ISO Systems Explained

Steps to Gaining ISO Accreditation 

To begin your journey, you should download the most up to date version of your ISO to get a basic understanding of the requirements. 

Every ISO will at least require some form of Quality Management system as well as a point person with the responsibility AND authority to implement and maintain any such system.

Each Quality System will include at least the following elements..

  • Quality manual - Policies and Procedures
  • Staff  Hire / Induction / Training and other Records
  • Internal / External Audit Management
  • Document Control
  • CAPA System
  • Risk Analysis / Register System
  • Supplier / Customer Contracts

While it is not technically difficult to achieve most ISO accreditations, there is significant work involved for the technical manager and other people involved.

Structure and Commitment

Without a defined structure or framework within which to work, it will be very difficult to implement any ISO compatible QMS (Quality Management System).

Equally if you only view ISO Accreditation as a tick box exercise without a commitment to making it a central part of the day to day running of your business, it will be difficult to maintain the QMS correctly.

Here is the bare minimum of what will be required.

  • Have a responsible person tasked with implementing and maintaining the QMS.
  • Create a GAP analysis between what exists and any ISO requirements.
  • Create a defined, flexible QMS structure that works for your business.
  • Create a clear roadmap for your ISO roll out.
  • Decide early on how you will handle document control and approval.
  • Create all necessary documents and procedures required by the ISO.
  • Decide how you will conduct internal audits.
  • Make the ISO QMS a central element of running your business.
  • Maintain all records in an easily retrievable fashion.

Senior management must be fully committed to the principals of ISO and not just give it lip service. This is fundamental to success.

    ISO Services

    Need Assistance in Gaining ISO Accrediation?

    We have considerable experience in ISO Accreditation and Software Services to support this.

    We have built bespoke systems covering all aspects of any ISO Accreditation, Quality Manuals, Internal / External Audit system and records maintenance.

    • Digital Quality Manual Systems
    • Digital Staff Records
    • Digital KPI Monitoring systems
    • Digital CAPA Systems
    • Digital Risk Analysis and Risk Registers