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ISO 9001: 2015 (Quality Management System)

This is the name of series not a certificate Started in 1987. First revision in
1994. Second revision in 2000 & third revision in 2008 which is the latest.
ISO 9001:2015
This revision has become obsolete on 23RD Sept 2015. Such clients who
got their certificates before that period has been upgraded to ISO
9001 : 2015.
Validity of the certificate is three years. This requires one certification
audit and surveillance audits depending on the performance of your
system.
 The ISO certification process 3

 Gap analysis of the system

 Preparation of quality policy & Establishing
quality objectives
 Preparing quality manual & related document
 Training of staff & other responsibility holders.
 Pre-audit
 Certification audit
DOES NOT…… 4
 touch financial aspects like purchase price, sales price,
profitability, Balance Sheet etc.
 audit transactions, which are not mentioned in records.
 get into business secrets like chemical composition etc.
 require any product sample for destructive testing.
 ADVANTAGES 5
 Organization commitment towards quality can be
established.
 Makes Organization systematic. Reduces dependence on
individuals.
 Increases organizations acceptance in the market.
 Better chances of getting National/ International orders
through tenders.
 Cost saving due to reduced time and effort.
 Reduces wastage/ rejections.
 When systems are implemented properly the organizations
profitability increases by 2-10%
 When MIS is in place, the monitoring of all-important
parameters of business is much easier and it improves
profitability by 5-10%.
Internal Benefit 6

 Better
management of core business
processes.
 Increased awareness of quality among
staff.
 Improved productivity and quality.
 Improved internal communications.
 Reduced wastage and cost per
unit/service
EXTERNAL Benefit 7
 Competitive Advantage: 72.3 % of corporations with ISO
9001:2015 report a major competitive advantage. This means
they are winning more business. (Source –Dun and Bradstreet
Survey).
 Improves Customer Demand: 33.4 % of corporations with ISO
9001:2015 report improved customer demand. This means they
are winning more business. (Source –Dun and Bradstreet Survey).
 Protect Your Business: 69.3 % of surveyed business that do not
have ISO 9001:2015 say they have lost a customer bid or proposal
to an ISO 9001:2015 certified competitor. Many of these
companies said they didn’t know why they were losing the
business until it was too late.
 Your competitors Are doing It: In many industries, 35 to 40 % of
your competitors are ISO 9001:2015 Registered or in the process.
The longer you wait to start, the greater is their competitive
advantage.
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 Easy & cost Effective: Getting ISO 9001:2015 is no longer the costly,
time consuming proposition that it once was. Using our system to
become ISO 9001:2015 compliant is very simple and inexpensive.
It will put you way ahead of your competition and will enable you
to improve your systems and operations.
 Quality for Government Contracts: The Department of Defense,
Food and Drug Administration, Railways, Department of Energy
and the General Services Administration have all approved the
use of ISO 9001:2015 in contracts and bids.
 Increased Credibility: You can generate a significant increase in
business, as many corporations will only deal with ISO 9001:2015
Registered or Complaint companies.
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8 Principles of QMS

Principles contain greater scope

requirements than ISO 9001:2000,
but have less specific
documentation requirements.
 Principal 1–customer focus 10

Organizations depend on their customers, and therefore should

understand current and future customer needs. They should
meet customer requirements and strive to exceed customer
expectations.
Key benefits:
 Increased revenue and market share obtained through flexible
and fast
 Responses to market opportunities.
 Increased effectiveness in the use of the organization’s
resources to enhance customer satisfaction.
 Improved customer loyalty leading to repeat business.
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Principal 2–LEADERSHIP
Leaders establish unity of purpose and direction in the
organization. They should create and maintain the internal
environment in which people can become fully involved in
achieving the organization’s objectives..
Key benefits:
 People will understand and be motivated to achieve the
organization’s goals and objectives
 Activities are evaluated, aligned and implemented in a unified
way.
 Bad communication within the organizational levels will be
minimized
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Principal 3–INVOLVEMENT OF PEOPLE

The involvement to people at all levels in an organization is

essential to the success of a Quality Management Systems
implementation.
Key benefits:
 Motivated, committed and involved people within the
organization
 Innovation and creativity and furthering the organization’s
objectives.
 People eager to participate in and contribute to continual
improvement
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Principal 4–PROCESS APPROACH

Quality is achieved more efficiently when activities

and related resources are managed as processes.
Keybenefits:
 Lower costs and shorter cycle times through effective
use of resources.
 Improved, consistent and predicate results.
 Focused and prioritized improvement opportunities.
Principal 5–SYSTEM APPROACH TO MANAGEMENT 14
Identifying, understanding and managing interrelated processes as
a system contribute to the organization’s effectiveness and
efficiency in achieving its objectives.

 Key benefits:
 Integration and alignment to the processes that will best
achieve the desired results.
 Ability to focus effort on the key processes.
 Providing confidence to interested parties regarding the
consistency, effectiveness and efficiency of the
organization.
 Principal 6–CONTINUAL improvement 15

The continual improvement of the organization’s overall

performance should be a permanent objective of the
organization.

Keybenefits:
 Performance advantage through improved organizational
capabilities.
 Alignment of improvement activities at all levels of the
organization’s strategic intent.
 Flexibility to react quickly to opportunities
Principal 7–FACTUAL APPROACH TO DECISION MAKING
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Effective decisions are based on the analysis of data and
information

Keybenefits:

 Informed decisions.
 An increased ability to demonstrate the effectiveness
of past decisions through reference to factual records.
 Increased ability to review, challenge and change
opinions and decisions
 Principal 8–MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS 17
An organization and its suppliers are interdependent,
and a mutually beneficial relationship enhances the ability
to both to create value.

Key benefits:

 Increased ability to create value for both parties.

 Flexibility and speed of joint responses to changing market or
customer needs and expectations.
 Optimization of costs and resources.
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 ISO 22000:2005 FSMS
(Food Safety Management system) 19
 FSMS is the management system dealing
with food safety. Food product life cycle
is the object of FSMS starting from raw
material purchase, product
manufacturing, preserving, distribution &
consumption. It is a systematic approach
to identify the specific hazard its effective'
control & monitoring, it can also be
integrated with Quality management
system.
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How ISO 22000 benefit society?
 For businesses, the widespread adoption of ISO
22000 means that suppliers can base the
development of their products and services on
specifications that have wide acceptance in their
sectors;

 This, in turn, means that businesses using ISO 22000

are increasingly free to compete on many more
markets around the world
 How ISO 22000 benefit consumers? 21

 For consumers:

- conformity of products and services to

International Standards

-provides assurance about:

-quality
-safety
-reliability
 How ISO 22000 benefits everyone? 22
 ISO 22000 can contribute to the quality of life in
general by:
-ensuring safe food
-reducing foodborne diseases
-better quality and safer jobs in the food industry
-better utilization of resources
-more efficient validation and documentation of
techniques, methods and procedures
-increased profits
-increased potential for economic growth and
development
How ISO 22000 benefit governments? 23

 For governments, ISO 22000 provides:

-technological and scientific know-how
-bases for developing health, safety and
environmental legislation
-education of food regulatory personnel
How ISO 22000 benefit governments? 24
(Cont’d)

-certification or registration
-international acceptance of standards used globally
-economic benefits
-social benefits
-trade liberalization
-food quality
-food safety
-food security
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What are the benefits of ISO 22000 for other
stakeholders?
 Confidence that organizations implementing ISO
22000 have the ability to identify and control food
safety hazards;

 International in scope;

 Provides potential for harmonization of national

standards;

 Provides a reference for the whole food chain;

 Provides a framework for third party certification;

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What are the benefits of ISO 22000 for other
stakeholders? (Cont’d)
 Fills a gap between ISO 9001:2015 and HACCP;

 Contributes to a better understanding and further

development of Codex HACCP;

 Auditable standards with clear requirements;

 System approach rather than product approach;

 Suitable for regulators

Summary of benefits of ISO 22000
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 More efficient and dynamic food safety hazard
control;

 Systematic management of prerequisite

programmes;

 Valid basis for taking decisions;

 Increased due diligence;

 Control focused on what is necessary;

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Summary of benefits of ISO 22000 (Cont’d)

 Saves resources by reducing overlapping system

audits;

 Organizes and targets communication among

partners;

 Resource optimization;

 Improves documentation;

 Better planning, less post-process verification

Management Responsibility 29

 Commitment
 Food Safety Policy
 Food Safety Management System Planning
 Responsibility & authority
 Team Leader & Team
 Communication (External & Internal) [Innovation]
 Emergency preparedness & response
 Management Review
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HACCP –
What is It?
 HACCP (Hazard Analysis and Critical Control Points)
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 It is a systematic preventive approach to food
safety from biological, chemical, and physical hazards in
production processes that can cause the finished product
to be unsafe, and designs measurements to reduce these
risks to a safe level. In this manner, HACCP attempts to avoid
hazards rather than attempting to inspect finished products
for the effects of those hazards. The HACCP system can be
used at all stages of a food chain, from food production
and preparation processes including packaging,
distribution, etc
Food Safety - is it 32

expected?
Your customer/consumer expects
that your product is
 Free from microbial
contamination
 free from insect/rodent
contamination Groceries

 free from pesticides / chemicals

 free from physical hazards
What Causes Food Safety 33

Incidents
 direct causes include biological
/ physical / chemical hazards
 indirect causes are the result of
managerial and employee
deficiencies
 company needs to address
changes in people’s behavior
to prevent reoccurrence →
have the right attitude!
 How can We Achieve Better
Food Safety in our Product 34

 Think about the best way to do

things right
 Implement a HACCP plan that
protects food going through
our plant
 Tackle underlying causes of
food contamination
 Have a clean and sanitary
environment
Why do we worry about 35
Food Safety?
 Consumers / buyers / governments demand that
we produce safe food
 Recalls are expensive → can cost jobs
 We can get sick
 our families: children, parents - not some unknown
person in a far away place
How do we achieve food 36
safety in our product?
 Be aware of food hazards
 Biological / chemical / physical
 Keepout / minimize food
hazards
 Develop system to ensure food
safety in product
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Brief history of HACCP

 HACCP was developed by
Pillsbury for the NASA space
program in the 1970’s
 Codex Alimentarius (FAO) has
developed it for international
use
 Canada refined it in 1992 as the
Food Safety Enhancement
Program (FSEP)
What is HACCP? 38

 Hazard Analysis
 What are Hazards?
 Where can they be found?
 How can they be controlled?
 Critical Control Points
 How do we control hazards?
 CCPs – measuring product acceptabilty
 Prerequisite Programs – creating an environment to
produce safe product
Food Safety Hazards 39

Potential hazards can include:

 Biological
 Microorganisms: bacteria / yeasts / molds /
viruses
 insects
 Chemical
 Cleaners
 Lubricants / fuel / hydraulic fluid / coolants
 pesticides
 Physical
 Glass / plastic / wood / rocks
 Metals
What is a food safety 40
management system?
A food safety mgt system helps
the process & people to
produce a safe product by
controlling hazards
A food safety mgt system needs:
 Effective procedures
 Delegated responsibilities
 Trained people
What are the components 41
of a food safety program?
 Programs supporting food safety in the
following areas:
 Sanitation and Pest Control
 Preventive Maintenance
 Traceability / Recall Program
 Making employees more knowledgeable
 Employee Training
 Doing things right the first time
 Standard Operating Procedures
 Policies
Food Safety Management 42
System
 Good Manufacturing Practices (GMP)
/ Prerequisite Programs
 must-do / should-do
 Operational controls and Standard
Operating Procedures (SOP)
 HACCP Plan(s) for product(s)
 Critical Control Points (CCP)  must do
 Review / verification procedures
 Self-inspection or audit
 Government inspection or audit
 What are Prerequisite 44
Programs?
They are the foundation of
a food safety
management system:
1. Premises
2. Transportation and Storage
3. Equipment
4. Personnel
5. Sanitation and Pest Control
6. Recall / Traceability
Having effective 44
Prerequisite Programs
 Well maintained premises
 Proper receiving / storage /
shipping practices
 Sanitation and pest control
programs
 Well maintained and correctly
operated equipment
 Properly trained employees
 Tracking/Recall program
Critical Control Points 45

(CCP)
 Control Point - A step in the process where the
product can be stopped and a measurement
taken
 Critical Control Point
 Measurement is taken to determine if product is
acceptable or not
 Has corrective actions that:
 Bring the process back to acceptablity
 Takes care of product that is unacceptable
What is IndianLife Foods 46
doing about HACCP?
 Developing a HACCP-based
plan for each product with
CCPs
 Developing Prerequisite
Programs
 Providing employee
training
HACCP and the 47

employee
 Observe Good Manufacturing Practices
 Know Critical Control Points
 Who is responsible?
 Why is it a CCP?
 Monitoring procedure
 Frequency of monitoring
 Keep records as required
 Sequence of 12 Steps 49
1. Assemble HACCP team
2. Describe product
3. Identity intended use
4. Construct process flow and plant schematic
5. On site verification of flow and schematic
6. List hazards associated with each process step
(principle #1)
 Sequence of 12 steps 50
7. Apply HACCP decision tree to determine CCP’s
(Principle #2)
8. Establish critical limits (Principle #3)
9. Establish monitoring procedures (Principle #4)
10. Establish deviation procedures (Principle #5)
11. Establish verification procedures (Principle #6)
12. Establish record keeping/documentation for
principles 1 - 6 (Principle #7)
HACCP team 51

People chosen that have expertise in different areas:

 Production
 Shipping
 Quality Assurance
 Sanitation
 Maintenance
 Sales
Product Description 52

 Product Name(s)
 Important Product Characteristics
 How it is to be used
 Packaging
 Shelf Life
 Where it will be sold
 Labelling Instructions
 Special Distribution Control
 Specific Ingredients
Define the processing 53

steps

Packaging
Storage and
Receiving Preparation and Storage Distribution
Holding
Labelling
ISO 14001:2015 EMS (Environmental Management System)
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 In view of awareness among the global community, there has been
growing interest and commitment to improve environmental management
practices in all spheres of life. Regulated agencies & bodies, associated
industries & trade organization strive to minimize environmental
degradation

EMS Benefits

Improving process efficiency

Reduces emission & discharges
Preventing uncertainties & risks
Cuts energy, transportation & distribution costs
Ensure the status of compliance with legal requirements
Improve the confidence level of staff & society as a whole
 ISO 27001:2005 ISMS (Information Security Management System)
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 An information management system is based on a systematic
business risk approach ,to establish, implement, operate, monitor,
review, maintain and improve information security. It is an
organized approach to information security. Information is vital for
an organization in today's business world. Organization are
increasingly facing security threats from wide range of sources,
computer assisted fraud, espionage, sabotage, vandalism hacking
and denial of service.

Benefits of ISMS

Improves credibility and enhances customer confidence

Reduces the needs for multiple assessments
Provides opportunity for continuous improvement
through regular audits.
Provides more avenues for trade in the global market
 HALAL CERTIFICATION
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Halal is a term from Quran that means “permitted” or “lawful”. Therefore,
in relation to food, Halal is used for food and other consumables that
are permissible for consumption and used by Muslims, based on the
Islamic law, the Shariah. Halal promotes cleanliness in all aspects of a
person and halal foods ensure that food consumed by a person in their
daily lives are clean, hygienic and not detrimental to their health or
well-being. Having a halal certification ensures that the food product is
deemed safe for consumption and with rising awareness about Halal
foods, more and more businesses are seeking Halal Certification for their
products, premises, restaurants, etc.,
Benefits of HALAL:
 Make the business or product marketable to
over 2 billion people across the world.
 Use of the Halal logo
 Enhance the marketability of the product in
Muslim countries
 Improve the quality of the food or product
or hygienic systems
 Improve the quality of the food or product