Your Guide to Expert Certification in Quality Management
At CJ & L Consultancy Ltd, we provide expert, flexible, and cost-effective consultancy services designed to support your business across multiple domains—Quality Management Systems, Medical Device Compliance and Information Security. With over 20 years of experience, we partner with organisations to achieve regulatory compliance, enhance operations, and drive long-term value.
Flexible Engagement Models
We understand that every business has different needs and budgets, which is why we offer:
- Pay-as-you-go support, giving you access to expertise when you need it most.
- Fixed daily rates, ideal for consistent budgeting.
- Project-based pricing, for initiatives with defined scopes and timelines.
No matter which model you choose, you’ll receive dedicated support from start to finish, ensuring the success of every project or initiative.
For further information on how we can support your business, please feel free to either set up a first 30 minute call via Calendly on the link below or using the contact page fill out the form and we will respond as soon as received:
Quality Management Systems (QMS)
No matter which ISO certification you require—ISO 9001, ISO 13485, or PS 9000—we support you in:
Developing new QMS processes and documentation that comply with all relevant regulations to achieve certification.
Revising and aligning existing systems with ISO 13485/ISO 9001 standards, while addressing country-specific regulations (MDD, MDR, IVDD, IVDR) for smooth market entry.
Conducting gap analyses to enhance audit readiness and compliance.
Simplifying and consolidating your QMS for increased clarity and efficiency.
Supporting electronic QMS (eQMS) implementations, from system selection and registration to ongoing maintenance.
Medical Device & Technical Compliance
Full support for medical device documentation and compliance needs, whether you’re working with Design History Files, Product Summary Files, or Technical Files. We can assist with:
Global market registrations, helping your devices reach broader audiences.
Creating and maintaining compliant technical documentation for all device classes.
Gap analysis and updates to align with UK Medical Device Regulations and EU MDR 2017/745 & IVDR 2017/746.
Risk management and design/development documentation aligned with your QMS.
Clinical evaluation plans and reports, essential for CE and UKCA markings.
Post-market surveillance (PMS) plans and reports, supporting the long-term safety and efficacy of your devices.
Full expert support through Design and Development Phases with a SaMD, from Concept to Market release
Information Security Management System (ISMS)
ISMS Gap Analysis – We evaluate your organisation’s current security posture through stakeholder interviews and documentation reviews. You’ll receive a detailed report with findings and tailored recommendations.
Implementation Support – Planning to implement ISO 27001? We offer practical, hands-on support throughout the implementation and certification process—saving your team time and stress while ensuring your ISMS is strong, efficient, and audit-ready.
Policy and Procedure Development – We help you develop customised ISMS policies and procedures to meet ISO 27001 requirements and address your unique IT security needs. Whether you’re starting from scratch or enhancing existing documentation, we’ve got you covered.
ISO 45001 Implementation Service
Initial Gap Analysis & Planning – We begin with a structured gap analysis to assess your current health and safety practices against ISO 45001 requirements. This includes reviewing existing documentation, processes, risk controls, and legal compliance. From this, we develop a tailored implementation roadmap with clear milestones and responsibilities.
System Design & Documentation – Developing policies, risk frameworks, compliance registers, and reporting procedures.
Training & Awareness – Equipping leaders and staff with the knowledge to foster a culture of safety.
Implementation Support – Embedding processes, coaching auditors, and integrating safety into daily operations.
Internal Audits & Management Review – Ensuring effectiveness, compliance, and continual improvement.
Certification Audit Readiness – Mock audits, documentation reviews, and full support during external certification