AjaCertX · Outsourced Quality Management

Outsourced Quality Management

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Interim QMS Support

Interim Quality Management System Support

Short-term and project-based QMS support — covering certification drives, system rebuilds, regulatory submissions and management system gaps without the cost of permanent resource.

Interim QMS Implementation Support

On-site or remote QMS implementation support — covering document development, process design, training and audit preparation during your certification journey.

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QMS Gap Analysis & Remediation

Independent QMS gap assessment identifying nonconformities, documentation gaps and system weaknesses — with hands-on remediation support to close findings.

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Certification Drive Support

Intensive certification drive support covering documentation, internal audit, management review and pre-audit preparation to meet your certification timeline.

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QMS System Rebuild

Full QMS rebuild for organisations with legacy, non-compliant or ineffective management systems — designing a fit-for-purpose system from the ground up.

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Post-Audit Corrective Action Support

Hands-on corrective action support following audit findings — addressing major and minor nonconformities and building evidence of effectiveness.

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Fractional Quality Manager

Fractional Quality Manager Service

Access experienced quality management leadership on a retainer basis — without the cost and commitment of a full-time Quality Manager hire.

Fractional Quality Manager (Retainer)

Dedicated quality manager resource on a monthly retainer — covering QMS oversight, audit management, supplier quality and continual improvement leadership.

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Management Review Facilitation

Annual and periodic management review facilitation — preparing inputs, chairing reviews and producing outputs that meet ISO standard requirements.

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Internal Audit Programme Management

Annual internal audit programme planning, scheduling, execution and reporting — maintaining your ISO certification between third-party surveillance visits.

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CAPA Programme Management

CAPA programme design, tracking and effectiveness verification — ensuring corrective actions are closed out and root causes are systematically addressed.

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Supplier Quality Management

Outsourced supplier quality management — covering supplier qualification, audit programme execution, performance monitoring and development activities.

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Document Control & Records Management

QMS document control system design and ongoing management — ensuring your documentation remains current, controlled and audit-ready at all times.

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Outsourced Compliance Programmes

Outsourced Compliance Programmes

End-to-end outsourced compliance programmes for organisations that need structured compliance capability without building an in-house team.

Outsourced GxP Quality Programme

Fully outsourced GxP quality programme for life science organisations — covering GMP, GDP, CAPA, deviations, change control and regulatory submission support.

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Outsourced Food Safety Programme

Outsourced food safety management programme covering HACCP, allergen management, supplier audits and FSSC 22000 / BRCGS certification maintenance.

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Outsourced ISO Surveillance Programme

Ongoing outsourced management of your ISO certification — covering internal audits, management reviews, CAPA and pre-surveillance preparation.

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Outsourced ESG Reporting Programme

Outsourced ESG data collection, reporting framework design and disclosure preparation — supporting annual sustainability reporting obligations.

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Sector Experience

Sectors We Serve

Our outsourced quality management team brings sector-specific expertise across 11 industries — not generic quality management consultancy.

Life Science & Pharmaceutical

GxP, GMP, GDP, CSV, CAPA and regulatory submission support for pharmaceutical, biotech and medical device organisations.

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Manufacturing & Engineering

ISO 9001, ISO 14001, ISO 45001 and IMS management for manufacturing, precision engineering and industrial organisations.

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Food & Consumer

HACCP, FSSC 22000, BRCGS and allergen management programme support for food manufacturers and retail supply chains.

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Technology & Financial Services

ISO 27001, SOC 2, GDPR and AI governance programme management for technology companies and financial services organisations.

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Aerospace & Defence

AS/EN 9100 and NADCAP quality programme management for aerospace manufacturers, MRO organisations and defence suppliers.

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Construction & Infrastructure

ISO 9001, ISO 14001 and ISO 45001 programme management for contractors, project organisations and infrastructure developers.

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Our Approach

How AjaCertX Works With You

A structured engagement methodology — from initial assessment through to ongoing governance and continual improvement.

Step 01
Assess

We assess your current quality management system, certification obligations and internal capability gaps — establishing the scope and nature of outsourced support required.

Step 02
Design

Outsourced quality programme design — covering engagement model, responsibilities, reporting lines, deliverables and KPIs.

Step 03
Mobilise

Rapid mobilisation of sector-aligned quality management resource — on-site, remote or hybrid — aligned to your operational timeline.

Step 04
Execute

Ongoing quality programme execution — internal audits, management reviews, CAPA management, document control and supplier quality activities.

Step 05
Transfer

Knowledge transfer and internal capability building — progressively equipping your team to take ownership of quality management activities.

Step 06
Review

Regular programme reviews — assessing performance, adjusting scope and ensuring the outsourced programme continues to meet your evolving needs.

Insights & Resources

Knowledge For Your Team

Guide
Outsourced Quality Management: When to Use It and How to Make It Work

How to structure an outsourced quality management engagement — covering scope, roles, handover and how to ensure internal capability is built, not dependency.

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Article
Fractional Quality Manager vs Full-Time Hire: What Makes Sense and When

When a fractional quality manager delivers better outcomes than a full-time hire — and how to structure the engagement for maximum value.

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Whitepaper
ISO Certification Without a Quality Manager: How Smaller Organisations Can Achieve and Maintain Certification

How organisations without dedicated quality resource successfully achieve and maintain ISO certification through outsourced and fractional quality management.

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Webinar
Outsourced Quality Management — Live Q&A for SMEs and Growing Organisations

Our outsourced quality specialists walk through engagement models, sector experience and how to get started — with live Q&A.

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Ready to access expert quality management without the full-time overhead?
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