CJ & L Consultancy Ltd – Business Management Service

Services

• Operational Excellence guidance

  I collaborate with you to define your vision and translate it into actionable steps for your business. Whether it’s focused tasks in specific areas or large-scale transformation projects, I identify ways to enhance your business while actively involving your teams and guiding them through the changes. My focus is on improving operations and value chains. I design clear strategies, build effective structures, and foster the essential skills and behaviours needed within your organization. I assess the following areas: Internal Cost Reduction: I leverage data to understand cost drivers within your business, identifying sustainable ways to reduce costs. Unlike random cost-cutting, I focus on strategic approaches that align with long-term goals. Target Operating Model (TOM): The TOM is a roadmap designed to enhance business performance. I target five key areas: core business processes, technology, organizational structure and leadership, workforce and culture, and data, metrics, and KPIs. By addressing these areas, I gain a deep understanding of your business and drive lasting cost savings. Operational Excellence: Operational excellence fosters a culture of continuous improvement. It integrates enhancements into your company’s core to support strategic goals. My approach incorporates Lean thinking principles, emphasizing employee involvement to drive meaningful change. Performance Management: My performance management solution aligns processes, people, and technology to strengthen your business strategy. I focus on key strategic areas and collaborate with you to implement small daily changes that lead to significant improvements. This ensures the organization follows a plan-do-check-act cycle, enabling data-driven decision-making and promoting behaviours that align with your strategy. Lean and Process Improvements: I apply a systematic approach to eliminate waste in manufacturing or office operations. Using proven Lean tools, I work with you to identify and remove non-value-adding activities, optimizing processes and reducing costs.

• Information Security Management System (ISMS)

  Information Security Gap Analysis: My ISMS Gap Analysis offers organizations an overview of their security posture. This is achieved through interviews and documentation reviews. Will also give a detailed report of findings and recommendations. Duration varies based on the organization’s size and industry, allowing for tailored service. ISMS Implementation Support for ISO27001: Want to implement an information security management system like ISO27001? provide support to guarantee your ISMS is efficient and robust. With a hands-on approach, I will save you time, labour, and stress in planning and executing your ISMS. I also guide you through the ISO27001 certification process. Information Security Policies and Procedures: Comprehensive policies and procedures are essential for maintaining your ISMS and protecting your organisation. Many organisations’ struggle with the resources needed to create this documentation. I will support in drafting tailor-made policies focused on your organisation’s IT gaps.

• Quality Management System

  No matter which ISO certification you require—whether ISO 9001, ISO 13485, or PS 9000—our services are here to support you in: Developing new Quality Management System (QMS) processes and documentation that comply with all relevant regulations to achieve certification for your site. Revising your existing QMS to align with ISO 13485 and ISO 9001 standards, while ensuring compliance with country-specific regulations, such as MDD, MDR, IVDD, or IVDR, facilitating your medical device’s market entry. Enhancing audit compliance by performing gap analyses of your current systems. Simplifying and consolidating your QMS to reduce complexity, giving you greater clarity and confidence in your processes. Offering guidance and support in implementing an electronic QMS (eQMS) within your organization. Starting with system registration and ensuring ongoing system maintenance, allowing you to focus on other critical business areas.

• Medical Device and Technical Compliance

  If you’re working on Design History Files for the first time, we’re here to assist. This includes support for Product Summary Files and Medical Device Technical Files. Whether you need help with updates or ongoing maintenance, we’re ready to help. With extensive experience collaborating with various Notified Bodies, we can support you in: Facilitating global market registrations to help your medical device reach a broader audience and connect with those who will benefit from it. Creating and maintaining technical documentation to ensure your devices remain compliant. Conducting a gap analysis and updating technical files to align with the UK Medical Device Regulation, as well as ensuring compliance with EU Regulations 2017/745 and 2017/746. Developing documentation for risk management, design, and development to meet your QMS requirements. Preparing clinical evaluation plans and reports to confirm your medical devices comply with MDR 2017/745 and IVDR 2017/746, which is essential for their sale in Europe and obtaining CE and UKCA markings. Developing post-market surveillance plans and reports to reassure customers of the safety and efficacy of your device.