ISO 9001-2015 Changes

April 25, 2017 | Author: mukundiso | Category: N/A
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Short Description

Describes changes in ISO-9001:2015...

Description

ISO 9001:2015 Changes

10/10/2014

1

Revision history of ISO 9001 • ISO 9001 is scheduled to revise every 6 years. • TC 176 – that’s the group responsible for revisions of ISO 9001. 1987 • 20 Elements, More Manufacturing Based, Procedure based.

1994 • 20 Elements, Emphasis of Preventive action, also Procedure Based

2000 • (Major Change) • 5 Major Clauses, Process Approach, least emphasis on procedures.

2008 • Minor Amendments from ISO 9001:2000. Mainly to clarify certain clauses.

2015 • Scheduled • Major Change • Cont’d next Slide

ISO 9001 2015 DEVELOPMENT TIME LINE

2013 COMMITTEE DRAFT

2014 APR-2014 DIS

2015 JUL-2015 FDIS (Tentative)

DRAFT INTERNATIONAL STANDARD. FINAL DRAFT INTERNATIONAL STANDARD

SEP-2015 INTERNATIONAL STANDARD (Tentative)

10-Oct-14

3

ISO 9001:2015 - Changes ISO 9001:2015: • 10 Major Clauses as per Annex SL Structure. • Risk Based Quality Management System. • Risk analysis will decide need for: – – – – – –

Objectives Quality Manual Procedures Manpower Process Controls Inspections etc…

What is Annex SL • Structure of all New Standards and Standards that are revised will be as per Annex SL. • Annex SL was published by ISO’s Technical Management Board (TMB) in 2012.

Clause wise Comparison ISO 9001:2008

ISO 9001:2015

0. Introduction

0. Introduction

1. Scope

1. Scope

2. Normative Reference

2. Normative Reference

3. Terms and Definitions

3. Terms and Definitions

4. Quality Management Systems

4. Context of the Organisation 5. Leadership

5. Management Responsibility

6. Planning for Quality Management System

6. Resource Management

7. Support

7. Product Realisation

8. Operation

8. Measurement Analysis and Improvement

9. Performance Evaluation 10. Improvement

ISO 9001:2008 Vs ISO 9001:2015 ISO 9001:2008

ISO 9001:2015

Process Approach

Risk Based Approach

Quality Manual Mandatory

Not mandatory, Based on risks identified

6 Procedures Mandatory

Not mandatory, Based on risks identified

19 Records Mandatory

Not mandatory, Based on risks identified

Management Involvement

Management Accountable

Management Representative

Not mandatory, Based on risks identified

Procedures and records

Documented Information

Control of Documents

Control of Documented Information

Control of Records Policy

Required

Process Based Objectives

Risk based Objectives

Process based Internal Audits

Risk Based audits

ISO 9001:2008 PROCESS MODEL Continual Improvement of the Quality Management System

7. Product Realization

Requirements

10-Oct-14

Input

Output

Customer

8. Measurement Analysis and Improvements

6. Resource Management

Satisfaction

Customer

5.Management Responsibility

Products and Services

8

ISO 9001:2015 (PROPOSED MODEL) 10. Continual Improvement

5.Leadership

Customer and other relevant interested party

Requirements

6. Planning – Risk Assessment

Input

9. Performance Evaluation

8. Operations

Output

Customer Satisfaction

Products and Services

7. Support Processes 10-Oct-14

9

Implementation approach ISO 9001:2008 PLAN

DO

• Prepare procedures for Key Processes. • 6 procedures and 19 records that are mandatory. • Objectives and Targets • Responsibility and Authority.

• Implement the procedure and controls • Record findings in records.

CHECK

ACT

• Analyse the process results • Conduct Internal audits • Conduct Management Review

• Take Corrective Action to remove nonconformity. • Provide necessary infrastructure

Implementation approach ISO 9001:2015 PLAN

DO

• Internal and External issues related to organisation. • Identify the risks related to QMS. • Set objectives, procedures, controls to mitigate the risks. • Allot responsibilities and set targets. • Accountability lies with Management

• Implement identified actions • Record the results.

CHECK

ACT

• Analyse the process results • Conduct Internal audits • Conduct Management Review

• Take Corrective Action to achieve planned results. • Provide necessary infrastructure • Improve.

ISO 9001:2015 Changes-Area of Focus:

• Leadership

– Top management involvement becomes more responsible and accountable.

• No explicit requirement of Quality Manual, Procedures or records. • No requirement of Management Representative. • Requirement of level and complexity of QMS to be decided based on the risks and their action identified.

Synopsis

• More Involvement of Top Management is mandatory. • Risk assessment a major exercise – Risk assessment only in terms of Quality of Service.

• Process procedures, reports and manuals to be based on the identified risks.

WATER QUALITY MONITORING AT A GLANCE Raw Water Sources

TULSI

VIHAR

TANSA

MODAK SAGAR

MIDDLE / UPPER VAITARNA

BATSA

Color, Turbidity, Temperature, pH, Residual Chlorine and Jar Test ( All test monthly except Vihar and Tulsi done weekly)

Chlorine Dosage decided based on Jar Test

TULSI WTP

VIHAR WTP

BHANDUP COMPLEX WTP

PANJRAPUR WTP

Color, Turbidity, Temperature, pH, Residual Chlorine and Jar Test ( All test Hourly / Bi hourly Basis ) Stages of Test: Inlet, Settling tank, filtration and outlet.

POWAI HL RESERVOIRS POWAI LL RESERVOIRS VERAVALLI HL RESERVOIRS

MALABAR HILL I& II TROMBAY I & II WORLI I & II RAOLI I & II PALI I & II GOLANJI POWAI LL BHANDARWARA MALAD I & II FOSBERY BORIVALLI I & II BHANDUP I & II GHATKOPAR I & II 254 water supply zones, 310 fixed location fixed for sampling. 36 Samples tested from 27 Reservoirs. 40 to 50 Samples per day are tested at G North ward lab. Result take 18 hrs, result is forwarded to respective ward. (By the time results come the water is consumed by the customer) Logging contamination and monitoring Corrective action .

SCADA AT A GLANCE SCADA

SCADA

SCADA

MCC

MAINTENANCE

WSP

MONITORING OF FLOW AND PRESSURE

PREVENTIVE MAINTANANCE SCHEDULE PREPARED FOR 3 YEARS AND MONITORED.

COVERS:

SPECIFICATION FOR NEW PROJECTS 34 MAINTENANCE STAFFS STATIONED .

INTERACTION WITH PUMPING STATION, WTP AND SECONDARY RESERVOIRS

SCADA SERVICES FOR NEW WATER PROJECTS.

NOTIFIED BREAKDOWN OF SENCORS / PLC ARE ATTENDED AND RECORDED..

REVIEW OF VENDOR OFFERS. ACCORDING TO REQUIREMENT. MONITOR THE PROJECT MONITOR OPERATION UNTIL HANDING OVER TO MCGM FOR REGULAR USE.

TARGET TIME: 48 hrs.

10-Oct-14

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