In the ISO 9001:2015 is a greater emphasis on risk-based thinking as a basis for the management system, more focus on achieving value for the company and its customers, increased flexibility regarding use of documentation, and a more approachable structure for service businesses.

We've developed a short knowledge test to give you a quick insight of some changes. We challenge you to perform this test as a start of the transfer plan ISO 9001:2008 > ISO 9001:2015.

Do not hesitate contact us if you as organization need assistance in defining the transition and or implementation plan. 

Link On Line Knowledge Test ISO 9001:2015

10 things that everyone should know

1. What does the revision of ISO 9001 mean for your organisation? 

It’s actually been a long time since the standard was last revised with any significance and a lot has changed in that time. The potential organisational impact of the revised ISO 9001 is dependent upon how your organisation and incorporated QMS has evolved in time. Factors such as

• the maturity and complexity of the existing ISO 9001:2008 management system,
• the existence of other management systems (such as ISO 13485),
• the global environmental management system standard (i.e. OHSAS 18001), and
• the organisation’s current evaluation and management of risk

will all heavily influence in the degree of change that your organisation will need to undertake in order to meet the requirements of the ISO 9001:2015. 

2. Annex SL

The introduction of Annex SL, which establishes a consistent structure featuring 10 clauses as well as common terminology and definitions applicable to all ISO Management System Standards (MSS), is probably the biggest change to the ISO 9001:2015.  As organisations begin to understand and appreciate the value of different management systems all speaking a common language, thereby making MSS integration easier,  it will be organisations and - and in turn the consumer - who stand to be the true beneficiaries.

3. Process-Based Approach

The ISO 9001:2015 contains many references across several clauses to organisations placing a greater emphasis on applying a process-based approach to their management system. 

4. Risk-Based Approach

The incorporation of Annex SL into ISO 9001:2015 now drives a risk-based approach to thinking and acting. The requirements under a risk-based approach affect quality planning and now incorporate much of what was previously referred to as “Preventive Action”. Now an organisation will need to determine the risks and opportunities that need to be addressed to give assurance that the QMS can achieve its intended results.  Many organisations already have risk-based thinking and planning in many parts of their organisation which may or may not have been connected to the QMS in the past. This greater focus on risk will mean that an organisation will need to demonstrate how this requirement is met. The extent and formality of the approach needed in a particular organisation will - of course - be influenced by its context.

5. Leadership

The requirements relating to the relationship between the role Top Management play in creating and supporting an effective QMS have been enhanced. There are now more areas where Top Management needs to demonstrate their involvement and engagement with the quality management system including accountability for the effectiveness of the QMS and ensuring integrated with the overall business processes.

6. Context of the Organization

This is new and has two distinct elements. 

Firstly, context requires an organisation to determine the internal and external issues and requirements that can impact on the planning of the quality system. Context becomes an important consideration and helps to ensure that the management system is designed and suitably adapted for a specific organisation. This helps provide the right focus, approach and balance to the different elements of the management system rather than the same generic approach across all organisations. 

The second element is  the consideration of relevant interested parties.  There is now a requirement to determine their requirements and ensure these are monitored and reviewed as these now form primary inputs into the design of QMS.

7. Knowledge

An organisation will now need to consider what knowledge it needs to achieve conformity of products and services along with how it will develop, maintain and retain such knowledge.

8. Control of externally provided products and services

Formerly known as Purchasing, this clause has been retitled to make it clear that the requirements apply to both physical product and services related to the end product of the organisation. Whilst not specifically a new requirement, there has always been some confusion around certain categories of externally provided products and services whether this has been through an associate company, joint venture or outsourced activity. Now it is clear that however provided, an organisation will need to apply a risk-based approach and determine the type and extent of controls necessary.

9. Transitioning

Current information from ISO shows that organisations will have three years from publication to transition to the new standard, so they can choose to transition at any point within this period.  Some may choose their next certification cycle, although many will want to be ‘among the first’ given the increased functionality that ISO 9001:2015 will deliver, along with the bonus of a clear commitment to best practice being demonstrated to their interested parties.  Starting the transition planning early, including setting and communicating a transition date will enable you and your organisation to pro-actively manage the transition at your pace.

10. Next Steps

Organisations should start by obtaining a copy of the ISO standard and focus on the areas that are completely new or have been revised. Those are the areas that are likely to be included in any transition plan. Also, make sure that quality managers and internal auditors understand the differences that Annex SL will bring to the QMS and any other management system standards in the organisation. 

Ensure that when selecting a consultancy firm, they not only understand the ISO 9001:2015, but more importantly, understand what this ISO means to the QMS and the wider organisation.  Engage a consultancy firm to find out how a gap analysis and training on specific areas of ISO 9001:2015 can be of benefit to your organisation.

Finally, ask MRM to support you in formalising a transition plan and process and ensure that top management is involved from the start. 

Summary

Remember that the ISO 9001

• is important for any standard
• does have a significant amount of changes through the incorporation of Annex SL’s core text and high level structure.

Qualified Person training Program 

MRM has a program of education for today's quality and regulatory affairs professional. If you want to improve your competence, enroll in our flexible quality and regulatory modules: 

• Module 1 - EU Regulatroy Frameworks
• Module 2 - EU Medical Device Design and Risk Management
• Module 3 - Clinical Evaluation for Medical Devices
• Module 4 - Developing and Maintaining Technical Documentation
• Module 5 - Quality Management Systems for Medical Devices
• Module 6 - Post-Market Surveillance and Vigilance for Medical Devices
• Module 7 - Working with EU Regulatory Stakeholders as Part of the EU Conformity Assessment Process

Who Should Enroll?

• Industry professionals representing product developers, manufacturers, distributors, service providers, entrepreneurs, investors and regulators dealing with medical device products, 
• Whose work responsibilities include the preparation and management of medical device pre- and post marketing submissions to Competent Authorities 
• Who prepare regulatory submissions to Competent Authorities and or Notified Bodies  
• Engineering or life sciences graduates in the early stages of their regulatory careers. 
• Professionals working for regulatory agencies

The MDR proposal will make Post-Market Clinical Follow-up (PMCF) mandatory as part of the clinical evaluation cycle for the device concerned, essentially implementing the PMCF MEDDEV 2.12/2 Rev2.

This is a further degree of harmonization because at the moment there are different approaches implemented in EU Member states.

PMCF is defined as a continuous process to update the clinical evaluation. It is repeatedly stated that this shall be part of the manufacturers’ post-market surveillance plan.

The manufacturer must analyze the findings of the PMCF and document the results in a PMCF - Evaluation Report that will be part of the technical documentation. It has now been proposed to amend this requirement such that this report should be sent periodically to the concerned Member States.

For class III devices and implantables  this report shall be further reviewed by a third party or external expert under the principles of highest scientific competence and impartiality.

 PMCF implies that the requirements for clinical evidence increases substantially and will require an significantly higher investment from medical device manufactures in employing staff who are knowledgeable in (a) regulatory affairs, (b) Good Clinical Practice (GCP) and (c) clinical investigation design in order to work with and interpret clinical studies. By hiring or employing a person responsible for regulatory compliance this QP is able to communicate with Competent Authorities and Notified Bodies.

Post Market (Clinical) Surveillance / Follow-Up

• Post-market follow-up, ... is a continuous process ... and shall be part of the manufacturer's post-market surveillance plan.
• To this end, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device, which is authorized to bear the CE marking, within its intended purpose ... with the aim of confirming the safety and performance throughout the expected lifetime of the device, the continued acceptability of identified risks and to detect emerging risks on the basis of factual evidence.

MDR - Post Market Clinical Follow-Up

•  '... PMCF shall be performed pursuant to documented method laid down in PMCF plan ...'
  • 'specify general methods and procedures, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data ...'
• 'The notified body shall periodically, at least once every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer applies the approved quality management system and the post-market surveillance plan.'

Elements of Post Market (Clinical) Surveillance / Follow-Up => Post Market Surveillance Plan - Content

• The plan shall define the source of data and the means to collect those data and shall be proportional to the risk of device/device family.
• The plan may include:
  • Complaints Handling;
  • Return Products Analysis
  • Vigilance Reports
  • Literature Review
  • Registry Review
  • PMCF
  • Regulatory Feedback

If you would like to maximize your QP / AR services, please contact  us via This email address is being protected from spambots. You need JavaScript enabled to view it..  

Global medical device market regulators are asking manufacturers of medical devices to provide a Free Sales Certificate (FSC) what is showing that their devices are adequate CE marked and approved for sale in Europe. Your FSC must be presented to local authorities as part of your registration process. In many situations your FSC must have an apostille or must be legalized by the Ministry of Foreign Affairs and by the local Embassy

A FSC will be issued by the Dutch Competent Authority upon request by us as assigned Authorized Representative on behalf you as medical device manufacturer.

This according to the European Medical Device Regulations: Directive 93/42/EEC and the In-Vitro Diagnostic Directive 98/79/EC.

To get the FSC for MDD and IVD devices, two conditions need to be met:

• The device must bear the CE Marking
• The manufacturer has appointed a European Authorized Representative for his device

If the device(s) are CE marked, but not properly notified/registered with the European Authorities by the appointed European Authorized Representative (as required by Law for MDD Class I and IVD devices), the CE Marking is NOT valid and therefore the Free Sales Certificate cannot be issued!

If we act as your EU Authorized Representative we need to receive the following information

• Description, intended use and risk classification of the device
• Name and type of the device
• Declaration of Conformity
• Valid CE Certificate and QMS Certificate
• Background information about the manufacturer
• Name and contact details
• Production Site
• 'Certicate of Insurance' 

If we are not appointed as your Authorized Representative yet we'll support you to transfer your AR contract to MRM.

In many situations your FSC need to have also an Apostille, something what is included in our FSC serves. 

Establishment Registration

Medical Device Listing

In een 7-stappenplan structureren en implementeren we een kwaliteitmanagementsysteem (QMS). De organisatie bepaalt de norm op basis waarvan zij het QMS wil opbouwen. Dit kan ofwel ISO 9001:2015 ofwel ISO 13485:2016 zijn. Het stappenplan is vooral gericht op de zelfwerkzaamheid van de organisatie om het draagvlak van een QMS te optimaliseren. Het plan kent de volgende stappen:

1. Doel en reikwijdte
2. Nulmeting
3. Processen in kaart brengen
4. Processen vastleggen + kwaliteitsniveau
5. Start verbeterprojecten
6. Uitvoeren van audits
7. Continue aanpassing van de organisatie

Wat levert het U op?

Een goed functionerend en geïmplementeerd QMS op basis van de door u gekozen norm, al dan niet gecertificeerd.

Meerwaarde aanpak MRM

Het 7-stappen heeft zich in de praktijk al bewezen. Dat betekent dat voor u er geen tijd en geld verloren gaat met het zoeken naar de juiste weg.

In goede samenwerking met het management en kritische proceseigenaren wordt het QMS opgebouwd en geïmplementeerd in uw organisatie. Dit zorgt voor een breed draagvlak en biedt een goede basis voor een succesvol certificatietraject.

The sponsor of a clinical investigation - who is not established in the EU - has to appoint a natural or legal person inside the EU as his 'Legal Representative'. As professional full service provider (with medical and clinical expertise in house) we're looking forward to act for you as 'Legal Representative' as defined in MDR Article 62.2 and (EU) Clinical Trial Regulation 536/2014.

After accepting ‘Letter of Authorization’ we

• unlock the EU to your clinical studies
• provide representation to your medical device study
• cover representation as enforced by the General Data Protection Regulation (GDPR)
• verify your compliance with applicable obligations
• will be seen by the authorities as liaison in the communication with you as sponsor.

Please contact our office for more information: This email address is being protected from spambots. You need JavaScript enabled to view it.

Via our strategic partner in the US we're able to support you with US Agent Service. Please contact us if you need more information.

US Agent

Every company that is involved with production or distribution of medical devices intended for the USA (manufacturer, packager, exporter, importer, specification developer, etc) must: register with US FDA, list the devices by category, and if foreign, must have a US Agent.

Each year by December 31st, each registered company must renew its registration.

Economic Operators:

Contract Manufacturer

Manufactures a finished device to another establishment's specifications.

Contract Sterilizer

Provides a sterilization service for another establishment's devices.

Foreign Exporter

Exports or offers for export to the United States (U.S.), a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the United States. A foreign exporter must have an establishment address outside the U.S.

Initial Distributor

Takes first title to devices imported into the U.S. An Initial Distributor must have a U.S. address.

Manufacturer

Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in Section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

Repackager

Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).

Relabeler

Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.

Reprocessor of Single Use Devices

Performs remanufacturing operations on a single use device.

Specification Developer

Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.

U. S. manufacturer of export only devices

Manufactures medical devices that are not sold in the U.S. and are manufactured solely for export to foreign countries.

Via our strategic partner in the US we're able to support you with US Agent Service. Please contact us if you need more information.

US Agent

Every company that is involved with production or distribution of medical devices intended for the USA (manufacturer, packager, exporter, importer, specification developer, etc) must: register with US FDA, list the devices by category, and if foreign, must have a US Agent.

Each year by December 31st, each registered company must renew its registration.

Establishment Registration

Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA. This process is known as establishment registration. Registration provides FDA with the location of medical device manufacturing facilities and importers. The regulations for establishment registration are provided in 21 CFR 807. All establishment registrations must be submitted electronically unless a waiver has been granted by FDA. Congress has also authorized FDA to implement a user fee for certain types of establishment registrations processed after September 30, 2007. Your registration is not considered complete until FDA has been notified that all requirements have been met.

Establishment

Any place of business under one management at one physical location at which a device is manufactured, assembled or otherwise processed for commercial distribution.

Owner / Operator

The corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registering establishment. The owner/operator is responsible for registering the establishment.

Registration of an establishment is not an approval of the establishment or its products by FDA. That is, it does not provide FDA clearance to market. Unless exempt, premarketing clearance or approval is required before a device can be placed into commercial distribution in the U.S.

Misbranding by Reference to Establishment Registration Number: Title 21 of the Code of Federal Regulations, Section 807.39, states, "Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding." Product labeling and Internet sites cannot reference your establishment registration number or make reference to your establishment being registered or approved by FDA. If your product labeling or Internet sites list your establishment registration number or makes reference to your establishment being registered and approved by the FDA, then these references must be removed.

Who Must Register

Manufacturers

An owner/operator of an establishment not exempt under 21 CFR 807.65 who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a medical device intended for commercial distribution (marketing) is required to register. This includes manufacturers, contract manufacturers and contract sterilizers that place the device into commercial distribution, specification developers, repackagers or relabelers, reprocessors of single-use devices, remanufacturers, U.S. manufacturers of export only devices, and manufacturers of components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose (that is, manufacturers of components or accessories that are intended to be sold or leased directly to the end user.)

Initial Distributor

An initial distributor (or importer) takes first title to the devices imported into the U.S. and further distributes the devices. Initial distributors/importers are required to register. However, they are NOT required to list the devices that they import.

Foreign establishments (manufacturers and exporters)

Foreign establishments that manufacture, prepare, propagate, compound, or process a device that is imported, or offered for import, into the U.S. are required to register their establishments. This includes contract manufacturers and contract sterilizers. Foreign establishments must also list the devices that they export to the U.S.

Definitions of establishment activities are provided below. Prior to registering your establishment, please review the definitions and determine what type of activities your establishment is performing. Please note that most establishments are also required to list their devices.

Please note that the following groups are not required to register:

• Wholesale distributors of devices who do not manufacturer, repackage, process or relabel a device. A "wholesale distributor" is defined as any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.
• Refurbishers and domestic distributors.

Establishment Registration Fee

The following types of establishments are required to pay the establishment registration fee to the US FDA:

• Device manufacturers Contract sterilizers Contract manufacturers Single-use device reprocessors Specification developers.
• US Agent for Foreign Establishments
• All foreign establishments must advise and notify FDA of the name, business name, address, phone number, and email address of their designated US Agent.

Responsibilities of US Agent

The responsibilities of the US Agent include:

• assisting FDA in communications with the foreign establishment,
• responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and
• assisting FDA in scheduling inspections of the foreign establishment.

If the FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the US Agent, and such an action shall be considered equivalent to providing the same information or documents to the foreign establishment.

• The US agent has no responsibility to report adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or to submit Premarket Notifications [510(k)] (21 CFR Part 807, Subpart E)
• The US Agent must be designated at the time of electronic submission of establishment registration information.

When to Register

Domestic establishments must register within 30 days of the establishment entering into any activity requiring registration, including processing devices for exportation outside of the U.S. If you are required to list your devices, you must submit device listing information at the time of initial registration.

Foreign establishments must register, notify their US Agent, as well as list their devices prior to exporting to the U.S.

Your registration must be renewed annually each year. The registration period extends from October 1st through September 30th.

How to Register

In September, 2007, Section 207 of the Medical Device User Fee Modernization Act of 2002 (MDUFMA) amended section 510 of the Federal Food, Drug and Cosmetic Act (the Act) to require electronic submission of device registration and listing information unless FDA grants a waiver request. MDUFMA also authorizes FDA to collect a user fee for annual registration of certain types of establishments. Effective October 1, 2007, all establishment registrations are to be submitted electronically using FDA’s Unified Registration and Listing System (FURLS), unless a waiver has been granted by FDA.

Note:

If you are required to list your devices, you must submit that information at the same time as you submit establishment registration information. Establishments must register within 30 days after entering into any activity requiring registration or prior to importing or exporting a device.

Establishments must pay their establishment registration fee and receive notification from FDA that their payment has been received by December 31 of each year for their registration to be considered active and current for the fiscal year (October 1st through September 30th). It can take up to two weeks for your payment to be processed. You are not considered registered for the new fiscal year until FDA has notified you that your payment has been received.

Updating Registration Data

All registration information must be verified annually between October 1st and December 31st of each year. Establishments must pay their establishment registration fee by December 31 of each year for their registration to be considered active and current for the fiscal year (October 1st through September 30th).

Definitions of establishment activities

Contract Manufacturer

Manufactures a finished device to another establishment's specifications and places the device into commercial distribution. (Please note that contract manufacturers are also required to list their devices).

Contract Sterilizer

Provides a sterilization service for another establishment's devices and places the device into commercial distribution. (Please note that contract sterilizers are also required to list the devices sterilized at their establishment).

Foreign Exporter

Exports or offers for export to the United States, a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the U.S. A foreign exporter must have an establishment address outside the U.S.

Manufacturer

Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

Re-Manufacturer

Processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance, safety, specifications, or in any way changes the intended use.

Repackager and / or Relabeler

Repackager: Packages finished devices from bulk or repackages devices made for the establishment by a manufacturer into different containers (excluding shipping containers).

Relabeler: Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.

Initial Distributor / Importer

Takes first title to devices imported into the United States. An initial distributor must have a U.S. address.

Specification Developer

Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment's name by a contract manufacturer.

Reprocessor of Single-Use Devices

Performs remanufacturing operations on a single-use device.

U.S. Manufacturer of Export Only Devices

Manufactures medical devices that are not sold in the U.S. and are offered solely for export to foreign countries.

Frequently Asked Questions

How much does registration cost? Appropriate fees are charged annually.

How long is my registration valid? Each establishment registration is valid for one fiscal year. Firms must complete their annual registration establishment requirement each year for the registration to be valid.

Does registration or device listing fulfill my Premarket Notification 510(k) requirements? No. The establishment registration and device listing requirement is a separate requirement from the Premarket Notification 510(k) submission process. See Device Advice for information on how FDA regulates devices including how to submit a 510(k).

I am a distributor located outside the U.S. Do I have to register? Yes, foreign exporters must register their establishment, list the devices exported to the U.S., and identify the designated US Agent.

Are foreign dental and optical laboratories required to register and list? Yes, foreign dental and optical laboratories are required to register and list. They are not exempt from registration and listing. The exemption in 21 CFR 807.65(i) only applies to domestic establishments.

My establishment only does design work. Am I required to register the establishment? Company owned design facilities must register. That is, if a manufacturer owns a manufacturing facility and a separate facility for design work, both must register. Third party design facilities (design contractors) are not required to register. The manufacturer that contracts out the design work is responsible for maintaining the design control documentation in accordance with 21 CFR 820.30.

In addition to registration, foreign companies must also designate a qualified U.S. Agent.

<< Content copyright US FDA and obtained from the US FDA website at www.fda.gov >>