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What is ISO 9001?

ISO 9001 is the international standard for quality management which maps out what is needed to implement a quality management system. The purpose of this is to improve your organisation’s overall performance and provide a sound basis for sustainable development initiatives. ISO 9001 certification can provide many benefits for both the organisation and its customers. It is suitable for all types of organisations regardless of size, location or sector. 

ISO 9001 was initially known as BS5750, developed in 1987, known then as the quality assurance standard. It was designed to help organisations meet the needs of customers and stakeholders while also meeting regulatory requirements relating to products and services. The latest version is ISO 9001:2015, which is a similar layout to the previous one, ISO 9001:2008 in that it follows a plan, do, check, act model in a process-based approach. The main development is the focus on risk-based thinking.

Need support implementing ISO 9001?

The expert consultants at Assent Risk Management can support you during your whole ISO Management System Implementation project.

Key Themes of Quality Management

  • Customer Feedback
  • Resource, infrastructure and work environment
  • Design & Development Processes
  • Purchasing & Outsourced Requirements
  • Quality Objectives & Continual Improvement

Quality management systems allow you to better align and integrate numerous management standards, and adopt a risk-based approach,  becoming a preventative action tool. It moves away from prescriptive paperwork and assists all types of organisations in improving customer satisfaction and building a sustainable future. 

What does ISO 9001 look like?

There are 10 clauses, most of which overlap with other standards in the Annex SL structure (a structure of clauses designed to help integrate standards together). The key requirements to be aware of are:

  • A Quality Policy
  • The Control of Processes
  • Identifying Interested Parties
  • Identification and Planning to Address Risks and Opportunities
  • Objectives
  • Planning of Changes
  • Support
  • Operational Control
  • Design and Development
  • Control of External Providers
  • Production and Service Provision
  • Performance Evaluation
  • Non-Conformance Management

Our FREE Knowledge Base has over 20 ISO 9001 documents to help support your ISO implementation including; how to manage Non-Conformances & Actions in ISO 9001:2015, how to Obtain Customer Feedback for ISO 9001:2015, how to document the Design & Development Process for ISO 9001:2015 and Quality Management System Objectives for ISO 9001:2015. 

Need Help?

An experienced consultant can help you work through your project, translating the jargon, adapting existing processes to meet the requirements of the standard and providing support to help the project run as smooth as possible.

Who needs to be involved?

Your whole organisation should be aware of the QMS, as they all have a part to play in making sure that it does what it should. In particular, top-level management must be actively involved (even if they delegate individual tasks), as they retain overall responsibility for the success of the QMS.

Most organisations appoint an individual or team of people to manage the QMS on a day-to-day basis, and sometimes this involves the support of an external quality consultant. This person or group of people take the main responsibilities for ensuring the standard’s requirements are met, that processes are functioning as they should and that any issues are handled appropriately and in good time.

Some requirements can also be shared out among individuals, allowing those with the knowledge and experience to help maintain the system. For example, sales and business development teams often assist with the Interested Parties related requirements, line managers can help identify Objectives, and everyone can follow an issue reporting process to identify and properly manage non-conformances and improvements.

If you have been tasked with implementing an ISO 9001 Quality Management System but need support, contact us.

How long will it take?

How long it takes to properly implement a QMS and achieve certification really depends on the organisation. It is essential to have adequate resources such as individuals to manage the QMS, the time to do the things that need doing, and the support of everyone in the organisation.

However, as a guide, we suggest a comfortable amount of time is 6-9 months. At a minimum, the QMS must have been fully active for 3 months before you can achieve certification, as certification bodies require a full 3 months of evidence for auditing purposes.

Still have questions?

If these requirements sound like the kind of project your organisation could benefit from, but you aren’t sure quite where to start, a quality consultant can assist you.
Get in touch with us to discuss how our qualified and experienced ISO 9001 consultants can provide guidance and support to see you through your ISO journey comfortably.

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