QMS - Implementation
Overview

Achieve Excellence with ISO 9001 – Let’s Start Your Quality Journey Today!
Delivering defect-free products and services starts with a robust Quality Management System (QMS). At Coral, we specialize in guiding organizations toward ISO 9001 compliance, creating a governance framework that ensures consistent quality and builds customer trust.
Our seasoned consultants will partner with you every step of the way, providing tailored solutions to streamline your processes, enhance product and service quality, and achieve certification seamlessly.
Ready to elevate your quality standards? Contact us to start your ISO 9001 compliance!

Start your QMS - ISO 9001 Journey Today!

QMS - ISO 9001 Consulting Phases

With an experienced team of ISO 9001 QMS consultants, we deliver the most comprehensive Quality Management System. Here are the key steps:

Phase I - Business Requirements and Scoping

Every Business is unique in terms of its business model, customers, technology, people, and internal processes.
As ISO 9001 certification consultant, our journey starts by understanding what matters to the customer most.
With this perspective, we determine and advise QMS goals and metrics that management wishes to achieve as part of the ISO 9001 implementation journey
Scope is a boundary statement for ISO 9001 certification that encompasses organization products and services and internal functions that support a Quality management system.
Scope is also a boundary for determining the applicable ISO 9001 clause-wise requirements. For example, not all organizations may require a design clause.
In this phase, we define the quality 'measurable' objectives that clients want to achieve as part of the program
Depending on the size and complexity of the business, we determine the key functions and processes that impact the overall product or service quality.

Phase II - Gap Analysis and Quality Risk Assessment

Depending on the size and complexity of the organization, we meet and discuss withe ach function and assess its current quality metrics
This phase includes assessing the business process which may require process reengineering
Our recommendations can involve changes in roles, technology, and internal processes to better guide the client in optimizing productivity and customer satisfaction.
In this phase, we assess each of the ISO 9001 certification requirements and its current process maturity using a 5-point maturity scale.
QMS consultants will discuss each QMS requirement and handhold the organization towards decision-making and implementation.

Phase III - Implementation including Policy Design and Documentation

The implementation phase is the most crucial phase of the project.

Both the iso 9001 consulting service firm and the client representatives must collaborate discuss and deliberate on the risks and gaps, organizational changes and new policy implementation, with specific action and target dates.
Although the standard does not require a Quality Manager, depending upon the organization this could be a dedicated or a program management role.
Documentations are generally divided into two categories.
The first category of documents are those that need visibility to all staff in terms of optimizing processes. These are your internal processes that effects the delivery of goods and services.
The second set of documents relates to fulfilling the certification requirement.
As ISO 9001 QMS consultants, we support you in designing and documenting both.
There are several benefits of policies and procedures including a 'system-wide-approach'

Phase IV - Training

Client staff responsible for managing the QMS must undergo training and awareness of QMS, and how they individually contribute to the Quality program as a whole.
They must be aware of the newly established policies and procedures, which will drive their day-to-day operations.
Awareness can be both through the classroom style sessions as well as participation in scenario-based training that is unique to the organization.

Phase V - Internal Audit

An internal audit for iso 9001 is conducted to test QMS implementation and compare it against the goals and objectives set in Phase 1.

An independent ISO 9001 Consultant conducts Internal Audits that will covere of all teams, their awareness, their alignment with the newly formed policies, and an assurance that newly designed policies and practices will remain effective in future.

Summary

At this stage:

As a result of undergoing these phases, the organization has effectively implemented an operational Quality Management System (QMS) that includes people, processes, technology and metrics.
At this stage, each of the ISO 9001 certification requirements has been completed by a combination of one or more of policy, responsibilities, process, technology, and automation.
The organization now has a plan that demonstrates its continued commitment to quality to drive this initiative forward
At this stage, the organization is ready to invite an external certification body to certify them to ISO 9001.

Phase VI - External Audit Support

Coral's ISO 9001 QMS certification consultants will support the organization during the external audits, which have the following phases:

Stage 1 – Documentation Review, and
Stage 2 - Implementation Verification

When the two phases are completed, the chosen certification body issues an ISO 9001 certificate, which has a validity of 3 years subject to annual surveillance audits.
The ISO 9001 certificate received by the organization can be used by the organization to display in its website as well as in any other forms of business communication.

Start your QMS - ISO 9001 Journey Today!

QMS - ISO 9001 FAQs

What are the responsibilities of a QMS ISO 9001 Certification Consultant?

Listed below are the list of responsibilities (non-exhaustive):
- Understanding Business
  - Analyze the organization's structure, processes, and key stakeholders.
  - Identify specific needs and align them with ISO 9001 requirements.
  - Evaluate the scope of products and services offered by the organization.
  - Strategic risks to quality in products and service delivery.
- Quality Objectives
  - Assist in defining measurable and achievable quality objectives.
  - Establish mechanisms to monitor and review the achievement of these objectives.
- Gap Analysis and Risk Assessment
  - Understanding key business processes.
  - Compare existing processes against ISO 9001 requirements.
  - Provide a detailed report highlighting areas of quality improvements.
  - Identify risks to quality management processes.
  - Develop strategies to mitigate identified risks effectively.
- Quality Design and Policy Documentation
  - Design requirements are core to Quality Management System ISO 9001 certification.
  - Define policies, procedures, and quality metrics.
  - Draft the quality policy to reflect the organization's goals and ISO 9001 requirements.
  - Ensure the policy is clearly communicated across the organization.
- Training
  - Conduct training sessions on ISO 9001 principles and requirements for employees.
  - Provide role-specific training for individuals involved in quality management.
- Measurement and Monitoring
  - Develop key performance indicators (KPIs) aligned with quality objectives.
  - Implement systems to collect, analyze, and report performance data.
- Internal Audit
  - Plan and conduct internal audits to verify compliance with ISO 9001.
  - Provide recommendations for corrective actions and continual improvement.
- External Audit
  - Assist in preparing for third-party certification audits.
  - Act as a liaison between the organization and the external auditors.
  - Support the client in facing stage 1 and stage 2 certification.
- Ongoing Compliance Support
  - Offer ongoing consultation to maintain ISO 9001 certification.
  - Update documentation and processes as required by changes in business operations or standards.
How Quality Management System (QMS) – ISO 9001 certification can increase business revenue?

Implementing a Quality Management System (QMS) based on ISO 9001 can increase revenue in several ways by improving efficiency, customer satisfaction, and market competitiveness. Here's how it contributes to revenue growth:
Improved Customer Satisfaction
- ISO 9001 emphasizes meeting customer requirements and enhancing satisfaction. Happy customers are more likely to become repeat customers and recommend your business to others, boosting sales.
Enhanced Operational Efficiency
- The standard focuses on process optimization and reducing waste. This improves productivity, reduces costs, and allows the business to allocate resources toward growth initiatives.
Design Thinking
- Strategically and operationally, every process will use design as the basis for improving products and services that meet and transcend customer expectations.
Access to New Markets
- Many organizations, especially large corporations and government entities, require suppliers to be ISO 9001 certified. Certification opens doors to contracts and markets that were previously inaccessible.
Improved Product and Service Quality
- By adhering to consistent quality standards, businesses reduce defects, returns, and rework. This builds a strong reputation, attracting more customers and fostering loyalty.
Competitive Advantage
- ISO 9001 certification is a mark of reliability and quality. It can differentiate your business in crowded markets, helping you secure more deals and expand your customer base.
Better Decision-Making
- The standard emphasizes data-driven decision-making, helping businesses identify profitable opportunities, improve forecasting, and allocate resources more effectively.
Increased Employee Engagement
- Clear processes and responsibilities lead to higher employee satisfaction and productivity. Engaged employees are more innovative and committed to driving the company’s success.
Risk Management
- ISO 9001 includes risk-based thinking, which helps identify and mitigate risks before they impact operations. Proactively managing risks reduces disruptions, improving revenue stability.
By integrating these Quality Management System principles, organizations create a robust framework for sustainable growth, ultimately driving revenue improvements.