There are two type of organizations in the EU that remanufacture single use medical devices (SUD) manufactured by ‘original equipment manufacturers’ (OEM):

1)        Hospitals and other healthcare providers called: reprocessors

2)        Commercial re-processors now called:  remanufacturers.

Not all EU countries allow ‘remanufacturing’ and up to now remanufactured devices did not fall under the Medical Device Directive 93/42/EEC but they will fall under the new Medical Device Regulation (MDR) to be published March 2017.

There are two countries, that we are aware of, that officially allow remanufacturing of single use medical devices:

1)        Germany.  has its  own regulations up to now; and  

2)        UK, who published a new guidance document in June of 2016.

France does not officially allow remanufacturing and the rest of the EU countries do not have formal policies,  but they are aware that remanufacturing is taking place in their countries.

The EU Parliament/ EU Commission decided to deal with this division among EU Member States with the following solutions in the MDR:

a)        EU countries have to decide if they legally allow remanufactured devices in their market or not;

b)        Hospitals and other healthcare providers will need to meet minimum requirements that hopefully will be more specifically outlined in the new regulation when it is published and many hospitals already fear they will be unable to meet these. Their activities are usually referred to as ‘reprocessing’ and the single use devices must be used in the same hospital, they may not be commercially placed on the market; and

c)        Commercial remanufacturers will need to meet the same MDR requirements as the original manufacturer (OEM) including Notified Body certification before they can apply the CE mark.  They must place their own name and trademarks etc. on the remanufactured single use devices.  This is a whole new group of clients for Notified Bodies whose resources to service their existing clients are already stressed.

This all seems very similar to other country’s regulations including US-FDA, Australia etc.

It is the specific guidance documents that are cause for concern. Let’s use the UK MHRA document as an example, you can find  the: Single-use medical devices: UK Guidance on remanufacturing of June 2016, right here:

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/534784/Remanufacture_SUD_guidance.pdf

There are a few sentences in this MHRA document  we would like to draw your attention to:

Page 4 of 11:  Note: all class I medical devices are excluded from this policy. The MHRA considers that Class I products should not be remanufactured as there would be no external or independent assessment of CE mark Compliance.

Page 6 of 11: To maintain traceability of the original manufacturer’s device and as part of the risk mitigation the remanufacturer should consider the need for the inclusion, on the device label and packaging, the original manufacturer’s identifiers, specifically the company name, full address and serial number or unique identifier.

The MHRA has responsibility for ensuring safe products in the UK. We have not considered the intellectual property of the Original Equipment Manufacturer (OEM) or their permission for their name/product being used.

Page 7 of 11: If during remanufacturing of the device a problem is identified and it:

1)        concerns the Original Equipment Manufacturer’s design and

2)        affects the safety of the original device, the remanufacturer should inform the Original Manufacturer of the issue.

We strongly recommend that you, the Original Equipment Manufacturer, read this 11 page UK document in its entirety and discusses with your legal advisors how to protect your intellectual property in the EU. We all need to keep track of any additional remanufacturing of single use devices guidance documents that may be issued on a country-by-country basis in the future.

The definition of Manufacturer means:  

‘the natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under his name or trademark.’

In other words: the entity that markets the device with its name or trademark on the device is the manufacturer! 

Manufacturer’s General Obligations:

(Article 10 of the MDR as published per Q2/2017)

1.        When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation.

2.        Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I.

3.        Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF.

4.        Manufacturers of devices other than custom-made devices shall draw up and keep up to date technical documentation for those devices.  The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed.

The Technical documentation shall include the elements set out in Annexes II and III.

The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in the light of technical progress, the Annexes II and III.

5.        Manufacturers of custom-made devices shall draw up, keep up to date and keep available for competent authorities documentation in accordance with Section2 of Annex XIII.

 6.        Where compliance with applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than custom made or investigational devices, shall draw up an EU Declaration of Conformity in accordance with Article 19, and affix the CE marking of conformity in accordance with Article 20.

7.        Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 27 and with the registration obligations referred to in Articles 29 and 31.

8.        Manufacturers shall keep the technical documentation, the EU Declaration of Conformity and, if applicable, a copy of any relevant certificate, including any amendments, and supplements, issued in accordance with Article 56, available for the Competent Authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market. In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market.

Upon request by the competent authority, the manufacturer shall, as indicated therein, provide the technical documentation in its entirety or a summary thereof.

A manufacturer with a registered place of business outside the Union shall, in order to allow its authorized representative to fulfill the tasks mentioned in Article 11 (3) ensure that the authorized representative has the necessary documentation permanently available.

9.        Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation.

Changes in device design or characteristics and changes in the harmonized standards or CS by reference to which the conformity of a device is declared shall be adequately taken into account in a timely manner.

Manufacturers of devices, other investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.

The quality management system shall cover all parts and elements of a manufacturer’s organization dealing with the quality of processes,  procedures and devices.  It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this regulation.

The quality management system shall address at least the following aspects:

(a)      a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;

(b)      identification of applicable general safety and performance requirements and exploration of options to address these requirements;

(c)       responsibility of the management;

(d)      resource management, including selection and control of suppliers and sub-contractors;

(e)      risk management as set out in Section 3 of Annex I;

(f)       clinical evaluation in accordance with Article 61 and Annexes XIV, including PMCF;

(g)      product realization, including planning, design, development, production and service provision;

(h)      verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and insuring consistency of information provided in accordance with Article 29;

(i)        setting-up, implementation and maintenance of a post-market surveillance system in accordance with Article 83.

(j)        handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders;

(k)       processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;

(l)        management of corrective and preventive actions and verifications of their effectiveness; and

(m)     processes for monitoring and measurement of output, data analysis and product improvement.

10.      Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article 83.

11.      Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an Official Union language(s) determined by the member State in which the device is made available to the user or patient.

The particulars on the label shall be indelible, easily legible, clearly comprehensible to the intended use or patient.

12.      Manufacturers who consider or have reason to believe that a device which they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate.  They shall inform the distributor of the device in question and, where applicable, the authorized representative.

Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities of the Member States in which they made the device available and, where applicable, the notified body that issued a certificate for the device in accordance with Article 56, in particular, of the non-compliance and of any corrective action taken.

13.      Manufacturers shall have a system of recording and reporting of incidents and field safety corrective action as described in Article 87 and 88.

14.      Manufacturer shall upon request by a Competent Authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official EU language determined by the member state concerned.

The competent authority of the member state in which the manufacturer has its registered place of business may require that the manufacturer provide samples of the device free of charge or, where that is impracticable, grant access to the device, manufacturers shall cooperate with a competent authority, at its request, on any corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market or put into service.

If the manufacturer fails to cooperate or the information and documentation is incomplete or incorrect, the competent authority may, in order to ensure the protection of public health and patient safety, take all appropriate measures to prohibit or restrict the device’s being made available on its national market, to withdraw the device from that market or to recall it until the manufacturer cooperates or provides complete and correct information.

If a competent authority considers or has reason to believe that a device has caused damage, it shall upon request, facilitate the provision of the information and documentation referred to in the first subparagraph to the potentially injured patient or user, as appropriate, the patient’s or user’s successor in title, the patient’s or user’s health insurance company or other third parties  affected by the damage caused to the patient or user, without prejudice to data protection rules and, unless there is an overriding public interest in disclosure, without prejudice to the protection of intellectual property rights.

The competent authority need not comply with the obligation laid down in the third subparagraph where disclosure of the information and documentation referred to in the first subparagraph is ordinarily dealt within the context of legal proceedings.

15.      Where manufacturers have their devices designed or manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 30(1).

16.      Natural or legal persons may claim compensation caused by a defective device in accordance with applicable EU and national law.  (In other words: adequate Product Liability insurance is obliged!)

Manufacturers shall, in a manner that is proportionate  to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under directive 85/374/EEC, without prejudice to more protective measures under national law.

As professional EU Authorized Representative service provider we’re looking forward to support you in your efforts to be in compliance with the EU regulatory requirements! Please contact us.

January 21, 2017

A French court ordered European Notified Body TUV to pay 60 million euros ($64 million) in compensation to 20,000 women who received defective breast implants that the group had approved.

TUV Rhineland was ordered to make a provisional payment of 3,000 euros to each plaintiff for certifying that implants made by French firm Poly Implant Prothese (PIP) met safety standards.

In the far-reaching health scandal, the devices were later found to contain substandard, industrial-grade silicone gel that was seven times cheaper than medical-grade silicone.

“The final amount will be determined after an assessment, but (TUV) is required to make a provisional payment of 3,000 euros” per person, said lawyer Laurent Gaudon, representing 7,000 women.

Another lawyer Olivier Aumaitre, representing some 13,000 women, praised the commercial court of Toulon for a ruling he said was inevitable given “TUV’s glaring negligence”.

TUV’s lawyer Cecile Derycke said the firm would appeal the latest ruling in a long-running saga.

The court “persists in ignoring very clear elements of the PIP dossier that establish that (TUV Rheinland) fulfilled its mission of a certifying body with diligence and full conformity with applicable regulations,” she said in a statement.

The Toulon court in 2013 ordered TUV to pay 53 million euros to six foreign distributors of the implants as well as 1,600 users.

But an appeals court later overturned that decision, saying that TUV had fulfilled its obligations as a certifying body and could not be held responsible for failing to detect PIP’s cover-up.

The company maintains it was never its job to check the actual implants, and their task was only to inspect the manufacturing process.

The court said that if TUV staff had carried out “the slightest unannounced inspection… the fraud would have been easily detected.”

The scandal made global headlines in 2011, the year after doctors first noticed abnormally high rupture rates in the implants.

Some 300,000 women in 65 countries, most in Latin America, are believed to have received the faulty implants.

PIP’s founder, Jean-Claude Mas, was convicted of fraud and sentenced to four years in jail in 2013, confirmed on appeal in 2016.

PIP implants scandal in numbers

• Some 400,000 women affected in 65 countries
• 4,000 reported ruptures
• PIP exported 80% of its implants, with half going to Latin America
• 42,000 British, 25,000 Brazilian, 15,000 Colombian, 30,000 French, 16,000 Venezuelan women received PIP implants
• 15,000 French women have had their PIP implants removed under instruction from the government
• 5,000 women registered as plaintiffs in the PIP trial
• 1,700 women registered in the TUV Rheinland trial

Source: Agence France-Presse

Although preliminary MDR and IVDR requirements are well known by notified bodies for a long time, many challenges within these notified bodies can be identified. An important challenge is the internal capacity to serve their clients after the publication of the MDR and IVDR. A lack of clinical expertise and a proper understanding of the medical claim in the assessment teams of the notified bodies is still a recognized issue. Further, the administration of some significant registrars and or notified bodies is today still an Achilles. A new style of supervision by competent authorities and accreditation institutions will creating a new style of bureaucracy, will decrease the flexibility among notified bodies and or registrars further. These developments will influence expected service level by their clients: manufacturers of medical devices and critical (supply chain) partners.

The impact of the MDR demands more clinical data.  This means more investments for SME companies. We’ve developed and invested in a special service program for small companies to organize and to perform clinical evaluations, to validate their devices on i.e. safety, performance, usability. We do have independent medical professionals, i.e. cardiologist, under contract to be able to support you in the communication between you and your notified body and or national competent authority.

The consequence of the MDR and IVDR implies more resources and investments by the economic operators. At this moment the real cost picture of the CE marking process after the adoption of the MDR or IVDR does know multiple factors. MRM is able to support you in this process to identify creative solutions.

The Brexit will bring a lot of uncertainties for many economic operators active in the medtech niche who’re depending on UK based notified bodies and Authorized Representative service providers. MRM does have the infrastructure to support these economic operators on such way to the continuity is guaranteed.

2017 is going to be a memorable regulatory year within the medical device field. As we want to highlight  a few major issues that will affect manufacturers of ALL medical device risk classifications

Risk Class I medical devices and self-certifiable In Vitro Diagnostic devices(IVD):

• The era of Risk Class I devices and IVD’s not being subjects to audits is over. The National Competent Authorities (NCA’s) decided that in the absence of Notified Body audits for these devices they will be performing Compliance Inspections at the EU manufacturing level or at the Authorized Representative level for non-EU manufacturers.
• The audits focus on completion of technical files. While the audits are friendly enough, they are performed for the purpose of enforcement. No remediation period is extended to address any non-compliance issues, it leads to immediate fining. Several companies are already on the receiving end of fines varying from 50,000 to 150,000 Euros.
• This makes inspections for Risk Class I devices and self-certifiable In-Vitro Diagnostics by the NCA’s tougher than audits by a Notified Body for the higher risk classifications.     

Notified Body changes:

• Notified Bodies are no longer friendly commercial organizations that you contract with to audit your compliance with the Medical Device or In-Vitro Diagnostic Directives.  Under the new  medical device regulations (MDR) they change to for profit enforcement agencies.
• Notified Bodies are under extreme pressure preparing for the new Medical Device and In-Vitro Diagnostic Regulations (MDR / IVDR) set to be published as of April of 2017. There used to be 83 Notified Bodies, as of this month there are only 53.  Further reduction is expected.
• Notified Bodies need to hire and train auditors and staff with higher competence and higher expertise, resulting in higher salaries roughly estimated at 50%. Leading to higher costs for manufacturers.
• In an attempt to find new staff and auditors Notified Bodies are ‘stealing’ auditors from each other or from industry. Industry is looking for replacements of lost knowledgeable staff members and is ‘stealing’ personnel from Notified Bodies . Competent Authorities and the European Commission are also looking for more staff members. The big problem is that medical experts are not exactly looking for new jobs and are happy where they are.  This is going to create a BIG Shortage of Notified Body services …

Summary:

• This is not the time to consider a change in Notified Body. Manufacturers perceived as ‘problem accounts’ will most likely be ‘cancelled’ or ‘not renewed’ by Notified Bodies. Applying to a different Notified Body will be most difficult if not impossible especially for SME’s. There is no recourse for the resulting loss of EU sales. These agencies simply do not owe manufacturers a path to a CE certificate.
• The best prevention is tough internal audits that do not leave findings for Notified Body auditors or National Competent Authority inspectors!
• 2017 will be the ‘regulatory enforcement and change’ year in European Union!

(September 2015)

This updated guideline Meddev 2.7/2 revision 2, includes nine new appendices to support the validation and assessment processes of clinical investigations. The updated guideline states that clinical investigations should generally be 'designed, conducted and reported' either in accordance with the EN ISO 14155 (Good Clinical Practice requirements for medical device clinical trials) or to comparable standards, and in compliance with the Declaration of Helsinki and other national regulations.

The updated guideline:

• Contains several new terms for which clear definitions have been provided. Some of these definitions will be adjusted later on when the Commission finalizes changes to its existing guidance Meddev  2.7.1.
• Outlines procedures/documents/information that are of primary, but not exclusive importance for validation and decision-making with regard to ethical considerations of a device trial.
• Describes considerations on which validation process (i.e. the administrative review) should be based. During the validation process the guideline states that national competent authorities should assure, among other things, that the investigational product qualifies as a medical device, and that the sponsor provides a rationale for the given classification of the device. In addition, the outlining the basic information that manufacturers should submit in their validation application, the guideline also lists 'additional documentation/information that competent authorities usually required to comply with national regulations'.
• Outlines the steps to be followed for the assessment of clinical investigation applications to ensure that the essential requirements applicable to the investigational medical device, apart from those which are to be examined in the clinical investigation, are correctly identified and fulfilled (i.e. use of relevant harmonized standards).
• Explains the types decisions that a national competent authority might issue based on the outcome of the validation and/or assessment process. In cases where an objection letter is issued, the guideline states that it should contain specific information required of the manufacturer in a resubmission in order to address the grounds for objection.
• Describes the types of actions that national competent authorities can take while a clinical investigation is ongoing and the types of action that sponsors shuld take when they terminate or temporary halt a trial.

Ondersteuning bij implementatie ISO 13485:2015

Productenten en gelieerde organisaties van medische hulpmiddelen en of biotechnologie worden steeds meer geconfronteerd met striktere eisen vanuit de Europese en Amerikaanse wetgeving. Een goed en stabiel kwaliteitsmanagement is van belang om in staat te zijn om nieuwe eisen effectief en efficiënt te implementeren. Een voorbeeld hiervan zijn de nieuwe ISO 13485 die wellicht ergens in kwartaal 2 van 2016 gepubliceerd zal worden. In deze periode zal dan ook de nieuwe Europese medische richtlijnen van kracht worden (MDR en IVDR). Overgangsperiode voor de ISO 13485 en de MDR zal drie jaar zijn. Nieuwe eisen zijn bijvoorbeeld UDI, PMCF, scrutiny procedure.

MRM kan u ondersteuning bieden tijdens dit transitieproces.  

ISO 13485:2016 & MDR

Zowel de 'nieuwe' ISO 13485:2016 en de MDR brengen significante wijzigingen met zich mee! Door tijdig en proactief de nieuwe eisen in uw management en product systeem te implementeren zal tot gevolg hebben dat uw organisatie succesvol geïnspecteerd zal worden door onze nationale overheden (bijvoorbeeld IGZ) en notified bodies. Hiermee bent u dan verzekert dat de CE markering van uw producten aantoonbaar aan de nieuwe eisen voldoen. Het risico dat uw CE en of ISO certificaten opgeschort worden weet u zo te voorkomen.

GAP Analyse

Indien gewenst verrichten we graag een GAP analyse, zodat U

• in staat bent om eventuele omissies vast te stellen,
• duurzame verbetertrajecten kunt initiëren, en
• nodige kennis en expertise in te huren om u te ondersteunen.

We bieden een service programma die uw organisatie helpt bij ontwikkeling, implementatie en onderhoud van een robuust kwaliteitmanagementsysteem.

Waarom MRM?

We hebben meerdere organisaties ondersteund bij het opzetten, en het onderhouden van kwaliteitsmanagementsystemen. We zijn in het bijzonder gericht op de gezondheidszorg, biotechnologie en medische technologie.

Door onze doelgerichte praktische benadering door onze adviseurs met deskundige kennis van de markt zijn we in staat om ons te onderscheiden. We hebben de ambitie om duurzame oplossingen te bieden, zodat uw investeringen terugverdiend worden. Juist door deze benadering kan het voorkomen dat we minder competitief zijn, maar onze oplossingen wel duurzamer en effectiever zijn.  

We zijn overtuigd dat de door ons ontwikkelde methodologie van het overdragen van kennis en expertise naar uw medewerkers en organisatie werkt. Daarom accepteren we onder bepaalde condities 'no cure no pay'. 

(Tailor-Made)

Together with our CRO-partner in Lisbon (Potugal) we offer tailor-made trainings to meet the needs of different group of clients. Depending on the project we can also combine training sessions with consultancy services in developing research projects. 

Training courses can take different formats:

• On-site courses
• Individual courses
• Workshops
• Courses accompanied by consultancy
• Post-grad or master’s modules
• Seminars and lectures during congresses and meetings

Course venues:

• At your company or the location of your choice anywhere in the world.
• Eurotrials classrooms in Portugal, Brazil, Chile or Argentina

Examples of tailor-made courses:

• Development of Scientific project training programme
• Biostatistics in SPSS with interpretation of scientific articles
• Interpretation and presentation of clinical study results: clinical study reports
• Quality of life scales
• Sample size in polynomial and logistic regression analysis in health research
• Key points in the design of a clinical study in a real-life setting
• Statistical methods: the assessment of an abstract
• Writing and reviewing scientific articles
• Clinical epidemiology in multiple sclerosis: analysis and interpretation of scientific publications results
• Site Capacity building and coordination of clinical research
• Basic tools in the interpretation, construction and presentation of statistical results
• Good Clinical Practices training
• Good Clinical Practices training: refreshment
• Clinical Trial– current and future legal framework
• Interpretation of effect measures in clinical trials
• Principles in statistical analysis in clinical studies
• Clinical research centres: new challenges

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

Zie tekst Engelstalige versie voor toelichting.

NB Trainingen kunnen zowel in het Nederlands als ook in de Engelse taal gegeven worden.

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.