Find answers about ISO 13485 audits, MDSAP readiness, regulatory remediation, practical training and QMS implementation.
Do you offer accredited certification?
No. QMS Professionals provides independent auditing, consulting, training and remediation support, not accredited certification services.
What is the FDA QMSR and when did it take effect?
The FDA Quality Management System Regulation took effect February 2, 2026 and incorporates ISO 13485:2016 by reference with additional applicable U.S. requirements. FDA does not require an ISO 13485 certificate.
Does every U.S. device manufacturer need ISO 13485 certification?
No. Applicable finished device manufacturers must meet QMSR requirements; third party ISO 13485 certification is not itself required by FDA.
Is MDSAP mandatory?
Requirements vary by market. MDSAP participation is generally voluntary in the U.S.; Canada relies on certificates recognized under MDSAP for applicable Class II, III and IV medical device licensing requirements.
Can you conduct our annual internal audit?
Yes, subject to scope, competence, availability and independence. We can audit selected processes, sites or an integrated management system.
Can internal audits be completed remotely?
Many document and process interviews can be remote. Manufacturing observations, physical controls and certain supplier processes may require onsite verification.
What is included in a supplier audit?
A scope based on risk, supplier process review, sampling of evidence, findings and a report with practical follow up recommendations.
Can you audit suppliers outside Canada and the U.S.?
Potentially, subject to auditor availability, travel requirements, local restrictions and the supplier’s agreement.
Can you help respond to an FDA Form 483?
We can help investigate observations, organize containment and CAPA, draft technically supported responses and plan effectiveness checks. FDA alone determines regulatory acceptance.
Do you guarantee closure of major or minor nonconformities?
No. We support correction, root cause analysis and corrective action with supporting evidence. The issuing body decides whether responses are accepted.
What makes your customized training different?
Participants use their organization’s approved QMS and anonymized real examples to complete coached exercises and demonstrate practical application.
Can training use our complaints and nonconformity records?
Yes, with authorization, confidentiality safeguards and appropriate redaction of sensitive data.
Can training be onsite, virtual or hybrid?
Yes. Format, class size and exercises are selected to fit the subject, operational needs and training objectives.
Can a small company use your remote QMS implementation service?
Yes. The scope and documentation are scaled to the organization, products, risk and applicable regulatory obligations.
Does remote implementation eliminate every site visit?
Not always. We use remote methods by default where effective; onsite verification is recommended when essential for reliable assessment.
Can you combine ISO 9001, ISO 13485, ISO 14001 and ISO 45001?
Yes, where applicable. Shared processes can be integrated while retaining regulatory and technical controls for each sector.
Are ISO 9001:2026 and ISO 14001:2026 published?
Yes. ISO 9001:2026 was published in September 2026 and ISO 14001:2026 in April 2026. Transition plans should follow applicable accreditation and customer requirements.
Do you provide templates?
Where appropriate, we help develop documents and records that suit your actual processes, rather than relying only on generic templates.
How is a proposal priced?
Pricing depends on scope, locations, complexity, audit days, delivery format and urgency. We provide a written scope and fee before work begins.
What information is needed to request a quote?
Company and contact details plus a few selected options such as service, standards, locations and timeframe. A detailed description is optional.