How do you cope with the changes and updates in the ISO 9001 standard and requirements?

Familiarization - make sure you know what has changed. Create a quick Excel comparing all the former clauses to the new clauses. Highlight those clauses that have changed or that are new. Once you have an idea of what needs to be addressed, assess with the stakeholders and leadership how the organization wants to address those changes. With your organization's objectives in mind, proceed to build the adjustments in collaboration with process owners and subject matter experts.

As an Auditor, one needs to regularly engage in professional development activities to ensure up-to-date knowledge of ISO 9001 standards. In my experience, to stay current with ISO 9001 updates, I attended relevant training sessions, webinars, and industry conferences. For instance, when ISO 9001:2015 was introduced, I participated in a specialized training program that detailed the new requirements and changes from the previous version. This training provided me with a comprehensive understanding of the updated standard, which was crucial for guiding the bank through the transition.

Auditors should always aware in the changes and latest revisions of standards. Revisions in the standards have significant changes and updates in the clauses and unable to cope up with this will result to unsuccessful audit.

To navigate the ISO 9001:2015 changes and updates effectively, familiarize your team with the new high-level structure and adopt risk-based thinking in your processes. Involve top management in aligning quality objectives with organizational goals, and use the flexibility in documentation to streamline practices. These steps ensure compliance while fostering a culture of continuous improvement.

Auditors should also conduct training and awareness programs to ensure that all employees understand and adhere to updated standards. In my role as a Lead Auditor, I designed and implemented a training program to educate employees about the changes in ISO 9001:2015 and how these changes impacted their work. For instance, I conducted training sessions that focused on risk-based thinking, process approach, and the importance of customer satisfaction. These sessions included practical examples and interactive discussions to reinforce the concepts. This training ensured that all employees were aware of and understood the new requirements, leading to smoother implementation.

Communications is fundamental to any type of change. According to the ADKAR model, tailor communications to different parts of the change lifecycle: - Awareness - high level communications so those impacted by change are aware that change is coming. - Desire - Provide detailed communication as to why we are changing, what is in it for them, and how change will impact organizational goals. - Knowledge - Give colleagues the knowledge they need to succeed. - Ability - Provide regular feedback to confirm and support ongoing enthusiasm for change. - Reinforcement - Build communications into regular operational and administrative meetings, have feedback mechanisms, and tie adoption of changes to performance metrics.

To cope with the changes, a proper training and seminars is a must. After training you can now implement the changes in your organization thru policies, procedures and other quality management documents. Explain the advantage of changes and changes in standards and communicate it in concise manner.

When making changes or updates to the system, ensure you are engaging process owners and subject matter experts. By opening this communication early, your system will be more in line with operational realities and therefore better adopted when it goes live. Maintain a historical record of change. This will support succession planning and training of others on your team. It will house information as to where your system came from and what was important at different points.

Auditor needs to engage with stakeholders to ensure understanding and smooth implementation of changes. In my previous role, I organized workshops and meetings with key stakeholders, including department heads and process owners, to explain the changes in the ISO 9001:2015 standard. For instance, I held a workshop to discuss the new emphasis on leadership and commitment, risk management, and the need for documented information. By effectively communicating the benefits and implications of these changes, I ensured that everyone was on board and understood their roles in the transition process.

Once the updates have been added into the process, you can begin to work with your stakeholders and subject matter experts on building your audit checklist. Again, this is a collaborative process - as a quality professional you are the expert on the standard, but colleagues executing the work are experts on the business. Together you will be able to build a checklist and audit program that: - Ensures standards are met (ISO9001, ISO 19011), - Ensures effective communication, training and deployment, - Supports business objectives, - Integrates with other activities that may be in your organization (health and safety or other standards, for example).

Reporting of audit findings is important and should engage all levels of the organization: 1) Frontlines - Those working that impact compliance should be informed of findings immediately and constructively. Positive feedback is a must if you are finding compliance. 2) Department management - Open communication throughout the audit about how the unit can better meet the standards should occur whenever there is a finding. Positive feedback relating to effort is required. 3) Leadership - This level is mandated in the standard. They require trends on findings in a clear manner. When meeting with leadership, always have options for continual improvement to help open dialogue.

Driving continual improvement is a cornerstone of ISO9001 and any business model. Audits provide one block of information that will help leadership and department heads form business decisions. Learning and improving is easier when you have openly collaborated with process owners and subject matter experts from the very beginning of this process. People who are engaged in change are also engaged in the success of that change. Be aware of how your findings and continual improvement suggestions link to the bottom line of the organization. Activities that provide multifaceted benefits to the organization (revenue generating, client contract compliance, process improvement, cost savings, etc.) are more likely to be adopted and successful.

As an Internal Auditor, conducting internal audits and reviews to ensure ongoing compliance and identify areas for improvement. In my previous experience, after updating the QMS as planned in the audit program, I scheduled and conducted internal audits to assess compliance with the ISO 9001:2015 standards. During these audits, I used checklists based on the new requirements to evaluate the effectiveness of the updated processes. For example, I audited the risk management process to ensure that risks were being identified, assessed, and mitigated as required. These internal audits helped in identifying any gaps or areas for further improvement, ensuring ongoing compliance.

Auditors must establish mechanisms for continuous monitoring and improvement to ensure sustained compliance. In my role as a Lead Auditor, I implemented a system for continuous monitoring and improvement of the QMS. This included setting up regular management reviews to evaluate the effectiveness of the QMS and its compliance with ISO 9001:2015. For instance, I introduced key performance indicators (KPIs) to monitor the performance of critical processes and conducted periodic reviews to identify improvement opportunities. This continuous improvement approach ensured that the QMS remained compliant and effective over time.

Change is hard for any organization. This may cause resistance in some colleagues or departments. Ensure you have a plan to positively engage with this resistance - - Have a sponsor (leadership) who will help convey the message from an organizational direction perspective. - Have managers of people actively engaged in communicating with their staff - people will be more open to communications from their supervisor. - Have a communication plan. Build transparency into the change. - Do not be afraid to engage with conflict. Remember, people are uncomfortable with change, not upset with you.