ISO 9001 consulting for Connecticut manufacturers,
from gap assessment to audit readiness.
SolveXa Consulting helps small and midsized manufacturers build, repair, and maintain an ISO 9001 quality management system that fits how they actually work. Hartford-based, on site across Connecticut and New England, led by a certified Lean Six Sigma Black Belt with more than 17 years in regulated manufacturing.
What ISO 9001 consulting from SolveXa includes
ISO 9001 is the international standard for quality management systems. Certification tells customers that your processes are defined, controlled, measured, and improved. Most small manufacturers do not need a bigger system; they need one that matches their operation and produces the evidence an auditor expects.
SolveXa works in defined stages so you buy only what your situation needs. A Focused Assessment & Improvement Roadmap reviews your current state against the standard and returns findings, priorities, a 90-day roadmap, and a results presentation. The ISO 9001 QMS Implementation Module then delivers up to eight standard operating procedures and eight forms, document controls, training, and implementation reviews for an agreed scope. An Audit-Readiness Review checks up to five processes against sampled evidence before your certification or surveillance audit. Ongoing Improvement & QMS Support keeps the system alive afterwards with up to twelve consulting hours a month.
Who this is for
Operations and quality managers at Connecticut manufacturers who have been asked for ISO 9001 certification by a customer, who inherited a system nobody maintains, or who are preparing for a first certification audit or a surveillance audit with findings still open. Typical clients run one site with a few dozen to a few hundred people and have no full-time quality-system owner.
How an ISO 9001 project runs in practice
Understand. We agree the scope of the quality system, the customer and regulatory requirements that apply, and which processes matter most. Analyze. We compare existing procedures, records, and daily practice against the clauses of ISO 9001:2015 and rank the gaps by risk to your audit and your customers. Implement. Process owners on your team review and approve procedures and forms written for your operation, not copied from a template library, and people are trained on what changed. Sustain. Internal audits, management review, and corrective action become routines your team runs, with SolveXa coaching rather than doing.
An assessment is required before an implementation module is quoted, because the module’s scope depends on what the assessment finds.
Related standards
SolveXa also takes engagements for ISO 13485, the standalone quality-system standard for medical-device manufacturers, and IATF 16949, the automotive supplier standard used with ISO 9001. Each has its own applicable requirements. The approach is the same: understand the requirements that apply to you, close the gaps that carry real risk, and build evidence into daily work.
What the results look like
Two projects led by Ammar Mahdi show the kind of change this work produces. In a medical-device plant, introducing one-piece flow cut the measured interval between completed cases from five minutes to 2:48, a 44 percent reduction. In an automotive heat-treatment operation, a validated stacking change reduced the total cost of poor quality, the combined cost of scrap, rework, inspection, and failures, by more than 70 percent over the implementation year. Both were measured in production, not estimated.
Questions clients ask first
Does SolveXa certify us?
No. Certification decisions are made by an independent certification body, and its fees are separate. SolveXa prepares your system and your people for that audit.
Do we have to document everything?
No. ISO 9001:2015 requires documented information where it adds control. A system with fewer, better procedures that people follow audits better than a thick manual nobody reads.
What about templates?
SolveXa maintains a documentation package of about ninety ISO 9001 templates, written to ISO 9001:2015 with Amendment 1:2024, that can accelerate an implementation module. Whether it fits your operation is a conversation, not a download; raise it on the discovery call.
What does it cost?
Each engagement is fixed in scope and quoted after a free 20-minute discovery call. Additional processes, sites, shifts, revisions, and travel are quoted separately. No prices are published because the right scope differs from one plant to the next.
START AN ISO 9001 CONVERSATION
Find out what your system needs before you buy anything.
A 20-minute call establishes fit and the right starting point. A paid assessment then gives you findings, priorities, and a roadmap you own whether or not you continue with SolveXa.