Services

No matter where your organization is at in the ISO 9001 certification process, we have you covered. Our comprehensive services include:

• Registrar quoting, selection, and audit scheduling
• Full compliance gap assessment
• Implementation of compliant systems
• Creation of Policies, Standard Operating Procedures, Work Instructions, and Forms
• Internal audit completion, training, and support
• Employee training
• Onsite or remote audit support

External audits can be intimidating and costly, but our team is well equipped to navigate them and maintain your organization’s well earned trust. The best defense is to find and correct issues well in advance through an internal audit program. Whether you need proactive or day of support, we offer:

• Full system internal audits
• Process audits
• Audit program development
• Corrective action verification
• Internal Auditor training
• Audit readiness assessments
• Onsite and virtual customer and regulatory audit support

Influencing and controlling supplier quality is consistently one of the most challenging aspects of a Quality Management System. We can help mitigate supply chain risks by:

• Setting up audit programs, ranging from simple questionnaires to onsite audits, and everything inbetween
• Scheduling and performing onsite or remote supplier audits
• Creating and implementing supplier scorecards, agreements, and triggers for corrective action

Is your organization correcting issues, only to find them resurfacing months later? This is a very common issue organizations face, but Strong QMS can reduce repeat issues by:

• Formalizing and training employees on your organization’s problem solving process and approach
• Creating or recommending tracking systems that ensure clear accountability and timely correction
• Establishing what most Corrective Action systems are missing – Effectiveness Verification
• Working alongside your team to correct current pressing issues

Unsure if your need is covered by Strong QMS? From ISO 14001 to FDA regulations, our team has a broad range of industry and regulatory experience. Contact us to see how we can help meet your needs.