ISO 9001:2015 QMS

These are the steps that we will guide you through towards establishing a QMS and ISO certification for your organization

Step 1: Understand the requirements.

• We will provide material to study the ISO 9001:2015 standard thoroughly to understand its clauses and requirements
• Management and staff will be trained on the ISO 9001 requirements to ensure everyone understands what needs to be implemented.

Step 2: Perform a GAP Analysis.

• Assess current processes: We will compare your company’s current processes with ISO 9001:2015 requirements to identify gaps.
• Develop a plan: We will create a plan to address any shortcomings and bring your processes into compliance with the ISO 9001:2015 standard.

Step 3: Top Management Commitment.

• Management buy-in: Top management will be required to be committed to establishing, implementing, and maintaining the QMS. This includes allocating necessary resources (budget, personnel, etc) and supporting the development of quality policies and objectives.
• Appoint a Quality Representative: A person should be appointed to manage the implementation of the QMS.

Step 4: Develop a Quality Management System (QMS).

• Define the scope: We will guide you to clearly define the scope of the QMS, specifying what parts of the business will be included.
• Document Processes: We will then develop or update your company’s process documentation, including procedures, work instructions, and forms.
• Create a Quality Policy and Objectives: We will guide your organization to establish a quality policy and specific objectives that are aligned with the strategic direction of the company.

Develop Control Mechanisms: We will help to implement controls for monitoring and measuring product quality, customer satisfaction, and other key performance indicators (KPIs).

Step 5: Implement the QMS:

• Communication and Awareness: We will make sure employees are aware of the QMS, their role in the system, and the importance of meeting customer and regulatory requirements.
• Training and Competence: We will ensure staff are competent to perform their duties as per the QMS requirements through training and evaluations.
• Operationalize the Processes: We will then implement the processes defined in the QMS, ensuring that they align with the quality objectives. 

Step 6: Internal Audits:

• Conduct Internal Audits: We will perform internal audits to check if the QMS is functioning as planned and meets the ISO 9001 requirements.

Correct Non-Conformities: We will identify any non-conformities found during the internal audits and take corrective actions to address them.

Step 7: Management Review:

Conduct a Management Review: We will guide senior management to review the QMS performance periodically to ensure its continuing suitability, adequacy, and effectiveness. This review helps identify opportunities for improvement.

Step 8: Pre-assessment or Mock Audit (Optional):

Pre-assessment: Some organizations choose to conduct a pre-assessment (mock audit) by an external consultant to ensure readiness for certification. ICS can handle this process for your organization.

Step 9: Select a Certification Body:

Certification Body: We have an accredited certification body that we liaise with (also known as a registrar) that will conduct the certification audit.

Step 10: Certification Audit:

• Stage 1 Audit (Documentation Review): The certification body will first review your QMS documentation (quality manual, procedures, etc.) to verify that it meets ISO 9001:2015 requirements.

Stage 2 Audit (On-Site Audit): After successfully passing Stage 1, the certification body will conduct an on-site audit to evaluate the implementation and effectiveness of your QMS. Auditors will check how well your company adheres to the ISO 9001 standard and processes. We will represent you throughout this process.

Step 11: Corrective Actions (If Necessary):

Address Non-Conformities: If any non-conformities are found during the audit, we will help your organization to address these and submit evidence of corrective actions to the certification body.

Step 12: Certification Granted:

• Obtain Certification: Once the certification body is satisfied with your QMS, you will receive the ISO 9001:2015 certification.

Promote Your Certification: You can now promote your certification to customers, suppliers, and stakeholders, demonstrating your commitment to quality management.

Step 13: Ongoing Maintenance and Improvement:

• Surveillance Audits: Certification bodies will typically conduct surveillance audits annually or biennially to ensure that the QMS continues to comply with ISO 9001. Integrated Conformance Solutions Inc will be available to help your organization stay within compliance.
• Continual Improvement: We will continue to monitor, measure, and improve the QMS to maintain certification and drive business success of your organization.