Consulting Methodology

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 first time compliance or registration to the ISO 9001 requirements.

ISO 9001 Compliance can be achieved through Seven Phases:

1.      Executive and Management Overview / Planning

2.      Gap Assessment and Planning

3.      Documentation

4.      Implementation and Training

5.      Internal Assessment and Management Review

6.      3rd Party Registration Assessment

7.      Sustain and Continual Improvement

The Quality-One Seven Phase Approach is detailed as follows:

1. Executive and Management Overview / Planning

    • 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 Organizations Objectives and Targets
    • Communication and Training Plan
      • Define Communications Plan
      • Define Training Plan
    • Executive and Management Overviews
      • Executive and Management Overviews
      • Requirements of the ISO 9000 Series of Standards
      • Process Approach to Quality Management Systems
      • Managing The Interaction 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 Systems Map as a guide
      • Perform Assessments with Process Owners
      • Document Results and Use Results as inputs into Process Development
    • Planning
      • Re-assess planning performed in Phase 1
      • From Gap Assessment Findings Revise / Update (as required):
        • Project Plans
        • Communications Plans
        • Training Plans

3. Documentation

    • Policy Development
      • Create Level 1 Policy Document
      • Involve Leadership in Policy Development
      • Include Quality Management Systems 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 Owners / Process Teams / Facilitators (i.e. QA Dept.)
      • Determine Document Control Requirements
      • Review / Approvals / Document Nomenclature
      • Review ISO 9001 Requirements with Process Owner/Teams

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4. Implementation and Training

    • Implementation
      • Develop Implementation Plans
      • Define by Process
      • Amount of Detail Dependent on Process Risk
        • New
        • Revised
      • Current Non-Conformance's with Process
      • Implementation Plan Detail
        • Purpose: describes 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 Requirements
        • Deliverables: Define Plan Deliverables
        • Responsibility: Define Responsibilities
        • Other as appropriate
      • QMS Training
        • All Employee
          • Use communications process developed in phase 1 to cover general requirements
          • Communicate Quality Plan Requirements
          • Leadership / Process Owner / Manager / Internal Assessors
          • Review new Quality Management System
          • Quality Manual
            • High Level Processes (Procedures)
          • Management
            • Review new Quality Management System
            • Quality Manual (Policies)
            • High Level Processes (Procedures)
          • Functional Area Requirements
            • As per Implementation Plans for those areas
          • Other
            • As appropriate to the organization
          • 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 Systems Map and Defined Processes
      • Assessments by Core and Support Functional Areas
      • Internal Assessments (Validate QMS Implementation)
      • Define Who Will Perform Assessments
      • Define Assessment Schedules
      • Communicate Assessment Schedules to Process Owners / Auditees
      • Perform Assessments and Initiate Corrective Actions as Required
      • Prepare Internal Assessment Reports for Management Review
    • Management Review
      • Plan Management Review Meeting
      • Attain all process output and Analyze Data
      • Summarize Analyzed Data for Review Input
        • Results of Internal Assessments
        • 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 Man. 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 ISO 9001 Requirements
      • Where to find Documentation
    • Prepare Registrar Assessment Plan with Registrar / Select Guides (Process Owners)
    • 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