Three years in the making, the latest and greatest revision to the Quality Management Systems standard was published on September 23, 2015 as ISO 9001:2015. It felt like Christmas morning waiting to get the new standard – well almost. I’ve already purchased my copy from ASQ for $173 USD and it was immediately available for download as a PDF once the payment processed. I’m excited to learn more about how ISO 9001:2015 can help organizations improve and deliver value to customers in a variety of industries and markets. For anyone that is currently certified to ISO 9001:2008, you have a 3 year grace period to become certified to the new standard’s requirements. This means you have until September 2018 in order to adopt and demonstrate compliance to the new requirements of ISO 9001:2015. According to a recent webinar with Quality expert Peter Merrill hosted by the ISO 9001 club, 80% of organizations that were transitioning to ISO 9001:2004 did not achieve certification until December 2003 – putting additional stresses on their organizations and registrars to achieve certification at the 11th hour. Make sure that your organization doesn’t wait until the last minute to roll out ISO 9001:2015 as part of your QMS. Get proactive and start planning today to identify what resources, expertise, tools, and software you need to make your transition to the new standard as smooth as possible.
Before we get into the details behind what’s changed in the new standard, I want to highlight how easy it is to get caught up in the day-to-day operational activities, without stepping back to reflect on the bigger picture. What do these standards mean to your customers, employees, suppliers, operations, and society as a whole? Ultimately, ISO 9001:2015 and other standards and regulations help companies to implement best practices as part of their management systems in a safe, effective, and reliable manner, while minimizing impact to the environment. This helps companies to focus on achieving bold goals and using certification activities as the impetus to build cultures of continuous improvement and performance excellence.
ISO (the International Organization for Standardization) is no different – it also seeks ways to continuously improve published standards, guides, and resources. ISO looks after the best interests of the international community to help facilitate global trade. Revisions to existing standards and new standards are developed and released through the assistance of technical committees, industry experts, and global partners to ensure that quality products and services are provided to global markets safely and efficiently.
With the release of ISO 9001:2015, there are some key changes that will impact organizations currently certified to ISO 9001:2008. The main items organizations should focus on first as part of their transition to the new standard are highlighted below:
- Introduction of Risk-Based thinking
- Requirements for “Documented Information”
- Harmonization of clauses across ISO Standards (ISO 9001: 2015, ISO 14001: 2015)
- Organizational Knowledge, which is now a prescribed requirement in clause 7.1.6
The introduction of risk-based thinking in ISO 9001:2015 puts an end to the confusion that historically exists around whether an action is corrective or preventive. If you identify the root cause of the problem and take appropriate action to prevent recurrence, 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 containment that is part of your corrective action plan? The new version of the standard provides clarity by replacing Preventive Action with Risk-Based thinking. In this regard, Risk-Based thinking will require organizations to identify risks that could impact the outputs of processes and the QMS based on nonconformances, audit findings, controlling changes, continuous improvement initiatives, among others, and implement mitigation plans. Cross-functional teams in organizations can review identified risks to determine their appropriate response. They will decide whether the identified risk will be avoided (take a different approach completely so the risk no longer exists), transferred (a 3rd party becomes responsible to manage the risk), mitigated (controls are put in place to minimize the impact or probability that the risk event will occur), or accepted (believe that the probability the risk event occurs is so low that the organization does not need to mitigate the risk). Risk-Based thinking enables the firm to take a longer term view and incorporate this approach as part of their planning activities rather than purely reacting to events as they occur. Organizations that are able to do this successfully can move away from firefighting and towards performance excellence.
The next significant change relates to documented information in the standard. A Quality Manual is no longer a prescribed requirement as in clause 4.2.1 of ISO 9001:2008. Because ISO 9001 historically had a reputation for being very document heavy and somewhat bureaucratic, the new standard has tried to remove this obstacle for organizations and focus on value added activities. ISO 9001:2015 makes it clear that there is no single recipe for what documentation should be prepared in order to meet the requirements of ISO 9001 and can vary between organizations. Rather, it highlights that key pieces of documented information must exist for organizations to have an effective QMS regardless of the medium in which the documented information exists (i.e. electronic, hardcopy). This includes documenting the quality objectives, quality policy, processes and procedures, records of reviews, results from operational activities, changes to products and/or services, audit activities and results, and so on to ensure that products and services conform to requirements, including actions taken to ensure conformance to requirements. Although the type of content expected in ISO 9001:2008 is still required in ISO 9001:2015, with the exclusion of a consolidated Quality Manual, the new standard puts emphasis on the organization to create the required documents that they deem relevant and valuable to their business, while satisfying the requirements detailed in the standard to demonstrate their QMS is effective and processes are under control.
Harmonization of Standards:
ISO 9001:2015 also makes it easier to achieve certification to ISO 14001:2015 (environmental) and eventually ISO 45001:2016 (Health & Safety), expected in October 2016, by aligning the clauses in the standards where possible. This helps companies because if they are able to comply with a clause in one standard then they will also comply with the same clause in the other standards.
Using the Annex SL format, ISO has now made it easier for organizations to implement multiple management system standards. In the long term, this will give organizations incentive to adopt multiple international standards that might have previously been cost prohibitive as the costs associated with implementing multiple standards will decrease. Overall, this will bring a greater benefit to trade as more organizations adopt standards that will help them achieve improved levels of safety, quality, and efficiency while minimizing their impact on the environment.
Lastly, ISO 9001:2015 had added clause 7.1.6 regarding Organizational Knowledge. What is particularly interesting about this section of the standard, is the emphasis on breaking down silos and promoting collaboration by ensuring that information is readily available, accessible, and disseminated throughout firms. This new clause considers the importance and prevalence of the digital age on business and builds this into the standard. Encouraging lessons learned from successful projects to be shared, as well as ones that have failed, highlights the value of the learning organization – always adaptive and continuously learning wherever possible. To do this successfully, companies will need to ensure that they have the required systems and tools in place. Intelex Technologies Inc. has a variety of solutions for Environment, Health & Safety, Quality, and Supplier Management. To help companies transition to the new standard, a new software application called Integrated ISO 9001 was launched in May 2015 to help clients get ready to achieve certification to ISO 9001:2015. If your organization is shopping around for a new tool, I encourage you to contact Intelex to learn more about how this solution, as well as Intelex’s platform, will help your organization today and beyond.
So with all this in mind, here are 3 tips to help your business transition from ISO 9001:2008 to ISO 9001:2015:
- Purchase a new copy of the ISO 9001:2015 standard to become familiar with the requirements. If necessary, work with a subject matter expert 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 employees.
- Remain committed and persistent to achieve your goals. Sometimes, it’s difficult to recognize the forest from the trees. Take the time to get on the balcony and envision how ISO 9001:2015 fits in with your organization’s overarching strategy for market leadership and domination.