Medical supplies including stethoscope, pill organizer with tablets, thermometer, band-aids, medical tape, and blister packs on a white background.

ISO 9001 Implementation Success at Maclean Health

Client: Maclean Health
Industry: Medical and Pharmaceutical Product Distribution
Engagement: ISO 9001:2015 Quality Management System Implementation and Certification Support

About Maclean Health

Maclean Health is an ISO 9001:2015 certified wholesale distributor of medical and pharmaceutical products. They specialize in supplying market innovators and government clients by leveraging cutting-edge technology and high-touch service. With extensive experience in healthcare and distribution, Maclean Health delivers tailored solutions to meet the unique needs of government buyers and regulated customers.

Project Overview

Maclean Health engaged Alex Lackey (Wintersmith Advisory Principal Consultant) to guide them through the full design and implementation of an ISO 9001:2015-compliant Quality Management System (QMS). The goal was to establish a reliable quality framework that ensures consistent delivery, regulatory alignment, and readiness for new market opportunities.

Alex’s Role

Alex Lackey provided:

  • A structured ISO 9001 implementation roadmap tailored to Maclean Health's operations

  • Custom QMS documentation aligned with actual business practices

  • Training for leadership and operational teams

  • Support in setting measurable quality objectives and driving performance tracking

  • Internal audit preparation and guidance for certification readiness

Client Testimonial

“Alex helped us design and implement a new ISO 9001 QMS from the ground up. I really appreciate how he listened to us and made sure the system worked with how our team already operates—without unnecessary bureaucracy. He was responsive, clear, and always willing to explain the ‘why’ behind a requirement. We now have a system that supports our operations and prepares us for market access.”
— Maclean Health Representative

Results

  • Successfully implemented an ISO 9001:2015-compliant QMS on schedule

  • Created documentation and workflows that reflect real-world operations

  • Enabled internal ownership of quality and continuous improvement

  • Positioned the organization for certification and expanded customer confidence

Why It Matters

A functional QMS is essential for delivering consistent service and building trust—especially in regulated and high-stakes sectors like medical product distribution. Alex Lackey helped Maclean Health develop a practical, certifiable system that not only meets ISO 9001 requirements but actively supports operational performance.

Need ISO 9001 support that fits your business?
Let’s talk about how Alex can help you build a quality system that works—for certification, compliance, and continuous improvement.