ISO/IEC 9001

ISO/IEC 9001

ISO/IEC 9001 Consulting Quality Management System (QMS) in the Global Workspace

The significance of ISO/IEC 9001 cannot be overstated, as it serves as a foundation for millions of companies worldwide in shaping their quality approach and business practices. Its widespread adoption underscores its pivotal role in the global business landscape. ISO/IEC 9001 is widely recognized for its many benefits, including:

  • Providing a structured framework for management to establish and measure objectives.
  • Defining an organization’s functional and operational capability.
  • Enhancing focus on customer satisfaction.
  • Ensuring that organizations effectively manage quality assurance and quality control processes.

Implementing an ISO/IEC 9001 Quality Management System (QMS) offers several benefits that contribute to improved performance and competitiveness for organizations. Some key performance differentiators observed in companies with ISO/IEC 9001 certification include:

  • Enhanced Efficiency
  • Improved Customer Satisfaction
  • Increased Productivity
  • Better Risk Management
  • Access to New Markets
  • Continuous Improvement Culture
  • Enhanced Supplier Relationships
 

Undoubtedly, multiple studies have demonstrated that companies that engaged the services of an ISO/IEC 9001 Consultants, developed a Quality Management System (QMS), and obtained ISO/IEC Certification, tended to outperformManagement comparable organizations lacking an ISO/IEC 9001-based quality management system.
Key performance differentiators were:

  • Enhanced Efficiency
  • Improved Customer Satisfaction
  • Increased Productivity
  • Better Risk Management
  • Access to New Markets
  • Continuous Improvement Culture
  • Enhanced Supplier Relationships

ISO/IEC Overview and Objectives

The objectives of ISO/IEC 9001 requirements are to provide a methodology on how an organization ISO/IEC implements ISO/IEC 9001 and operates a Quality Management System (QMS).

The standard is designed to be applicable to all types of organizations, focusing on developing strategic quality and operational objectives, as well as ensuring commitment to customer satisfaction.

Building a Quality Management System

  • Planning & Discovery: This phase focuses on understanding the current state and planning to move to the desired state. Typical activities include a planning meeting, orientation training, performing a gap analysis, identifying a scope of the effort, producing a report of the findings which details strengths, weaknesses, and gaps between the actual state versus the planned (or desired) state. These findings are then used to develop a project plan which outlines tasks, timelines, and key milestones.
  • Development: After the planning phase is complete, the process development begins. Typical activities include forming a steering committee which defines roles and responsibilities, identifying and defining policies, processes, plans, procedures, manuals, and work instructions, and documenting business processes, inputs, and outputs.
  • Implementation: The implementation of the process includes introducing new processes; mentoring employees; setting objectives and measurements; training personnel on new requirements and monitoring their overall effectiveness.
  • Validation: This is the final phase, which assesses the validity of the system. Standard tasks include audits; testing; assessing performance; evaluating data and analyzing reports.


Collectively, these four phases culminate in a convergence of your business processes and best practices, and eventually reinvent the “way things are done” across the organization within that scope.

In order to ensure the project is well managed, it is helpful to identify an executive sponsor for escalation points; to identify process owners; to demonstrate management commitment; to determine repositories and tools early on and to establish channels for communication. Lastly, it is our belief that the success of a project depends on how well it is planned, monitored for effectiveness, and communicated to staff.

ISO/IEC 9001
Certification Process

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ISO/IEC 9001

Gap Analysis

ITG Consulting Services initiates each project with a comprehensive gap analysis (or gap audit) of a company's practices, aimed at gaining insights into the current operational state of the organization.

We base our approach on thorough assessments, involving interviews, process reviews, workflow analysis, and examination of infrastructure and architectural needs. Our strategy aims to pinpoint an organization's strengths, uncover best practices, and identify areas for growth to support ongoing development and success.

Our ISO/IEC Pre Assessments include:

  • Pre-planning and assessment scope development with key stakeholders to ensure all parties understand the initiative and focus,
  • Development of schedule and assessment activity,
  • Assessment with participation of Consulting Services consultants, and
  • Development and presentation of Assessment results; including findings, assessment rating against Standards/requirements, and recommendations and next steps.

Our qualified team members have many years of experience in strategic management, business operations, quality management practices, and ISO/IEC Pre Assessment activity. Our knowledge and expertise brings a valued and independent verification capability, through gap audits, to every organization’s efforts in process and operational improvement initiatives.

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Business Process Reengineering

ITG is an established business process reengineering provider, with over 20 years of experience in helping companies achieve improvement in strategic capabilities and overall cost savings.

We are qualified and trained Lean Six Sigma Consultants that utilize quality strategies to drive and improve business practices. Our Lean Six Sigma Consultants’ approach centers on an independent and un-biased analysis of an organization, to identify the operational production (takt time) and workflow with attention to efficiencies, gaps, and redundancy. In addition, our talented team utilizes industry experience and best practices gathered from Agile practices and CMMI improvement initiatives to develop a complete approach to our client’s process improvement solutions.

We offer practical support for implementing effective process improvements, focusing on tangible results rather than just theoretical concepts and methodologies.

Driven analysis, the guiding principles of DMAIC (define, measure, analyze, improve, control) and Lean strategies are the basis for the optimization of an organization’s process and procedural capabilities. ITG’s primary goal is to support improvement of 6 core areas:

  • Organizational Commitment
  • Functional And Operational Workflow
  • Effective Change Management
  • Business Strategy and Needs
  • Resource Utilization and Efficiency
  • Continuous Improvement


Our experience with both large and small companies provides a unique understanding of companies that are in transition or need assistance in quantifying current capabilities. ITG’s industry knowledge and practical experience ensures that our clients are supported by a complete approach, focusing on the business objectives of the organization and the inter-relation of processes, personnel, and capabilities.

ISO/IEC 9001
ITG Consulting Services is comprised of experienced and talented ISO Consultants who are industry practitioners and experts in quality, service, and information security management principles.
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Organizational commitment

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Functional and operational workflow

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Effective change management

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Business strategy and needs

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Resource utilization and efficiency

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Continuous improvement

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ISO/IEC

Our team collaborates with clients to identify areas requiring improvement or corrective action, focusing on activities and associated challenges. Our expertise covers multiple sectors and functions, including:

  • IT services,
  • Software development,
  • Supplier management,
  • Security,
  • Contract management,
  • Project management,
  • Quality assurance,
  • Human resources, staff augmentation, and talent management.

ITG Consulting Services’ Team is comprised of certifiedand experienced ISO/IEC Consultants who are proficient in the ISO/IEC standards, the CMMI framework including:

  • ISO/IEC 9001
  • ISO/IEC 20000-1
  • ISO/IEC 27001
  • CMMI for Development
  • CMMI for Services
  • NIST 800-171

Internal Audit Methodology for ISO/IEC 19011:2018

ITG applies guidance from ISO/IEC 19011:2018 (Guidelines for Auditing Management System) and Process and Product Quality Assurance practice approach to internal auditing, which jointly mirrors common registrar practices. This methodology emphasizes the results of the activities performed in addition to providing sufficient depth to capture any quality related challenges.

The organization of focused on increased use of formalized best practices within the organization. ITG will ensure to capture areas of improvements to business practices and process areas that can be considered by the organization to implement as part of continual improvement activities.

Key Tasks:

Plan for performing the internal audits for each management  system.

Audit Activities:

Perform audits according to Internal Audit Process requirements.

Audit Participants:

Leadership supporting the effectiveness of the management systems and process owners within scope.

Governance (Deliverables: GOV)

1. Delivery of internal audit report(s); to include a list of recommended opportunities for improvement.

2. Present identified nonconformance findings and recommended improvements to management and staff via virtual meeting and discussion .

3. If applicable, post-audit review and approval of corrective action plans for issued non conformances.

ISO/IEC 9001

Frequently Asked Questions for ISO/IEC 9001

Any organization that wants to improve its quality management system, meet customer and applicable statutory and regulatory requirements, and enhance customer satisfaction can use the ISO/IEC 9001 standard. It is suitable for organizations of any size, and applies to all sectors, including manufacturing, services, healthcare, education, government, and non-profit organizations. ISO/IEC 9001 can also be used by certification bodies or other third parties to assess an organization’s conformity with this International Standard.

A definition of quality is part of the core vocabulary for quality management which can be found in ISO/IEC 9001:2015 and applies to all ISO/IEC quality management standards, including ISO/IEC 9001. It says that quality is the “degree to which a set of inherent characteristics [or distinguishing features] of an object”, which in turn is defined as anything perceivable or conceivable, such as a product, service, process, person, organization, system or resource, “fulfills requirements.”

The ISO/IEC 9001 standard specifies requirements for the establishment, maintenance, and continuous improvement of a quality management system, covering a wide range of topics including:

  • Context of the organization
  • Leadership
  • Planning
  • Support
  • Operation
  • Performance evaluation
  • Improvement

 

Overall, ISO/IEC 9001 helps organizations address all aspects of managing the quality of their products and services, with an emphasis on customer satisfaction and constant enhancement of the quality management system.

An organization can become ISO/IEC 9001:2015 certified by successfully completing the certification process as mentioned above. Preparation for the certification requires the establishment of a Quality Management System, which meets the requirements of the ISO/IEC 9001:2015 Standard.

We’ll promptly contact you to discuss ISO/IEC 9001 and address any inquiries you may have.