In a previous article, we discussed the initial steps required to begin implementing the QMS based on ISO 9001, 2015 version. We touched upon the preliminary stages that fall under P (of the PDCA), planning your certification. We also emphasized the importance of acquiring the necessary knowledge of the standard, gaining top management’s support, and assembling the right implementation team. Plus, we mentioned where (which part of the standard) to kick off the project. So, if you haven’t read that piece yet, we suggest you check it out before continuing with this read.
Today, we proceed with Part 2, sharing the remaining parts of the project and providing more useful tips to ensure a smoother and more accurate certification. If you’ve completed all the previous steps, it’s time to genuinely start implementing the practices from the standard!
Practical Beginning of QMS Implementation Based on ISO 9001
After evaluating your company’s context (as required by item 4 “Organizational Context”), you will have a clearer view of the necessary actions. With that in place, it’s time to truly implement what’s required to meet the ISO 9001:2015 standard. This means adjusting processes, introducing new control points, or even creating processes that incorporate the standard’s best practices. Additionally, this phase often intimidates quality professionals, let’s see why:
Creating Necessary Documented Information
At this stage, many procedures will be developed to support process execution. It’s worth noting that these procedures can be in any format that suits the company’s objectives, be it video, audio, written, etc. Moreover, numerous records will be generated during and after the process, such as meeting minutes, critical analysis records, and other types of documentation. This phase is crucial for the certification process since many of the documents serve as conformity evidence and will be requested by the auditor later on.
First Check: Internal Audit of the Quality Management System
Once you’ve set the entire system in motion and recognized the critical points of both your QMS and company, we move on to the C (check) of PDCA, initiating system verification. The first step is conducting an internal audit, led by a qualified internal person, or you can outsource this step. The aim here is to identify improvement areas, non-conformities with the standard, and refine the system before the external audit.
Critical Analysis Meeting and QMS Adjustments
Following this initial check, you’ll need to conduct a critical analysis of the audit’s outcomes. At this point, everything about the QMS ISO 9001 implementation process will be reviewed. Concerns about the system, project management, and compliance (along with non-conformities) will be discussed, leading to QMS modifications. This enables the launch of the first improvement cycle and the system’s alignment with the company’s needs and ISO 9001:2015.
External Audit – Final Stage of QMS Implementation Based on ISO 9001
After project execution and essential adjustments, it’s time for the final audit. The certification audit (also known as an external or third-party audit) is when an internal body assesses your company’s processes to determine their conformity with ISO 9001:2015 requirements. During this phase, the certifying entity will immerse itself in your company’s day-to-day operations, interviewing individuals and reviewing processes, procedures, and documented information. It’s crucial to hire a certifier that genuinely assists in enhancing your company and pinpointing improvement areas. This will greatly impact your organization’s outcomes and the smoothness of its processes!
For this, rely on QMS Certification and our extensive expertise in the field. We’ve certified thousands of companies across various standards and boast the industry’s best auditors! Click here to reach out and request a quote.
Achieving Certification – A Reward Greater Than the Certificate Itself!
If all goes well, after the external audit, your company will finally attain the ISO 9001:2015 certification! This certificate attests to your organization’s capability to adhere to the standard’s norms and establish a coordinated, cohesive, and structured management system. It signifies a major accomplishment, unlocking new markets and setting your company apart. However, the certificate alone is merely the outcome of a much grander process that brings numerous advantages to your business.
ISO 9001 doesn’t explicitly instruct on how to meet its requirements. It merely suggests best practices and vital facets of an effective management system. Thus, when crafting your QMS, the company adapts the standard, achieving greater increased efficacy and efficiency.
Therefore, the implementation is tailored in a manner that yields the best results and suits your unique context. This creates stronger, more resilient processes aligned with your strategic objectives. While achieving the certification is beneficial, the real value comes from the implementation of a system that ensures heightened customer satisfaction, improved productivity levels, and, furthermore, a cycle of continuous and sustainable improvement in the mid to long-term.
The ISO 9001 certification process isn’t merely about adhering to certain standards, but about cultivating a culture of quality and excellence within the organization. It’s about recognizing areas of opportunity, refining processes, and fostering an environment where continuous improvement is not just an ideal but a daily practice.
In the end, while the certificate itself is a tangible representation of your commitment to quality, the real reward is the operational excellence, improved customer relations, and competitive advantage your company gains. The journey of implementing and maintaining ISO 9001 standards is as valuable, if not more so, than the final certification. As the saying goes, it’s not just about the destination, but the journey itself.