ISO 13485 Medical Devices Quality Management System Consultancy

The documents ISO 13485 asks you to have

A standard does not ask for a library. It asks for evidence that you decide things deliberately and can show how. This is what an auditor will look for on a ISO 13485 system — specific to the standard first, then the records every management system needs.

• Quality manual, including the scope and the justification for any exclusion
• Medical device file for each device family
• Design and development file — inputs, outputs, review, verification, validation, transfer
• Risk management file to ISO 14971, running across the whole lifecycle
• Process validation records, including sterilisation and software validation where they apply
• Complaint handling, vigilance and adverse-event reporting records
• Traceability records, and unique device identification where required
• Post-market surveillance plan and reports
• Roles, responsibilities and authorities, written down and known to the people holding them
• Competence and training records for anyone whose work affects the system
• Internal audit programme, audit reports and the findings raised
• Management review minutes, showing what was decided rather than that a meeting happened
• Nonconformity and corrective action records, with root cause and effectiveness checked
• Document and record control — what is current, who approved it, how long it is kept

Length is not compliance. A procedure nobody follows is worse than no procedure, because an auditor will find the gap between the two. Our test is whether the person who has to do the job recognises their own work in it.

How to start

The first instinct is usually to look for a template pack. It is the most expensive way to begin, because a system written before anybody looked at how the work is actually done has to be re-written once somebody does. Start here instead.

• Establish what is being asked, and by whom. A customer, a tender, a regulator and a parent company each want something slightly different, and the answer decides the scope.
• Fix the scope in writing — which sites, which activities, which products. Scope drives cost more than any other single decision, and a scope widened after the audit is booked is re-work.
• Have a gap assessment done against ISO 13485, on evidence rather than on a questionnaire. You can score yourself first with the free readiness checklist on this site; the expert assessment is what turns that score into a plan.
• Appoint somebody internally who owns it. Not necessarily full time, but named, and senior enough to get decisions made.
• Document only what the gap assessment showed is missing, in the words the people doing the work already use.
• Train, then run the system long enough to generate real records. Three months of genuine records cannot be produced in a fortnight, and this is the step organisations try hardest to skip.
• Audit yourself, hold a management review that actually decides something, then book the certification audit.

How to choose a certification body

The body you choose matters more than most people expect, and for a reason that has nothing to do with price: their accreditation is what makes your certificate mean something to the party that demanded it.

Four things decide it. Accreditation: the body should be accredited for your standard and your industry by a recognised accreditation body, and the certificate should carry that mark. Sector competence: an auditor who has audited your industry asks better questions and wastes less of your time. Recognition: ask the customer or tender that triggered this whether they name particular bodies. Cost and diary: audit days are set by your headcount and scope, so quotes should be comparable — and if one is far cheaper, look at the audit days before the price.

Among the bodies most widely recognised, in no particular order: BSI, TÜV, SGS, SIS Certifications, Intertek, DNV, BVQI.

MSCi works with a pool of accredited certification bodies rather than one. That is a commercial advantage to you, and worth being plain about why: bodies differ in audit-day rates, in travel cost to your location, in how quickly they can get an auditor to you, and in which sectors they are accredited for. Having several to approach means we can put your scope in front of the ones that fit it and bring you back comparable quotes, instead of you taking the first number offered.

What it does not change is the audit. We cannot influence a finding and would not try — the body's independence is the entire value of the certificate, and any consultancy offering otherwise is selling you something worthless. We prepare you so that the audit is uneventful, and the body decides.

Note also that whoever builds your management system must not be the body that certifies it. Accreditation rules prohibit it, which is why we prepare and never certify.

What ISO 13485 is usually taken with

Few organisations stop at one standard, and the second costs far less than the first — the clauses that take longest are the ones they share. Where ISO 13485 sits next to something else, this is what carries over.

• CE Mark consultancy — is the route to the European market that this system is usually built to support.
• CDSCO Compliance consultancy — is the Indian licensing route, and the device file you build here answers much of it.
• ISO 9001 consultancy — is the structure this standard is based on, minus the device-specific requirements.

Certified to more than one, you hold a single management system with one set of objectives, one internal audit programme and one management review — audited in one visit. Run as separate systems they cost roughly twice as much to keep, which is the usual reason a second certificate feels harder than it was.