ISO 9001 : 2015 Certification

ISO 9001 : Quality Management

ISO 9001 sets out the criteria for a quality management system and is the only standard in the family that can be certified to. It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001.

This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement.

Introduction to ISO 9001 Consulting

Poorly designed and implemented Quality management system (QMS) can cause detrimental burdens on an organization, making it difficult to keep customers satisfied and attain business goals.

If the QMS is developed and implemented correctly it can have an immediate and long term effect with successes of:
  • Improved Customer Satisfaction
  • Exceeding Business Objective Goals
  • Increased operational Efficiency
  • Lower Management System Administrative Burden
  • Less Management System Redundancy
  • Integration of Quality Management Principles through it's Design
  • Integration of Multiple Standards

Lexium can assist in the development and implementation of the QMS to assure for its immediate and long term success. We will assess, design and assist in developing and implementing your QMS. We specialize in utilizing best practices from multiple industries to provide a well balanced QMS solution for our customers.

Benefits of ISO 9001 Consulting

It’s not possible to develop and implement a quality management system without help. However an unguided QMS development and implementation plan usually produces suboptimal results.

The QMS Consulting expertise from Lexium consulting befits your organization by quickly applying our QMS knowledge by being in the forefront of management system best practices, and the founders are having over 30 years’ experience in auditing and implementation.

The QMS Consulting expertise from Lexium consulting befits your organization by quickly applying our QMS knowledge by being in the forefront of management system best practices, and the founders are having over 30 years’ experience in auditing and implementation.

Benefits of our QMS Consulting & implementation include :
  • Reduced no. of customer complaints
  • Reduced no. of operational process defects
  • Exceeding the organizational objectives and increasing business opportunities
  • Reduced QMS development and implementation time
  • A QMS designed to suit the organization and your customer’s requirements

Best practices and depth of knowledge and experience significantly impacts the QMS design and ability to meet the organization’s business goals. There is no substitute for experience. An experienced consultant helps your organization live and own the QMS and operate it at its optimal level.

Methodology for ISO 9001 Consulting

A proven Quality management system development and implementation approach should be used based on project management methodologies. A structured approach should be used for defining project plans, specific responsibilities and verification of results. The result will be a development and implementation strategy that is more efficient and provides for the first time compliance or registration to the ISO 9001 requirements.

ISO 9001 Compliance can be achieved through seven phases
  • Executive and Management Overview/ Planning
  • Gap Assessment and Planning
  • Documentation
  • Implementation and Training
  • Internal Assessment and Management Review
  • 3rd Party Registration Assessment
  • Sustain and Continual Improvement

The Lexium Seven Phase Methodology is detailed as follows :

    1. Executive and Management Overview Planning

  • Define Context of Organization
  • Define Interested Parties and Requirements
  • Define QMS Scope
  • Define High Level Processes and System Map
  • Define High Level Project Plan Description
  • Define High Level Risks
  • Define Organization Objectives and Targets
    Communication and Training Plan
  • Define Communications Plan
  • Define Training Plan
  • Executive and Management Overviews
  • Requirements of ISO 9000 Series of Standards
  • Process Approach to Quality Management System
  • Managing the Interactions of Processes and Systems
  • Description of the Organization’s Project Plan

    2. Gap Assessment and Planning

    Gap Assessment
  • Perform a gap assessment of the current QMS against revised or added requirements of the ISO 9001 standard
  • Use Quality Management System Map as a Guide
  • Perform Assessment with Process Owners
  • Document Results and use Results as Inputs Into Process Development
  • Re-assess Planning Performed in Phase 1
  • From Gap Assessment Findings Revise / Update ( As required )
  • Project Plans
  • Communication Plans
  • Training Plans

    3. Documentation

    Policy Development
  • Create Level 1 Policy Documents
  • Involve Leadership in Policy Development
  • Include Quality Management System Map
  • Use as a Guide in Policy Development
  • Include QMS References Versus the ISO 9001 Requirements
    Process Development
  • Create QMS Processes Using the Process Approach
  • Define Roles and Responsibilities
  • Process owner / Process Teams / Facilitators
  • Determine Document Control Requirements
  • Review/ Approvals / Document Nomenclature
  • Review of ISO 9001 Requirements with Process Owners / Teams

    4. Implementation and Training

  • Develop implementation Plans
  • Define by Process
  • Amount of Detail Dependent on Process Risk
  • New
  • Revised
  • Current Non-conformance with Process
  • Implementation Plan Detail
  • Purpose : Describe the Implementation Requirements for the Defined Process in Order to Support the QMS requirements
  • Scope : Define the Scope the Plan Covers (Process / Area)
  • Activity : Define Required Activity Steps
  • Who is Involved : Define Who Needs to be Involved
  • Timing : Define Timing Requirement
  • Deliverables : Define Plan Deliverables
  • Responsibilities : Define Responsibilities
    QMS training
    All Employee
  • Use communication process developed in phase 1 to cover general requirements
  • Communicate quality plan requirements
  • Leadership/ Process Owner / Manager / Internal accessor
  • Review New Quality Management system
  • Quality Manual
  • High level processes (Procedures)
  • Review New Quality Management System
  • Quality Manual (Policies)
  • High Level Processes (Procedures)
    Functional Area Requirements
  • As Per Implementation Plan for Those Areas
    Internal Assessor Training
    Current Assessors
  • ISO 9001 Overview
  • Process Assessment Methodology
    New Assessors
  • ISO 9001 Overview
  • Internal Auditing Basics
  • Process Auditing Methodology

    5. Internal Assessment and Management Review

    Internal Assessment
  • Internal Assessment Planning
  • Based on quality system map and defined processes
  • Assessments by Core and Support Functional Areas
  • Internal Assessment (Validate QMS Implementation)
  • Define Who will Perform Assessments
  • Define Assessment Schedules
  • Communicate Assessment Schedule to Process Owners / Auditees
  • Perform Assessment and Initiate Corrective Action as Required
  • Prepare Internal Assessment Reports for Management Review
    Plan Management Review Meeting
    Attain all Process Output and Analyse Data
    Summarized Analysed Data for Review Input
  • Results of Internal Assessment
  • Customer Feedback
  • Process Performance and Product Conformity
  • Status of Corrective and Preventive Actions
  • Follow up Actions from Previous Meetings
  • Changes that Could Affect the QMS, and Recommendations for Improvements
    Prepare and summarize Management review output decisions or actions required to
  • Improve the effectiveness of the QMS and its processes
  • Improve the product related to customer requirements

    6. Compliance / 3rd party Registration Assessment

      Close any open items / corrective actions from internal assessment or management reviews
      Complete cross reference of QMS versus ISOM 9001 requirements
      Where to find documentation
      Prepare registrar assessment plan with registrar / select guides
      Schedule assessment and communicate to process owners and auditees

    7. Sustain and continual Improvement

    Summarize continual Improvement activities by process and align to
  • Business Goals
  • Quality Objectives
  • Quality Planning Activities
  • Measures of Effectiveness
    Continued Internal Assessment and Management Review to Assure Process and System Continual Improvement

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