MDEL Quality System Documents
CliniEco Medical maintains a complete set of Standard Operating Procedures (SOPs) as part of our Medical Device Establishment License (MDEL) quality management system.
Documents Included
| SOP | Title | Purpose | Applied To |
|---|---|---|---|
| SOP-01 | Complaint Handling | Systematic process for receiving and investigating complaints | All products |
| SOP-02 | Recall Procedure | Effective recall of medical devices that may present health risk | Imported medical devices |
| SOP-03 | Adverse Event Reporting | Identification and reporting of adverse events to Health Canada | Imported medical devices |
| SOP-04 | Traceability System | Product tracking from supplier through to end customer | Imported medical devices |
| SOP-05 | Document Control | Quality document creation, review, approval, and maintenance | All products |
| SOP-06 | Supplier Management | Supplier selection, evaluation, and ongoing monitoring | Imported medical devices |
Sample SOP Content
Each SOP includes: Purpose, Scope, Definitions (where applicable), Detailed Procedure, Record Retention requirements, and Regulatory References. SOPs reference Health Canada GUI-0016, GUI-0060, ISO 13485:2016, and SOR/98-282 Medical Devices Regulations.
Note: The full SOP document package is available upon request for MDEL audit purposes. Contact our quality team at alina@clinieco.ca.
What each SOP covers
SOP-01 Complaint Handling. Defines who receives a complaint, what is written down, how the issue is investigated with the supplier, and how the outcome is recorded. A complaint you send us enters this procedure rather than an inbox.
SOP-02 Recall Procedure. Defines how affected units are identified, how further distribution is stopped, how customers who received the product are contacted, and how the recall is documented and closed.
SOP-03 Adverse Event Reporting. Defines how an incident involving a device is assessed against the mandatory reporting criteria and, where the criteria are met, how it is reported to Health Canada.
SOP-04 Traceability System. Defines the records that link each unit we import to its supplier, its lot or serial number where the manufacturer provides one, and the customer it was supplied to, so a problem can be traced in both directions.
SOP-05 Document Control. Defines how these procedures are written, reviewed, approved, versioned and retired, so that the version in use is identifiable and superseded copies are not left in circulation.
SOP-06 Supplier Management. Defines how a manufacturer or supplier is evaluated before we buy, and how that evaluation is kept current through ongoing monitoring.
Why a supplier's SOP package matters to your records
When your facility buys medical devices, including consumables such as sterilization pouches, biological indicators or specimen transport bags, the trace of where those items came from is part of your own recordkeeping. If a question comes up later, whether that is a failed load, a complaint or a recall notice, the practical difference is whether the supplier can turn a product name and a lot number into a supplier, a date and a set of records. That is what this document set exists to do, and it is the record set that sits behind a licensed establishment's obligations in Canada. Our establishment licence is MDEL #35334.
What to ask any supplier for
The same questions work for any supplier you are evaluating:
- Which establishment licence do you hold, and under what name, so it can be checked against Health Canada's published list?
- Can you trace a lot number from a product you shipped back to the manufacturer that produced it?
- What happens if I report a problem with a unit, what do you record, and what do you tell me afterwards?
- How would you contact me if a recall affected something I bought?
- Is there a document control process behind your procedures, or are they undated files?
Looking for a facility-side document instead
These are supplier-side quality documents. They are not a fill-in-the-blank sterilizer SOP, a monitoring log or an audit checklist for your own facility. If that is what you need, start with the free sterilization and disinfection recordkeeping tools in our compliance log center, and send us the specifics of your setting, including your province, your sterilizer or cycle types and what you currently run, and we will answer against the standard that applies to you. Ask a sterilization compliance question.
Frequently Asked Questions
Are these SOPs the same as the sterilizer SOP my clinic needs?
No. These documents describe how CliniEco Medical controls the devices it imports and distributes. A clinic's sterilizer SOP describes how that clinic cleans, packages, sterilizes and monitors instruments on its own premises, written around its own equipment and provincial requirements. The two serve different purposes and are held by different parties.
Can I request the SOP package?
Yes. The full document package is provided on request for MDEL audit purposes. Write to alina@clinieco.ca from your facility address and say which documents you need.
Can I verify that CliniEco Medical is a licensed establishment?
Yes. Health Canada publishes the establishments that hold a Medical Device Establishment Licence. Our licence number is MDEL #35334, which is the number to search for.
Do biological indicators and sterilization pouches fall under these procedures?
They do. Complaint handling, traceability, recall and supplier management apply to the medical devices we import and distribute, which includes sterilization monitoring consumables and packaging.