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FOR

SUCCESSFUL

BUSINESS

MANAGEMENT

SYSTEMS

ISO 9001:2015 and ISO 14001:2015

Seminar & Expert Panel Discussion

Seminar Agenda

ISO 9001:2015 – A Guide to the Changes

Quality Principles

Step by

Step

Guide to

the

Transition

ISO 9001:2015

Clauses

Annex SL

ISO 9001:2015

An Overview

Risk

Based

Thinking

ISO9001:

2015

Case

Study

Introduction

Agenda


Introduction

A changing world - background to the revision ISO 9001 & 14001

What are the key changes for ISO 9001 & 14001

What you need to do


Introduction

The International Organization for

Standardization (ISO) normally

reviews standards every seven

years

A changing World


Quality

Principles

A Brief History of ISO 9001


Introduction

Concepts Driving the Changes


• There is a greater emphasis for senior managers to be involved in the strategic alignment of the management systemLeadership

• An effective risk management process will be critical for successful certification to the new versionRisk

• Relevant needs of interested parties are a new focusContext of

Organization

• New management system format

• The standard has been written in accordance with the new high level structure with a more holistic approach

Annex SL

Introduction ISO 9001 Key Changes

Annex SL

ISO 9001:2008 ISO DIS 9001:2014

0 Introduction 0 Introduction

1 Scope 1 Scope

2 Normative references 2 Normative references

3 Terms and definitions 3 Terms and definitions

4 Quality system 4 Context of the organization New requirement

5 Management responsibility 5 Leadership

Enhanced requirements

6 Resource management 6 PlanningSignificant changeEnhanced requirements

7 Product realization 7 Support Enhanced requirementNew requirement

8 Measurement, analysis and improvement

8 Operation

New requirementEnhanced requirementSimplified requirementEnhanced requirement

9 Performance evaluation New requirement

10 Improvement More structured approach


ISO/DIS 14001:2015Analysis and Transition


ISO 14001:2015

Explaining the Key Changes

The working group revising the international environmental management systems standard ISO 14001 has finalised the technical requirements of the new standard.

Following a final edit and translation, a ballot of ISO members will be conducted in July and August, with the new ISO 14001:2015 standard set for publication in September/October 2015.


ISO 14001 – Key changes

• Integration of environmental aspects and impacts into strategic risk management and core business processes

Environmental Importance

• There is a greater emphasis for senior managers to be involved in the strategic alignment of the management systemLeadership

• Evaluate risks and opportunities, both to the environment and the organization

• This will be critical for successful certification to the new versionRisk

• Understand the strategic context of the organization

• Understand the relevant needs of interested parties are a new focusContext of Organization

• The standard has been written in accordance with the new high level structure with a more holistic approachAnnex SL


ISO 14001 – Key changes

• An organisation will be required to look at their products and services from the beginning to the end of its life cycleLife cycle perspective

• extent control and influence through supply chains and design processesSuppliers and Outsourcing

• Significant additional emphasis is given to continual improvement of environmental performance

Environmental Performance

• Organisations will have to determine the scope of the management system and maintain this as documented informationScope and applicability

• The nature and type of documented information that an organisation needs to maintain or retain is dependent on the context and the operating environment.

Documented Information


ISO 9001:2015

What do you need to do

I. Monitor the ISO 9001/14001 2015 Revisions LinkedIn Page for updates II. Purchase the new ISO standard (s)III. Set up a project teamIV. Identify organisational gaps which need to be addressed to meet new ISO requirements.V. Develop an implementation plan to implement the new requirements on leadership, risk management and understanding of context of the organizationVI. Provide appropriate training and awareness VII. Update the existing management system and make changes to your documentation to

reflect the new structure (as necessary) VIII. VIII.Highlight the changes as opportunities for improvementIX. Conduct an internal audit X. Where applicable, liaise with your Certification Body for transition arrangements.

Quality Principles

Annex SL

– What is it

– Headlines

– What will it mean

ISO9001:2015 - Overview

– Wording

– Exclusions

– Risk Based Thinking

ISO9001:2015 - Clauses

– Clause 4 - Context of the organisation

– Clause 5 - Leadership

– Clause 6 - Planning

– Clause 7 - Support

– Clause 8 - Operation

– Clause 9 - Performance evaluation

– Clause 10 – Improvement

Step by Step Guide to the Transition


ISO 9001:2015 Agenda


1. Customer Focus

2. Leadership

3. Involvement of People

4. Process Approach

5. System Approach to

Management

6. Continual Improvement

7. Factual Approach to

Decision Making

8. Mutually Beneficial

Supplier Relationships

1. Customer Focus

2. Leadership

3. Engagement of People

4. Process Approach

5. Improvement

6. Evidence-based Decision

Making

7. Relationship

Management

Quality

Principles


Quality

Principles

EXISTING NEW - Principle NEW - Rationale

Organizations depend on their

customers and therefore should

understand current and future

customer needs, should meet

customer requirements and strive to

exceed customer expectations

The primary focus of quality

management is to meet customer

requirements and to strive to exceed

customer expectations. Every

aspect of customer interaction

provides an opportunity to create

more value for the customer.

Understanding current and future

needs of customers and other

interested parties can contribute to

sustained success of an organization

Sustained success is achieved when

an organization attracts and retains

the confidence of customers and

other interested parties on whom it

depends.

Customer Focus


Quality

Principles


Leaders establish unity of purpose

and direction of the organization.

They should create and maintain the

internal environment in which

people can become fully involved in

achieving the organization's

objectives.

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.

Creation of unity of purpose,

direction and engagement enable

an organization to align its strategies,

policies, processes and resources to

achieve its objectives.

Leadership


Quality

Principles


People at all levels are the essence

of an organization and their full

involvement enables their abilities to

be used for the organization's

benefit.

Competent and engaged people at

all levels who are empowered to

take initiatives to deliver value to an

organization and its customers are

the essence of the organization.

In order to manage an organization

effectively and efficiently, it is

important to involve all people in the

organization, to strive to enhance

their knowledge, skills and

engagement, and to respect them

as individuals.

Engagement of People


Quality

Principles

EXISTING NEW - Principle NEW -Rationale

Process approach

A desired result is achieved more

efficiently when activities and

related resources are managed as a

process.

System approach

Identifying, understanding and

managing interrelated processes as

a system contributes to the

organization's effectiveness and

efficiency in achieving its objectives.

Desired outcomes are achieved

more effectively and efficiently when

activities are managed as

interrelated processes functioning as

a coherent system.

The quality management system is

composed of interrelated processes.

To achieve consistent and

predictable outcomes, it is necessary

to understand how outcomes are to

be generated by the system and to

manage its processes.

Process Approach


Quality

Principles


Continual improvement of the

organization's overall performance

should be a permanent objective of

the organization.

Improvement is a permanent

practice of a successful

organization. Improvement projects

include process analysis, prioritization

and implementation of value adding

changes and evaluating their

effectiveness.

Active application of an

improvement strategy is essential for

an organization to sustain long term

success.

Improvement


Quality

Principles


Effective decisions are based on the

analysis of data and information

Decisions based on the analysis and

evaluation of data and information

will result in a higher likelihood that

desired outcomes will be achieved.

.

An evidence-based and systematic

approach is necessary condition for

determining objectives, identifying

means to achieve objectives and

understanding causal relationships.

Evidence Based

Decision Making


Quality

Principles


An organization and its suppliers are

interdependent and a mutually

beneficial relationship enhances the

ability of both to create value

Effective engagement of interested

parties who can impact the

performance and reputation of an

organization, such as suppliers, is vital

to its sustained success.

Sustained success is more likely to be

achieved where an organization is

able to manage relationships with its

interested parties so as to provide its

customers with value. An

organization’s relationship

management within its supplier and

partner network is important.

Relationship Management

Agenda


Annex SL


Annex SL

What is it? Headlines What will it mean?

Common structure for management

systems

Also called “the high level text”, “the

high level structure (HLS)”

No change allowed unless justified

Has to be on the basis that the text

will not work in the particular context

(not that the committee has a

preference for something else

4: Context of the organisation

5: Leadership

6: Planning for the QMS

7: Support

8: Operation

9: Performance evaluation

10: Improvement

Planning

Preventative Action

Context

Quality Manual

Management Representative

Objectives

Organisational Knowledge

Communication

Purchasing > External Suppliers


No need to change you

management structure

Don’t throw out the Quality Manual

You have 3 years to make the

change

Single Process


Process Based QMS System


Agenda


ISO 9001:2015 An Overview


ISO

9001:2015

An

Overview

New Terms What’s in a word? Continued

Products and Services

Replaces Products


Replaces Documents and Records

External Providers

Replaces Outsourcing /

Purchasing

Determine

Investigate and establish / do

something

Replaces “identify” in some cases

Assure

To give confidence

Ensure

To make sure

Responsibility but not

accountability can be delegated

TRANSLATIONOutput (Sp. Salidas)

Result of process

Outcome (Sp. Salidas)

Not used (Spanish don’t have a

separate word)

Result (Sp. Resultas)

The impact of an output

Retain or Maintain (e.g. documents)

Maintain: documentation to support

process

Retain: documentation to support

records

Establish

Put in place with continuity

Implement

Do it

Each or All

Each – singular / All -

encompassing

Wording


ISO

9001:2015

An

Overview

What’s in word cntd… Cntd… Cntd…

Take account of / Take into account

Not used

Like “consider” but can not be

rejected

Consider

Think about (but can be rejected)

Describe

Not used

Identify

Only used with “Identification/

traceability”

As appropriate

suitable or proper in the

circumstances

Some degree of freedom

As relevant

closely connected or appropriate

to the matter in hand:

As applicable

As relevant or possible to apply

If it can be done, it should be done

Data

Raw information

Information

Processed data with meaning

Continuous

Duration without interruption

Continual

Duration over a period of time but

with intervals of interruption

Continual used with “improvement”

Wording


ISO

9001:2015

An

Overview

Clause 4.3

If a requirement CAN be applied, it

SHALL be applied

If a requirement CAN NOT be

applied

Document “why not”

No certification granted if something

which could be applied is not.

Exclusions


ISO

9001:2015

An

Overview

We do it everydayWhat makes it different

in ISO 9001:2015

Whether to

Take an umbrella

Overtake the car in front

Go to the doctor

Take out travel insurance

Eat food over its “best before

date”

Leave the children with baby sitter

Does not have to be systematic ….

(But it helps, I think)

But not 31000

ISO 31010 may be useful

Driven by (inputs)

Strategic direction / Objectives

Context (4.1 / 4.2)

Scope of operations (4.3)

Risk Based Thinking


ISO

9001:2015

Clauses

4.1 Understanding the Organisation and its context

4.2 Understanding the

needs and expectations

of interested parties

The organization shall determine:

external and internal issues, that

are

relevant to its purpose and

its strategic direction and that

affect its ability to achieve the

intended result(s) of its quality

management system.

SWOT Analysis

Internal / External

Challenges

Strategic Direction

Where the business is going

Vision / Mission / Objectives /

Targets

Link to Risk Based Thinking

Relevant interested parties

Requirements, needs and

expectations of interested parties

(potential) Impact on the

organisation’s ability to meet

customer expectations and

legal/regulatory requirements –

link to risk

Clause 4: Context of the

Organisation


ISO

9001:2015

Clauses

Relevant requirements of relevant interested parties


Organisation

INTERESTED PARTIES

RELEVANT INTERESTED PARTIESREQUIREMENTS

RELEVANT REQUIREMENTS, NEEDS AND EXPECTATIONS(OF RELEVANT INTERESTED PARTIES)


ISO

9001:2015

Clauses

4.3 Determining the

scope of the QMS

4.4 QMS and Process

Approach

4.4.2 Documented

InformationDetermine the:

boundaries and

applicability of the QMS

Use outputs of 4.1 and 4.2

Exclusion definition

Scope to be documented

The old clause 4.1

Emphasis on “inputs” and “outputs”

Minor changes

Responsibilities

Continuous improvement

Risks

Change management

MAINTAIN Documented Information

to support operation of processes

RETAIN Documented Information to

have confidence that the processes

are being carried out as planned


Organisation


ISO

9001:2015

Clauses

Rule 1 - Do it where it says soRule 2 – Do it where it’s

neededMaintain

4.3 (scope)

5.2.1 (Quality Policy)

6.2.1 (objectives)

8.1 e (processes)

8.5.1 a (production)

Retain

7.1.5.1 (M&M General)

7.1.5.2 a (basis of calibration)

7.2 d (competence)

7.5.3.2 (retained DI)

8.1 e (processes)

8.2.3.2 (contract review)

8.3.2 j (D&D Planning)

8.3.3 (D&D Inputs)

8.3.4 (D&D Controls)

8.3.6 (D&D changes)

8.4.1 (general – Externally

provided)

8.5.3 (customer property)

8.5.6 (control of changes)

8.6 (release of products)

8.7.2 (NCP)

9.1.1 (monitoring and

measurement – general)

9.2.2 f (internal audit)

9.3.2 (management review)

10.2.2 (corrective actions)

Where you need to demonstrate that

you’ve done something that’s

planned


RULE 1 & 2


ISO

9001:2015

Clauses

5.1.1 Commitment5.1.2 Leadership and 5.2

Quality Policy

5.3 Organisation Roles

and ResponsibilitiesClear definition of what this means

Old 5.1 etc. plus

Accountability for effectiveness of

QMS

Ensuring achievement of intended

results

Integration with business systems

Engaging and supporting people

involved with QMS

Leadership

Determination of risks and

opportunities

Statutory and regulatory

requirements

Customer focus

(enhancing/meeting)

As old 5.1 and 5.2

Quality Policy

No real change

Available to interested parties

Available as documented

information

Framework for setting objectives

No real change

Processes to deliver intended

outputs

Reporting on need for innovation

Ensuring integrity of QMS during

change

Management Representative

replaced by responsibilities for

similar areas

Clause 5:

Leadership


ISO

9001:2015

Clauses

6.1 Risks and

Opportunities6.2 Quality Objectives

6.3 Planning for

Changes1. Actions needed to address these

risks

2. Opportunities how to integrate

and implement the actions

3. Evaluate the effectiveness of

these actions.

4. Actions taken to address risks

and

1. Take into account applicable

requirements;

2. Be relevant to conformity of

products and services and

3. The enhancement of customer

satisfaction;

4. Be monitored;

5. Be communicated; and

6. Be updated as appropriate.

1. What will be done,

2. What resources will be required;

3. Who will be responsible;

4. When it will be completed; and

5. How the results will be evaluated

6. Changes to improve

performance

7. Undertake in planned way

8. Need to consider:

I. Purpose

II. Integrity of QMS

III. Resources

IV. Responsibilities and

authorities

Clause 6:

Planning


ISO

9001:2015

Clauses

Clause 7:

SupportNo Changes

7.1.6 Organisational

Knowledge1. 7.1.2 – People

2. 7.1.3 – Infrastructure

3. 7.1.4 – Environment of Operating

Processes

- psychological and physical

environments

1. 7.2 – Competence

MUST CONSIDER

1. Capabilities and constraints

2. External providers

1. Moved to SUPPORT

2. Focus on capability

3. Provide and maintain suitable

M&M systems

4. Can be used for SERVICES

5. No specific requirements for

software.

1. Determine and Maintain

2. Consider when making changes

3. External and internal sources

7.1.1 – General

7.1.5 – Monitoring and

measuring processes7.1.6 Organisational

Knowledge


ISO

9001:2015

Clauses

Clause 7:

Support7.5 – Documented

information7.3 – Awareness

1. No Quality Manual needed

2. “obsolete documents” replaced

by “improper use”

3. “Documented information”

1. The quality policy;

2. Relevant quality objectives;

3. Their contribution to the

effectiveness of the QMS

including the benefits of

improved quality performance;

and

4. The implications of not

conforming with the QMS

requirements

7.4 - Communication

1. On what it will communicate;

2. When to communicate;

3. With whom to communicate;

4. How to communicate; and

5. Who communicates.


ISO

9001:2015

Clauses

8.1 – General 8.2.1 –customer communication

1. Criteria for acceptance

2. Reference to outsourced

processes

1. Information on products and

services

2. Enquiries, contracts or order

handling, including charges

3. Obtaining customer views and

perceptions, including customer

complaints;

4. The handling of customer

property

5. The specific requirements for

contingency actions, where

relevant..

8.2.2 – Requirements related to

Products & Services

• Similar to 7.2.2

8.2.3 – Review of customer

requirements

• Similar to 7.2.1

Clause 8:

Operation


ISO

9001:2015

Clauses

8.3 – Design and

Development8.4 – Control of external provision of products and services

1. Process should recognise the

nature, duration and complexity

of the design and development

activities;

2. Need to involve customer and

user groups

3. Consequences of failure

4. Interested parties

5. Standards and Codes of Practice

6. Inputs v outputs (verification /

validation)

7. Identify and control changes

1. Where supplying directly from

external provided incl.

outsourcing

2. Focus on risk rather than 7.4.2 list

3. Deals with outsourcing

4. Types and extent of control /

information for external providers

1. The products and services

2. Approval methods;

3. Competence / qualification;

4. Their interactions with the QMS

5. The control and monitoring; and

6. Verification

7. Adequacy of specified

requirements prior to

communication to external

provider

Clause 8:

Operation


ISO

9001:2015

Clauses

8.5 – Realisation and provision of products and services

8.6 – Release of products

and services

8.7 – Nonconforming

products and services1. Competence

2. Validation clause shortened

3. Focus on post delivery activities

4. Control of changes

1. Clearer requirements

2. KEY: Evidence of conformity and

traceability to authorisation for

release

1. Added “informing the customer”

Clause 8:

Operation


ISO

9001:2015

Clauses

9.1.1 – General9.1.2 – Customer

Satisfaction9.1.3 – Analysis of Data

1. Determine requirements 1. Monitoring customer perception 1. Demonstrate conformity

2. Enhanced customer satisfaction;

3. Ensure QMS conformity and

effectiveness

4. Planning successfully

implemented;

5. The performance of processes;

6. The performance of external

provider(s);

7. Determine opportunities for

improvements

Clause 9:

Performance Evaluation


ISO

9001:2015

Clauses

9.2- Internal Audit9.3 – Management

Review9.1.3 – Analysis of Data

1. Results to be reported to

management

2. Specific mention of follow-up

actions deleted

1. nonconformities and corrective

actions;

2. monitoring and measurement

results;

3. audit results; customer

satisfaction;

4. issues concerning external

providers and other relevant

parties;

5. adequacy of resources

6. process performance and

product conformity of products

and services;

7. the effectiveness of actions taken

to address risks and opportunities

(see clause 6.1);

1. Demonstrate conformity

2. Enhanced customer satisfaction;

3. Ensure QMS conformity and

effectiveness

4. Planning successfully

implemented;

5. The performance of processes;

6. The performance of external

provider(s);

7. Determine opportunities for

improvements

Clause 9:

Performance Evaluation


ISO

9001:2015

Clauses

10.1 – General10.2 – Nonconformity

and corrective action

10.3 – Continual

Improvement1. Improving processes to prevent

non-conformances;

2. Improving products and services

to meet known and predicted

requirements; and

3. Improving quality management

system results

1. Look at similar occurrences

2. Make changes as necessary

1. Link to management review

2. Reference to tools

Clause 10:

Improvement

Agenda


Quality Principles

Step by Step

Guide to the

Transition

ISO 9001:2015

Clauses

Annex SL

ISO 9001:2015

An Overview


Step by Step

Guide to

Transition

Step 1:

QMS Health

Check

Step 2:

Context of

the

Organisation

Step 3:

Risk Based

Thinking

Step 4:

Applies /

Does Not

Apply

Step 5:

Organisation

Knowledge

Step 6:

Change

Management

Step 7: The Small Stuff

Seminar Agenda


Quality Principles

Step by Step

Guide to the

Transition

ISO 9001:2015

Clauses

Annex SL

ISO 9001:2015

An Overview

Risk Based

Thinking

Introduction


Risk Based

Thinking

Risk – an event that has not yet occurred

Do automatically

Consider Opportunities

Positive side of risk

Replace the requirements for Preventive Action

Makes preventive action part of the routine

Opportunities as well as risks

Agree a Process to follow

Apply the Risk Process

Business based - Business Plan may be starting point

Risk Based Thinking


Risk Process

Step 1:

Identify Risks &

Opportunities

Step 2:

Analyse

Step 3:

Plan

Approach

Step 4:

Track

Step 5:

Control

Continuous Monitoring


Risk Based

Thinking

Conduct Risk Identification Workshops

Involvement of all relevant stakeholders

Use Risk Categories

• To focus thinking on risk areas

• To ensure clarity of analysis

SWOT Analysis

Identify and record all relevant risks

Consider Risk Register to record information

Identify Risks/Opportunities


Risk Based

Thinking

Categories Examples Examples

Strategic RisksFinancial Risks

Product RisksEnvironmental RisksHealth & Safety RisksLegal/Compliance RisksQuality RisksProject Management RisksConstruction Risks

Organisational RisksPerformance RisksInformation Technology Risks

Unsafe site for workers

Unidentified hazardous waste

Unanticipated noise impacts

Vehicle breakdown

Computer virus

Project not fully funded

Estimating and/or scheduling errors

Lack of coordination and

communication

Reliance on external contractors

Inadequate project scoping and

scope creep

Experience of staff

Risk Categories


Risk Based

Thinking

Analyse Risks with Respect to two Attributes:

• Probability

• Impact

Probability

• Low: less than once a year

• Medium: monthly

• High: once or twice a week

Analyse

If You Think that Probability is “around 50/50”

• Mark Value of Medium

If the Probability is Significantly Higher than Above

• Mark Value of High

If the Probability is Significantly Lower than Above

• Mark Value of Low


Risk Based

Thinking

Impact - Customer

• Low: No loss of customer but valid complaint

• Medium: Customer looks to competitors but is retained

• High: Customer walks and goes public

Impact - Costs

• Low: Consumption of some budget contingency

• Medium: Budget overrun >30%

• High: Budget overrun >50%

Analyse

Impact - Schedule

• Low: Consumption of some slack – not on critical path

• Medium: Delay >30%

• High: Delay >50%

• Scoring performed by each stakeholder

• Discuss only those with variances

• Reach consensus

• Determine the appropriate RAG status

Example

Likelihood

HIGH

MEDIUM

LOW

Impact LOW MEDIUM HIGH

ISO 9001:2015 57

Example

ISO 9001:2015 58

Pro

ba

bil

ity

Impact

Sample Risk Bubble Chart

GREEN

AMBER

RED


Risk Based

Thinking

Assign responsibility for each risk

Identify necessary controls

• All Risks

• High and Medium Risks

• Low Risks

Current Controls and Future/Additional Controls

PlanResponses - PRACT

Prevention – Eliminate the risk - stop the problem or prevent it from impacting

Reduction – Control the risk so that it is less likely to occur or the impact is limited to acceptable levels

Acceptance – Tolerate the risk by deeming its occurrence to be acceptable

Contingency – Plan actions that will be taken only if the risk becomes a reality – track as an issue

Transference – Pass the risk elsewhere such to another party – still needs to be monitored and tracked!


Risk Based

Thinking

• Implement the plan – take action

• Check the effectiveness of the actions

• does it work?

• are having desired effect?

• Update scoring/status as necessary

• Invoke mitigation actions as required

• Summary and Exception Reporting

Track and Control

• Continuously asses risks

• Not a once of activity

• Learn from experience

• Continual Improvement


Risk Based

Thinking

• Results are not acted upon

• Over controlling of risks – cost benefit analysis

• Risk become stale – provide same results each time

• Integrate into business processes

Challenges


Risk Based

Thinking

• Risk based thinking is not new

• Is continuous

• Makes prevention a habit

• Reduces the probability of unplanned results

• Assists to identify “quick wins” and longer-term improvement opportunities

Conclusion

Seminar Agenda


Quality Principles

Step by

Step

Guide to

the

Transition

ISO 9001:2015

Clauses

Annex SL

ISO 9001:2015

An Overview

Risk

Based

Thinking

ISO9001:

2015

Case

Study

Introduction

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