The International Organisation for Standardisation (ISO) is the top developer of voluntary International Standards. They offer best practices and solutions for almost all types of businesses and technology to help companies increase their performance while also protecting consumers.
The ISO’s standards are developed through global consensus aimed at breaking down barriers to international trade. One of their most well-known standards is ISO 9001.
So what exactly is it? Let’s start with first understanding what a quality management system (QMS) is and how it relates to the ISO 9001 standard.
What is a quality management system (QMS)?
A quality management system (QMS) can be defined as a system that documents all the processes, responsibilities and procedures used in achieving quality objectives and policies. Simply put, a QMS refers to your job and processes that need to be well done and delivered with quality.
What is ISO 9001:2015?
ISO 9001:2015 is the world’s most recognised QMS standard. It outlines a framework for ensuring consistent quality and a vocabulary of understanding when it comes to the provision of goods and services. Rather than dictate how an organisation should set and achieve its objectives, ISO 9001:2015 essentially provides a flexible standard that acts as a guideline for each organisation to define its objectives.
ISO 9001:2015 guiding principles are used in creating efficiencies in an organisation by streamlining processes to cut costs, create new opportunities, meet regulatory requirements and help companies expand into new markets where clients demand the certification.
ISO itself doesn’t perform certifications to ISO 9001:2015, instead, companies use an independent certification body to audit their QMS implementation against the ISO standard. Any organisation of any size, including small businesses, can get certified.
What are the requirements of your quality management system (QMS)?
As stated, ISO 9001:2015 specifies requirements for a QMS. There are 10 clauses in ISO:9001, though only sections four to ten contain auditable requirements. Therefore, to successfully implement ISO 9001:2015 in your organisation, you must satisfy the requirements within these sections along with meeting other applicable statutory and regulatory requirements.
Let’s go through some of these clauses to gain a better understanding of ISO 9001:2015.
Clause 4.1: Understanding the organisation and its context
This section requires you to establish the aim of your organisation, the nature of its business and even identify its strengths weaknesses, threats and opportunities. You’re to assess the internal and external influences that can affect your organisation, its processes and the work that needs to be delivered. On top of the traditional customer, competitive and economic factors, this clause notes that influences can also stem from how technical developments, laws or even social/political/cultural changes can impact the mission of an organisation.
Clause 4.2: Understanding the needs and expectations of interested parties
This section addresses the desires and expectations of all those who have an interest in the organisation and ultimately can impact its mission and influence its processes. If you’re seeking the ISO 9001:2015 certification, you’re being asked to have an ongoing system that helps determine your organisation’s interested parties and their requirements.
Clause 4.4: Processes
The ISO 9001:2015 standard maintains the process approach where there’s a need to have established inputs, outputs and continuous improvement of the delivery process in between. There’s a requirement to control and understand each phase of your job’s processes and how one element affects the other. These processes are what help you determine what capabilities, investment and support are needed and how they will be provided.
Clause 5.1: Leadership and commitment
Under this clause, your organisation’s leadership is responsible for implementing the process approach and risk-based thinking. They are the ones to provide the necessary support required to fully implement and manage your organisation’s processes while also engaging and directing the individuals contributing to it. In addition, leaders should demonstrate a commitment to the customers by understanding and tracking customer needs and satisfaction.
Clause 6.1: Actions to address risks and opportunities
Building upon the need to understand the wider influences that affect your organisation (under clause 4), clause 6: planning, now fully embraces the risk and opportunity management approach. Your risk management process should be evaluated and each risk should be given a priority/ scaling of when, where, how and to what level it should be applied.
Clause 6.2: Quality objectives and planning to achieve them
This clause defines quality objectives as measurable goals relevant to enhancing customer satisfaction and are consistent with your quality policy. These objectives will be first established when planning your role and understanding its requirements, then redefined in management reviews if needed. Some examples of these objectives can include goals to improve delivery time, product defects and scrap. It’s required to document your objectives and update them when the need arises.
Clause 7: Support
This section takes a general view of all the resources you’ll need to realise the requirements of ISO 9001:2015. From labour, skills, facilities, equipment and even the working environment. You should be able to measure the type, level, scope, continuity and sustainability of these resources while also being able to justify their need. Ask yourself whether these resources are sufficient enough to create quality products and services and satisfy your customers.
Clause 8: Operation
Clause 8 discusses operationalising the plan and control processes needed to meet the requirements for your products and services. These processes include the design and development of the products/services, the production and service provision, the external providers, the release of products and services, nonconforming outputs etc.
Clause 9: Performance evaluation
This section requires your organisation to monitor, measure, analyse and review its processes. ISO 9001:2015 emphasises both a process approach and the need to utilise an evaluation phase. The standard requires you to determine what information needs to be collected, how it’ll be collected and analysed and what results will require action when performing your role.
Clause 10: Improvement
The requirements under this section are based on the continual improvement of the processes involved in delivering your work. This will be done by identifying nonconformities and taking the necessary corrective actions to eliminate the root cause of the nonconformance.
We hope this read has helped you better understand the principle of ISO 9001:2015 and the value it can provide to you, your processes and your organisation. Here at IMS Africa, we can help you and your organisation implement this management and leadership system.
Comments