UK Responsible Person

QCS International

QCS International, a subsidiary of PHSC plc, is a registered UK Responsible Person (UK RP) with the Medicines and Healthcare Products Regulatory Agency (MHRA). They specialize in assisting manufacturers located outside the UK to export medical devices into the UK market. With over 15 years of experience in medical device regulations, QCS International ensures compliance with the amended UK Medical Devices Regulations 2002 (UK MDR 2002) and post-Brexit regulatory requirements. Their service is cr

The UK Responsible Person (UK RP) for this directory listing is the Home Office. As a key UK government department, the Home Office is responsible for a wide range of public services including immigration, security, and law and order. Their media presence is managed through official channels, including the 'Home Office in the media' blog, which provides updates on home affairs-related stories, official statements, and ministerial comments. This blog serves as a primary source for news reviews, responses to breaking news, and rebuttals to inaccurate reports. The Home Office also maintains a dedicated media enquiry service for journalists. This service provides a news desk for inquiries, operating during specific hours with an out-of-hours option for urgent matters. It is important to note that the press office is unable to answer calls from members of the public, directing them to alternative contact methods for specific services like UK Visas and Immigration or general public inquiries.

About

**Who they are**
QCS International, established in 1987, is a UK-based specialist in management system consultancy and training, part of the PHSC plc group. They focus on helping organizations establish, implement, and maintain management systems, particularly in relation to ISO standards.

**Expertise & scope**
* Expertise in medical device projects.
* Consultancy services for system development and certification.
* Auditing services for various management systems including Quality, Environmental, Information Security, Health & Safety, Medical Devices, and Energy Management.
* Support for UK Responsible Person (UK RP) requirements.
* Training courses covering foundational, practitioner, and professional levels.
* Development and implementation of Q-Hub Online Management System.

**Reputation / proof points**
* Over three decades of experience in operations and maintenance services for windfarm owners (Shetland Aerogenerators case study).
* Consultants are members of CQI and registered management system auditors with IRCA.

Additional information

QCS International provides comprehensive auditing services, which can be focused on a single standard or integrated across multiple standards. They emphasize that having an effective internal audit system is a requirement for gaining and retaining certification. For organizations struggling with internal resources, QCS offers to complete these audits on their behalf. All audits are conducted by IRCA-certified auditors, providing assurance that management systems conform to both internal and ISO standard requirements. Detailed audits are presented as a driver for overall business improvement and system certification maintenance.

Key Highlights

  • Established in 1987, QCS International has over three decades of experience in management system consultancy and training. Source
    “Established in 1987, QCS International has grown to become one of the UK’s leading management system consultancy and training specialists.”
  • Consultants are members of CQI and registered management system auditors with IRCA. Source
    “All of our consultants are members of CQI and all are registered management system auditors with IRCA.”
  • Offers comprehensive auditing services for Quality, Environmental, Information Security, Health & Safety, Medical Devices, and Energy Management systems. Source
    “We offer comprehensive audit services for various management systems, including Quality, Environmental, Information Security, Health & Safety, Medical Devices and Energy Management.”

Certifications & Trust Signals

  • Part of the PHSC plc group, indicating a larger corporate structure and potential for broader resources. Source
    “part of the phsc group”

Buyer Snapshot

Best for
  • Organizations seeking ISO certification or maintenance.
  • Companies needing assistance with audit and non-conformance closure.
  • Businesses requiring support for UK Responsible Person mandates.
How engagement typically works
  • Assigned consultant for project delivery.
  • Project lead for progress tracking and expert resource access.
  • Client-centric approach fostering continuous improvement.
Typical deliverables
  • Management system development and certification.
  • Auditing services (internal and external).
  • Training programs.
  • Outsourced system management.
  • Guidance on legal compliance.
Good to know
  • Best when organizations require specialized expertise in ISO management systems and regulatory compliance.
HQ: United Kingdom, UK
Languages: English
Timezones: GMT
Status: listed

Services & Capabilities

Best UK Responsible Person (UKRP) | Compare & Get Quotes

Jurisdictions: UK
Countries: UK
Industries: Medical Devices, Pharmaceuticals, Biotech
Onboarding time: 7–21 days
Pricing model: Custom pricing
Supports GB: Yes
Supports NI: No
MHRA Support: No
Can Be Named On Label: No
MHRA Portal Support: No
Vigilance Support: No

Additional uk_rp Details

Device Classes Supported
Not explicitly stated, but expertise in medical device projects is mentioned.
Supports MDR
Not explicitly stated, but expertise in medical device projects is mentioned.
Supports IVDR
Not explicitly stated, but expertise in medical device projects is mentioned.
Supports GB
Yes, coverage is UK.
Vigilance Support
Not explicitly stated.
Post Market Support
Not explicitly stated.
UK Entity Country
Not explicitly stated, but based in Cumbernauld, Scotland.
Onboarding Steps
Enquiry form completion, followed by contact from a team member.
Request quotes
Cruxi - Regulatory Compliance Services