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ISO 9001:2015
Quality management system
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IAF CertificationFinal price. No GST charged.View certificationQUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES
ISO 13485 Certification
Quality management system for medical devices. IAF Certification. Assessment timing is confirmed after scope and audit review.
This certificate does not replace regulatory licences, and regulators may require ISO 13485 certificates from specifically accredited or recognised bodies.
What is ISO 13485?
ISO 13485 is the quality management standard for organisations that design, make, distribute or service medical devices. It places strong emphasis on risk management, traceability and regulatory documentation throughout the life of the device.
Who needs it?
- Medical device manufacturers
- Component and sub-assembly suppliers
- Importers and distributors of devices
- Sterilisation and device servicing providers
Review the ISO 13485 preparation checklist
What it can do for your business
- A structured system for regulated products
- Supports regulatory submissions
- Expected by hospital and distributor buyers
- Lower risk of recalls
FROM APPLICATION TO DECISION
How it works
01
Define scope and buyer needs
Identify activities, sites, the standard and edition, and any buyer or tender accreditation requirement.
02
Confirm the certification route
Check the issuing body, accreditation scope, assessment arrangements and total fees in writing before payment.
03
Prepare documents and evidence
Submit initial business documents and the records needed to demonstrate how your management system operates.
04
Complete review and assessment
The applicable review or audit may require additional evidence and corrective action. Timing depends on scope and readiness.
05
Decision and ongoing review
Issuance depends on successful review, not payment alone. Check the issued scope and arrange applicable surveillance and renewal.
STARTING YOUR APPLICATION
Initial business documents
These establish who is applying and the proposed business scope. They are the starting point; the service-specific review or assessment can require additional operational evidence.
Business registration
Udyam, incorporation certificate or shop licence.
Letterhead or visiting card
Your business name and contact details.
One business invoice
A recent sales or purchase invoice.
Your business scope
What you do, in one or two clear lines.
Prepare for ISO 13485
Use these quality management system for medical devices checks to organise your preparation. For each item, identify the responsible person, the procedure used and a recent record showing what happens in practice.
- A documented quality system and a file for each device type
- Risk management across design and production
- Design and development controls
- Supplier control and full traceability
- Complaint handling, reporting and corrective action
Make your evidence match your scope
- Describe the actual activities and locations to be reviewed, including outsourced work and responsibilities retained by your business.
- Choose current examples from your own operation. Record the date, responsible person and outcome so the reviewer can connect the evidence to your stated scope.
- Identify missing records or unfinished actions before assessment. A policy or blank template alone does not show how a process operates.
- Ask which records apply to your selected service and scope. This preparation checklist is not an exhaustive assessment or a promise of certification.
This certificate does not replace regulatory licences, and regulators may require ISO 13485 certificates from specifically accredited or recognised bodies.
BEFORE YOU COMMIT
Confirm these details in writing before payment
Use the published price alongside the agreed scope and service terms when deciding whether the offering meets your requirement.
- Scope and deliverable: the applicable standard or scheme, edition, activities, sites and exclusions, and exactly what document or support the service provides.
- Issuing or assessment body: its name and role. If accredited certification is required, confirm the accreditation body and that the relevant standard and scope are covered.
- Buyer acceptance: share the actual tender or customer clause and confirm that the proposed route meets it. A certificate title alone does not establish acceptance.
- Assessment arrangements: required documents, audit or review stages, remote or on-site work, travel, readiness requirements and expected timing.
- Fees and exclusions: the selected service price, what is included, and any separate implementation, testing, site visit, travel or statutory registration costs.
- Ongoing obligations: applicable surveillance, renewal or reassessment, their fees, and how changes to your activities or locations should be reported.
Certification and accreditation have different roles. See ISO's guidance on choosing a certification body.
ICS✓
CERTIFICATE OF REGISTRATIONIAF Certification
ILLUSTRATIVE LAYOUT
ILLUSTRATIVE LAYOUT
Good systems.
Great possibilities.
Great possibilities.
This is to certify that the management system of
YOUR BUSINESS NAMEhas been assessed against the requirements of
ISO 13485
QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICESCertificate numberSAMPLE-XXXXXIAF Certification
SAMPLE
Authorized
signatory
signatory
SAMPLE · NOT A VALID CERTIFICATE
A credential. Not a question mark.Independently checkable, right here.
A VERIFIABLE RECORD
More than a piece of paper.
The sample shows the layout. Issued records include your company, certified scope, applicable standard, dates and status. Specialist schemes follow their own issuer requirements.
Verify a certificateQuestions about ISO 13485
01Does it replace a CDSCO licence?+
No. Licences and registrations under medical device rules are still required. ISO 13485 is a quality system standard.
02Is ISO 9001 enough for medical devices?+
ISO 9001 is general. Buyers and regulators of medical devices normally expect ISO 13485.
03Which edition is current?+
ISO 13485:2016. The 2003 edition listed on some sites has been replaced.
A stronger system, together.
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