What are the first three new clauses in the ISO 9001:2015 standard?

When your business is ISO 9001 certified, you’re used to continual improvement – after all, it’s what ISO 9001 is all about. You have to be continually assessing and reflecting, building and improving your business.

Otherwise, you aren’t unlocking the true potential and value of your organisation to capture the essence of what ISO9001 adds.

ISO standards are continually improving and evolving with the times, making sure they still provide value to businesses and workplaces.

So what are the new clauses? In this blog post, we will run you through the first three.

Clause 4. Context of the Organisation

This is a new requirement and requires you to think about your business and the world around it.

Context of organisation

You don’t need documented information specifically defining the context of your organisation, but it is a key step in understanding your business holistically.

There are four sub-clauses which can help you and your business improve your existing processes:

Clause 4.1. Understanding the organisation and its context

We’ll break this one down for you: when transitioning to the updated standard, the following steps should be taken to have a clear understanding of your business:

  • Identify internal and external issues.
    • Internal issues are those which impact how the organisation works (e.g. contracts, relationships with stakeholders).
    • External issues are those which impact on the organisation (e.g. government regulations, economic changes and changes in technology).
  • Identify internal and external parties and their needs.
  • Document the context of the organisation in either a new or existing quality manual.
  • Regular monitoring and review.

Clause 4.2. Understanding the needs and expectations of interested parties

After completing step one you’ll have a framework of your business, and the issues around it. From this, you need to begin understanding the needs of your stakeholders.
These can range from your employees and customers to regulatory bodies and the government.

Take the time and work through each of the interested parties, identifying their needs and expectations.

Clause 4.3. Determining the scope of the QMS

This is essentially outlining what your business is about, and why. This will vary by the type of business you work in, but this should be the overarching goal and purpose your business is working towards.

Clause 4.4. QMS and its processes

This clause relates to the processes your business has and sets out the high-level requirements your business will have with respect to designing the management system.

Clause 5. Leadership

Leadership was previously about management responsibility, however, as workplaces have changed the focus has changed to relate to teamwork and work communities.

Clause 5.1. Leadership & commitment

This sub clause relates to leadership’s commitment to ensuring the quality management system is a success. This involves taking responsibility for its success and effectiveness.

Clause 5.2. Quality Policy

The quality policy sub clause relates to the creation of quality policy and the communication around developing and using the policy. This quality policy needs to align with the strategic direction of your business.

Clause 5.3. Organisational roles, responsibilities & authorities

Organisations are made up of people with various roles and responsibilities. This clause relates to the communication and management of those roles. Leadership must ensure everyone is aware of the role they play in the business, with the aim of delivering the high-quality outputs outlined by the business.

Clause 6. Planning

Clause 6.1. Actions to address risks and opportunities

Risks and opportunities are one area of the standard which has experienced a major overhaul. This particular clause relates to the plans and systems which need to be developed in order to achieve business goals while maximising opportunities.

Clause 6.2. Quality objectives and planning to achieve them

This clause directs businesses to look at their long-term goals, and create plans and strategies to ensure they achieve those goals. This includes creating SMART goals and sharing this with your team

Clause 6.3. Planning of changes

Things will change – this much is inevitable. A business must be prepared for these changes, and consider how to deal with them.

As you can see, there are several changes to the latest ISO 9001 standard. QMS can help you with the transition to the ISO 9001 update, just contact us today for more information.
checklist for ISO9001