ISO 9001-2015 International Standard, Lecture notes of International Management

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ISO 9001:

OVERVIEW

7s HOUSEKEEPING

and

Annacel B. Delima

• (^) ISO 9001: 2015 – Quality Management Systems
• (^) ISO 9000:2005 – Fundamentals and vocabulary
• (^) ISO 19011:2011 – Guidelines for Auditing Management Systems
• (^) ISO 9004:2009 – A Quality Management Approach

Only ISO 9001 is auditable. The rest serves s references only.

ISO 9000 Family

ISO

9001:

Developments

All the developments of ISO 9001:

are generic and are intended to be

applicable to any organization,

regardless of its type or size, or the

products and services it provides

ISO

Procedures

ISO 9001:

Preventive

Action

ISO 9001:

Process

Approach

& PDCA

Process Approach & PDCA ISO

ISO 9001:

Risk and Opportunities

Key Improvements of ISO

9001:

• (^) Consistently provide products and services that meet

customers need.

• (^) Facilitate opportunities to enhance customer satisfaction
• (^) Address risks and opportunities associated with your

organization’s context and objectives

• (^) Demonstrate conformity to specified quality management

system requirements

The new version of the standard brings the

organization the following:

All of these add value for the organization

What is Quality?

Requirements

provides

Products/services

How was

it?

Satisfied? Not Satisfied?

Customers

Organization

results

Customer Satisfaction

Continuous improvement

‘’Degree to which a set of inherent characteristics fulfils requirements”.

What is Quality Management System

‘’A system to direct and control an organization

with respect to quality”.

QMS: 3 Core

Concepts…

‘’Continually monitor the Risk

(Risk-based thinking)”.

Why use risk-based thinking?

• (^) Improve governance
• Establish a proactive culture

or improvement

• (^) Assist with compliance
• (^) Assure consistency of quality

of goods and services

• Improve customer confidence

and satisfaction

• (^) Is not new and is something we

probably do already

• Is ongoing
• Ensure greater knowledge of risk

and improves preparedness

• (^) Increase the probability of reaching

objectives

• Reduces the probability of negative

results

• (^) Makes prevention a habit

Risk-based thinking:

QMS: 3 Core

Concepts…

‘’Manage the processes and the system using

PDCA”.

ISO 9001:2015 approach is

based on the

PLAN-DO-CHECK-ACT Cycle

Plan – establish the objective of

the system and its processes.

Do – Implement what was planned.

Check – monitor and measure

processes.

Act – take actions to improve

performance, as necessary.

ISO 9001:

Internal audit, Audit

approach, Continual

improvement, Audit

findings

Why there

is an

Internal

audit?

To ensure the whole Quality

System is audited to check the:

• (^) The system is being followed
• (^) The system meets the ISO requirements

The system is effectively implemented and

maintained

Continual

improvemen

t Concept

Plan

Do

Check

Act

Establish objectives and processes needed to

deliver results

(in line with the QMS)

Take actions to continually

improve the QMS

Implement the needed

processes of the QMS

Check the processes against policy, objectives, targets,

regulations and result of the audit

Audit findings

TYPES OF NON-CONFORMITIES

Observation

Major Non-Conformity Minor Non-Conformity

defined as the failure to

meet one or more

requirements that prevents

meeting the ISO standards.

defined as an incident that does

not meet the ISO 9001

requirements, but that does not

have any major consequences.

Defined as a statement of fact

made during an audit and

substantiated by objective

evidence.

Example: failure to take

corrective or preventative

action, not implementing a

part of the standard, or not

implementing a procedure.

Example: failure of a few

personnel to correctly follow a

process, or a single incident of not

having proper paperwork for

inspecting equipment.

Example: lack of

information or details

How to handle Audit

Session and interact

with Auditors…

How to

handle

Audit

Session?

• (^) Do not panic
• (^) Ask and clarify

Admit obvious non-conformities

Offer evidences and explain patiently

• (^) Take note of improvement areas

highlighted by the auditor

• (^) Show evidences when necessary