For medical device and pharmaceutical employers
Competent, current and safe is not optionalIt is written into every standard you answer to
Your nurse advisors and clinical educators teach NHS staff, sign off their competence and support product evaluations on live wards. The regulator, the industry codes and your own quality system all expect you to be able to evidence that they do it safely. The Industry Nurse Professional Standard™ is how you show it. Team enrolment opens in January 2027.
The problem nobody owns
The obligations moved into industry with your nurses. The structure around them did not.
A registered nurse who joins your company is still accountable to the Nursing and Midwifery Council (NMC) for everything they do. In the NHS, a ward manager, a practice educator and a clinical governance team kept that accountability visible and evidenced. In your organisation, none of those roles exist for them.
So when a trust, an auditor or a code panel asks how you know your nurse was competent to teach, assess or advise, what do you show them? Product training records and a sales appraisal do not measure professional practice.
- No ward manager
- No practice educator
- No clinical governance team
- No professional supervision
The values and principles set out in the Code can be applied in a range of different practice settings, but they are not negotiable or discretionary.The Code, Nursing and Midwifery Council
The Code applies to nurses “bringing their professional knowledge to bear” in roles such as education and leadership, not only in direct care. That includes every nurse you employ.
What the rules already say
Five sets of rules. One question at audit: show me the evidence.
Every quotation below is taken word for word from the published source, listed at the foot of this page. None of these bodies names the Industry Nurse Professional Standard, and none requires a particular course. What each one does require is that you can show your people are competent. That is the gap the Standard fills.
The NMC Code and revalidation
Applies to every NMC-registered nurse you employ, in every role.
Binding on the nurse. Your company is part of how they meet it.
“maintain the knowledge and skills you need for safe and effective practice”The Code, clause 6.2
“complete the necessary training before carrying out a new role”The Code, clause 13.5
“Where possible, your confirmer should be your line manager. Your line manager doesn’t have to be a NMC-registered nurse or midwife.”NMC revalidation guidance, Confirmation
What it means for you
Every three years your nurse must show 450 practice hours, 35 hours of Continuing Professional Development (CPD) including 20 participatory, practice-related feedback and written reflections. The NMC’s first choice of confirmer is their line manager, which in industry is often a sales or marketing manager with no framework for judging nursing practice. Moving from the ward to industry is a new role: clause 13.5 asks for the training to come first.
How the Standard evidences it
A scope-of-practice statement, structured feedback from at least six learners, and a reflective account worked through the Code, all from the nurse’s real role. A dedicated lesson covers revalidation from an industry role, including who may act as confirmer.
Care Quality Commission (CQC) regulations
Applies wherever your organisation is registered with the CQC to carry on a regulated activity, for example a nurse-led clinical homecare service.
Binding on the registered provider in law.
“ensuring that persons providing care or treatment to service users have the qualifications, competence, skills and experience to do so safely”Regulation 12(2)(c), Safe care and treatment, Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
“receive such appropriate support, training, professional development, supervision and appraisal as is necessary to enable them to carry out the duties they are employed to perform”Regulation 18(2)(a), Staffing
“be enabled to provide evidence to the regulator in question demonstrating, where it is possible to do so, that they continue to meet the professional standards”Regulation 18(2)(c), Staffing
What it means for you
Regulation 18 puts the duty on the employer, not only the nurse: you must provide professional development and supervision, and you must enable your registered staff to evidence to the NMC that they still meet its standards. A product course does neither.
How the Standard evidences it
Competence is assessed in a real setting and observed by a workplace assessor against twelve domains. The portfolio gives the nurse documented evidence of professional practice they can take into revalidation.
The ABPI Code of Practice
The Association of the British Pharmaceutical Industry (ABPI) Code, administered by the Prescription Medicines Code of Practice Authority (PMCPA). 2024 edition.
Binding on pharmaceutical companies that have agreed to it.
“Companies are responsible under the Code for the acts and omissions of their personnel which come within the scope of the Code, even if they act contrary to the instructions which they have been given.”Supplementary information to clause 5.2
“All personnel (and others retained by way of contract) must be fully conversant with pharmacovigilance requirements relevant to their work, and this must be documented.”Clause 9.2
“Representatives must be given adequate training and have sufficient scientific knowledge to enable them to provide full and accurate information about the medicines which they promote.”Clause 9.3
What it means for you
If your nurse advisor’s teaching drifts into promotion, the company is answerable, even if they were told not to. Adverse event awareness must be documented for everyone, nurses included. A nurse who calls on health professionals in relation to the promotion of medicines meets the Code’s definition of a representative (clause 1.19).
How the Standard evidences it
A full module on education versus promotion, a twelve-domain review of a real training deck, and a workplace observation that includes the clinical and commercial boundary. Reporting routes and escalation have a module of their own.
The ABHI Code of Ethical Business Practice
The Association of British HealthTech Industries (ABHI) Code for medical technology companies. The edition ABHI publishes, dated July 2019.
A condition of ABHI membership.
“The safe and effective use of health technology and Related Services requires Member Companies to offer Healthcare Professionals and Healthcare Organisations appropriate instruction, education, training, service and technical support.”ABHI Code, Safe and Effective Use of Health Technology
“Member Companies shall ensure that personnel conducting the Product and Procedure Training and Education Events have the appropriate expertise to conduct such training.”ABHI Code, Product and Procedure Training and Company Organised Education Events
What it means for you
The Code links training directly to safe use, and places the duty on the company to ensure its trainers have the appropriate expertise. Knowing the product is one kind of expertise. Knowing how to design, deliver and assess clinical education inside the NHS is another, and it is the one most often assumed rather than evidenced.
How the Standard evidences it
The whole educator core: a training needs analysis and plan for a real clinical area, a delivered session with learner feedback, and an observed session, all assessed. Training is built for the ward, not the classroom, and aligned to the Instructions for Use (IFU).
ISO 13485 and your quality system
ISO 13485:2016, Medical devices, Quality management systems. Clause 6.2, Human resources.
Audited by your certification body.
“Does the organization have documented process (es) for establishing competence, maintaining competence, providing needed training, and ensuring awareness of personnel?”National Standards Authority of Ireland (NSAI), ISO 13485:2016 certification questionnaire, clause 6.2
What it means for you
Clause 6.2 asks you to set the competence needed for work that affects product quality, train for it, check the training worked and keep records. A clinical educator who teaches NHS staff to use your device, and who is often the first to hear when something goes wrong with it, is doing exactly that kind of work. Product training alone does not show they are competent to do it.
How the Standard evidences it
An assessed eight-piece portfolio that works as a competence record, plus modules on documentation and Instructions for Use, and on how clinical feedback should travel into the quality system when commercial pressure gets in the way.
Why this is a safety issue
Four moments where your nurse’s judgement reaches a patient
These are the points in an ordinary week where an industry nurse acts with real clinical consequence, and where the Standard tests them hardest.
Moment one
Signing off NHS staff as competent
When your nurse signs a competence record, a trust may rely on it to let staff use a device on patients. The Standard asks what they are actually signing, whether the decision is theirs to make, and how they avoid bias when they assess staff on a product they sell.
Module 10, evidence E4. One real competence assessment, planned, carried out and recorded.
Moment two
Running a product evaluation on a live ward
Four different activities get called a “trial”. Each sits under different rules, and some bring in the Medicines and Healthcare products Regulatory Agency (MHRA) or the Health Research Authority. Getting the classification wrong can put patients into research that was never approved.
Module 12, evidence E8. A full evaluation protocol with the research classification justified.
Moment three
Hearing about harm or a near miss
The nurse on the ward is often first to hear that something went wrong. Whether it reaches the Yellow Card scheme and your quality system depends on whether they recognise device-related harm and know where they sit in the reporting chain.
Module 13. Recognising harm, reporting routes, Field Safety Notices and the route into the quality system.
Moment four
Teaching that turns into promotion
Commercial interest can distort education without anyone intending it: an unbalanced claim, an image that contradicts the IFU, a deck that is out of date. Clinicians act on what they were taught.
Modules 6 and 8, evidence E2. A real deck reviewed against a twelve-domain rubric.
Requirement to module
Where each requirement is covered, and the evidence it leaves behind
Fourteen modules over three stages, plus an eight-piece portfolio built from the nurse’s real job. Every piece is checked by the people who saw the work: the learners, a workplace assessor and a final recorded professional discussion.
What your organisation gets
Evidence you can stand behind in a governance conversation
- One consistent framework for every nurse advisor and clinical educator in your team, instead of whatever each one brought from their last NHS post
- Three independent sources of evidence for each nurse: the nurse, their learners and a workplace assessor
- A portfolio built from real work in your clinical areas, with your products, not invented case studies
- NMC registration checked at enrolment and again at completion
- A clear answer when a trust, an auditor or a code panel asks how you know your nurses are competent
Mapped to and informed by NMC standards. Not an NMC-approved programme. Does not confer NMC revalidation and does not certify fitness to practise. It does not replace your sector’s Code examination, Code training or credentialing for site access.
For quality, compliance and medical directors
The questions your directors will ask
Does any regulator or code require this specific course?
No, and we will not claim it does. The NMC Code, the CQC regulations, the ABPI and ABHI Codes and ISO 13485 each require competence, training or documented awareness. None names a course. The Standard is a way to meet and evidence those requirements for the registered nurses in your team, in a way product training cannot.
Does it replace the ABPI examination or our Code training?
No. The ABPI representatives examination (clause 9.4) and your sector’s Code of Practice training are separate requirements. The Standard sits alongside them and covers what they do not: how a registered nurse practises, teaches, assesses and evaluates inside NHS settings.
Will it count towards our nurses’ revalidation?
The Standard does not confer NMC revalidation. It does produce the kind of evidence revalidation asks for, including participatory learning, practice-related feedback and a written reflection against the Code, which the nurse may choose to use. The NMC leaves the choice of CPD to the registrant.
How much time does it take out of the field?
Three stages over roughly nine to twelve months part-time. The taught content is self-paced online, there is one face-to-face day, and the portfolio is built from work your nurse is already doing.
Can we enrol a whole team, and pay by invoice?
Team enrolment is by enquiry. Email contact@elevateandthrive.uk with the number of nurses and how you would like to be invoiced, and we will come back to you.
Team packages
Packages for your whole team, priced by team size
Every package includes the full Standard and twelve months of Medical Sales Hub access for every nurse. Pricing is for the whole team, not per person, and is sent on request.
1 to 5
nurses
Email for pricing
6 to 10
nurses
Email for pricing
11 to 20
nurses
Email for pricing
21 or more
nurses
Email for pricing
Every package includes, for every nurse
- All fourteen modules across the three stages, each with a knowledge assessment
- The eight-piece evidence portfolio, assessed, with the scenario paper and the recorded professional discussion
- The face-to-face day, with a facilitator and other nurses
- Twelve months of Medical Sales Hub access, including the clinical section
- Twelve months of programme access and a Certificate of Achievement on successful completion
For NMC-registered nurses only. Registration is checked at enrolment and at completion.
Industry Nurse Professional Standard™
Give your nurses the standard they are already held to
Fourteen modules, one face-to-face day, and a portfolio built from their real role, verified by the people who saw them do the work.
For NMC-registered nurses only. Registration is checked at enrolment and at completion.
Sources
Every quotation on this page was checked against the published source on 20 October 2026. ISO 13485 is a paid standard, so its requirement is quoted here as it appears in a certification body’s published audit questionnaire.
- Nursing and Midwifery Council. The Code: read the Code online. Introduction and clauses 6.2 and 13.5.
- Nursing and Midwifery Council. Revalidation requirements: confirmation; practice hours; CPD.
- The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. Regulation 12 and Regulation 18, legislation.gov.uk.
- Prescription Medicines Code of Practice Authority. 2024 ABPI Code of Practice: Introduction, clause 1.19, clause 5.2 and supplementary information, clause 9.
- Prescription Medicines Code of Practice Authority. Clause 9 Training, 2024 interactive Code.
- Association of British HealthTech Industries. ABHI Code of Ethical Business Practice, July 2019, via ABHI Code documents.
- National Standards Authority of Ireland. ISO 13485:2016 technical questionnaire, clause 6.2.