ISO 9001:2015 Certification
End-to-end support from gap analysis to successful certification. We build the quality management system, prepare your team, and walk you through the audit.
Investment Range
KES 350,000 - 800,000
Project Timeline
6 - 12 Months
What's Included
A comprehensive package covering every step of your ISO 9001:2015 certification journey.
Gap Analysis & Current State Assessment
Thorough evaluation of your existing systems against ISO 9001:2015 requirements to identify gaps and priorities.
QMS Development & Documentation
Full quality management system design tailored to your operations, industry context, and business objectives.
Quality Manual & Quality Policy Creation
Professional quality manual and policy documents that reflect your organization's commitment to quality excellence.
Complete SOP Suite (15-25 Procedures)
Comprehensive set of standard operating procedures customized to your processes, covering all critical operations.
Process Mapping & Workflow Documentation
Visual process maps and workflow documentation that clarify responsibilities, inputs, outputs, and interactions.
Internal Audit Program Setup
Structured internal audit program with schedules, checklists, and reporting templates to maintain ongoing compliance.
Management Review Framework
Established management review process with agendas, data collection templates, and action tracking mechanisms.
Staff Awareness & Competency Training
Training sessions to ensure all team members understand their roles within the QMS and are audit-ready.
Pre-Certification Internal Audit
Full-scale internal audit simulating the certification process to identify and resolve any remaining gaps.
Certification Body Liaison & Audit Support
We coordinate with accredited certification bodies on your behalf and provide hands-on support during the audit.
Post-Certification Surveillance Support
First-year surveillance audit preparation included, ensuring you maintain certification status with confidence.
Project Timeline
A structured four-phase approach to take you from initial assessment to successful certification.
Gap Analysis & Planning
Month 1-2Laying the groundwork with a thorough understanding of where you stand and where you need to go.
Documentation & Development
Month 2-5Building the documentation backbone of your quality management system with practical, operations-aligned documents.
Implementation & Training
Month 5-8Bringing the system to life across your organization. Training your people and embedding quality into daily operations.
Certification & Audit
Month 8-12The final stretch -- preparing for and navigating the certification audit with expert guidance at every step.
Who Is This For?
This package is designed for organizations in the pharmaceutical and healthcare sector ready to formalize their quality systems.
Pharmaceutical Distributors
Seeking first-time ISO certification to strengthen operations, meet supplier requirements, and build credibility in the market.
Manufacturers
Looking to formalize quality systems, improve consistency, and demonstrate compliance to regulators and partners.
International Partnership Ready
Organizations preparing for international partnerships, tenders, or export markets that require ISO 9001:2015 compliance as a prerequisite.
Frequently Asked Questions
Common questions about ISO 9001:2015 certification pricing and process.
The final cost depends on your company size, the number of processes to be documented, number of locations, and the maturity of your existing documentation. Smaller organizations with some existing documentation will fall toward the lower end, while larger companies requiring more extensive system development will be closer to the upper range. We provide a detailed quote after the initial assessment.
No, certification body fees are separate and typically range from KES 200,000 to KES 400,000 depending on the body you choose and your organization's size. Our service covers all the preparation, documentation, and support needed to successfully pass the audit. We help you choose an accredited certification body and manage the entire process on your behalf.
We offer post-certification retainer support to ensure your QMS stays active and audit-ready. Preparation for the first surveillance audit is included in this package. For ongoing support beyond that, we offer retainer plans starting from KES 30,000 per month, covering continuous improvement guidance, document updates, and surveillance audit preparation.
Get Your ISO Certification Roadmap
Start with a free consultation to understand your current position and what it takes to achieve ISO 9001:2015 certification. We will map out a clear, costed plan tailored to your organization.
No obligation. Response within 24 hours.