PMI Lebanon Chapter

ISO 9001:

Countdown to 2015

New trends in the revised standard ISO

9001:2015,

A project management approach and mind set

Dr. Claude N. Khalil

President of PMI Lebanon Chapter

Session Outline

ISO 9001:2015 facts

Transition from 2008 to 2015

Major changes

Risk Management and Leadership approach

Impact and relevance of standards with the Project

management tools and techniques

Discussion and networking

Impact of standards like ISO 9001

Standards are “enablers for other major business

processes.”

– The Boeing Company

“The more standardized components we can use to

deliver reliable functionality, the less we, and our

customers, have to pay.”

– Deere & Company

“Standards influence the design, development,

manufacturing, and marketing of many products

worldwide.”

– Motorola

International standard for quality management systems (QMS) Originally published in 1987 Underwent major revision in 2000 Applies to any organization regardless of size or industry Implemented by more than one million organizations in over 170 countries ISO standards are based on consensus National standards institutes from more than 160 countries participate

More emphasis on risk-based thinking

Getting value out of QMS organizational context and

leadership engagement

Use of new common structure for management system

standards for smoother integration

The 2015 revision: what to expect

Key Themes

Increased emphasis on intended outcomes and

customer focus

De-emphasis on prescriptive requirements and

documented procedures

Improved applicability for service organizations

Increased leadership requirement

Increased organizational alignment

Risk Based Thinking

Process Approach

PDCA Cycle

High level Structure Elements There are 10 elements in the Annex SL high-level

structure: Clause 1 Scope

Clause 2 Normative References

Clause 3 Terms and Definitions

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

High level Structure Elements

These elements have driven the changes that users

will find in ISO 9001, including the restructuring of the

standard from Eight clauses in the 2008 version to Ten

clauses in the 2015 version.

Key concept (1): Risk-based thinking Risk (in ISO 9000:2015) is defined as the ‘effect of uncertainty’. An effect is a deviation from the expected – positive or negative. In this Standard ‘opportunities’ can derive from either. Hence this Standard refers to both risks and opportunities. One of the purposes of a QMS is to act as a preventive tool. Consequently, this Standard does not have separate clauses/sub-clause titles such as ‘Preventive action’. This concept is expressed through a risk-based approach to formulating QMS requirements. The concept of risk-based thinking is explicit in this Standard, being incorporated throughout its requirements. It does not advocate a risk management approach though, as detailed in ISO 31000 for example.

PMBOK definition of Project Risk An uncertain event or condition that, if it occurs, has a positive or negative effect on the project objectives. Risk response is the process of developing strategic options, and determining actions, to enhance opportunities and reduce threats to the project's objectives. A project team member is assigned to take responsibility for each risk response.

Key concept (1): Risk-based thinking In Project management

Key concepts (2): Process

A process is defined as: a set of interrelated or interacting

activities that use inputs to deliver an intended result.

Identifying the processes that drive an organization’s

activities, products and services helps to understand the

‘coherent System’, and thus the risks incurred and the

appropriate controls.

• This International Standard ‘promotes’ the adoption of a

process approach when developing, implementing and

improving the effectiveness of a QMS, to enhance

customer satisfaction by meeting requirements.

• Organizations are therefore ‘encouraged’ to use this

approach.

• However, Organizations are often structured into a

hierarchy of functional units, and Organizations are

usually managed vertically, with responsibility for the

intended outputs being divided among functional units.

Key concepts (3): Process approach

The process approach with the revised standard introduces

Horizontal management

Crossing the barriers between different functional units

Unifying their focus to the main goals of the organization

in accordance with the quality policy and strategic direction

of the organization.

Key concepts (3): Process approach

Key concepts : Processes in PM

Confusion abounds in what are the differences and

similarities between process management and project

management.

There is a lot of literature in project management circles

that purports that we should be creating organizations that

are led by projects and project management and forming

Project Management Environments to support these.

But there are also circles that purport that all work is a

process and that we should be creating organizations that

are led by process management and, in turn, form Quality

Management Environments for support..

Key concepts : Processes in PM By examining the definition for project management,

it can be determined that the management of a project

is a process.

The management of a project follows a consistent

series of steps that ensures it is successfully managed

and meets the project’s customer requirements.

If the project management methodology (or process) is

followed, it is assumed that the project will successfully

meet its defined deliverables.

Key concepts : Processes in PM Through the work in Quality Management and Project

Management we can notice that all work is a

process.

It can be flowcharted, measured and improved.

Organizations that are quality driven will map all of

their work processes. It then becomes easy to

determine who does what and when they have to do it,

in order to ensure customer requirements are met.

In reviewing the definitions and literature, it becomes

apparent that the correct thinking is that all work is a

process and that projects fit into the framework of process

management.

Dr. Edwards Deming, once said,

“If you can’t describe what you are doing as a

process, you don’t know what you are doing”.

Key concepts : Processes in PM

Key concepts (4): Plan-Do-Check-Act

PDCA can be applied to all processes and to the QMS

as a whole. The clauses of ISO 9001also broadly

follow the PDCA cycle. This cycle can be briefly

described as:

•Plan: establish objectives, processes, resources

•Do: implement the above (what was planned)

•Check: monitor, measure processes and resulting

product/services against plans and requirements

•Act: take actions based on the ‘Check’ stage for

improvement of process performance

Representation of the structure of this International Standard in the PDCA cycle

Continual Improvement Continual improvement is a ‘recurring activity to

enhance performance’. PDCA is a recurring activity.

The process of establishing objectives and finding

opportunities for improvement is a continual process

through the use of audit findings and audit

conclusions, analysis of data, management reviews, or

other means, and generally leads to corrective actions.

This differs to ‘improvement’ which relates to an

‘activity to enhance performance’ (recurring or

singular).

Key concepts (5): Management Principles

ISO 9000 Quality Management System – Fundamentals

and vocabulary contains the details of Seven Quality

Management Principles (QMP’s).

They are however not requirements, in themselves, but

form the foundation of the requirements in ISO 9001:2015.

1.Customer Focus

The primary focus of quality management is to meet

customer requirements and to strive to exceed customer

expectations.

Key concepts (5): Management Principles 2. Leadership

Leaders at all levels establish unity of purpose and

direction and create conditions in which people are

engaged in achieving the organization’s quality objectives.

3. Engagement of People

Competent, empowered and engaged people at all levels

throughout the organization are essential to enhance the

organization’s capability to create and deliver value.

Key concepts (5): Management Principles 4. Process Approach

Consistent and predictable results are achieved more

effectively and efficiently when activities are understood

and managed as interrelated processes that function as a

coherent system.

5. Improvement: Successful organizations have an on-

going focus on Continual improvement.

6. Evidence-based Decision Making

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 providers.

Key concepts (5): Management Principles

Clause 4 introduces some new language and expands

concepts related to defining requirements.

A few of the more notable changes include:

• Understanding the organization and its context.

• External and internal issues.

• Understanding the needs and expectations of relevant

interested parties.

Understand Organizational Context

Sub clause 4.1 contains requirements for an organization

to determine external and internal issues that affect and are

relevant to its purpose and strategic direction, and to

monitor and review information related to these external

and internal issues.

An organization must know its strategic direction.

The standard mandates consideration of internal and

external issues that affect the ability of the organization to

achieve its intended results.

Understand Organizational Context

Examples of internal issues

One process, that is underused but powerful in

Identifying internal issues, it is the self-assessment

Through: Internal audit results.

Analysis of quality cost data.

Analysis of technology trend information.

Competitive analysis.

Results of customer reviews, audits, complaints and

feedback.

Actual versus intended internal values and culture.

Organizational performance.

Best practices of the organization and comparisons with

industry benchmarks.

Employee satisfaction data analysis.

Examples of external issues External issues can be found through several

Techniques such as analysis of:

Economic environment and trends.

International trade conditions.

Competitive products and services.

Opportunities and conditions related to outsourcing.

Technology trends.

Raw material availability and prices.

Potential changes in statutes and regulations.

Benchmarking best-in-class performers in and outside the

current marketplace.

Other issues

Also an organization should consider the potential interactions with other processes of your QMS. For example, sub clause 4.1 may have direct or indirect interactions with processes dealing with interested parties, risks and opportunities, or with clauses 8, 9 and 10. These new requirements related to the organization and its context should provide the organization an opportunity to expand the breadth and depth of its QMS, integrate the QMS with the strategic and tactical management of the organization, and align objectives throughout the organization.

Leadership The 2015 revision of ISO 9001 contains several

important improvements regarding top management.

Specifically, sub clause 5.1.1 on leadership and

commitment

The revised standard includes 11 requirements

designed to ensure top management is involved and

committed.

Leadership

According to sub clause 5.1.1:

Top management is required to “demonstrate

Leadership and commitment” with respect to the QMS

by:

1. Taking accountability of the effectiveness of a QMS.

2. Ensuring the quality policy and quality objectives

are established for a QMS and that they are Compatible with the

strategic direction and the context Of an organization.

3. Ensuring the quality policy is communicated, understood

and applied in an organization.

4. Ensuring the integration of the QMS requirements

into an organization’s business processes.

5. Promoting awareness of the process approach.

6. Ensuring the resources needed for a QMS are available.

Leadership 7. Communicating the importance of effective quality

management and of conforming to QMS requirements.

8. Ensuring a QMS achieves its intended results.

9. Engaging, directing and supporting persons to contribute

to the effectiveness of a QMS.

10. Promoting continual improvement.

11. Supporting other relevant management roles to demonstrate

leadership as it applies to leaders’ respective areas of

responsibility.

Documented Information: information required to be

controlled and maintained by an organization. [replaces

‘documented procedure’ and ‘records’] The organization shall maintain documented information to the extent

necessary to support the operation of processes, and retain

documented information to the extent necessary to have confidence

that the processes are being carried out as planned

Products and Services–replaces “product”; The organization shall plan, implement and control processes needed

to meet requirements… for the provision of products and services…

Other New terms and Concepts

External Providers–replaces ‘Purchasing’ and ‘Outsourced’;

also to include associated organizations (e.g. divisions)

“The organization shall ensure that externally provided processes,

products, and services conform to specified requirements”

Other New terms and Concepts

Requirements dropped

Quality Manual – not specifically required, nor mandated

as to its content.

Documented Procedures – none specifically called out,

but left to the organization’s determination and needs (4.4,

7.5.1).

Management Representative – not specifically called out

as an individual having the sole responsibility and authority

for the QMS; now considered part and parcel of the

organization’s leadership and top management (5.1.1, 5.3).

Preventive Action – not a specific clause/record moving

forward, but risk is assumed to supplement

Requirements dropped

• No reference made to exclusions ( Scope 1.0) The standard clarifies that the organization can not decide a requirement

to be not applicable if it falls under the scope of its QMS. Also non-

applicability is not allowed if that could lead to failure to achieve the

conformity or to enhance customer satisfaction

8.3 Design and development of products and services

8.3.1 General

Where the detailed requirements of the organization’s

products and services are not already established or not

defined by the customer or by other interested parties, such

that they are adequate for subsequent production or service

provision, the organization shall establish, implement and

maintain a design and development process

Key terms and definitions (from ISO 9000:2015)

Quality

‘Degree to which a set of inherent characteristics of an object fulfils

requirements’ Note 1 to entry: The term “quality” can be used with adjectives

such as poor, good or excellent. Note 2 to entry: “Inherent”, as opposed to

“assigned”, means existing in the object.

Management ‘Coordinated activities to direct and control an organization’

Quality Management

‘Management with regard to quality’ Quality management generally includes

establishment of the quality policy, quality objectives and processes, quality

planning, quality control, quality assurance, and quality improvement.

Quality Management System ‘Part of a management system with regard to

quality’

Thank You!