How many clauses are in ISO 9001?

Clauses are requirements written in the quasi-legal language, which can help organisations achieve compliance. In today’s business environment, the spotlight has turned towards auditing management systems to drive compliance, effectiveness and quality.

In simplest terms, auditing can be described as checking an organisation’s management system with the clauses outlined in the chosen standard.

If you wish to obtain the ISO 9001:2015 certification and face no obstacles in the entire certification process, then you need to develop an in-depth knowledge of the clauses of ISO 9001. In this article, we will briefly discuss what each standard contains so that you understand what the standard expects from you and where your Quality Management System (QMS) may be lacking. In this article from iso 9001 consultant australia, we answer the question How many clauses are in ISO 9001.

Clause 1: Scope

The purpose of this section is for you to define your QMS, including its boundaries, limitations and extent. The more concise your scope statement is, the easier it will be for you to audit and sustain your QMS, as it will help you understand what processes are included under the QMS and what has been excluded.

Additionally, as an auditor, your scope statement will help describe your key stakeholders and the applicability of your QMS. If you are interested in learning more about the concept of internal audit, refer to the ISO 9001 internal audits page.

Clause 2: Normative references

This section aims to ensure that any document utilised within the quality management system has been appropriately referenced. This makes it easier for the external auditor, as they do not have to scramble to look for all your documents.

Clause 3: Terms and definitions

The purpose of the entire standard was the ease of usage, and therefore, the creators included this section to introduce business owners to the terms that will be used further along the standard.

Clause 4: Context of the organisation

This clause has been further categorised into four sub-clauses, where 4.1 focuses on understanding the organisation and its context. Similarly, 4.2 aids in understanding the needs and expectations of all interested parties, and 4.3 outlines the scope of the QMS.

The final subsection, namely, 4.4, talks about the processes of the QMS. The purpose of this section is to introduce the auditor to your QMS so that they can plan how to conduct the audit.

Clause 5: Leadership

This clause has five sub-clauses where 5.1 talks about leadership and commitment, 5.2 talks about the quality policy, and 5.3 focuses on organisational roles, responsibilities and authorities.

The purpose of this section is to help leaders showcase their commitment by establishing an appropriate customer-focused quality policy and planning how to communicate the policy across the organisation. if you want learn more, please read ISO 9001 lead auditor in our blog.

Clause 6: Planning

This clause is further divided into three sub-clauses, where 6.1 focuses on actions to address risks and opportunities. Sub-clause 6.2 focuses on quality objectives and creating a plan to achieve these objectives.

Subclause 6.3 helps the organisation’s leaders create a space for any future. Amendments or changes in the plan. The purpose of this section is to help initiate the implementation of the QMS by allowing the managers to develop a plan of action.

Clause 7: Support

This clause is further divided into five subsections, where 7.1 focuses on resources, 7.2 on competence, 7.3 on awareness, 7.4 on communication and 7.5 on documented information.

This section aims to help the organisation’s leaders get an idea about what resources would be needed to implement the QMS and begin allocating the identified resources.

Resources are beyond finances and can include people, infrastructure, environment for the operation of the processes, monitoring and measuring resources, and organizational knowledge. Additionally, managers must create communication channels to relay the quality policy across the organisation and create a structure for controlling their documented information. if you want to learn more about document control please read iso 9001 document control article. 

Clause 8: Support

This is a large section and is further divided into seven sub-clauses. 8.1 focuses on operational planning and control, whereas 8.2 outlines the requirements for products and services, including customer communication and review requirements.

Section 8.3 focuses on the design and development of products and services, 8.4 on control of externally provided processes, 8.5 on the production and service provision, 8.6 on the release of products or services and 8.7 on control of nonconforming outputs. in you want more learn, please read iso external audit on our blog. 

Clause 9: Performance evaluation

This clause is further divided into three subsections, where 9.1 focuses on monitoring, measurement and analysis, 9.2 on internal audits and 9.3 on management reviews.

Clause 10: Improvement

This clause is further divided into three sub-clauses, where 10.1 outlines the general requirements to develop an environment of continuous improvement, 10.2 lists the potential non-conformities and related corrective actions, and 10.3 focuses on continual improvement.

Conclusion

To achieve compliance and certifications, organisations must adhere to the ten clauses of the ISO 9001:2015 standard. They include scope, normative references, terms and definitions, the organisation’s context, leadership, planning, support, operation, performance evaluation and improvement.