systems needed to scale with confidence.

Quality • Manufacturing • Scale

Growing Hardware Companies Eventually Reach a Quality Inflection Point

Your engineering team built the product.

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Customers are starting to buy it.

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Suppliers and contract manufacturers are producing it.

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And suddenly you're dealing with:

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• Supplier Quality issues
• Product changes and configuration control
• NCRs and corrective actions
• Incoming inspection
• Manufacturing deviations
• Customer Quality requirements
• Product traceability
• ISO requirements
• Reliability and field failures
• Increasing documentation requirements

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But you may not need a full-time Quality Director yet.

That's where Lean6QMS comes in.

Fractional Quality Leadership

Get experienced Quality leadership without immediately building an entire internal Quality organization.

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Lean6QMS can function as an extension of your leadership, engineering and operations teams to establish and manage the Quality infrastructure needed as your company scales.

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Support can include:

  • QMS leadership and Quality strategy

  • Supplier and contract manufacturer Quality

  • NPI and manufacturing readiness

  • NCR, CAPA and structured problem solving

  • Change and configuration control

  • Quality KPIs, management review and executive reporting

  • Internal audits and certification readiness

Supplier Quality & NPI

Build the Quality controls needed to move confidently from product development into production.​

  • Supplier qualification & development

  • Contract manufacturer oversight

  • FAI & incoming Quality strategy

  • Supplier corrective action / 8D

  • Manufacturing deviations & rework control

  • NPI Quality planning & production readiness

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    Learn About Supplier Quality & NPI

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Quality & Manufacturing Scale-Up Assessment

Not sure where the biggest risks are?

Our Quality & Manufacturing Scale-Up Assessment evaluates the Quality infrastructure supporting your product from development through production.

We assess areas including:

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  • Product development

  • Supplier management

  • Manufacturing readiness

  • Quality systems

  • Change control

  • Inspection

  • Traceability

  • Nonconformance

  • Corrective action

  • Reliability

  • Compliance

  • Customer Quality

  • Field performance

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You receive a prioritized findings report and practical 30/60/90-day Quality roadmap.

From Prototype to Production

Hardware companies face a different set of Quality challenges than traditional software startups.

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As products move through development, validation and production, Quality controls need to mature without slowing innovation.

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Lean6QMS helps organizations establish practical controls around:

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Prototype → Verification → Validation → Production → Field Support

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Our approach focuses on implementing the right level of process at the right time—not bureaucracy for the sake of compliance.

Insights

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ABOUT US

Lean6QMS helps growing hardware, technology and manufacturing companies build the Quality infrastructure needed to scale from product development into commercial production.

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We combine senior Quality leadership, engineering experience, Quality Management Systems, supplier Quality, manufacturing Quality and Lean Six Sigma to solve practical scale-up problems without creating unnecessary bureaucracy.

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Led by an experienced Professional Engineer and Quality leader with 20+ years of engineering, manufacturing and Quality experience.

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P.Eng. | ISO 13485 Lead Auditor | Six Sigma Black Belt

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