Consultancy - QCS International

part of the phsc group

 

System Design and Implementation

Needing help in the development and implementation of your management system? At QCS, we're here to help you every step of the way. Our team will review your existing processes, develop a customised and fully certified management system, and guide you through its implementation. Whether it's ISO 9001:2015 for quality, ISO 14001:2015 for environment, ISO 45001:2018 for health & safety, or ISO 13485:2016 for medical devices, we have the expertise to create integrated systems tailored to your needs

Management systems serve as the backbone of your organisation's operational framework. They encompass the structured processes, policies, and procedures that guide your operations towards achieving objectives and maintaining compliance. These systems provide a clear roadmap for decision-making, risk management, and continuous improvement.

At QCS, we believe that developing a management system involves a holistic approach, integrating the best practices of your industry with your unique organisational culture. Through our 8-stage approach, we collaboratively build and implement a management system that not only meets certification requirements but also enhances your wider business.

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Our unique approach includes:

  • Gap Analysis: We capture what you already do, identify the gaps and then provide you with an easy to understand project plan that we can both work with.
  • System Documentation: We produce a policy, manual and essential procedures and records, in a style and format that fits your organisation. We shall ensure documents relating to the regulatory framework relevant to your product are fully up to date and in compliance with the latest requirements (such as technical files).
  • Procedures & Records: We identify and produce drafts of key procedures and documented information for you to use.
  • Registers: We produce electronic registers to ensure you log all your results in a systematic way to effect ease of analysis. Registers might include, for example, Corrective Actions, Risk and Hazards, Environmental aspects & impacts and Compliance Obligations. For medical devices, it may also include FMEA, supplier information, complaints and vigilance records.
  • Implementation: Regular reviews makes sure that your project is on track and that the system is implemented into your business not your business into the system.
  • Awareness Training: We will design and deliver a tailor-made training course in your company so that everyone is aware of the system and how to use it. This will include elements of training on relevant regulations.
  • System Auditing: We can train you or your team or do your first round of audits for you.
  • Pre-Certification Assessment: A full independent system audit to ensure first time certification.

GET IN TOUCH WITH US

Call or email us today to see how our approach works and for us to provide you with a no-obligation quote...
01236 734447

We also delivery management systems for medical device manufacture

System Design & Implementation Enquiry


Fill out our online form below or call our friendly team for more information on 01236-734447.

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01236 734447

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