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Requirement of quality management system on global market

What is requirement of quality management of medical device?


The easiest requirement of quality management is evidence of existing valid ISO 13485 certification or exceptional ISO 9001 certification in a few markets.

In some countries it is called also as good manufacturing practise, quality system documentation, Quality Management System Regulation.

Quality management system is as well an evidence of safety and performance of medical device besides product registration. Local authority wants to monitor foreign manufacturer in regular renewal how quality management system is updated, changed and maintained.


The key elements of quality management are

  • Person

  • Premises and equipment

  • Procedure

  • Document


Not typical for quality management manager in global legislative is not only country specific dossier:

  • Registration record (valid certificate)

  • Marketing history

  • Vigilance history

  • Design control with country specific req.

  • Sales number in subject and home country

  • Local template

  • Regional LOA


The familiar international inspection is Medical Device Single Audit Program (MDSAP) which covers Australia, Brazil, Canada, Japan and US. The country specific chapter is marked in red below



  • Device marketing authorization and facility registration

  • Measurement analysis and improvement

  • Medical devices adverse events and advisory Notice Reporting

  • Design and development

  • Production and servicing controls

  • Purchasing

Global QM requirement from easy to complex


We define the complex quality management from frequency of renewal to factory inspection onsite. Normally class I medical device is waved by quality management inspection.

  1. Every year renewal

  2. Every 3 year renewal

  3. Every 5 year renewal

  4. Every 10 year renewal

  5. Overseas factory inspection (on-site)


90% of global quality management renewal is in paper work as for product registration to submit. Don’t be surprised the QM-certification has also expiration date. The certificate must be renewed or re-certified in time otherwise in most case the approved medical device (IVD) couldn`t be place in this market till renewal.

The example of QM-inspection each year is Ukraine. Taiwan has 3 years QSD renewal.

The country with frequency of 3y -and 5y QM-renewal is Japan and Taiwan which could partly simplified with existing MDSAP audit.


There is always regular initial on-site inspection as in Russia or pre-announced factory inspection in China, Japan, Korea und US. In this case the authority will come to legal manufacturer and execute a face to face inspection.

The hardest inspections which legal manufacturers scare are MDR and MDSAP inspection (oft combined). It is definitely an annual highlight for the whole company to provide evidence to the regulation.

Critical documents to get renewal of quality management


The typical QM documents are listed below. Every authority has its focus, sometime production site, sometimes outsourced design and production partner, or rarely the submission dossier as sampling.

  • ISO 13485 or ISO 9001 (legal manufacturer and subcontractor)

  • Production workflow

  • Organisation chart

  • Management review

  • Audit report

  • CAPA

  • Layout of building and floor

  • SOP documents compliant to ISO 13485 or country QM guidance

  • Vigilance records and procedure

  • Records of quality control

  • Validation of production

  • Design history file and device master record


In our practise, device master record or design transfer record is often failed by many authorities in review stage. Actually authority just wants to prove whether product specification, device with all released components, production procedure and labelling are well transferred in production.


Here is one easy example for DMR in Taiwan at which no single mentioned SOP must be submitted.

Device master record for QSD in Taiwan
QMS of medical device in Japan

Contact us for any country specific template of quality management.


Best practise of global quality management system


The efforts to maintain regular and irregular paper - or onsite international inspection of quality management system will never be easy. It needs cooperation of regulatory affairs, quality management and all related departments.

Here our lessons lerned

  1. Start renewal of QM renewal as early as possible

  2. Integrate market special req. in own QM system

  3. Learn to focus on QM emphasis in each market

  4. QM renewal with update of regional product registration

  5. Make a mock-audit as a good preparation

  6. Have a master folder or tool of quality management documents with newest revision (at least before next international inspection)

We want to be part not only of international product registration but also global quality management system.

We have alwyas first 45 min free consulting.

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