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What is ISO9001?

The ISO9001 international standard for a Quality Management System (QMS) was published by the ISO in 2015 and is based upon the original British standard BS5750. It details the requirement for certification to the standard.

ISO9001 specifies the requirements that your QMS will need to meet in order for your organization to become certified to the standard. The requirements in ISO9001 are supplemented by guidance contained in ISO9000 and ISO9004 which were published in 2015 and 2018 respectively. ISO9004 is well worth reading as it fills in some of the gaps in understanding how the requirements in ISO9001 should be met and gives more clues about what the auditor may be looking for.

How does implementing a QMS benefit an organization?

There are several benefits of implementing a QMS to small and large organizations. It can help enormously in focusing attention on objectives and being able to base decisions on measured data, rather than rough perceptions.

Other benefits include:

  • Increased customer trust.
  • Continual business improvement.
  • Increased business sustainability.

What is a QMS?

When looking at quality management the emphasis is usually on the processes used to define requirements, design products and services, and provide the things that the organization regards as its core business. These processes tell everyone what to do to deliver products and services to the customer and satisfy requirements.

The ISO9001 standard proposes that we don’t just need a set of processes; we need a Quality Management System. The function of the QMS is to wrap itself around the processes and ensure (among other things) that:

  1. We know what the processes are supposed to achieve (objectives).
  2. We have thought about what could go wrong (risk and opportunity assessment).
  3. Everyone knows their part in operating the processes (roles, responsibilities and authorities).
  4. It is clear that this is the way we do things (leadership and commitment).
  5. We update the processes when things change (management review).
  6. The processes get better over time (continual improvement).

What are the contents of the standard?

The ISO9001 standard consists of major headings which are common across other standards:

  1. Scope
  2. Normative references
  3. Terms and definitions
  4. Context of the organization
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance evaluation
  10. Improvement

Sections 1 to 3 don’t contain any requirements and so an organization wouldn’t be audited against these. We do recommend reading through them as they provide useful background to what the standard is about and how it should be interpreted. Section 0 is the introduction to the standard.

It is sections 4 to 10 that set out the requirements of the standard. These are the compulsory requirements that must be met by an organization to be compliant to the standard in order to achieve certification. If any of these sections within the standard aren’t met, then your business could face a nonconformity raised by the auditor and the organization will need to address it to gain or keep their certification to the standard.

How to become certified

There’s no obligation to go for certification to ISO9001 and many organizations choose to simply use the standard as a set of good practice principles to guide them along the way to running their organization.

For certification, the steps to are similar of all the ISO standards, and involve:

  1. Implementing procedures and methods as requirements of the standard.
  2. Perform an internal audit to highlight any nonconformities before the external audit. We advise an internal audit to be completed by an independent third-party auditor or an impartial qualified auditor within your organisation.
  3. The final external audit to achieve certification is by an accredited Registered Certification Body (RCB). This is in two stages. Stage one is basically a review of how ready you are for the main event, the stage two certification audit. You may pick up a few pointers for improvement (known as nonconformities) at stage two but, if these aren’t too serious, your organization will become certified and can advertise the fact to anyone with an interest.

Once certified, you will then have an annual surveillance audit to confirm your compliance, and then every three years there will be a re-certification audit, which is when you will be re-issued certification.

How can CertiKit help?

ISO9001 is recommended for organizations of any size and industry that want to ensure continual improvement. CertiKit’s ISO9001 toolkit includes more than 50 template documents and guides, and unlimited email support with a qualified consultant. Written by a QMS auditor, the toolkit will help you align to Quality Management System best practise fast and effectively.

Download our ISO9001 implementation guide:

You can find out more information about embedding a QMS by downloading our implementation guide using the form below:

  • Privacy Policy

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    When you request to download our free implementation guide, we use your name, company name (which is optional) and your email address to email you a link to download the requested document. We may also email you after your download in order to follow up on your interest in our products and services. We will do this based on our legitimate interest in marketing to prospects for our products and services. Your name and email address are stored on our website which is hosted with Digital Ocean. Your personal data is stored for one year after you requested your download, after which it is deleted.

 

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Just so you know, we got ISO/IEC 27001-2013 certified in December 2015 (last year) thanks to this toolkit. The best part is that the toolkit had 99% of the text for all documents and some actually were generic enough, just to the point and made me feel as if it was tailored purposely for our environment. You guys do put in a lot of work into your documents and it is always almost ready.

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Reeher LLC

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