ISO 9001:2015 Executive Briefing

By: AJA Registrars Inc. 2/16/2017

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Why bother?

As CONSUMERS -We DEMAND QUALITY!!!

In the things we buy
In the services provided to us

As PROVIDERS -We NEED QUALITY!!!

To keep existing clients happy
To get new clients
To earn a profit and stay in business
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Nightmare Scenarios without a Quality Management System – RISKS

 INCREASED COSTS POOR QUALITY OF PRODUCT/ SERVICE

 INADEQUATE RESOURCES
 HIGH MAINTENANCE COST
 PROJECT DELAYS
 EMPLOYEE FRUSTRATIONS
 BAD PUBLIC IMAGE
 POLICY CONFLICTS
 CONFLICTING PRIORITIES
 MANAGEMENT DISINTEREST
 LACK OF SKILLS
 UNPLANNED VARIATIONS
 HIGH MATERIAL WASTAGE

 UNSATISFIED CUSTOMERS
 DOWNGRADING
 LOW OR ZERO ORDERS
HIGH CUSTOMER COMPLAINTS
 ANOTHER CUSTOMER LOST
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What is ISO?
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International Organization for Standardization

• Wait a minute that’s IOS not ISO???

ISO derived from

the Greek Word
“ISOS” meaning

EQUAL
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International Organization for Standardization

So what’s the organization all about?

 “International Organization for Standardization” (ISO) a worldwide federation of

more than 150 national standard bodies, whose stated intention – “policy” is to:

 ”Facilitate the international exchange of goods/services, and

develop cooperation in the spheres of intellectual, scientific,
technological and economic activity”

 ISO Standards are created in response to “Customer Needs”. These Standards

define the principles for Systematic Management

 The standards also requires continual improvement

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Management System Standards were created to Manage Risks

• Some examples

• Risks related to • Risks related to the • Risks related to

environment are information security
quality of product or are managed via
services are managed via
managed via
• ISO 9001:2015 • ISO 14001:2015 • ISO 27001:2013
Quality Management Environmental Information Security
Management Systems
Systems Management Systems
These have 1 common denominator - RISK MANAGEMENT – for both
internal and external benefit.
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The Evolution of ISO 9000

• So what’s the organization all about?
SEPT 23, 2015

2008 3rd revision

2000 2nd revision

1994 1st revision

1987 1st official release

1980s ISO 9000 was developed

1979 BS 5750:1979 – Considered the progenitor of ISO standard

Quality of making bombs post World War II
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The 7 Quality Management Principles

- The Foundation of ISO 9001:2015
1. Customer Focus
2. Leadership
3. Engagement of People
4. Process Approach
5. Improvement
6. Evidenced-Based Decision Making
7. Relationship Management

Customer Focus
- Understand their needs
- Meet their requirements
- Strive to exceed their
expectations
Leadership
- Establish direction and
ensure that everyone in the
organization understands
what you are trying to
achieve
Engagement of people
- Full involvement of people at
all levels of the organization
who are competent,
empowered and engaged
Relationship Management 2/16/2017
- Identify the important
relationships with interested
parties
- Set out a plan to manage them
Evidence-based Decision
for sustained success
Making
- Ensuring decisions are based
on the analysis and evaluation
of data
Improvement
- Reacting to changes in the
internal and external
environment to continuously
deliver value to the customers
Process Approach
- Desired results are achieved
more effectively when
activities and resources are
controlled as a process
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The ISO 9000 Family

Plan Act
ISO 9000
Fundamentals & Vocabulary

ISO 9001 ISO 9004

QMS Requirements Guidance for performance
(“SHALL”) Improvement (“SHOULD”)

QA QM
ISO 19011
Quality and/or Environmental
auditing
Do Check
 The ISO 9001:2015 Standard 2/16/2017

• International consensus on good management

practice
• Looks for repeatability and meeting customer
requirements
• Defined sets of standards for conformance
• Broad in scope and acceptance
• Voluntary
• Descriptive in nature
• What versus how
• Unique to organizational context
• Flexible and customizable
• Allows management to stay “in the driving seat”
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The objective of ISO 9001:2015 is to provide a set of requirements that, if they are
effectively implemented, will provide you with confidence that you can:

 Consistently provide products and services that MEET

CUSTOMER and APPLICABLE STATUTORY and
REGULATORY REQUIREMENTS
 FACILITATE OPPORTUNITIES to enhance customer
satisfaction
 ADDRESS RISKS and OPPORTUNITIES associated with its
context and objectives
 Demonstrate CONFORMITY to specified QMS requirements.
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How is the standard structured?

ISO 9001:2015 contains 10 clauses , 28 sub-clauses and two annexes. Each of
the 10 clauses concentrating on the requirements involved in different aspects
of a quality management system.

1. Scope 6. Planning
2. Normative References 7. Support
3. Terms and Definitions 8. Operation
4. Context of the Organization 9. Performance Evaluation
5. Leadership 10. Improvement
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This restructuring to encourage and

support integration is also based on the
consistent use of the:

 Process Approach
 The PDCA Approach
 AND NOW a common (to all
Standards) requirement for
Management Systems to be:
RISK- BASED
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The ISO 9001:2015 Clauses

There are 7 Auditable Clauses:

• Clause 4 – CONTEXT OF THE ORGANIZATION

• Clause 5 – LEADERSHIP
• Clause 6 – PLANNING
• Clause 7 – SUPPORT
• Clause 8 – OPERATION
• Clause 9 – PERFORMANCE EVALUATION
• Clause 10 - IMPROVEMENT
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Clause 4– Context of the Organization

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Clause 4– Context of the Organization

CLAUSE 4

4.1 Understanding the Context of the Organization

4.2 Understanding the needs and expectations of interested

parties

4.3 Determining the scope of the QMS

4.4 Quality management system and its processes

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4.1. Understanding the Organization and its Context

Summary:
• The organization shall determine external and internal issues that are relevant to its purposes and
its strategic direction and that affect its ability to achieve the intended results of its QMS
• The organization shall monitor and review information about these external and internal issues
External context can include: Internal Context can include:
• Legal • Values
• Technology • Culture
• Competition • Knowledge
• Market • Performance
• Cultural
• Social
• Economic
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4.2. Understanding the Needs and Expectations of Interested Parties

Summary:
The organization shall determine:

a) The interested parties that can affect or potentially

affect its ability to consistently provide products and
services that meet customer and applicable and
regulatory requirements,
b) The relevant requirements of these identified
interested parties

The organization shall monitor and review information about

these interested parties and their relevant requirements
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4.3. Determining the Scope of the Quality Management System

Summary:
The organization shall determine the boundaries and applicability of the QMS to establish its
scope, taking into consideration:

a) The external and internal issues (Clause 4.1)

b) The requirements of relevant interested parties (Clause 4.2)
c) The products and services they provide

The organization shall apply all the requirements of ISO 9001:2015 IF they are applicable within
the determined scope of its QMS. The scope of the QMS shall be available and maintained as
documented information.
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4.4. Quality Management System and its Processes

Summary:
The organization shall establish, implement, maintain and continually improve a QMS, including the processes. The
organization shall determine the processes needed for the quality management system and their application throughout the
organization, and shall:

a) determine the inputs required and the outputs expected from these processes;
b) determine the sequence and interaction of these processes;
c) determine and apply the criteria and methods (including monitoring, measurements and related performance
indicators) needed to ensure the effective operation and control of these processes;
d) determine the resources needed for these processes and ensure their availability;
e) assign the responsibilities and authorities for these processes;
f) address the risks and opportunities as determined in accordance with the requirements of 6.1;
g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended
results
h) Improve the processes and the QMS

To the extent necessary the organization shall:

a) Maintain documented information to support the operation of its processes
b) Retain documented information to have confidence that the processes are being carried out as planned
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SUMMARY

BEFORE developing a QMS the organization needs to:

• Completely understand its external and interested parties’ needs and expectations in the
context of its products and services and its business strategies
• Completely understand the Risks and Opportunities that that these represent
• Plan the QMS in such a way as to attempt to ensure that the QMS addresses each of the Risks
in the best possible way within the context of the organization

For companies who have already established a QMS against ISO 9001:2008, this obviously
means that a large % of them may well have to REVISIT this in line with the new and expanded
Requirements and REALIGN and EXPAND their existing QMS accordingly.
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Clause 5– Leadership
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Clause 5– Leadership
CLAUSE 5

5.1 Leadership and Commitment

5.1.1 General
5.1.2 Customer focus
5.2 Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibilities and authorities
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5.1. Leadership and Commitment

SUMMARY:

Top management shall demonstrate leadership commitment with respect to the QMS by taking accountability of
the effectiveness of the QMS. This means:
• Ensuring the quality policy and quality objectives are established and compatible with context and strategic
direction
• Ensuring the integration of the QMS with its business processes
• Promoting the process approach and risk based thinking
• Ensuring availability of resources
• Communicating the importance of effective QMS and conforming to requirements
• Ensuring the QMS achieves its intended result
• Engaging, directing and supporting persons who contribute to the effectiveness of the QMS
• Promoting improvement
• Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of
responsibility
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5.1. Leadership and Commitment

SUMMARY:

Top management shall demonstrate leadership and commitment

with respect to customer focus by ensuring that:

a) customer and applicable statutory and regulatory

requirements are determined, understood and consistently
met;

b) the risks and opportunities that can affect conformity of

products and services and the ability to enhance customer
satisfaction are determined and addressed;
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5.2. Policy
SUMMARY:

Top management shall establish, implement and maintain a quality

policy that is:

• appropriate to its purpose and context and supports

strategic direction
• provides a framework for setting quality objectives
• Includes a commitment to satisfy applicable requirements
• Includes commitment to continual improvement of the
QMS

The quality policy shall be available and maintained as documented

information that is communicated, understood and applied within
the organization and be available to relevant interested parties
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5.3. Organizational Roles, Responsibilities and Authorities

Summary:

Top management shall ensure that the responsibilities and authorities for relevant roles are
assigned, communicated and understood within the organization.

Top management shall assign the responsibility and authority for:

a) ensuring that the quality management system conforms to the requirements of this International
Standard;
b) ensuring that the processes are delivering their intended outputs;
c) reporting on the performance of the quality management system and on opportunities for
improvement (see 10.1), in particular to top management;
d) ensuring the promotion of customer focus throughout the organization;
e) ensuring that the integrity of the quality management system
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SUMMARY

• Top Management to establish, implement, maintain a quality policy:

• Appropriate to the purpose and context of the organization

• Available to relevant interested parties, as appropriate
• Commitment to improve the QMS
• Communicated, understood, and applied within the organization
• Maintained as a documented information
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Clause 6– Planning
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Clause 6– Planning

CLAUSE 6

6.1 Actions to address risks and opportunities

6.2 Quality objectives and planning to achieve them

6.3 Planning of changes

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6.1. Actions to Address Risk and Opportunities

Overall Requirement:

When planning for the QMS the organization shall consider the issues referred to
in 4.1 (context of the organization) and the requirements referred to in 4.2
(understanding the needs of external and internal interested parties) and
determine the risks and opportunities that need to be addressed to:

• Give assurance that the QMS can achieve its intended results
• Enhance desirable effects
• Prevent or reduce undesired effects
• Achieve improvement
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6.1. Actions to Address Risk and Opportunities

6.1.2
The organization shall plan

a) Actions to address risks & opportunities

b) How to
1. Integrate and implement the actions into its QMS processes
2. Evaluate the effectiveness of these actions

• Actions taken to address risk and opportunities shall

be proportionate to the potential impact on the
conformity of products and services
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6.1. Actions to Address Risk and Opportunities

Options to address risks can include:

• Avoiding risk
• Taking risks in order to pursue opportunity
• Eliminating risk source
• Changing likelihood of consequences
• Sharing the risk
• Retaining the risk by informed decision
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6.1. Actions to Address Risk and Opportunities

Opportunities can:

 Lead to adoption of new practices

 Launching new products
 Opening new markets
 Addressing new clients
 Building partnerships
 Using new technology
 Other desirable and viable
possibilities to address the
organization’s or its customers’ needs
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6.2. Quality Objectives and Planning to Achieve Them

When planning how to achieve its quality objectives

the organization SHALL determine:

 What will be done

 What resources are required
 Who will be responsible
 When it will be completed
 How the results will be evaluated
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6.2. Quality Objectives and Planning to Achieve Them

6.2.1 - …….. SHALL be established and be:

 Consistent with the quality policy
 Be measurable
 Take into account applicable requirements
 Be relevant to conformity of products and services and
to enhancement of customer satisfaction
 Be monitored
 Be communicated
 Be updated as appropriate
 Be documented
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6.3. Planning of Changes

When it is determined that there is a need

for changes to the QMS, this shall be carried
out in a planned manner taking into
consideration:

 Purpose of the change and their

potential consequences
 The integrity of the QMS
 The availability of resources
 Allocation and re-allocation of
responsibilities and authorities
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SUMMARY
What does that all mean?
It means – in effect – a risk assessment shall have been conducted.

However it does NOT specify this in those words (“Risk Assessment”) and there is no requirement for a
defined process or documented procedure or even records being created/maintained

It DOES requires the overall activity SHALL be performed and that the QMS SHALL be planned as a result
of this

“Risk and Opportunity”

SWOT Analysis
Business Planning
Risk Assessment

The methods are “open” – the results should be the plan of which part(s) of the QMS address which issue –
positive and/or negative – that can impact the organization’s ability to satisfy the internal and external issues
involved
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Clause 7– Planning
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CLAUSE 7 WHAT CLAUSE WAS IT IN THE 2008

VERSION?
7.1 Resources Clause 6
7.1.1 General NEW
7.1.2 People NEW & EXPANSION OF 6.2.1
7.1.3 Infrastructure CLAUSE 6.3
7.1.4 Environment for the operations of processes CLAUSE 6.4 BUT EXPANDED
7.1.5 Monitoring and measuring resources CLAUSE 7.6 BUT EXPANDED
7.1.6 Organizational Knowledge NEW

7.2 Competence CLAUSE 6.2.1 BUT EXPANDED

7.3 Awareness CLAUSE 6.2.1 BUT EXPANDED
7.4 Communications CLAUSE 5.5.3 BUT EXPANDED
7.5 Documented Information CLAUSES 4.2.3 & 4.2.4
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
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SUMMARY
Clause 7.1.
• The clause (and related sub-clauses) provides that the organization shall determine resources required
and provide them, considering the capabilities of and constraint on existing internal resources and
what needs to be obtained from external parties.

• Determine the necessary personnel needed for the effective implementation

• Determine and maintain the needed infrastructure

• Determine, provide and provide maintain the environment necessary

• Determine, provide and maintain the necessary monitoring and measuring equipment

• Determine, obtain and maintain the knowledge necessary

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SUMMARY
• Clause 7.2 requires the determination of the necessary competence of person(s) and that they are
competent on the basis of appropriate education, training or experience, take actions to acquire necessary
competence, evaluate the effectiveness of actions taken and retain documented information as evidence of
competence
• Clause 7.3 requires that persons doing work under the organizations control to be made aware of the quality
policy, quality objectives, their contribution to the effectiveness of the QMS, including the benefits of
improved performance and implications of not conforming to the QMS
• Clause 7.4 requires the determination of both internal and external communication relevant to the QMS
(what, when, with whom, how and who)
• Clause 7.5 requires determination of documented information to be maintained and retained, and the
establishment of controls.
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Clause 8– Operation
 Clause 8– Operation
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CLAUSE 8

8.1 Operational planning and control

8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements for products and services
8.2.3 Review of the requirements for products and services
8.2.4 Changes to requirements for products and services
8.3 Design and development of products and services
8.3.1 Design and development planning
8.3.2 Design and development inputs
8.3.3 Design and development controls
8.3.4 design and development outputs
8.3.5 Design and development changes
 Clause 8– Operation
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CLAUSE 8

8.4 Control of externally provided processes, products and services

8.4.1 General
8.4.2 Types and extent of control
8.4.3 Information for external providers
8.5 Production and service provision
8.5.1 Control of product and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
8.6 Release of products and services
8.7 Control of non-conforming products
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8.1. Operational Planning and Control

SUMMARY:
Plan, implement and control the processes needed to meet the requirements and implement
actions determined by:

 Determining requirements for the product and services

 Establishing criteria for the processes and the acceptance of products and services
 Determining the resources needed
 Implementing control of processes
 Determining, maintaining and retaining documented information
 Control planned changes and review consequences of unintended changes
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8.2. Requirements for Products and Services

SUMMARY:
The clause and sub-clauses require what to include in customer communications,
ensure that requirements for products and services are defined and that the
organization can provide them, that reviews shall be conducted to ensure that
requirements can be met both stated and implied, and any differing are resolved and
that documented information shall be retained . When changes occur, the relevant
documented information are amended and relevant persons are informed.
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8.3. Design and Development of Products and Services

SUMMARY:
The clause and its sub-clauses require management establish, implement and maintain
if applicable methodologies and control of design and development plans taking into
consideration the determination of inputs to the design and development , and as a
result the corresponding outputs , the review of these activities inclusive of verification,
validation as well as establishing and implementing the necessary controls during
various stages and whenever changes occur.
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8.4. Control of Externally Provided Processes, Products and Services

SUMMARY:
The clause and its sub-clauses require the organization to ensure
that externally provided processes, products and services conform to
requirements. This means the application of controls, evaluation,
monitoring, of performance as well as re-evaluation of external
providers and ensuring the provision of complete information to the
external provider.
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8.5. Production and service provision

SUMMARY:

The organization shall implement production and service provision under controlled
conditions

The clauses also provides for the identification of outputs by suitable means when it
is necessary to ensure conformity, handling of customer & external provider property
and preservation of outputs to the extent necessary, meet requirements for post
delivery associated with product and service and review & control of changes for
production and service provision to the extent necessary to ensure conformity.
Documented Information shall be retained.
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8.6. Release of Products and Services

8.7. Control of Non-conforming Outputs

SUMMARY:

Clause 8.6 requires implementation of planned arrangements at appropriate

stages to verify if requirements have been met so that products and services
may be released. Documented information shall be retained.

Clause 8.7 requires identification, documentation and control of non-conforming

outputs
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Clause 9– Performance Evaluation

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Clause 9– Performance Evaluation

CLAUSE 9
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.3 Management review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review outputs
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SUMMARY

The clauses and their respective sub-clauses require the organization to

determine methodologies to determine customer satisfaction, to
analyze and evaluate appropriate data, to verify performance of the
quality management system through internal audits (now taking into
consideration changes affecting the organization), conduct
management reviews with the now expanded inputs including: d.)
Adequacy of resources, e.) the effectiveness of actions taken to address
risks and opportunities, and f.) opportunities for improvement
(reworded from recommendations for improvement)
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Clause 10 – Improvement

CLAUSE 10

10.1 General

10.2 Non-conformity and corrective action

10.3 Continual improvement

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SUMMARY

The clauses and their respective sub-clauses require the organization to

determine and select opportunities for improvement and implement
any necessary actions to meet customer requirements and enhance
customer satisfaction. Should a non-conformity occur the organization
shall institute corrective actions appropriate to the effects of the
nonconformity encountered. There is an explicit requirement to
determine whether other similar nonconformities exist, or could
potentially exist. Continually improve the suitability, adequacy and
effectiveness of the QMS.
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Looking back, RISK-BASED Thinking is in:

• Introduction – the concept of risk-based thinking is explained

• Clause 4– organization is required to address the risks and opportunities
associated with its QMS processes
• Clause 5 – top management is required to promote awareness of risk-
based thinking and determine and address risks and opportunities that
can affect product/service conformity
• Clause 6– organization is required to identify risks and opportunities
related to QMS performance and take appropriate actions to address
them
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• Clause 7– organization is required to determine and provide the

necessary resources
• Clause 8 – organization is required to manage its operational processes
• Clause 9– organization is required to analyse and evaluate effectiveness
of actions to address risks and opportunities
• Clause 10– organization is required to correct, prevent, or reduce
undesired effects and improve the QMS and update risks and
opportunities
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ISO 9001:2015 maintains the PDCA and Process Approach, but adds
Risk-based thinking – most particularly as the ‘Front end’ approach to
planning the QMS

This ‘Front end’ change is intended to:

Ensure the QMS is based on and planned for management of RISK and
OPPORTUNITY which must be identified and classified by the organization
themselves with specific relevance to their OWN circumstances
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The PDCA Cycle

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BENEFITS

 Compliance with regulatory requirements

 A “documented management system” is intended to provide the framework for
consistency of approaches
 Efficiency of actions and approaches and cost savings associated from preventive
rather than reactive management
 Elimination, or at least, minimization of risk of damaging - to profit and to
reputation – customer complaints, penalties imposed.
 Employee motivation and satisfaction - cost saving of staff “turnover”
 Better records keeping
 Better Public Perception
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The Roadmap to ISO Certification

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The Preparation Process

Once Management is decided on pursuing certification and gets a “buy-in” with all
employees, the organization can prepare in any of the following manner:

• Hire a consultant to assist them throughout the preparation period

• Attend trainings and handle setting up the QMS by themselves.

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The Preparation Process

 These consultants should be able to provide you with a timeline which would be
workable by your division or section. Depending on size and complexity, of the
business preparation time should take anywhere between 4-10 months and that also
largely depends on the company's commitment to get certified.

 Also, a timetable should be provided to you on the “road to certification”. It should

generally, show the following activities in the next slides.
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 The Preparation Process

 Awareness Training on the Standard(s) and its requirements
 Background on ISO
 7 Management Principles
 ISO 9001:2015 Requirements

 Formulation/Review of Management System Team

 Top Management / Departmental Heads
 Core Team (Document Controller, Lead Auditor/Auditors,
 Department Representatives)
 Understanding the Context of the Organization
 Identification of Internal and External Issues
 Identification of Interested Parties and their Requirements
 Understanding the Risks and Opportunities
 Determine the scope of the QMS
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The Preparation Process

 Formulate Actions to Address Identified Risks and Opportunities
 Formulation of Quality Policy, Quality Objectives, Targets and Programs

 Establishing the QMS and its Processes

a) determine the inputs required and the outputs expected from these processes;
b) determine the sequence and interaction of these processes;
c) determine and apply the criteria and methods (including monitoring, measurements and
related performance indicators) needed to ensure the effective operation and control of these
processes;
d) determine the resources needed for these processes and ensure their availability;
e) assign the responsibilities and authorities for these processes;
f) address the risks and opportunities as determined in accordance with the requirements of 6.1;
g) evaluate these processes and implement any changes needed to ensure that these processes
achieve their intended results
h)Improve the processes and the quality management system
Maintain and retain documented information
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The Preparation Process

 Awareness Campaign and Training of ALL EMPLOYEES
 Implementation of established QMS, establishing records of implementation

 Conduct of Internal Audits (QMS ) to determine whether the implemented management

systems:
- conforms to planned arrangements for quality management established
by the organization, including the
requirements of ISO 9001:2015 - are effectively implemented and
maintained
- provide information of results of audits to management
 Conduct of Management Review
- Review conducted at planned intervals to ensure continuing suitability,
adequacy, and effectiveness.
- Review shall include assessing opportunities for improvement and the
need for changes to the management systems, including policy,
objectives and targets.
- Gauge readiness for Certification Audit