With so many different quality standards available, is ISO 9001 certification still important and valuable to businesses? And, perhaps more importantly, is it relevant to your industry in particular?
This article, with input from well-known business stalwart and QMS Ambassador Nick Hewer, will answer these commonly asked questions by exploring the central elements covered by this quality assurance system and examining how these are practically applied in the modern commercial and industrial environments.
What is ISO 9001?
ISO 9001 is simply a standard that sets out the requirements for consistent and effective management. It helps businesses and organisations to become more efficient and improve customer satisfaction.
A quality management system is a way of defining how an organisation can meet the requirements of its customers and other stakeholders with an investment in the outcomes of its activity. ISO 9001 is a flexible standard capable of assuring quality through a process of continual improvement.
ISO 9001 does not specify what the objectives relating to quality or meeting customer needs should be, but requires an organisation to create targets for improvement based on growth or increased satisfaction rates. Each related internal business process then undergoes an iterative system of measurement and refinement until the target is achieved.
‘Both Technical Standards and Management Standards play an important role in today’s business. The two should dovetail in a seamless manner, and of course technical implementation is vital,’ says Nick Hewer, QMS Ambassador. ‘The process approach requires the Management System to be woven into and totally aligned with the strategic direction of the Organisation.’
ISO 9001 started out as a tool for manufacturers, but it is now relevant to organisations of all sizes and sectors. In fact one of the key improvements of the newly revised
ISO 9001 : 2015 was to make it more applicable and accessible to accommodate every type of enterprise, with a focus on allowing smaller companies lacking dedicated quality-centric employees to still enjoy the benefits of implementation.
The ISO 9001 Quality Management System covers 8 key business principles:
- Customer focus
- Involvement of people
- Process approach
- System approach to management
- Continual improvement
- Factual approach to decision making
- Mutually beneficial supplier relationships
It’s been well documented that by managing the processes in a business, together as a unified and interlinked system, efficiency will be improved and objectives more easily attained. Measuring and evaluating these processes helps to identify areas for improvement, and the essential framework for assessing vital business metrics is supplied by ISO Certification.
The Plan-Do-Check-Act Methodology and ISO 9001
‘The Plan-Do-Check-Act methodology applies to both individual processes and to the management system as a whole’… Nick Hewer, QMS Ambassador
Plan Do Check Act (PDCA) cycles are an established quality control procedure, and as a principle of the ISO 9001 Standard, they help promote a process driven culture across an entire organisation. PDCA is a proven way of ensuring it plans, resources, and manages its processes and interactions effectively.
The holistic PDCA concept is a cycle for implementing change, and when successfully followed and repeated, it promotes continual improvements within the specified management process. As an iterative model as opposed to a one-time quick fix, this process is a cornerstone of the ISO 9001 Management Standard, delivering a system that allows companies to target excellence.
ISO 9001 deploys this cyclical process to power real business evolution. Non-conformance reporting and trend analysis help identify areas for improvement in any business, ensuring processes are followed by the appropriate teams. This reduces the risk of delivering low quality products or services to clients by establishing conformance with processes set out by the management system.
Risk-Based Thinking and ISO 9001
‘Risk-based thinking applied from the outset is an overall focus to prevent undesirable outcomes’… Nick Hewer, QMS Ambassador
Understanding risk leads to preventative action, and ISO 9001 was revised in 2015 to adapt to today’s increasingly pressured business environments. This included updated terminology, a restructuring of essential information, increased leadership requirements and an emphasis on modelling risks and process snag points to prevent poor quality.
ISO 9001 specifies the requirements for Quality Management Systems and Certification, and has a focus on using metrics to influence decision making. The Standard covers effective document-handling processes from start to finish, which in turn leads to improved record keeping, meaning you have the data you need to make objective decisions based on facts, as opposed to simple observations. This greatly reduces risk when implementing changes in your organisation.
The individual clauses within ISO 9001 were subject to several changes in 2015. Clause 4, which encompasses risks within the production process, was extensively revised. This included new clauses which require senior management to understand how internal and external challenges could affect an organisation’s ability to meet key performance indicators.
To achieve this, the clause has a focus on process management, requiring businesses to explore contingencies and implement measures to create consistently effective operations, whilst giving team members specific responsibilities over certain processes.
The main objective of this clause is to unite the Quality Management System with the overall business’ strategy, helping to create business cohesion by building true understanding of operational processes in the boardroom.
In conclusion, ISO 9001 evolves with the requirements of your business. It is constructed in line with your organisation’s goals for growth. As opposed to a rigid system based on conformity, it is a proven framework that fosters achievement within your organisation.
ISO 9001 has been deployed effectively on a world-wide basis. In 2013 alone, over one million certificates were issued across 187 countries, and many other companies and organisations have used the standard without seeking certification.
‘You can see that when the ISO system is fully and properly implemented, the business should operate like clockwork’ — Nick Hewer, QMS Ambassador
Success with ISO 9001 can take many forms. For some enterprises, it is all about attracting new clients. The Standard is often a pre-requisite to tender for public and private sector business – while others see it as the blueprint for internal efficiency.
From a universal standpoint however, it is viewed as a statement to your stakeholders, employees and senior management that your company is driven and focused to overcome key challenges and meet the company objectives.
And a final word from Nick Hewer…
‘Of course, yes, ISO certifications are still important. They ensure the safety and quality of products and services. They ensure that business operations are as efficient as possible. They increase productivity… and they help companies access new markets’.