By The Pro QC Quality Assurance Team What is ISO 9001:2015? If you want to indicate that your organization has a functional quality management system, ISO 9001:2015 is the certification you need. The official ISO.org website says the steps a company takes to demonstrate its ability to consistently provide quality products and services that meet customer and applicable regulatory requirements, combined with the company’s aim to enhance customer satisfaction through the effective application of the system, are the core tenets of the certification. ISO 9001:2015 is applicable to any organization of any size – whether it offers manufactured goods of any kind, or services. Why do we need an ISO 9001:2015 certification? The certification tells customers that the goods manufactured, or the services offered by the company they are looking to potentially be a client of, adhere to the best practices laid out by the official ISO 9001 quality management system guidelines. It is very much a global standard, so anyone will recognize it anywhere in the world. So how do you prepare for ISO 9001:2015 certification? Getting an ISO 9001 audit is imperative to working through the journey toward being certified. There are six key steps to achieving the ISO 9001 certification: Understanding the ISO 9001 – classroom training on the standard and documentation review ISO 9001 audit – conducted by a third-party audit company to complete an on-site gap analysis and suggest an action plan Preparation of documentation – based on the results of the ISO 9001 external audit, the third-party audit company works with the team on necessary documentation and next steps ISO 9001 implementation – committing the entire organization to effective uptake of a quality management system that adheres to the certification standard ISO 9001 audit – as part of the requirements for the ISO 9001:2015, an internal audit review is required annually to demonstrate continued effectiveness of implementation of the quality management system at the company ISO registration – before an organization can apply for an ISO 9001:2015 standard, evidence of consistency within the quality management system is required for up to six months; this is verified through a third-party audit The process to complete the necessary steps can take up to nine months if starting from scratch. Proving consistency and verifying this through a specific audit is imperative to the process. What are the challenges to getting ISO 9001 certified? Preparing for the ISO implementation is often the hardest part of the process – aligning the company and having everyone fully onboard, defining the technical requirements, collating relevant documentation, and communicating the procedures to the entire company are just some of the challenges. Many organizations assign an internal representative or champion and often outsource the audit and facilitation to a third-party auditor who is familiar with the certification process and can provide unbiased advice to drive changes more successfully. The ISO 9001:2015 quality management system is a core building block of an organization’s foundation. This means that each and every member of the team needs to be on board throughout the process and ensure that nobody flips back into old or bad habits. To ensure quality management system consistency is maintained, a third-party auditor can ensure quality management system gaps and the associated corrective action plan are managed to completion. This approach can help to ensure that ISO 9001 certification is just around the corner for your organization. If you are looking for help with a customized plan for reaching ISO 9001 certification, Pro QC can help.
