I know…you’ve all been wondering – What has ISO 9001 done for me lately?
Well, fasten your seat belts and get ready for a wild ride. The new ISO 9001:2015 standard is not just about compliance. It’s about implementing a Quality Management System that is practical, proactive, and progressive. With the release date of September 15, 2015, we, as quality professionals and organizations are excited about what could be possible and how the new standard can help transform our businesses. All of this despite the 3 year grace period to adopt the new standard.
There are many reasons for this building excitement.
First, it puts an end to those confusing debates that I’m sure you’ve had at some point about whether an action was a corrective action or a preventive action. What is the difference? If you identify the root cause of the problem and take appropriate action to prevent occurrence, is that action a corrective action, a preventive action, or both? If you take immediate action to contain a particular nonconformance to prevent it from reaching your customers, is this action merely a containment that is part of your Corrective Action plan?
The new version of the standard puts an end to this confusion and replaces Preventive Action with Risk Based approach and Risk Based thinking. In this regard, a Risk Based approach introduces longer term thinking that is also collaborative with cross-functional team members. This approach is longer term in nature as it focuses on the identification of existing and potential risks as well as opportunities, so that actions can be taken as required to either mitigate risks or take advantage of identified opportunities.
Imagine all the time you’ll save! You can now put that effort towards meeting and exceeding customer requirements.
Secondly, ISO 9001:2015 no longer prescribes that a Quality Manual be created and maintained in order to become certified. The standard only now requires that organizations define the context of their organization as it applies to their ISO 9001 certification.
Really, it is up to each organization to determine the amount of documentation required to demonstrate compliance and that it can vary from one organization to the next based on a number of factors (such as complexity, size, industry, etc.). Companies can still create and maintain their Quality Manual however this change in the standard gives organizations more flexibility to determine what works best for them based on their individual needs and value derived from activities like creating the Quality Manual. Ultimately, the new standard is giving organizations the opportunity to define how they want to best represent their business while maximizing how they use their resources in a way that delivers optimal quality to their customers. In the end, it’s all about customer satisfaction.
The new standard also shifts from being manufacturing-centric to being both goods-and-services-centric. This is achieved by replacing terminology associated with “product” to “goods and services” throughout the standard. Whether your organization delivers healthcare, consulting, financial services or manufactures printed circuit boards, the new standard applies to a broad new spectrum of businesses. This represents a great opportunity for new companies to achieve ISO 9001:2015 certification as the certification will enable them to demonstrate to global markets that they have achieved a globally recognized standard accepted as good business practice and can be a basic requirement in order to participate and compete in certain market segments.
Another interesting change has been made to the clauses in the standard. ISO has attempted to use universal clause numbers to address the same requirements in ISO 9001:2015, ISO 14001:2015, and OHSAS 18001. This will help organizations to streamline their ambitions to become certified in one or more world class standards with shorter implementation times and optimal use of constrained resources.
With all of these elements at play, a robust Quality Management System that integrates these requirements in a comprehensive way can help transform these organizations to become a leader in their industry, exceed customer requirements, increase profits, demonstrate compliance to interested stakeholders, and establish new sources of differentiation and competitive advantage. Organizations need to strategically identify the best approach to operate their existing or new Quality Management System in their company. It may be time to replace that old paper based system with an automated workflow solution that incorporates the subject matter expertise embedded in ISO 9001:2015 and easily scaled across other departments, facilities, and even geographic business units depending on the size of the organization.
So with all this in mind, here are 5 tips to help your business get ready to achieve ISO 9001:2015:
- Determine the objectives and goals that you would like to achieve as a result of becoming ISO 9001:2015 certified. Identify how this will support the vision of your organization and what it will mean for your current and future customer base.
- Purchase a new copy of the ISO 9001:2015 standard after it is released in September to become familiar with the requirements. If necessary, work with a consultant or research online to help you determine what the standard means and how it will help your company grow.
- Determine what it will take to help your company achieve certification. This may mean investment in new equipment, software, training, and potentially hiring employees.
- Always evaluate your options available to you on the market. We live in a competitive world today. It is in your best interest to compare and evaluate what options you have available to you to ensure that your requirements will be met and you are getting maximum value out of your ISO 9001:2015 implementation and ultimately your Quality Management System that should bring you increasing value for years to come.
- Remain committed and persistent to achieve your goals. Sometimes, it’s difficult to recognize the forest from the trees. Take the time to step back and look at your organization’s projected path and how ISO 9001:2015 fits in with that puzzle.
To learn more about the changes coming in ISO 9001:2015 and what Intelex can offer, register for our upcoming webinar on April 30, 2015 – “ISO 9001:2015 How to Successfully Prepare your Business“.
Look forward to discussing this topic further during the webinar!