Quality Management SystemISO 9001:2015 Implementation kick offStimulus Consultancy Services Date- 17 Feb-2017

AgendaQMS implementation kick off Meet

Quality Team

Mr Anupam Ray( Quality Manager)

Mr XX ( Project Manager- QMS)

Mr. AKT(Consultant- Quality )

External ConsultantStimulus consultancy services

Certification BodyXXX

Quality is not an act, but a habit…

• Goal: to re-orient the team towards quality improvement and process standardization. We want to continue our effort in pushing quality to the forefront of everything we do.

What is Quality Management System ?

Quality management refer to, what the organization does to-

• Ensure that its products and services satisfy the customer’s quality requirements

• Comply with any regulations applicable to those products and services

• Enhance customer satisfaction

• Achieve continual improvement of its process

Objective Policy

Processes

“A system to direct and control an organization with respect to quality !”

QMS expressed as the organizational goal and aspirations

Quality management System

QMS Team will..

• Facilitate to implement ISO 9001:2015 standard within the organization

• Liaison with certification body and consultant for organization

• Trained SPOCs (Single Point of contact) from each process /function to make implementation effective

• Assign start date and end date of each task.

• Coordinate and lead the ISO implementation project

SPOCs will • Ensure awareness of QMS within the team

• Be single point of contact for particular process/ functions

• Share daily progress report to Top management and QMS Team.

• Ready and available for Internal audit and other related task.

• Be responsible for QMS implementation apart from his/her regular work

5 Major Steps for Implementation

• Preparation ( Gap Analysis etc.)

• Defining Quality processes.

• Implementation, training and work Instructions.

• Internal Audit

• Certification process

Preparation

• Gap Analysis

• Select SPOCs

• Familiarize team with ISO 9001.

• Determine scope of certification.

• Define Quality policy.

• Establish Quality objective

Quality and Standardization process • Quality manual• Quality Procedures• Control of documented Information• Internal Audit

• Control of nonconformity products • CAPA• Process flow chart• Work Instructions• Forms/ Template and checklist

Implementation, training and work Instructions

• Quality and procedures manual are understood and implemented throughout the organization.

• QMS awareness and Internal auditor training

• Work process are reviewed.

• Work process are improved.

• Documentation.

Internal Audit

• Audits are performed internally by SPOCs and/or consultant.

• Designed to ensure continued quality effort.

• Identify any problem and nonconformity in the system

Certification

• Stage-1 Audit- document adequacy check

• Stage-2 Audit - Physical audit, Auditor will check evidence of all process.

• If certification audit fail- Follow up audit

Time involved.

Time: depends upon these parameters:

• Size of the organization

• Number of site onsite and off site location

• Selection of certification body

Selection of certification body

• Certification body should be internationally recognized

• Should have experience to audit same kind organization

• Should have client base and acceptance globally

• Should be accredited by any IAF member accreditation board.

QMS Implementation benefits

ISO requirements are ways to implement a sustainable and effective quality management system within a company

A quality management system will

• Increase efficiency• Lower costs• Reduce rework• Increase customer satisfaction• Which will translate into increased profitability.

Project Objectives and Rationale:

Achieve and maintain compliance with the requirements of the ISO 9001:20015 standards

Create consistency in quality management processes across the organisation

Providing increased level of accountability for staff in contributing to the management of quality, safety and risk

Improve audit trail and records/evidence keeping of how quality processes are managed

Ensure KPI’s/benchmarks are measured

Sr. No. Activity  

Days Required

Tentative Starting Date Last Date

1 Gap Analysis   7 Days 17-Feb-2017 27- Feb-2017

2 Identify Requirements   10 Days 28-Feb-2017  14-March-2017  

3 Define scope   5 Days 15-March-2017  21-March-2017  

4 Define procedure and process   15 Days 22-March-2017  11-April-2017  

5 Implement Procedure and process   15 Days 12-April-2017   02- May-2017  6 Training and awareness   20 Days 03- May-2017   31- May-2017  

7 Preparation for Internal audit   10 Days 01-June-2017  14-June-2017  

8 Internal Audit   12 Days 15-June-2017   30-June-2017  9 Action plan for NC of IA   5 days 03-July-2015   07-July-2017

10 Closing of NCs   15 Days 10-July-2017   28-July-2017  11 Management Review Meeting   3 Days 31-July-2017   02-Aug-2017  12 Again Internal Audit Optional   10 Days 03-Aug-2017   17-Aug-2017 13 Call for Stage 1 Audit        14 Closing of NC if any        15 Call for Stage 2 Audit        

Project Milestones Start Date- 17-Feb-2017 Go-Live date- 30- August-2017

.

Risk Mitigation strategiesKey stakeholders are

not engaged and committed to the

project

• Authorised project plan• Commitment of resources

to system setup• Employee training

 

Communication about project and software tool is not effective

Employee meeting presentation by Project

Sponsor/Project Manager Project milestones are

not met Project plan and milestone

reportingProject sponsor accountability

Project scope and deliverables not

understood by top management

Authorised project plan 

Risk Management

Assumptions and constraints: Managers and employee are committed to

supporting the implementation of the QMS in new business processes.

Commitment of top management towards Quality management system

Organization will strive for continual quality improvement.

SPOCs and other concern person will take extra responsibility in implementation of QMS apart from their daily operational work.

Contact for QMS Implementation for any location Email:- anupam@scs-groups.com, anupam.ray951@gmail.comSkype- anupam.rai3Linkedin Id : https://www.linkedin.com/in/anupam-ray-059a112a/Mobile:- 91-9999-133-689