Rephine Barcelona Achieves ISO/IEC 17020 Accreditation for GMP and GDP Audits
We are pleased to confirm a significant milestone. Rephine Barcelona S.L. now holds ISO/IEC 17020 accreditation as an inspection body for specific GMP and GDP audit activities. In addition, the accreditation carries the number 626/EI961. ENAC, Spain’s official national accreditation body, granted it, and it continues to monitor us through ongoing surveillance.
For the quality and compliance teams who rely on our reports, this means more than a new certificate. An independent authority has examined how we work. It looked at how we select our auditors, how we protect our impartiality and how we run our inspections. It then assessed all of this against an international standard. After all, when you rely on someone else’s audit, you rely on their judgement. So the credentials behind a report matter as much as the report itself.
What is ISO/IEC 17020?
ISO/IEC 17020 is the international standard for the competence, impartiality and consistent operation of inspection bodies. Accreditation against it means something specific. An independent national accreditation body has assessed the organisation against those requirements, and it keeps assessing over time.
In practical terms, the standard examines three things. First, it checks whether the people performing inspections are genuinely competent. Second, it checks whether the organisation stays independent enough to report what it finds. Third, it checks whether we apply the inspection process the same way every time. For audits in regulated life sciences, a client should ask exactly these questions of any provider.
What Rephine's accreditation covers
The accreditation covers specific GMP and GDP audit activities within a defined scope, under ENAC number 626/EI961. It does not cover every Rephine service, audit or group entity. We think it is important to say so plainly.
Our auditors also carry out audits outside the accredited scope, and they apply the same internal standards. However, we do not deliver those audits under the accreditation. As a result, we will always tell you which one applies to your work. ENAC publishes the full accredited scope, and we can send it to you on request.
Why ISO/IEC 17020 accreditation matters when you rely on a third-party audit
When you accept a third-party audit report, you rely on findings you did not witness yourself. Accreditation therefore gives you independent proof that the provider stayed competent, impartial and consistent. Here is what that means in practice.
Auditor competence you can evidence
Sometimes you need to show who audited your supplier and why they qualified for the work. In that case, we have already documented the answer, and an independent body has reviewed it. ENAC checks whether our auditors hold the right qualifications, training and experience for each inspection. It also confirms that we can demonstrate this for every individual auditor.
Impartiality you can rely on
Accreditation requires us to demonstrate our independence in how we structure and run the business. For example, we check for any commercial relationship between an auditor and the auditee before each audit. This follows EMA recommendations. Where a relationship exists, a different auditor takes the work, so the findings reflect what the auditor actually saw.
Consistency across every report
We define our methodology and apply it the same way across different countries. Our accreditation assesses that methodology too. As a result, you receive the same standard of report whoever does the work. Your findings stay comparable across your supplier base and from one year to the next.
Evidence for your supplier qualification file
When you rely on a third-party audit report, you also need to satisfy yourself that the provider could produce it. Our accreditation gives you exactly that independent evidence. A national accreditation body issued it, more than 100 countries recognise it, and ongoing surveillance keeps it current.
In practice, you can reference it directly in your qualification file, and we will supply whatever documentation your process needs. That might include scope details, certificates, auditor qualification summaries, or a self-assessment questionnaire that we complete for you.
Recognised beyond Spain
ENAC is Spain’s official national accreditation body. More than 100 countries recognise its accreditations through mutual recognition arrangements between national accreditation bodies. This reach matters when your supply chain and your regulators sit in different jurisdictions. As a result, the credential travels well beyond the country that issued it.
How ISO/IEC 17020 differs from ISO 9001
Rephine holds both ISO/IEC 17020 and ISO 9001:2015, and the two credentials cover different ground. ISO/IEC 17020 addresses how we inspect. It covers technical competence, impartiality and the inspection process itself. ISO 9001 addresses how we run as an organisation. It covers document control, complaint handling and continual improvement. Both our UK team in Stevenage and our Spanish team in Barcelona hold ISO 9001:2015. They work under a single global quality management system. Together, the two standards cover both the work and the organisation doing it.
| Aspect | ISO/IEC 17020 | ISO 9001:2015 |
|---|---|---|
| What it governs | How we inspect | How we run as an organisation |
| Core focus | Auditor competence, impartiality, inspection process | Document control, complaint handling, continual improvement |
| Assessed by | ENAC (national accreditation body) | Certification body |
| Applies to | Specific GMP and GDP audit activities in scope | The whole quality management system |
What this means in practice
- Reports that travel: we produce reports under processes that an accreditation body has assessed.
- Evidence for your file: you can reference our documentation when you record how you qualified your provider.
- International recognition: more than 100 countries recognise the accreditation through mutual recognition arrangements.
- Comparable findings: you get the same methodology and reporting standard across auditors, sites and years.
- Assurance that continues: ongoing assessment keeps the accreditation current, so the standard holds over time.
Ask us about our accreditation
If you are qualifying Rephine as a supplier, you may need the accredited scope, certificates or auditor qualification details for your file. Just ask. It is a fair question, and we would rather you asked it than assumed.
Frequently Asked Questions
What is ISO/IEC 17020?
ISO/IEC 17020 is the international standard for the competence, impartiality and consistent operation of inspection bodies. Accreditation against it means an independent national accreditation body has assessed the organisation against those requirements.
Is every audit Rephine performs now accredited?
No. The accreditation covers only the audit activities within its scope. We perform other audits to the same internal standards, but we do not deliver them under the accreditation. We will always tell you which one applies.
What exactly does Rephine's accreditation cover?
It covers specific GMP and GDP audit activities within a defined scope, under ENAC number 626/EI961. It does not cover every Rephine service, audit or group entity. ENAC publishes the full accredited scope, and we can send it on request.
What is ENAC, and does the accreditation count outside Spain?
ENAC is Spain’s official national accreditation body. More than 100 countries recognise its accreditations through mutual recognition arrangements, so the credential reaches far beyond Spain.
How does the accreditation help us qualify Rephine as a supplier?
It gives you independent evidence that your audit provider stayed competent, impartial and consistent. A national accreditation body issued it and keeps it current, so you can record it directly against your supplier qualification requirement.
Can Rephine provide documentation for our supplier qualification file?
Yes. Tell us what your process needs, and we will send it. That includes scope details, certificates, auditor qualification summaries or confirmation of the accreditation.
