ISO 9001 Training Services in Scotland & UK | QCS International

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ISO 9001 – Let QCS Help You

iso 9001

"I enjoyed the course - feel much more confident about internal audits in general. Initially I thought 2 full days would be easy to switch off but there was plenty of interactive content which made it very enjoyable as well as knowledgeable"

ISO 9001 Internal Auditor Delegate

Training courses for ISO 9001 Quality Management Systems

We provide IRCA and CQI certified ISO 9001 training courses to help you achieve various levels of ISO 9001 certification.  Our courses are led by highly trained and qualified experts who teach in an interactive and engaging manner, making your journey to recognition as easy and rewarding as possible. 

We were the first company in Scotland to offer IRCA approved training courses and currently offer the following ISO 9001 training courses.  Upcoming dates and prices can be viewed on these pages:

As well as in house and public training courses, we also offer ISO 9001 consultancy services.

What is ISO 9001?

ISO 9001:2015 is the internationally recognised standard for a quality management system (QMS) of products and services.  Organisations can be certified to this standard to showcase that their products or services are likely to be of a higher quality and meet customer expectations.  It grants businesses the benefit of continuous improvement with a clear drive towards lower costs and improved customer experience.

Benefits of ISO 9001 Training & Certification

ISO 9001 is suitable for businesses of any size, industry, or location.  It provides scalable systems that are just as appropriate in small 2 - 10 employee organisations as they are in global brands.

Being ISO 9001 certified gives clients and customers the assurance that you are not likely to expose them to risk.  Training on implementing, maintaining, and improving your QMS will help you to ensure your products are of consistent high quality for your customers.  It will also provide you with a framework for helping you to understand the key risks you face and to develop strategies to manage them.

Customers with their own ISO 9001 certification often seek out suppliers with this accreditation to ensure that their supply chain works to similar standards.  Having ISO 9001 is often a prerequisite to be on a short list for tenders or proposals - without it you will not even get over the first hurdle.

iso 9001

How to get ISO 9001 Certification

The standard stipulates many and varied requirements that must all be fulfilled in order to achieve certification. It is likely that an organisation will already be fulfilling some of these  (e.g. mechanisms for maintaining the competency of staff, record keeping of customer requirements/orders, and controls that allow you to deliver the goods/services you provide of the correct type and on time).

However, there are some requirements that organisations will find harder to achieve if they are unfamiliar with quality management or the manufacture of medical device products. Gaining certification requires you to self-examine and to commit to improvement in your organisation’s processes. We can help you with this and train your staff to be able to take your certification forward.

We’ve outlined the steps to ISO 9001 certification below.

The first stage will be to review your current arrangements against the clauses of the standard, highlighting any gaps and what you have to do to gain certification.  We can complete this gap analysis for you and supply you with the training and support to deliver the identified actions.

Some gaps can take several months to fill as a certification body will want to see whatever systems you have are operating and that there is evidence that they have been for some time. The types of things you may have to action include:

  • A review of risks and opportunities and how you manage these (including risks associated with manufacture and the use of the medical device)
  • Setting and delivering key business objectives and targets
  • Introducing robust measures for tracing work flow and your products through the production process
  • A mechanism for maintaining equipment and infrastructure
  • A system for dealing with product failures and rework
  • Internal auditing
  • Meetings and review to monitor progress and decide upon next steps
  • Maintaining the work environment (in particular if this is a sterile environment)
  • Working with suppliers

When ready, you invite a certification body to undertake a stage one and stage two audit of your organisation. Stage one reviews the design, structure and elements of your quality management system and stage two seeks evidence that it is working effectively.

There can be up to several months between the stage one and two audits, but it can be just a few weeks if everything has been set up successfully. If all is satisfactory after stage two, you will be awarded certification. Certificates from UKAS accredited bodies are valid for three years.

Unfortunately, being awarded is not the end of the process. ISO 13485 requires a commitment to continual improvement and maintenance of the effectiveness of your quality management system. Your certification body will develop a programme of audits over three years (the frequency of audits depends on the size of your organisation and the risk profile of your product).  Most small businesses have an annual visit.  If there are no significant findings, or if you can resolve them, then you retain your certificate.  Note, unlike other ISO management system certification you may be subject to unannounced audits.

After three years a review is held and, if you have no major non-conformances that signify deviation from the requirements of the standard, a new three-year certificate will be awarded.

QCS only works with companies that are seeking a certificate awarded by a UKAS accredited body. The United Kingdom Accreditation Service (UKAS) is the only body based in this country that authorises organisations to award fully recognised certification to ISO 9001. Non-UKAS bodies exist but some organisations shall not recognise their certificates (be careful who you get your certificate from and for how long you are tied into a contract). If you are unsure what is best for you, then do get in touch.