International Organization for Standardization(ISO)

9001

Mrs. Shubhashri Waghmare

 What is ISO 9001?
ISO 9001:2015 is the International standard for Quality Management Systems
(QMS) Requirements.
• Process approach
• Identify the processes necessary for effective implementation
• Understand interactions between these processes
• Document the processes to assure effective operation and control

Aim of the standard

• To enhance customer satisfaction through the effective application of the
system,
• including processes for continual improvements of the system and the
assurance of conformity to customer and
• applicable statutory & regulatory requirements

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 ISO 9001 Structure
Quick History
i. Original Standard in 1987
a) 20 clauses
b) Procedure-based
ii. Revision in 1994
a) A “tweak”
iii. Revision in 2000
a) Major overhaul
b) 8 sections
c) Focus on the Customer
d) Focus on Business Results
iv. Revision in 2008
a) A “tweak”

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 Benefits of ISO 9001
• It reduces rejection/rework
• It improves housekeeping
• It increases morale of the company
• It ensures Quality and after sales service to customers
• It improves team work
• It saves cost by :
• avoiding repetition of work
• avoiding unnecessary records
• monitoring processes
….and many other ways
• Opportunities for export market
• Due to increased confidence of customers in you, you get more & more orders
• It improves discipline in the organization
• It increases credit in the market

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 What you must do for effective implementation of ISO 9001?

• You must know the complete details of the work we are doing
• You must know our Work Procedures in detail
• Our work place must be neat and clean
• Every thing must be attached with a label/tag/colour along with its status
i.e. For Inspection/Accepted/ Rejected /For rework etc.
• All the inspection, measuring & test equipment must be calibrated
• You must maintain records, wherever written in the work procedures
• You must be ready for change

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 ISO 9001 Frame

International standard is framed based on eight Quality Management

Principles are as follows

• Customer focus
• Leadership
• Involvement of people
• Process approach
• System approach to management
• Continual improvement
• Factual approach to decision-making
• Mutually beneficial supplier relationships

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 Clauses of ISO 9001 standard
Clause 1: Scope
Clause 2: Normative Reference
Clause 3: Terms and definitions (specific to ISO 9001,
not specified in ISO 9000)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, analysis and improvement

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 Use of clauses
Introduction (Clause 0) to Terms and Definitions (Clauses 3) :

• Do not provide any requirements for a QMS.

• They provide background information as to the purpose;
• Concepts and principles used in the standard (e.g. process approach; PDCA);
• Guidance on the QMS scope;
• Reference to related documents; and
• Key terms and definitions used

Clauses numbering 4 through 8 provide the control requirements that a

QMS must implement.

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 Use of clauses
Clauses Explanation
Clause 4 Quality • Sets requirements to identify, plan, document, operate and control QMS
Management System processes and
• to continually improve QMS effectiveness.

Clause 5 • Sets requirements for top management to demonstrate its leadership and
Management • commitment to develop, implement and continually improve the QMS.
Responsibility

Clause 6 • Sets requirements to determine, provide and control the

Resource various resources needed to operate and manage QMS processes; to continually
Management improve QMS effectiveness; and
• to enhance customer satisfaction by meeting customer requirements.

Clause 7 - Product • Sets requirements to plan, operate and control the specific QMS processes that
Realization determine, design, produce and deliver an organization’s product and services.

Clause 8- • Sets requirements to plan, measure, analyze and improve processes that
Measurement, demonstrate product and
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continually improve QMS effectiveness. 82
Improvement
 Emphasized of ISO 9001 standard

• All QMS processes must be planned, implemented, measured and improved

• ISO 9001 requirements focus on controlling QMS processes, not product.

• QMS controls must emphasize prevention of onconformities rather than

detection.

• QMS processes must be customer focused. Process personnel must be aware of

and strive to meet internal and external customer requirements.

• You must continually improve the effectiveness of your QMS.

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 Clauses of ISO 9001 standard
ISO Clause Number ISO Clause Name
0 INTRODUCTION
0.1 General
0.2 Process Approach
0.3 Relationship with ISO 9004
0.4 Compatibility with Other Management Systems
1 SCOPE
1.1 General
1.2 Application
2 NORMATIVE REFERENCES
3 TERMS AND DEFINITIONS
4 QUALITY MANAGEMENT SYSTEM
4.1 General Requirements
4.2 Documentation Requirements
4.2.1General
4.2.2Quality Manual
4.2.3Control of Documents
4.2.4Control of Records
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 Clause #4
1. Understanding of the org. (Introduction)
2. Need and expectations of the stakeholders (from ISO9001 implementation)- (must
be based on Internal and external Issues)
3. Define the scope of Quality management system (Included – locations, processes,
departments. Excluded from the consideration of ISO 9001 implementation)
4. Develop Org. hierarchical structure,
1. Vision and mission statements of an org.
2. Objectives (Dept..) -
3. Define Process (Dept. wise)
1. Using Supplier🡪 Input🡪 Process🡪 Output🡪 Customer (Internal/External)
2. Relationship across the processes (using SWIM diagram)
3. How these process fulfils the customer needs/ expectations

Document- Quality Manual

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 General requirements of Documentation..

Document Document Version No. Document Purpose of Users

No Name Owner/ this
Approving document
Authority
0.0.1(Org.de Quality Draft Director Implementat All the
pt.#) policy (Date),V1.0( ion of employees
Date) quality
practices in
an org.
Recruitment
policy

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 RACI chart
Process Name Responsible Accountable Consulted Informed/
Individual

Inspection of Shop floor Shop floor Shop floor Sr. Manager

product worker manager manager

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 Clauses of ISO 9001:2008 standard
ISO Clause Number ISO Clause Name

5 MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5 Responsibility, Authority, and Communication
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communications
5.6 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
6 RESOURCE MANAGEMENT / Planning
6.1 Provision of Resources
6.2 Human Resources
6.2.1 General
6.2.2 Competence, Training, and Awareness
6.3
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6.4 Work Environment
 Clause #5 implementation
• Management commitment-
– Department Operational hierarchical chart
– Process performance Measurement mechanism to be established
(SIPOC/Swimlane diagram)
For each process, gets presented at task level, Use Entry-Task-Validate/verify-eXit-
Measure (ETVXM) tool
Process Review mechanism
Process/Performance Audits
– Quality Policy – Quality vision, mission statements with Quality requirements of
an organization and their Quality Objectives
– Quality Procedure
– Who does, what, when, where, why and how?
– Who will audit, what will be audited?
– Who will be a management representative?
– Stakeholder (refer for quality policy)
– Communication protocol (Dept and process specific)
– Resources required
• Management review procedure
– Process -🡪 Input required/give against what is the expected output
– Review process –
» Plan for review
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» Schedule for review
» Perform Review
 ISO 9001:2008-Clause #6
implementation
• Resources Management
– Understand the Process (SIPOC), every process we
execute, what are the resources required
– Find out the list of respective process resources
required (Machinery, HR, raw material, stationary,
tools, infrastructure (Physical, IT, …),funds, …)
– Human resources –
• Competence (operational skill sets to work on process,
Training given, and Awareness program
• Healthy Work environment – cafeteria, tea/coffee facilities,
health checkup, every day morning prayer with standup
meeting (10 min), performer of the month, cultural
event,etc

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 Clauses of ISO 9001 standard
ISO Clause Number ISO Clause Name
7 PRODUCT REALIZATION
7.1 Planning of Product Realization
7.2 Customer-related Processes
7.2.1 Determination of Requirements Related to the Product
7.2.2 Review of Requirements Related to the Product
7.2.3 Customer Communication
7.3 Design and Development
7.3.1 Design and Development Planning
7.3.2 Design and Development Inputs
7.3.3 Design and Development Outputs
7.3.4 Design and Development Review
7.3.5 Design and Development Verification
7.3.6 Design and Development Validation
7.3.7 Design and Development Changes
7.4 Purchasing
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
7.5.2 Validation of Processes for Production and Service Provision
7.5.3 Product Identification and Traceability
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7.5.5 Preservation of Product
7.6 Control of Monitoring and Measuring Equipment
 Clauses of ISO 9001 standard
ISO Clause Number ISO Clause Name

8 MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1 General
8.2 Monitoring and Measurement
8.2.1Customer Satisfaction
8.2.2Internal Audits
8.2.3Monitor and Measurement of Processes
8.2.4Monitoring and Measurement of Product
8.3 Control of Nonconforming Product
8.4 Analysis of Data
8.5 Improvement
8.5.1Continual Improvement
8.5.2Corrective Actions
8.5.3Preventive Actions
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 How to achieve ISO 9001 certification - ISO 9001 implementation /
Certification steps ?

Steps to achieve ISO 9001 certification

• Gap Analysis/ status appraisal
• Awareness Training to all employee
• Documentation Design and finalization
• Implementation
• Conduct of internal audit
• Management Review Meeting
• Review of Implementation
• Stage 1 – certification audit
• Stage 2 – certification audit
• Recommendation for ISO 9001 certification
• Receiving certificate

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 Documentation requirement by ISO 9001:2008

• List of documents required by the standard

Quality policy (clause 4.2.1.a)
Quality objectives (clause 4.2.1.a)
Quality manual (clause 4.2.1.b)

• Documented procedures as required by the standard as follows

4.2.3 Control of documents

4.2.4 Control of records
8.2.2 Internal audit
8.3 Control of nonconforming product
8.5.2 Corrective action
8.5.3 Preventive action

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 List of Records required by the standard

• Management reviews (5.6.1)

• Education, training, skills and experience (6.2.2e)
• Evidence that the realization processes and resulting product fulfill requirements (7.1d)
• Design and development inputs (7.3.2)
• Results of design and development reviews (7.3.4)
• Results of design and development verification
• Results of design and development validation
• Results of review of design and development changes (7.3.7)
• Results of supplier evaluations (7.4.1)
• To demonstrate process validity where output cannot be measured (7.5.2d)
• The unique identification of a product (7.5.3)
• Customer property (7.5.4)
• Basis for calibration of measuring equipment (7.6a)
• Results of calibration (7.6)
• Internal audits (8.2.2)
• Release of product (8.2.2)
• Nonconforming product (8.3)
• Results of corrective action (8.5.2)
• Results of preventive action (8.5.3)

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 ISO 9001 standard Clause 1 Introduction
The implementation of a QMS should be a strategic decision for your organization.

Factors influence the design and implementation of your QMS which include –

• diverse needs and risks of organizations;

• particular goals and objectives;
• complexity of products and services provided;
• number of and complexity of processes employed; and
• size and structure of the organization.

As a result of these and other underlying factors, the ISO 9001 standard does not
require uniformity of QMS structure or documentation.

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 Clauses of ISO 9001 standard
Eight Principles of Quality Clause(s)
Customer-Focus Your organization depends on customers and therefore your organization should clause 5.2; 7.2; and
understand current and future customer needs, meet customer requirements and strive 8.2.1
to exceed customer expectations .

Leadership Leaders establish unity of purpose and direction of the organization. They should create clause 5
and maintain the internal environment in which people can become fully involved in
achieving the organization's objectives

Involvement of People People at all levels are the essence of an organization and their full involvement enables clause 6.2
their abilities to be used for the organization’s benefit.

Process Approach A desired result is achieved more efficiently when related resources and activities are clause 4.1
managed as a process .

System Approach to Identifying, understanding and managing interrelated processes as a system contributes clause 4.1
Management to the organization’s effectiveness and efficiency in achieving its objective

Continual Improvement Continual improvement of the organizations overall performance should be a permanent clause 8.5.1 and 4.1
objective of the organization.

Factual Approach to Effective decisions are based on the analysis of data and information clause 4.1e and 8.4
Decision Making
Mutually beneficial An organization and its suppliers are interdependent, and a mutually beneficial clause 7.4
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of both to Waghmare
create value . 97
 Videos…Basics of ISO 9001
• ISO 9001 IN A NUTSHELL | How it Works and
How it Can Work For You
• https://youtu.be/qSVqDNOkOTo
• What Is ISO 9001 ?
• https://youtu.be/FDyIcM-AFzU
• Benefits of ISO 9001:2015
• https://youtu.be/qh0sOY6iExA

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Video References…
• ISO Clause 4 Context of Organization Explained
• https://youtu.be/nx2lWOQkUvk
• ISO Clause 5.0 Leadership
• https://youtu.be/T2DVT5CISog
• ISO Clause 6 0 Planning
• https://youtu.be/SD2Aq3BGSOs
• ISO Clause 7.0 Support
• https://youtu.be/zYchzczc3Wk
• ISO Clause 8.0 Operation
• https://youtu.be/kUeaONqCcgk
• ISO Clause 9.0 "Checked"
• https://youtu.be/sM0T3cyseNw
• Easy steps to ISO Certification
• https://youtu.be/7ZVelrzXSPQ?list=PLJ0bCq_iq8chI4Ug7hOFmI5ZA202Kz7hi

• ISO Internal Quality Audit (IQA) Explained

• https://youtu.be/fckZK6l678E

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• ISO 9000 quality principles
• https://youtu.be/4zrbfsAdEw0?list=PLJ0bCq_iq8chI4Ug7hOFmI5ZA202Kz7hi
• ISO 9001:2015 Essentials Part 1
• https://youtu.be/6kUxSu-JGog?list=PLJ0bCq_iq8chI4Ug7hOFmI5ZA202Kz7hi
• ISO 9001:2015 Essentials Part 2
• https://youtu.be/WFqVEgpxaTM?list=PLJ0bCq_iq8chI4Ug7hOFmI5ZA202Kz7hi
• ISO 9001:2015 Essentials Part 3
• https://youtu.be/XZtOwO_iVYI?list=PLJ0bCq_iq8chI4Ug7hOFmI5ZA202Kz7hi
• ISO 9001:2015 Essentials Part 4
• https://youtu.be/eXLjfkH-tlc?list=PLJ0bCq_iq8chI4Ug7hOFmI5ZA202Kz7hi
• ISO 9001 Risk Based Thinking
• https://youtu.be/Ba_T0ewl0yM?list=PLJ0bCq_iq8chI4Ug7hOFmI5ZA202Kz7hi

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 ISO 9001:2015-Clause #6 Planning
• 6.1 Actions to Address Risks and Opportunities
The organizational risks an opportunities:
• identification (brainstorming session for identifying the Risk
– – 2 types of Risk – Known( List of probable risk – People, Process, Product,
Service, infrastructure. Prepare risk register with the risk handling procedure
• Risk register ={Risk #, Type of Risk, Description, impact on , Priority of
handling risk, Risk RACI, cost and resources associated}
• Procedure={Risk #, Steps to perform to address risk, beneficiary}

– Unknown Risk – environmental effects, health issues, fire, only one action i.e.
Contingency plan (allocate some amount of money)

– evaluations, measures,
• dates and responsibilities,
• previous risk management activities.
•

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 ISO 9001:2015-Clause #6 Planning
• 6.2 Quality Objectives and Planning to Achieve Them
• Align risk handling mechanism with org. quality policy

• 6.3 Planning of Changes

– changes to the QM system are assessed in type and scope,
– their influence on the organization and the conformity of products and services
is determined,
– measures/activities derived,
– responsibilities and authorizations are defined,
– changes are tested for effectiveness after implementation.

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 ISO 9001:2015-Clause#7-Support
7.1 Resources
– People (Record of people with their availability +personnel Competency) across the org.
– Infrastructure
– - office, workshop, storage area, IT infrastructure, …
– Environment for the Operation of Processes
– Monitoring and Measuring Resources
– Organizational Knowledge
7.2 Competence
7.3 Awareness
7.4 Communication – customer, process, risk oriented
7.5 Documented Information

QM manual, process description, work procedure, templates, job descriptions, video, technical document,
external document , records
Document owner

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• Resources
– People
– Infrastructure
– Environment for the Operation of Processes
– Monitoring and Measuring Resources
– Organizational Knowledge

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