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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 businesses. 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 it is that 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 will be common across other standards. These are:

  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 business. To become certified, you must:

  1. Become compliant to the standard by working through the policies and procedures within the standard and applying them to your organization’s practices.
  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. This is the final external audit to achieve certification by an accredited Registered Certification Body (RCB). This is not a requirement but is recommended as certification validates your ISO9001 compliance.

Click here to find out more about choosing the right RCB for your organisation.

How can CertiKit help?

Our ISO9001 Toolkit is an effective way to put a QMS in place quickly and achieve certification to the standard. Our Toolkit comes with 12 months of updates and support, helping you get your organization to certification fast. You can download a free sample document to begin your compliance journey today!

Over 3000 businesses have purchased our toolkits

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