ISO 9001 requirements, A clause-by-clause explanation

Companies of all sizes, types and sectors should strive for continuous improvement. It’s increasingly becoming a priority for businesses to do so as it helps them to maintain a relationship of trust and credibility with their customers, whilst actively driving them to improve the level of the products and services they offer.

The ISO 9001 requirements are in place to ensure your organization addresses several key areas – known as the ISO 9001 clauses – to achieve continuous improvement within your quality management system. The 9001 ISO 2015 clauses, when implemented correctly, help your business to successfully ensure a more effective quality management system.

Each of the ISO 9001 requirements is separated into different sections:

1) Organization context

Clause 4 of the ISO 9001 standard is where your business sets out its purpose and strategic direction, in terms of quality of output. Clause 4 covers the following issues:

  • The determining of any factors relating to your business (both internal and external) which could affect the quality of the services you provide.
  • Identifying who the stakeholders in your business are. This can include suppliers, staff and any other interested parties.
  • Understanding the needs of your customers, and how to meet them.


2) Understanding leadership

The ISO 9001 standard recognizes that any effective quality management system will be dependent on the commitment of the senior management of its organization. Clause 5, therefore, requires that the leadership team of your business takes responsibility for the following:

  • Creating a quality management system.
  • Establishing the policies and objectives which inform the quality management system.
  • Being able to communicate these policies and objectives to any employees who are responsible for the quality of the company output (be it products or services).
  • Managing annual reviews to maintain good QMS and address any issues with said QMS.


3) Planning

All effective quality management systems operate on risk-based thinking. This involves putting measures in place to address and identify both risks as well as opportunities. Part 6 of the ISO 9000 clauses are designed to ensure that companies will:

  • Document any potential risks, as well as providing detailed information regarding their severity and chance of occurring.
  • Put a plan in place to reduce or prevent any or all of these undesired effects.
  • Integrate plans to help enhance the potential for desirable effects.


4) Support

Clause 7 of the ISO 9001 standard requires that your organization can provide adequate resources to effectively operate your quality management system. This can include resources which ensure the following are present within the company structure:

  • Effective human resources management
  • An efficient working environment to maximise productivity
  • A robust infrastructure allows the company to flourish.


5) Operations

Within the ISO 9001 2015 clauses, there is a section dedicated to operation (otherwise known as clause 8), which describes the sort of work your company must be able to achieve to develop and deliver your goods/services to your customers. This process should set out:

  • The quality objectives of your products and services, and the requirements they must meet to ensure your customers receive a satisfactory result.
  • The documents, resources and process guides that your employees will need access to be able to successfully create and render your products and services.
  • Any routine inspection, monitoring or testing your company needs to implement to ensure your products and services are of consistently high quality.
  • Any rules which govern the creation and storage of records within your company.


6) Evaluation of performance

The ISO 9001:2015 standard requires your company to be able to demonstrably measure and analyse your processes, with a means to tangibly record the results. This is so that your company can show that it:

  • Conforms to every requirement of the ISO 9001 standard.
  • Ensures that all aspects of the quality management system are applied in full.
  • Supports continuous improvement in quality management throughout the entire organization.


7) Improvement

The last of the ISO 9001 requirements are designed to stress the importance of continuous improvement within an organization. To achieve this, businesses should put measures in place to achieve the following:

  • Improve products and services to help enhance the business.
  • Strive to better match the needs of customers, thereby improving customer satisfaction.
  • Identify areas within the business where current processes are not correctly achieving the goals they were set out to – and update them accordingly.


Difficulties in the implementation of ISO 9001 requirements

Perhaps the biggest difficulty faced by organizations attempting to implement standard requirements is ensuring that the resulting collection of procedures, policies, processes and records will meet the needs of both the company and its customers, while still allowing for the system to be improved upon in the future. System improvement is one of the main reasons why businesses implement a quality management system, as it is specifically designed to benefit the company in the long run.

However large or small your company, gaining ISO 9001 certification benefits your business and the people who work in it. Don’t be put off by the complexities of getting your business ready. If you need advice and guidance, then get in touch with the expert team at CS East, and we can guide you through to full certification.