Poorly designed and implemented Quality Management Systems (QMS) can place significant burdens on an organization, making it difficult to satisfy customers and achieve business goals.

However, when developed and implemented correctly, a QMS can have both immediate and long-term benefits, including:

  • Improved customer satisfaction
  • Exceeding business objectives
  • Increased operational efficiency
  • Reduced administrative burden in managing the system
  • Minimizing redundancy within the management system
  • Integrating Quality Management Principles into its design
  • Incorporating multiple standards (ISO 14001, ISO 45001, IATF 16949, AS 9100, etc.)

We specialize in developing and implementing QMS solutions that ensure immediate and long-term success. Our approach involves assessing, designing, and implementing a QMS tailored to your organization’s needs. By leveraging best practices from multiple industries, we provide a well-balanced QMS solution for our clients.

Benefits of ISO 9001 Consulting

While it is possible to develop and implement a QMS independently, an unguided approach often leads to suboptimal results.

Our QMS consulting expertise at MAKE Enterprise benefits your organization by quickly applying proven knowledge to your specific circumstances. With over 12 years of experience and extensive implementations across various industries, we have been at the forefront of Management System Support and best practices.

Key benefits of QMS consulting include:

  • Fewer customer complaints
  • Reduced operational process defects
  • Exceeding organizational objectives and increasing business opportunities
  • Shorter QMS development and implementation timelines
  • A QMS tailored to your organization’s and customers’ requirements

The depth of knowledge and experience in QMS design significantly impacts an organization’s ability to meet business goals. Experience matters. Our consultants help organizations fully integrate and optimize their QMS for sustainable success.

ISO 9001 Consulting Methodology

A structured project management approach is essential for QMS development and implementation. This ensures an efficient implementation process and increases the likelihood of first-time compliance or registration with ISO 9001 requirements.

Our Seven-Phase Approach to ISO 9001 Compliance

  1. Executive & Management Overview / Planning
  2. Gap Assessment & Planning
  3. Documentation Development
  4. Implementation & Training
  5. Internal Assessment & Management Review
  6. Third-Party Registration Assessment
  7. Sustainability & Continuous Improvement

Detailed Seven-Phase Approach

1. Executive & Management Overview / Planning

  • Planning
    • Define the organization's context
    • Identify interested parties and their requirements
    • Establish QMS scope
    • Map high-level processes and system structure
    • Develop a high-level project plan and risk assessment
    • Set organizational objectives and targets
  • Communication & Training Plan
    • Define communication and training strategies
  • Executive & Management Overview
    • Overview of ISO 9000 Series of Standards
    • Process-based approach to QMS
    • Managing process interactions and system integration

2. Gap Assessment & Planning

  • Conduct Gap Assessments to compare the current QMS with ISO 9001 requirements
  • Engage process owners to assess compliance gaps
  • Utilize results to refine project, communication, and training plans

3. Documentation Development

  • Policy Development
    • Draft Level 1 policy documents in collaboration with leadership
    • Include QMS references aligning with ISO 9001 standards
  • Process Development
    • Define roles and responsibilities
    • Establish document control requirements
    • Align QMS processes with ISO 9001 guidelines

4. Implementation & Training

  • Implementation Planning
    • Define detailed implementation steps for each process
    • Assign responsibilities, timelines, and deliverables
  • QMS Training
    • All Employees: General QMS requirements and Quality Plan overview
    • Management & Process Owners: Quality Manual & process responsibilities
    • Functional Teams: Role-specific implementation requirements
    • Internal Auditors: ISO 9001 overview and process auditing training

5. Internal Assessment & Management Review

  • Internal Assessments
    • Evaluate QMS implementation effectiveness
    • Conduct internal audits based on defined schedules
    • Address non-conformities and corrective actions
  • Management Review
    • Analyze key performance indicators
    • Review internal audit results, customer feedback, and process performance
    • Identify improvement opportunities for QMS effectiveness

6. Third-Party Registration Assessment

  • Address any open corrective actions
  • Prepare QMS compliance cross-reference documentation
  • Coordinate assessment with ISO 9001 registrar
  • Facilitate third-party audits and process evaluations

7. Sustainability & Continuous Improvement

  • Align continuous improvement activities with business goals
  • Maintain regular internal assessments and management reviews
  • Ensure sustained QMS effectiveness through ongoing optimization

Why Choose MAKE Enterprise?

At MAKE Enterprise, we take pride in being "Your Development Partner."

To fulfill this mission, we invest in highly qualified and experienced professionals. Our team consists of certified experts across various QMS disciplines, ensuring we provide the best solutions for our clients.

Let us help you develop and implement a Quality Management System that drives efficiency, compliance, and business success.