Quality Management System (QMS)
ISO 9001 Consulting Services Readiness, Implementation, Measurement, Program Management

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.