ISO 9001-2015 Changes
April 25, 2017 | Author: mukundiso | Category: N/A
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
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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
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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
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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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