ISO 9001:2015 QMS Changes & Challenges · To understand the changes in ISO 9001:2015 To attend 5...

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ISO 9001:2015 QMS Changes & Challenges

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INTRODUCTION


Learning Outcomes

01/09/2016 5

• Introduction to ISO

• Evolution of QMS till 2008 Version

• Introduction to the 9001:2015

• Overview of the New Changes

New Inclusions

Structure

Principles

Approach

Leadership, Outsourcing & Systems

• Challenges

• Pre-requisite for QMS Professionals

• Clarifications / Questions


What is ISO ?

• ISO – International Organization for Standardization

• Federation of national standards body

• Non profit organization

• Represented by 167 countries

• Working through Technical Committee (TC)

• Publishing standard by voting among members

• Review standard once in 5 years for continuation or revision or withdrawing of standard

• ISO/TC176 for QMS, ISO/TC207 for EMS


1968• NATO : AQAP

1971• BS 9000

1979• BS 5750

1987• ISO 9001:1987

1994• ISO 9001:1994

2000• ISO 9001:2000

2008• ISO 9001:2008

2015• ISO 9001:2015


Overview of Changes

Changes in the Structure

New Inclusions

Changes in the Fundamental Principles

Changes in the Approach

Changes in the Top Management related issues

Changes in the Documents / Records

Changes related to the Purchase / Outsourcing

Changes related to the System


• Structure has been aligned with that of Annex SL

• Compatibility increases and the ease of integration

• Now 10 Clauses

• Previous requirements are retained, re-numbered

• New requirements have been added

Changes in the Structure


Changes in fundamental Principles

2008• Customer Focus

• Leadership

• Involvement of People

• Process Approach

• System Approach

• Continual Improvement

• Factual Approach for Decision Making

• Mutually Beneficial Supplier Relationship

2015• Customer Focus

• Leadership

• Engagement of People


• Improvement

• Evidence Based Management

• Relationship Management


New Additions

•Understanding the organization Context (4.1)

•Understanding needs & expectations of interested parties (4.2)

•Risk based thinking & Approach (6.1) (See next slide)

•Environment for the operation (Social 7.1.4 a & Psychological 7.1.4 b)

•Organizational Knowledge (7.1.6)


Changes in Approach

Risk Based Thinking – Which might influence the QMS Performance

“Risks & Opportunities” to be considered prior to design of Context, Products, Services, Processes, Projects, QMS, Scope and Changes

Risks : Violations, Penalties/Notices, No customers, Delays, Customer dissatisfaction, Customer Complaints, Rejections, Reworks, Product re-call, Bad reputation in the market, Incompetence, High Staff Turnover, Cost of Quality failures, etc.

Opportunities : New Customers, New Markets, New Products / Services, New Scope, Customer Goodwill, Staff Goodwill, Employee Participation, Innovation & Creativity, Organizational Competence, Business Excellence, etc.

E.g. HR Planning , Operation Planning (Technology), Improvements & Suggestions


Changes related to Leadership

Management Responsibility Vs. Leadership

Leadership Accountability & Active Engagement

No more Management Representative

PDCA (Policy, Resources, Approaches, Communication, Promote Improvements, Ensure Effectiveness in MRM, Lead Changes, etc.)


Changes in Documentation

No more Documents or Records

Maintained & Retained Documented information

No need for the Quality Manual & 6 Documented Procedures


Changes Related to the Outsourcing

No more “Purchasing”, but “Externally provided products and services”

No more Supplier / Vendor / Sub Contractor, but “EXTERNAL PROVIDER”

A risk-based approach to determine the type and extent of controls

Properties of External providers also shall be protected and reported (8.5.3)


Changes Related to the System

No more “Preventive action (8.5.3)”, but included within “Risks and Opportunities (6.1)”

The terms “Products” has been replaced with “Products and Services”

Scope of applicability (4.3) to be defined, if not applicable, can be accepted if the exclusion does not affect organization’s ability to demonstrate QMS Conformance and customer satisfaction

Planning of Changes (6.3) is explicit than the 5.4.2 of 9001-2008

Quality Objectives Planning (6.2.2) -2015 is explicit than the QMS Planning (5.4.2 a) - 2008


Overview of Changes

Changes in the structure

New Inclusions

Changes in the fundamental principles

Changes in the Approach

Changes in the Top Management related issues

Changes in the Documents / Records

Changes related to the Purchase / outsourcing

Changes related to the System


Challenges Related to Leadership

No more Management Representative

Direct accountability

Requires more time and effective engagement.

Leaders understand the importance of QMS on BMS


Challenges : Risk Based Thinking

To understand the concept of Risk Based Thinking

To devise a risk assessment, in the absence of any prescribed format

It is not a tick box exercise, it shall be an integral part of business and not one-time.

To capitalize opportunities in the absence of Preventive action.


Challenges Related to Outsourcing

To define the scope and extent of control (Risk based)

To address and demonstrate how to manage with the external providers approved by the client

To maintain their properties and notify them in lieu of loss/damage.


Strategic Challenges

To define external & internal business context

To capture the perception of relevant stakeholders

To ensure alignment between QMS and BMS

To address a mechanism for the QMS Change Management


How to Manage the challenges

• Customer Focus

• Leadership

• Engagement of People


• Improvement

• Evidence Based Management

• Relationship Management


Milestones

To understand the changes in ISO 9001:2015

To attend 5 days LA Course from 3Fold - IRCA Certified QMS LA

To Prepare Audit Log and submit to IRCA with LA Certificate

Become an IRCA Registered QMS 2015 Auditor / Lead Auditor


Recap

• Introduction to ISO

• Evolution of QMS till 2008 Version

• Introduction to the 9001:2015 Latest Version

• Overview of the New Changes

New Inclusions

Structure

Principles

Approach

Leadership, Outsourcing & Systems

• Challenges

• Pre-requisite for QMS Professionals


Clarification… If any?

01/09/2016 25


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ISO 9001:2015 QMS Changes & Challenges · To understand the changes in ISO 9001:2015 To attend 5...

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