ISO 9001:2015

Who is “ISO”?

ISO stands for International Organization for Standardisation. Based in Geneva, ISO develop all kinds of international standards covering almost every industry. Over 160 countries are members of ISO, including the UK. You can visit the ISO website here https://www.iso.org/about-us.html

What is ISO 9001:2015?

ISO 9001:2015 is a standard (document) that lists some internationally-accepted, basic rules (requirements) for a model quality system. A copy can be purchased here https://shop.bsigroup.com/ (none affiliate link) *Update* see my blog post on where to buy ISO standards cheaply https://www.kmqualityengineering.co.uk/2019/05/14/where-can-i-buy-cheap-iso-standards/

What is a Quality Management System (QMS)?

Simply put a QMS is a way of organising business processes that affect the quality of your products and services. The aim of a QMS is to consistently meet internal and external customer needs by controlling the core processes that affect them e.g. sales, design, production etc. The requirements for ISO 9001 go beyond the core processes to include support processes e.g. purchasing, maintenance, calibration etc

Do I need a Quality Management System?

Short answer: You already have one, even shorter answer: YES. Long answer: See this blog post –https://www.kmqualityengineering.co.uk/2019/02/28/do-i-need-a-quality-management-system/

What is the ISO 9001:2015 approach?

ISO 9001:2015 promotes the adoption of a process approach when developing, implementing and improving the effectiveness of the quality management system. The quality management system contains all the business processes and the understanding of how the processes interrelate. The benefit of being able to manage and control the interrelationships and inter-dependencies of the processes means organisations have better control over the quality of their overall output (the product/service).

Do I need ISO 9001 certification?

An organisation can have any type of QMS it wants but customers won’t know in advance whether the system is good or bad. What ISO 9001 certification does is to let customers know that your QMS follows a set of rules that are recognised around the world as “good practice”.
Pro’s
• Greater Efficiency and Consistency
• Increased Control
• Marketing benefits to an organisation
• Effective management of risk
Con’s
• It does not guarantee the quality of a product
• Can be expensive
• Can be a lengthy process

Anyone who knows anything about quality management systems and ISO 9001 will have an opinion on whether certification is really needed and there are valid arguments on both sides. The motivation for certification plays a big part too. See this blog post https://www.kmqualityengineering.co.uk/2019/03/08/what-do-you-want-more-the-certification-or-the-quality-management-system/

How does my organisation become ISO 9001 certified?

Believe it or not, any organisation can say their QMS complies to ISO 9001, you could even create a unique accreditation mark and use it on your stationery. Hence the need for certification. Certification (or “registration”) to ISO 9001 is accomplished through regular, recurring “audits” by an independent ISO registrar, who comes on-site and inspects the company’s compliance with the standards.

How do I select a registrar?

The United Kingdom Accreditation Service (UKAS) is the sole national accreditation body for the United Kingdom. If you choose to go down the certification route you need to be mindful when selecting your certification body as not all are UKAS accredited. You can find UKAS accredited certification bodies here https://www.ukas.com/search-accredited-organisations/

Where do KM Quality Engineering fit into all this?

We are neither a registrar nor a certification body. We are people that can support your journey to ISO 9001:2015 certification. We specialise in end to end QMS implementation, quality consultancy and ISO 9001 awareness training. Take a look at an overview of our services here https://www.kmqualityengineering.co.uk/services/