Frequently Asked Questions

Everything you need to know about working with an ISO consultant and what the certification journey looks like.

• What does an ISO consultant do?
  An ISO consultant guides your organization through the process of building and implementing a management system that meets the requirements of a specific ISO standard — and through the certification audit with an accredited registrar. At MSI, our consultants handle scope definition, strategic planning, system design, documentation, training, internal audit preparation, and certification support. We don't hand you a template and leave — we work alongside your team until the certificate is in hand.
• How long does ISO certification take?
  Timeline varies by organization size, complexity, and the standard being pursued. Most MSI clients achieve initial certification within 6 to 12 months. We build your certification timeline around your operational calendar — not on top of it — so the project doesn't disrupt your daily business.
• Can ISO consulting be done remotely?
  Yes. MSI delivers fully remote ISO consulting engagements with the same methodology and outcomes as on-site work. Our consultants use structured interviews, collaborative documentation tools, and regular check-ins to keep the project moving — regardless of location. Remote consulting is particularly effective for organizations with distributed teams or multiple sites.
• What is the difference between ISO 9001, ISO 14001, and ISO 45001?
  ISO 9001 covers quality management — ensuring your organization consistently delivers products and services that meet customer requirements. ISO 14001 addresses environmental management — helping organizations reduce their environmental footprint and meet regulatory obligations. ISO 45001 focuses on occupational health and safety — protecting workers and managing workplace risks. Many organizations pursue two or three of these simultaneously through an Integrated Management System, which MSI supports.
• What is ISO 13485 and who needs it?
  ISO 13485 is the quality management standard specifically designed for organizations in the medical device industry. It's required by regulators in many markets — including alignment with the FDA's Quality System Regulation in the US. Any company that designs, manufactures, distributes, or services medical devices should be working toward ISO 13485 certification.
• How much does ISO consulting cost?
  Cost depends on the size and complexity of your organization, the standard or standards you're pursuing, and whether you need on-site or remote consulting. MSI provides a detailed, no-obligation proposal after an initial information-gathering conversation. Every milestone, deliverable, and cost is documented in your Project Plan Book before work begins — there are no surprises.
• Do you guarantee certification?
  Certification decisions rest with your accredited registrar, not with us — so no consultant can honestly guarantee an outcome. What MSI offers instead is presence: we've attended 200+ certification audits alongside clients since 1998, and we stay with you through yours. If you follow the SurePath™ process, your system will be ready.
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