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Awareness Program on ISO 9001:2015

Introduction to Quality Management


Health & Safety
Code of Conduct
Introduction to Quality management

You have the

official You tell me
definition, BUT what does
quality mean to
Introduction to Quality management

degree to which a
set of inherent
Introduction to Quality management

What is Quality
Introduction to Quality management

So, which person, or group of people defines

whether an organisation delivers quality, or not?

Differences in quality

In that case, which is of a better quality?

Introduction to Quality management

So, if the quality is

good for both, how
would you define the
Introduction to Quality management

Category or rank given to
different requirements for
an object having the
same functional use

Grade is inherent in the

Ref.: ISO 9000:2015 product and may be
altered by changes in
Introduction to Quality management

What is a
a quality management ?
Introduction to Quality management

What is the need for a

a quality management
System for any organization ?
Introduction to Quality management

Because they need to be as

near to the centre as possible
when aiming at the moving
target we call quality
Introduction to Quality management

How do you think that ISO 9001:2015 could help?

Benefits of management system..?

Are there any other benefits

that a management system
can bring to an organisation?
Benefits of Management System

Organisation improvement

Helps market positioning

Assurance of meeting
Customer requirement
Assurance of conformance to
Legal requirement
Supplier development
Benefits of QMS

Improved internal profitability
transfer of know how

Improved morale &

motivation of staff

quality costs
Enhanced customer
satisfaction and loyalty
Benefits of QMS

Certification of quality system to ISO 9001

as a bonus:

Tangible proof that the companys quality system

complies with internationally recognised standard

Avoidance of multiple second party audits Certificate

ISO 9001
Marketing edge
Why QMS is necessary..?

ISO 14001 Environment

Requirements OHSAS 18001
of Society Health & Safety
SA 8000
Social Accountability

TS 16949 Automobile
Sector TL 9000 Telecom
requirements EN 9100

ISO Manufacturing
Market access 9001 Services
Introduction to Quality management

From ISO 9000:2005

Customer focus
Customer focus
Involvement of people
Engagement of people
Process approach
Process approach
System approach to management
Continual improvement
Evidence-based Decision making
Factual approach to decision making
Relationship Management
Mutual beneficial supplier relationships
1.Customer focus

CUSTOMER Organizations depend on their


But never forget

the other
Quality of interested parties
Product / Service


Return on

The primary focus of quality management requirement is to meet customer

requirements and to strive to exceed customer expectations
Strategies, policies,
processes and resources

Leaders provide:
u Unity of purpose
u Direction
u Engagement,

Statement Leaders at all levels establish unity of purpose and

direction and create conditions in which people are engaged in
achieving the quality objectives of the organization
3.Engagement of people

People are the essence of the organisation

Statement:-It is essential for the organization that all people are
competent, empowered and engaged in delivering value

Their full involvement and engagement enables using their abilities to the
benefit of the organisation
4.Process approach

Extent to which planned
CONTROLS activities are realised and
planned results achieved

set of interrelated or
INPUT interacting activities OUTPUT PRODUCT
which transforms
inputs into outputs

Relationship between the
RESOURCES result achieved and the
resources used

Statement : Consistent and predctable results are achieved

more effectively and efficiently when activities are understood
and managed as interrelated processes that function as a
coherent system
4.Process approach in managing a system

Determining, R R
understanding and I
managing interacting I Process O I Process
and interrelated A B
processes as a I
system contributes to C C
the organisations I Process Process O
effectiveness and C O I D
efficiency in achieving
its objectives


Statement :-Successful organizations have an on-going focus on improvement.

The methodology known as Plan-Do-Check-Act can be applied to all processes of the QMS

Act: take actions to Plan: establish objectives

improve process
and processes necessary to
deliver results in accordance
with customer requirements
and the organisations
Check: monitor and
measure processes and
product against policies,
objectives and requirements
for the product and report
the results Do: implement the processes
A permanent objective of the organisation
6.Evidence-based Decision making

Statement:-Decisions based on the analysis and evaluation of data and information

are more likely to produce desired results
7.Relationship Management

For sustained success, organizations

manage their relationships with
interested parties, such as suppliers
Introduction to ISO 9001:2015
ISO 9001:2015 Presentation


Quick Summary Review of ISO 9001 through the years

Compare change from 2008 Revision to 2015 Revision

Some Examples of how changes can be implemented

Quick Review of Impact to Sector ISO QMS Standards

ISO 9001:2015 Presentation

ISO 9001 Through the Years

Foundation Mil Std 9858, BS5750
1987 (20 Elements; 3 Models (Design/Mfgr; Mfgr; Final
1994 (20 Elements; Some Clarifications; ease-up Docs)
2000 (1 Model; Process Approach; 20 Elements Gone)
2008 (Minor Clarifications)
2015 (New focus areas eg., Risk Based Thinking and
Context of the Organization, but many facets of 2008 still
apply; 2015 less prescriptive standard overall)
Compare/Contrast Evolution to Baldrige Award Criteria
ISO 9001:2015 Presentation

What does ISO Leadership say about the 2015 Revision

ISO Leadership on 2015 revisions - YouTube.mp4

ISO 9001:2015 Presentation

Standard Clauses
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 Organization
5. Management Responsibility 5. Leadership
6. Resource Management 6. Planning for the Q M S
7. Product Realization 7. Support
8. Measurement, Analysis & 8. Operation
Improvement 9. Performance Evaluation
10. Improvement
ISO 9001:2015 format design per ISO Joint Technical Coordination Groups
Requirements, as per ISO Guide 83. ISO 9001 and 14001 now revised.

Some Rearranging, however, some NEW requirements

ISO 9001:2015 Presentation

Terminology Changes
ISO 9001:2008 ISO 9001:2015
Products Products and Services
Exclusions Not Used (refer Clause A.5)
Management Rep Not Used
Documentation, Quality Manual, Documented Information (Q-
Procedures, Records Manual, Specific Procedures not
Work Environment Environment for the operation of
Monitoring and Measuring Monitoring and measuring
Equipment resources
Purchased Product Externally provided products and
Supplier External Provider
(Not Used) Interested Party
Preventive Action Not Used
ISO 9001:2015 Presentation

4. Context of the Organization High Level Strategic

New Section with New Requirements
Organizations must determine external and internal
issues impacting its purpose and strategic direction
Consider external context issues: legal, technological,
competitive, market, cultural, social, and economic
Consider internal context issues: values, culture,
knowledge, and performance of the organization
Organization shall determine a) interested parties (aka
Stakeholders ?), and b) needs/expectations of the
interested parties (Customer Reqmts Not used)
Must demonstrate with evidence all the above
ISO 9001:2015 Presentation

4. Context of the Organization Interested Parties

Interested Party Examples of Needs and Expectations

(not in standard) Examples of (not in standard)
Customers (and their Customers) Product/Service Quality; Price; On-Time
Owners/Share Holders Sustained Profitability; ROI

Employees Safe and pleasant work environment;

Job security; Competitive compensation
External Provider ( Vendor, Personnel Continuous Operations; Sustainable
Agency, ISO Registrar) markets and business
Competitors Be more competitive/innovative; Ethical
behavior (impacts all in the industry)
Society; Regulators Ethical behavior; Compliance with
Credit to QSG 2015
ISO 9001:2015 Presentation

5. Leadership and Commitment

Greater accountability for Top Mgt. re: Q M S
Top Management shall demonstrate Leadership:
Ensure integration of QMS requirements into
the organizations business processes
Promoting awareness of the Process
Assuring the QMS achieves its intended
results (PDCA)
Supporting other management roles to
demonstrate Leadership
ISO 9001:2015 Presentation

5. Leadership and Commitment

Top Management shall demonstrate Leadership
Ensuring Q-Policy and Q-Objectives are compatible
with Strategic Direction and the Context of the
Promote Process Approach and Risk Based Thinking
Promoting Continual Improvement
No more Management Rep
From my Registrar:
The requirement for increased Leadership
oversight for an organizations Q M S could be the
biggest challenge.
How to assess Risks more later
ISO 9001:2015 Presentation

6. Planning the Q M S
Quality Objectives: shall establish quality objectives
at relevant functions, levels, processes; be
monitored; maintain documented information
Actions to address risks and opportunities
Integrate/implement Actions into Q M S
Evaluate the effectiveness of these Actions (PDCA)
Risk Based Thinking, Risk Assessment:
Notation (from the standard): Options to address risks and
opportunities can include: avoiding risk, taking risk in order to pursue an
opportunity, eliminating the risk source, changing the likelihood or
consequences, sharing the risk, or retaining risk by informed decision.

Preventive Actions has been removed

ISO 9001:2015 Presentation

7. Support
Resources, People (Competence, Training), Infrastructure,
Monitoring and Measuring activities basically unchanged
Communication/Awareness now in this section (from
Management Responsibility Section)
Documentation: now Documented Information
Documented Information:

The Organization shall maintain documented

information to the extent necessary to support the
operation of processes and retain documentation to
the extent necessary to have confidence that the
processes are being carried out as planned
No requirement for a Quality Manual nor any specific Quality
Procedures are identified
ISO 9001:2015 Presentation

8. Operation
(The current Product Realization section)
Products and Services
Design process remains, but sections on
Verification and Validation removed
Section has few Impactful changes: same
overall flow remains: Customer Requirements
> Design > Externally Provided Products and
Services (Purchasing) > Production/Service
Controls > ID Traceability > Preservation >
Non-Conformances IDd and Controlled
ISO 9001:2015 Presentation

9. Performance Evaluation
Performance Evaluation:
The Organization shall determine what
needs to be monitored/measured
Customer Satisfaction Information
Process Performance
External Provider Performance
Internal Audits
Management Review, including
checking the QMS for alignment with
the strategic direction of the
organization this is NEW!!
ISO 9001:2015 Presentation

10. Improvement
- Determine and Select Opportunities for Improvement
- Examples of Improvement can include Correction,
Corrective Action, Continual Improvement, Breakthrough
Change, Innovation, and Re-organization.
- Corrective Action is in this section
- Retain Documented Information as evidence results of
Corrective Action

NOTE**: Improvement can be effected

Reactively (e.g. corrective action),
Incrementally (e.g. continual improvement)
Step-by-step (e.g. breakthrough)
Creatively (e.g. innovation)
Re-organization (e.g. transformation)
** - bullets for emphasis
ISO 9001:2015 Presentation
Term: Documented Information
Retaining Doc. Info. = Records Maintain Doc. Info. applies to

Quality Objectives Quality Policy

Fitness for purpose of monitoring and measuring resources Quality Objectives
Evidence of Competence Scope of the Q M S
Conformity of Products/Services

Review of Customer Requirements

Design and Development Process

Design and Development Changes

Evaluation/Performance of External Providers

Product/Service ID and Traceability

Pre and Post Delivery Change Authorizations
Conformity with Acceptance Criteria
Authorized Release of Products/Services
Non-conformances and C/A
Internal Audits
Management Reviews
ISO 9001:2015 Presentation

Risk Based Thinking

No Preventive Action sub-clause. P/A is expressed
through a Risk-Based Approach to formulating Q M S
Risk-based approach has facilitated some reduction in
prescriptive requirements and their replacement by
performance-based requirements
There is no requirement for formal Risk Management
or a documented Risk Management Process
Actions taken to address Risks and Opportunities
shall be proportionate to the potential impact on the
conformity of products and services
ISO 9001:2015 Presentation

Risk Based Thinking

From my Registrar:
Misconception: Risk assessment replaces
Preventive Action
Truth: Risk Assessment is the initiating process
and preventive action is the result
Root Cause of Preventive Action is Risk
ISO 31000 (Risk Management Principles and
Guidelines) a useful reference
So now what ????
ISO 9001:2015 Presentation

Risk Based Thinking

Remember from the Planning Section
Quality Objectives: shall establish quality objectives
at relevant functions, levels, processes
Develop Actions to address Risks
Retain documented information (Records)
Plan Do Check Act (PDCA)
Waterfall Effect / Cascading Objectives

Stated Assess
Objectives Risk
Company Objectives
Department Objectives
Individual Objectives
ISO 9001:2015 Presentation

WaterFall: Example of Goals/Obj. Functional Level

2016 Distribution Leadership Objectives and Goals
Objective Goals /Direct Result
Order Accuracy / VOC > 92%

Service - Improve service metrics year over year Inventory Accuracy > 99%

CSI Distribution Events < 20% of total

Overtime Dollars
< .15% of sales
Financial - Lower labor cost year over year < 10% of total payroll

Direct Labor
< 1.30% of sales
Productivity - Increase the facility productivity rate Increase Productivity Index by 5% over 2015

Implement and sustain 5S+1 Program

Associate Development - Develop bench strength
and increase facility readiness and awareness SOP/Observation Based Certification for all
Participate in Competency development

Individual Development - Focus on developing Complete and on-line learning

shared leadership skills and participate in the -share with the distribution leadership team
business outside of the day to day operations
Vendor/Customer relations
-visit a vendor or particpate in a customer audit
ISO 9001:2015 Presentation

Risk Based Thinking: Tools

Failure Mode and Effects Analysis (FMEA)
ISO 9001:2015 Presentation

Risk Based Thinking: Tools



Jay Stahan
January 12, 2016 PROBABILITY
ISO 9001:2015 Presentation
Risk Based Approach: Tools
Risk Register Ranking Matrix

ISO 9001:2015 Presentation

Risk Based Thinking: Tools

ISO 9001:2015 Presentation
If you have 3rd-party QMS software, check for updates
Risk Modules
ISO 9001:2015 Presentation
Use Flowcharts for Risk Assessment


ISO 9001:2015 Presentation

Other Sector ISO QMS Standards

IATF 16949 Automotive (US, German, French, Italian)

Follows Section format of ISO 9001:2015 with additions Supplemental
Engineering Specs, APQP, PPAP, MSA, Error Proofing, FMEA.
ISO 9001:2015 Presentation
Other Sector ISO QMS Standards
ISO 13485:2003 Medical Device Manufacturing
Follows format of ISO 9001:2008 with
Additions Cleanliness/contamination, Batch Records,
Production Validations, Installations, Servicing,
Sterility, Implantables, less emphasis upon Continual
Improvement and Customer Satisfaction compared to
Regulatory Compliance
Revision 2014 not approved; postponed
Revision 2016 (3rdedition Final Draft Vote (10/15 12/15)).
ISO 13485:2016 future European regulations and
21CFR820 come into force (implications for software
controls enhanced, documentation requirements;
validations for pre-clinical and clinical evaluations;
validation of packaging and distribution requirements;
Customer communications and complaint handling)
Jay Stahan
January 12, 2016
ISO 9001:2015 Presentation

Other Sector ISO QMS Standards

ISO AS9100:2016 Aerospace

Follows ISO 9001:2015 format
Will consider emerging International requirements, Product Safety, Counterfeit
Parts, and Configuration Management
ISO 9001:2015 Presentation

Other Sector ISO QMS Standards

ISO TL9000:2016 R6 Telecommunications

Includes Release 6 Handbook
Complaint Tracking and reporting via U of Texas (Dallas)
Published for benchmarking
ISO 9001:2015 Presentation

Other Sector ISO QMS Standards

ISO 14001:2015 Environmental Standards

Now released/published
Follows format of ISO 9001:2015
ISO 9001:2015 Presentation

SUMMARY of changes 9001:2008 > 9001:2015

Top Management Involvement

Context of the Organization
Risk Based Thinking
Optional Changes to current documentation:
Retain Q-Manual?
Retain Management Representative?
Revise Vocabulary?
ISO 9001:2015 Presentation

SUMMARY of changes 9001:2008 > 9001:2015

No need to change numbering of your
documents create a cross-reference
Must incorporate Risk Analysis
Determine Controls for External providers
Reduced documentation requirements
Increased focus on Leadership being
actively involved
ISO 9001:2015 Presentation

FINAL THOUGHTS on Conversion Plan:

Involve your Registrar

Gap Analysis
Update existing Q M S
Develop Implementation Plan &
Certification before September 2018