ISO9001:2008 or ISO9001:2015: Which should you implement?

If you’re working on getting certified to the ISO9001 quality standard, right now is a bit of an awkward time. Do you go for the current ISO9001:2008 standard or the upcoming ISO9001:2015 standard? It depends on your particular situation.

First, you should know that the ISO9001:2015 quality standard is scheduled to come out later this year. As of this writing, the new ISO9001-2015 standard has not yet been released, so it isn’t possible to get accredited to ISO9001-2015 right now. You could get started on your quality system manual and procedures now, if you base them on the ISO9001-2008 standard. But be advised that you’ll likely have to make many revisions to your documents once the final version of ISO9001-2015 is released.

The good news is that we have 3 years to transition to ISO9001:2015. Assuming the ISO9001:2015 standard is released in September 2015, you’ll have until September 2018 to get audited to the new standard. Three years is plenty of time to make the necessary changes to your quality system documents so they’re in conformance with the new ISO9001 standard.

If you’re under pressure from a customer…or a potential customer…to get your ISO9001 certifications as quickly as possible, I suggest you get accredited to the ISO9001:2008 standard now. If you’re under to pressure to get certified to ISO9001, then its probably better to wait another 6 months or so until the new ISO9001:2015 standard is finalized and released to the public.

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One Response to “ISO9001:2008 or ISO9001:2015: Which should you implement?”

  1. Daniel Lauer says:

    Before making the exhausting transition from the current ISO standard to the updated one, there are several things to consider first before analyzing a quality management system in light of the standards. The first and most important thing to determine is how well the company’s current system matches the expectations of the updated standard. Through thorough analysis of the current quality management system, the company can determine how well their specific processes and procedures line up with the updated standard. This process of examination and comparison is called gap analysis which allows the organization to identify how much change is needed in order to meet the new requirements. In the case of the new ISO9001:2015 standard, there are many requirements that parallel old requirements in the 2008 edition. Although many ideas and concepts are merely reiterations of previous concepts found in the old standard, there are several sections that add more emphasis to new concepts and ideas.
    One of the key changes from the old ISO standard to the new one is the emphasis on the Process Approach. The Process Approach is a general way of describing how an organization should go about managing their processes and projects. This concept was already mentioned in the 2008 standard but it is now a requirement. The Process Approach covers almost every aspect of the quality management system and essentially calls for an organization to create organized flow for its processes. The Process Approach allows companies and organizations to zoom in on specific processes and procedures and identify ways to organize those processes into step-by-step activities in order to maximize safety, quality, and time. In most cases, an organization’s quality management system may already follow the Process Approach but it is important to verify.
    The next key change in the new ISO standard is the Context of the Organization section. This section requires organizations to identify all external and internal issues that might have an effect on the quality management system’s ability to deliver intended results. The main objective for this section is to identify the needs and expectations of all interested parties involved with an organization. This mainly refers to clients or customers but it applies to all parties in business with the organization. By applying this method to the quality management system, companies can get a better feel for who they are as an organization and begin to take steps to maintain customer satisfaction through quality assurance.
    Another key change made to the ISO quality standard is heavy emphasis put on the scope of the quality management system. This is similar to the Context of the Organization section however, it is centered around the company’s mission and vision for the future in consideration to the Context of the Organization. More emphasis has been placed on the scope of the company which is described in the Scope Statement.
    Management Responsibility has been replaced with the Leadership section in the new standard. Although the name has changed, most of the ideas have remained the same. More focus has been placed on the people or individuals within the company as opposed to management as whole. In this section, top management is required to infiltrate the quality management system into routine business operations rather than being a separate entity on its own.
    Another key change that is one of the most important concepts in the quality management system is the Risks and Opportunities section. All references to preventative action in the old standard have been replace with ‘Risks and Opportunities’ in the updated standard. This section places emphasis on the idea of managing risks within a company. It is now a requirement to identify potential risks and opportunities that might affect the quality management system’s ability to deliver conformance or provide customer satisfaction and take the appropriate action when necessary.
    One key change that is more of a minor one is a change in terminology from the term ‘Product’ to ‘Products and Services’. This change only broadens the category by adding in ‘Services’ and applies to all forms of business not only manufacturing or discrete products.
    Another change that is also a very important concept within the QMS is the replacement of ‘Purchasing’ with ‘Control of Externally Provided Products & Services’. Again, most of the ideas have remained the same but all forms of external provision, purchasing, and outsourcing are covered in this section. Companies are now required to take a risk-based approach to determine the type and extent of controls that are necessary for each external provider and all outsourced processes. Along with the transition from the term ‘Purchasing’ to ‘Control of Externally Provided Products & Services’, the terms ‘Purchased Product’ and ‘Supplier’ were also change to ‘External Provider’. This was changed in order to broaden the applicability of the term in order for it to remain relevant to all external sources.
    Another one of the key changes from the old standard to the new one is another change in terminology from the terms ‘documents’ and ‘records’ to the term ‘Documented Information’. This change is another way to broaden the meaning of the term in order to encompass more information and applications.
    One of the more minor changes that was added without any real impact was another change in terminology from the term ‘Work Environment’ to ‘Environment for the operation of processes’. This change did not have as large of an impact as some of the other changes in terminology however it was changed to make the meaning more concise and in order for it to apply for all areas of operation.
    Last but not least, probably one of the largest changes to the new standard is that there isn’t a requirement for a quality manual. Although this change means that the document is not required to be included in the QMS as a whole, there may be content listed in the Quality Manual that is core to specific standards or processes of the organization. In this case, it may be wise to keep the Quality Manual and only adopt the new standard to make the changes necessary without losing the value that it adds to the QMS as a whole.
    In general, most of the changes to the new ISO standard are either a change in terminology or an emphasis on a special approach or process. Through the gap analysis exercise, it was discovered that most of the content of the new standard only reformats and reiterates ideas described in the old standard. The biggest difference is that the ideas once talked about and mentioned in the old standard are now direct requirements for the new standard. If the current QMS covers all of the sections discussed in the old standard, odds are most of the new requirements will only call for the writer to modify and improve the current document set in place for the organization.

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