The holiday season is over, we’re almost through the second month of the new year and it’s time to begin planning ahead for the rest of 2018. Now is the time to begin digging into one of the most critical obligations your organisation faces: it’s time to prepare for the transition to ISO 9001:2015, required before the September 2018 deadline.
I know what you’re thinking: “September is still more than half a year away, we have plenty of time. There’s no rush.” Well, you’re half right: September is still 6+ months away, but time is definitely an issue. It’s been almost three years since ISO 9001:2015 was announced, certificates based on the 2008 edition will no longer be valid, no further auditing will be performed per the 2008 edition and you’re still waiting… for what?!? If yours is like most organisations I talk with, the wait is due to any of a number of factors: the transition is complex and requires time and other resources to be set aside, it’s going to be costly and requires budget preparation, or even “Maybe if we ignore it, it will just go away!”
I’m here to tell you transitioning to ISO 9001:2015 is easier, faster and less complex than you think. And it’s also NOT going away. Key to realising a smooth and satisfactory transition is knowing the facts, including the primary differences between the 2008 and 2015 standards. Here’s what you need to know to make your organisation’s transition a successful one, with as little hassle as possible.
What Is ISO 9001:2015?
Some organisations are delaying transition because they don’t understand ISO 9001:2015 or what it means to their business. If this describes you, you’re in luck. I’ve prepared a handy ISO 9001:2015 summary that tells you everything you need to know, with answers to the most frequently asked questions. Now that the basics are covered, let’s move on…
5 Primary Differences Moving from ISO 9001:2008 to ISO 9001:2015
The 2015 edition has a more intent focus on business management and how an organisation’s entire business activity is viewed, analysed and managed. The certificate itself should be more than simply a check marked item or a piece of paper on the wall, but a tool deployed for ongoing use in organising operations and defining management rules. This updated philosophy is best tracked in the five primary changes from ISO 9001:2008 to ISO 9001:2015:
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Structure
Probably the biggest difference between the ISO 9001 standard 2008 and 2015 versions is the structure: 2008 has eight principles and 2015 has ten. In version 2015, the last seven clauses are arranged according to the PDCA cycle (Plan – clauses 4,5,6,7; Do – 8; Check – 9; Act – 10).
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Risk-Based Thinking
The ISO 9001:2015 standard frequently highlights using strategies and tools for risk analysis in addressing quality management challenges. Contrast this to the 2008 standard, where the concept of risk is only mentioned a handful of times. Within the new standard, organisations are encouraged to use strategies and tools that fully enable them to successfully perform risk analysis as a significant component of quality management challenges and potential solutions.
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Leadership and Commitment
ISO 9001:2015 emphasises the involvement of top managers and organisational leadership in quality management system control. This top-down focus encourages more effective integration and alignment with business processes and strategies. Unlike the 2008 version, quality is recognised as important to everyone, and at all levels within the organisation.
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More Focus on Process Input and Output Components
Every organisation needs to understand and respond to the expectations of all stakeholders within a process, to best realise success. Organisations also need to establish the number and types of processes necessary to achieve their business goals. ISO 9001:2015 focuses on measuring and accurately evaluating all relevant process inputs and outputs. This requires monitoring all specifications and information involved in the production process. All processes should be aligned with the scope of the organisation’s quality and complexity management system.
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Documented Information
ISO 9001:2015 provides fewer enforcement requirements for records and documentation. Organisations can now independently decide what documentation is required for operations and processes, as well as the appropriate format. At the same time, there are changes to some conditions, including the addition of 69 new definitions.
What If You’re Still Using ISO 9001:2008?
The answer is simple: upgrade and transition to ISO 9001:2015 as soon as possible. It’s not just a matter of doing the bare minimum required to satisfy regulatory obligations. The 2015 standard can help your business more successfully meet the challenges and expectations of the current marketplace. ISO 9001:2015 is not just an obligation. It’s a tool you can you use to better organise and manage your business, with improved outcomes for all stakeholders, including your staff, leadership, partners and customers. ISO 9001:2015 is an investment in your success and growth.
Making Your Implementation a Success
By familiarising yourself with what’s changed from 2008 to 2015 and what’s remained the same, you’re already on the right track. Those changes demonstrate that the scope of the transition may not be as daunting as you presume… but that’s just the beginning. Perform an audit to identify your organisation’s needs within the context of the new requirements, then develop a plan to make the necessary changes. Provide adequate training, update your quality management system and, if necessary, contact Certification Body for the transition.
Under no circumstances should you give up existing procedures and documentation! Satisfactory systems should always be maintained; just because certain requirements are no longer obligatory per ISO 9001:2015, that doesn’t necessitate they be eliminated. Stick with what works, especially those procedures that have helped your organisation progress and grow. It’s better to hang on to what you are happy with and what is working, rather than initiate an unnecessary overhaul from the ground up.
The new version of the ISO 9001 standard provides you a new opportunity to improve your quality management system. Now it’s up to you to seize that opportunity and implement positive changes.
Why ISO 9001?
- ISO 9001 is accepted as the standard for managing quality in a large number of very diverse industries.
- ISO 9001 empowers you to identify strategies and tools to meet the evolving needs of customers and stakeholders.
- ISO 9001 helps ensure a high and sustainable level of quality in your services and products.
- ISO 9001 makes your processes more efficient, so you can continue to optimise them and create a procedural structure in which everyone benefits.
ISO 9001 will evolve and be further refined as industries, technologies and society itself continue to grow; future updates are a certainty. Your organisation can always rely on ISO 9001 as a source for focus, guidance and improvement… and isn’t that something every organisation needs? To learn more about how you can make ISO 9001:2015 work for your business, contact QICE – our expert quality management consulting team can explore your options and guide you to the most effective solution.