Overview of ISO 9001 and ISO 14001

Food Quality Management

Nauman Khalid
Lecture # 07
Learning Objectives
• Provide background knowledge of ISO

• Grain overview of ISO 9001 structure and certification

process

• Grain overview of ISO 14001 structure and certification

process

• Understand the audit approach

Introduction
• ISO is an independent, non-governmental organization that
develop and publishes international standards

• ISO is derived from Greek word “isos”, which mean “equal”

• International standards gives word-class specifications

• For products and services

• To ensure quality, safety and efficiency

• It says “whatever the country, whatever the language, we are

also ISO”.
Introduction
• ISO international standards impact everyone, everywhere

Technolog
y

ISO
cover Healthcar
Agricultur e and
e almost many
every more

industry

Food
Safety
Introduction
ISO develop documents

Which provide

Requirements, specifications,
guidelines or characteristics
Which can be used consistently

To ensure that materials, products,

processes and services are fit for
purposes
History of ISO
• The ISO story began in 1946 when delegates of 25 countries
met at the institute of civil engineers in London and decided
to create a new international organization “to facilitate the
international coordination and unification of industrial
standards”

• On 23rd February 1947 the new organization ISO officially

began its operation.

• ISO (International Organization for Standardization) is the

world largest developer of voluntary international standards

• Since then it published 22025 International standards

covering almost all aspect of technology, manufacturing and
business
ISO structure and governance
• ISO is made up of members from 162 countries, the members
play an important role in operations of ISO

• Central Secretariat is in Geneva, Switzerland, coordinates the

system and runs day-to-day operations overseen by Secretary
General

General assembly

ISO council

Technically Management Board

ISO 9001 and ISO 14001 in brief

• ISO 9001 and ISO 14001 are among ISO's most well-
known standards ever.

• They are implemented by more than a million

organizations in some 175 countries.

• ISO 9001 helps organizations to implement quality

management.

• ISO 14001 helps organizations to implement

environmental management.
Quality management
• ISO 9001 is for quality management.

• Quality refers to all those features of a product (or

service) which are required by the customer.

• Quality management means what the organization does

to
• ensure that its products or services satisfy the customer's quality
requirements and

• comply with any regulations applicable to those products or

services.
Quality management (cont.)

• Quality management also means what the

organization does to

• enhance customer satisfaction, and

• achieve continual improvement of its
performance.
Environnemental management
• ISO 14001 is for environmental management. This
means what the organization does to:

• minimize harmful effects on the environment caused by

its activities,
• to conform to applicable regulatory requirements, and
to
• achieve continual improvement of its environmental
performance.
Generic standards
ISO 9001 and ISO 14001 are generic standards.

Generic means that the same standards can be

applied:
• to any organization, large or small, whatever its
product or service,
• in any sector of activity, and
• whether it is a business enterprise, a public
administration, or a government department.
Generic standards (cont.)

Generic also signifies that

• no matter what the organization's scope of activity
• if it wants to establish a quality management
system, ISO 9001 gives the essential features
• or if it wants to establish an environmental
management system, ISO 14001 gives the
essential features.
Management Systems
• Management system means what the organization does
to manage its processes, or activities in order that

• its products or services meet the organization’s

objectives, such as

• satisfying the customer's quality requirements,

• complying to regulations, or
• meeting environmental objectives
Management Systems
• To be really efficient and effective, the organization can
manage its way of doing things by systemizing it.

• Nothing important is left out.

• Everyone is clear about who is responsible for doing

what, when, how, why and where

• Management system standards provide the organization

with an international, state-of-the-art model to follow.
Management Systems (cont.)
• Large organizations, or ones with complicated
processes, could not function well without
management systems.

• Companies in such fields as aerospace,

automobiles, defence, or health care devices have
been operating management systems for years.

• The ISO 9001 and ISO 14001 management

system standards now make these successful
practices available for all organizations.
Processes, not products
• Both ISO 9001 and ISO 14001 concern the way an
organization goes about its work.

• They are not product standards.

• They are not service standards.

• They are process standards.

• They can be used by product manufacturers and

service providers.
Processes, not products (cont.)
• Processes affect final products or services.

• ISO 9001 gives the requirements for what the

organization must do to manage processes
affecting quality of its products and services.

• ISO 14001 gives the requirements for what the

organization must do to manage processes
affecting the impact of its activities on the
environment.
Certification and registration
• Certification is known in some countries as
registration.

• It means that an independent, external body has

audited an organization's management system and
verified that it conforms to the requirements specified
in the standard (ISO 9001 or ISO 14001).

• ISO does not carry out certification and does not issue
or approve certificates,
Accreditation
• Accreditation is like certification of the certification
body.
• It means the formal approval by a specialized body-an
accreditation body-that a certification body is competent
to carry out ISO 9001:2008 or ISO 14001:2004
certification in specified business sectors.
• Certificates issued by accredited certification bodies- and
known as accredited certificates-may be perceived on
the market as having increased credibility.
• ISO does not carry out or approve accreditations.
Certification not a requirement

• Certification is not a requirement of ISO 9001 or

ISO 14001.
• The organization can implement and benefit from
an ISO 9001 or ISO 14001 system without having
it certified.
• The organization can implement them for the
internal benefits without spending money on a
certification programme.
Certification is a business decision

• Certification is a decision to be taken for

business reasons:
• if it is a contractual, regulatory, or market
requirement,
• If it meets customer preferences
• it is part of a risk management programme, or
• if it will motivate staff by setting a clear goal.
The ISO 9000 family

• ISO 9001 is the standard that gives the

requirements for a quality management system.
• ISO 9001:2018 is the latest, improved version.
• It is the only standard in the ISO 9000 family that
can be used for certification.
• There are 16 other standards in the family that
can help an organization on specific aspects such
as performance improvement, auditing, training…
08 QMPs of ISO 9001:2008
 Quality management principles

1. Customer Focus
• What, where, how and when do your customer require?
• If you ensure it, it will ascertain in return that they would buy (or continue to
buy) from you

2. Leadership
• Leadership establishes environment, culture and direction
• Good leadership creates an environment where people can become fully
involved in achieving the organization’s objectives for quality

3. Involvement of people
• People at all levels are the essence of an organization and their full
involvement enables maximum utilization of individual abilities for the
organization’s benefit
• To educate, train and motivate employees to ensure their competence in
performing tasks affecting quality, environment, health and safety
 Quality management principles

4. Process approach
• A desired result is achieved more efficiently when activities and
related resources are managed as a process

5. System approach to management

• Identifying, understanding and managing interrelated processes as a
system contributes to the organization’s effectiveness and efficiency
in achieving its objectives

6. Continual improvement
• Continual improvement of the organization’s overall performance
should be the permanent objective of the organization
 Quality management principles

7. Factual approach to decision making

• Effective decisions are based on the analysis of data and information

8. Mutually beneficial supplier relationship

• An organization and its suppliers are inter-dependent and a mutually

beneficial relationship enhances the ability of both to create value.

• Promote quality, environmental, health and safety principles

• Requiring suppliers to improve their practices and encouraging wider

adoption of these principles by suppliers.
ISO 9001:2008 Structure

• Scope Section 1
• Normative References Section 2
• Terms & Definition Section 3
• Quality Management System Section 4
• Management Responsibility Section 5
• Resource Management Section 6
• Product Realisation Section 7
• Measurement, Analysis and
Improvement Section 8
Key difference
QMS-Section 4
Clause-4, Quality Management System

4.1 General Requirements

4.2 Documentation Requirements
(Process Approach)

Determine what processes? General- Quality Policy, Objectives,

Quality Manual, Procedures, Documents
& Records
Sequence & Interaction of processes
Quality Manual

Control methods for processes

Control of Documents

Provided resources for processes

Control of Records

Measure and analyze processes

Improve Processes
ISO 9001 Approach is Based on the Plan-Do-
Check-Act (PDCA) Cycle
PDCA and ISO 9001 Clause structure
Clause structure
QMS Documentation Requirements

Commitment & Policy &

Goals
Objectives

Overall summary
and system str. Quality Manual
Procedures
related to Quality System Procedures
QMS
(Auditing, Document Control, Corrective Action etc.)

Technical Process Procedures, Plans

Procedures (Operation procedures, plans, test methods, specifications etc.)

Records, Reports/ Logs

(Test Reports, Defect Reports, Training records etc.)

Proofs, Evidences
Management Responsibility-Section 5
• Management commitment - evidence of commitment to the
development and improvement of QMS

• Customer focus - ensure customer needs and expectations are

understood and satisfied

• Quality policy - appropriate for company, communicated and

reviewed

• Planning - quality objectives and planning

• Administration - responsibility and authority, management

representative and internal communication

• Review - QMS to be reviewed at planned intervals

Resource Management-Section 6

• General – Required and competent resources

• Competence -Training & Awareness

• Infrastructure- Building, workspace, process equipment &

other services

• Facilities - workspace, equipment and supporting services

• Work environment
Product Realization-Section 7
• Product realisation is the sequence of processes and sub-
processes required to achieve the product - must be planned

• Customer-related processes-identification of requirements,

product obligations and communication

• Design and/or development - planning, inputs and outputs,

review, verification and changes control

• Purchasing - control and purchasing information

• Production and service operations - operations control,

traceability, preservation and verification

• Control of measuring and monitoring devices

Measurement, Analysis & Improvement-Section 8

• Measurement, analysis and improvement (Processes,

Customer satisfaction, Product & Equipment)

- Planning
- Customer satisfaction
- Internal audit
- Control of nonconformity
- Analysis of data
- Improvement (CA & PA)
Conclusion (Sequencing & Interaction)
ISO 9001:2015 Certification
Transition Timeline
Continual Improvement
• Effectiveness of QMS must continually be improved by:

 Quality Policy
 Objectives (KPIs)
 Audit Results
 Analysis of data
 Corrective Actions
 Preventive Actions
 Management Reviews
ISO 9001 Implementation –Flow Chart
Selection of External QA Consultants for ISO9001
training and advisory Implement corrective actions to meet
ISO9001:2008 requirements

ISO9001 High level Training / Awareness Sessions

Mock Audit

Gap Analysis between Existing systems & ISO9001

External 3rd Party Audit &
standards
ISO9001:2008 Certification

System Development and Document Processes, SOPs Surveillance Audits

and Work Instructions

System implementation according to the

documented Processes, SOPs and Work Instructions

Perform Internal Audits

Steps to Implement ISO 9001:2008 QMS
• Management Decision and Commitment
• Establishment of Quality Council
• Appoint your Management Representative
• Establish Quality Policy and Objectives
• Establish QMS Organization
• Provide Infrastructure and other Resources
• Review of Current QMS (Gap Analysis)
• Documentation Process (Technical & QA)
• Implementation of Processes and Monitoring through KPIs
• Perform Internal Audit
• Improve performance by corrective and preventive actions
• Perform Assessment
• External Audit and Certification
ISO 9001 Implementation and Certification Process

Implementation Certification Maintenance

Activities Activities Activities

• Gap Analysis • Audit • Surveillance Audits

• System Design • Corrective Actions

• Implementation • Award of Certificate

& Documentation

6~12 Months 1~3 Months After each year

Some Reasons of Failure

• Over Documentation

• Emphasis on adherence and not adequacy

• Just get the certificate!

• Loss of direction and credibility

• Short term Corrective/ Preventive Actions

• Weak auditing system

Benefits of ISO Certification
Financial benefits:
• Profits are enhanced because of increased acceptability
• More work is done in less time thus increasing production rate
• Cost of quality comes down as a whole

For the Organization:

• Products are of consistent quality
• Production is more efficient with less reworks
• Export marketing is easier
• Increased market share
• Customer confidence is enhanced as they expect products of consistent
quality

For Employees:
• Better understanding of their work.
• Reduced stress level because of an efficient management system
• New staff learns their job quickly because it's written down
 Quality is the result of a carefully
constructed cultural environment. It has to
be the fabric of the organization, not part
of the fabric

(Philip B. Crosby)