What is ISO 9001?
ISO 9001 certification can help you achieve this by providing a solid framework for an effective and, more importantly, agile quality management system.
Certify your quality management system with ISO 9001
What is ISO 9001 Certification
Designed for organisations of any size and operating in any sector, ISO 9001 is an international management system standard that provides a recognised framework for quality management and continuous improvement. Over 1 million companies worldwide use ISO 9001 to better understand and meet their client and stakeholder needs and drive performance, making the standard arguably the most important piece of business literature ever written.
Industry trends influencing quality management
The rise of technology
The rise of technology – in what is often called the fourth industrial revolution – is well underway, bringing us the commercial and industrial use of drones and autonomous vehicles, additive manufacturing, and the increased use of robotics and artificial intelligence. It is estimated that between now and 2050, the number of devices connected via the internet will more than double. As a result, the impact of big data and analytics will be felt across many fields of industry and commerce.
The COVID-19 pandemic
The COVID-19 pandemic has probably had one of the largest impacts on quality management for businesses globally in the last few years – from the sudden shift to remote working to a lack of supply chain security, the pandemic opened a lot of eyes to the general lack of agility within existing quality management systems. One of the more notable factors that affected, and still is affecting, many businesses was the sudden shift to remote working; almost overnight, companies were forced to shut their doors, with their only options being to adapt to virtual working or shut down permanently. Historically, many quality control processes, policies and objectives involved elements of being on-site or in a face-to-face environment, resulting in the need for sudden adjustments to what were previously considered fundamental organisational components, which, of course, caused significant disruption.
Resource scarcity
This megatrend is sometimes linked to climate change but can also be driven more by the growth of the global population and by industrialisation. But there are also potentially more globally disruptive shortages, of, for example, the rare metals that are needed in ever larger quantities for batteries, electric vehicles, and electronic devices such as smartphones. There is also increasing concern about the stability and resilience of global supply chains, given the disruption caused by events such as the COVID-19 pandemic and the war in Ukraine, or even more modest events such as the temporary blockage of the Suez Canal in March 2021. Shortages may require organisations to redesign their products or processes, introducing new risks, or changing risk levels, and creating the need to adjust risk controls, possibly at short notice.
Integrate your management systems
ISO 9001 follows the Annex SL framework, the high-level structure for modern ISO Standards. The Annex SL structure ensures consistency and compatibility between the different management system standards and allows for a straightforward and harmonised implementation of multiple standards (integrated management systems). ISO 9001 easily integrates with all new and revised ISO management system standards, such as ISO 14001, ISO 45001 and ISO 27001.
At LRQA, we see very clear benefits for companies in implementing an integrated management system that features a number of ISO standards. This is an effective mechanism for companies to manage their risk profile in an integrated way across different aspects of their activities such as service delivery, environmental footprint, or health & safety of their workforce.
An integrated management system also allows companies to easily link their strategic objectives to their operations, and successfully engage stakeholders. Once the first management system standard has been established and the right foundations for building an integrated management systems approach are defined, the time, effort, and activity required to implement additional standards is significantly lower, with the returns far outweighing the investment.
Annex SL clauses
Context of the organisation
ISO 9001 requires organisations to look beyond quality issues that directly impact them and to consider their impact on wider society. Each organisation is unique, so context is important. The intended purpose of a Quality Management System (QMS) is to enable an organisation to enhance its quality performance applicable to the activities, products, and services it provides. Therefore, a QMS should be designed and implemented to meet the specific needs of the organisation, considering its activities, associated risk, compliance obligations, interested parties, products or services and the business environment in which it operates. It must be noted that these context considerations must not be solely limited to quality factors. A QMS context includes business environment, internal factors, such as organisational culture and capabilities, strategic direction, and external factors, such as socioeconomic conditions under which it operates. To better understand your business’s context, you may find techniques such as ‘PESTEL’ and ‘SWOT’ useful.
Leadership and worker participation
Senior management needs to be able to demonstrate a clear commitment to quality management. Where top management already plays an active role in driving quality management forward there will most likely be evidence of leadership participation. However, for those organisations where top management has devolved responsibility for quality management, the effect will be significantly greater. Auditors will seek evidence that top management has participated in establishing, implementing, and maintaining the quality management policy, as well as evidence that policies and objectives are effectively communicated to workers responsible for the quality of any goods and/or services.
Risks and opportunities
Planning, found in section six of ISO 9001, plays an integral role in addressing risks and opportunities, and focuses on how your organisation can prevent or reduce undesired effects, including non-conformities and legal requirements so that you can still achieve your objectives. Don’t forget to look at the positives, the opportunities for your organisation and how to optimise them.
Quality management throughout the supply chain
SO 9001 requires organisations to consider the quality control issues affecting the wider supply chain – both in terms of being an interested party and more clearly in the clauses covering procurement. The process of managing outsourcing, contractors, and procurement arrangements have been made explicit, which should lead to better risk identification and greater efficiency for a wider group.
Improvement
Organisations must actively seek out and realise opportunities for improvement that will facilitate the achievement of the intended outcomes of the quality management system. They must consider the results from analysis and evaluation of their quality performance, internal audits, evaluation of compliance and management review when taking actions to improve performance. Improvement can arise from corrective action, continual improvement, and innovation.
Working with a credible and respected partner to certify your management systems is a uniquely powerful way to show stakeholders that high standards are being set and met. Certification helps ensure that working practices minimise risks in the future while allowing you to enhance your reputation in the present by demonstrating your commitment to safe, sustainable, and ethical ways of working.
How do I get ISO 9001 Certification?
The path that your organisation takes to achieve ISO 9001 certification often depends on your business’s size, maturity, and existing approach to managing risk, amongst other factors. But the standard process to becoming ISO 9001 certified includes three main steps.
Stage 1 Audit – document review and planning:
Your auditor will review the design and documentation of your management system – in most cases, this is carried out remotely.
Stage 2 Audit – evaluating your implementation:
Your auditor will evaluate the implementation and effectiveness of your existing QMS in line with the requirements of ISO 9001. If there are no non-conformities, you’ll receive your certification. This stage can be carried out remotely or on-site. Promote your ISO 9001 certification: Your certification demonstrates a commitment to internationally recognised best practices and continual improvement – helping you win new business and meet stakeholder demands.
How are ISO Audits Conducted?
Our services blend remote and on-site audit activities to provide unrivalled insight and expertise. Using secure, remote technology, we can provide a fast and flexible way to maintain your audit schedule, help reduce carbon footprint associated with travel, and minimise health and safety risks for people working on hazardous sites or hard-to-reach areas. Outcomes are consistent with on-site audits, so the integrity of your audit and accredited certification remains exactly the same.
Why work with us?
Strategic vision
Our technical know-how, industry expertise, and innovative, forward-thinking approach will help you meet the challenges of today – and become a safer, cleaner, more resilient, and more ethical organisation tomorrow.
Technical Expertise
Our people are leading experts in their sectors and technologies across certification, inspection services, sustainability, training, and cybersecurity. We work alongside your teams to gain a clear understanding of risks, challenges, and needs – then share our knowledge to help your business thrive, today and tomorrow.
Global capability
Operating in more than 160 countries, recognised by over 30 accreditation bodies worldwide, and covering a wide breadth of industries, we can help you manage risk, drive business improvements, build credibility with stakeholders and meet sustainability goals – both within your business and across your supply chain.
Effective partnerships
Every business is unique. That’s why our experts work with you to fully understand your needs and goals and determine how we can best support them.
Pioneering approach
We have led the way in shaping our industry – and continue to take every opportunity to collaborate with clients and pioneer new ideas, services, and innovations.
