ISO 9001: 2015 and Auditing – Making the Transition

Released in September 2015, ISO 9001 2015 is an update (aka revision) of the standard used by manufacturing firms to demonstrate their ability to provide products and services which meet both customer and regulatory requirements consistently. The previous version has been in place since 2008, and the 2015 version includes several features, including specifying requirements for a quality management system (QMS) and providing a more process-focused approach.

Key Changes with ISO 9001: 2015

All ISO standards are revised every seven years, and 2015 was no different. Some of the key changes found with the 2015 version were truly beneficial to improve companies from top to bottom, and include:

• Engaging leadership to becoming more involved in the quality management system (QMS), and not just create policies;
• Require companies to establish processes to monitor inputs and outputs involved;
• Ensuring organizations recognize risks (both internal and external), creating solutions to mitigate them;
• Create key performance indicators (KPIs) so accurate metrics can evidence success or failure;
• Frequent internal audits allow transparency of processes;
• Reduction in procedure implementation; This prevents companies from feeling pressured to create procedures under duress, which may not be truly necessary.

Benefits to Updating to ISO 9001: 2015

Increased effectiveness of a company’s quality management system (QMS) is perhaps the chief benefit to the revision. In the past, auditors often revealed inefficiencies in annual internal audits, and timely modifications could not be achieved. With the new process-focused approach, audits can be completed more frequently, and any process inadequacies can be pinpointed clearly, allowing the specific issue to be resolved with negligible effect on other company processes. A reduction in records (now called documented information) allows companies to focus on creating measurable processes without unnecessary regulations that don’t add value to customer satisfaction.

Increased Emphasis on Leadership in 9001: 2015

One of the most advertised aspects of the 2015 revision is to engage the executive team in QMS creation and application. In the past, leaders were frequently disconnected from the day-to-day operations in the firm. Auditors discovered that non-performance was often due to lack of leadership commitment and disinterest in managing operations. Further, they found a lack of communication, both in onboarding new employees and during instances where processes failed to meet company standards. Employees need to understand the reasons behind procedures and leaders needed to ensure team members were fully trained.

Undergoing the Move from 9001: 2008 to 9001: 2015

According to the SMC team, for most manufacturing firms which are already utilizing the 2008 standard, the process should take 12-14 months. With the addition of more detailed measuring and assessing inputs and outputs, firms must outline their processes.

Quality Management Systems (QMS)

One of the most significant aspects of the update is in the QMS, and the certification involved in the ISO 9001: 2015 standard. If a firm doesn’t have a thorough QMS, it is a complex procedure to undertake. The best approach is to hire a consultant or QMS expert, as many layers are involved. The steps include:

1. Perform a gap analysis
2. Select a registrar (3^rd party auditor) who gives the certification
3. Registrar completes his/her gap analysis
4. Registrar verifies that the gap analysis recommendations were implemented
5. Registrar completes the certification audit.

This process can take up to 18 months. For those who have a comprehensive (based on 9001: 2008 standards) QMS in place, this progression can be significantly shorter. There was a time when companies would “prepare” for an audit; however, if the QMS is effective and fully implemented, there is no preparation to be done. The processes are being followed every day, and an audit can be performed at any time.

New Focus on Risk Assessment

The 2015 standard brings an increased focus on risk assessment. One of the biggest benefits of this change in thinking equates to a shift from a reactive to proactive culture when dealing with processes, risk assessment, and management, employee, and ultimately, customer satisfaction. There is a transformation in thinking; where previously, the “WHAT IFs” weren’t addressed. Now, potential risks and outcomes (plan A, B, and even C) are laid out in advance.

One key factor in a culture focused on risk assessment is the understanding that it is a living thing; a process cannot be a “one and done” kind of activity. Not only must it be monitored, as outputs and metrics may indicate necessary revisions, but as technology and products provided by the manufacturing firm change, so must the process. Additionally, team leadership must provide “buy in,” and promote the new way of thinking throughout the organization.

ISO 9001: 2015 and Auditing

With the 2015 update, auditing has moved from a checklist-based process to a more investigative style. Some companies may ask “Will our auditors be prepared for the new standard and method for audits?” Provided that the auditors receive proper training, they should be prepared. SMC recently performed its own auditor training. Auditors were selected based on diversity, and impartiality. The training involved four intense days of education and a final day for completing the exam.

SMC’s Experience with ISO 9001: 2015

SMC is in the process of moving to ISO 9001: 2015, and plans to have it fully in place by February 2018. Kevin Baskin, SMC’s Quality Engineering Manager, feels they are prepared for the changes which will occur with the new standard, indicating that although they are in developing revisions to their processes, there is always room for improvement. Ultimately, customer satisfaction drives manufacturing firms to integrate advancements in their business practices. A reduction in defects with this process approach equals delighted customers!