ISO 9001

Gamal A. Hamid

ISO 9001-2008

Quality management system

[email protected]://www.chemistgamal.com

UMTFZCO Gamal A. Hamid 2

ISO 9

001 - 2008

You have to be organized.


Contents

A- Quality Management Principles

1- Customer focus

2- Leadership

3- Involvement of people

4- Process approach

5- Systems approach to management

6- Continual improvement

7- Factual approach to decision making

8- Mutually beneficial supplier relationships


Contents

B- ISO 9001 – 2008 Standard

0. Introduction

1. Scope

2. Normative Reference

3. Terms and Definitions

4. Quality Management System

5. Management Responsibility

6. Resource Management

7. Product Realization

8. Measurement, Analysis and Improvement


Contents

C- Steps to ISO 9001 Certification

1. Learn About ISO 9001

2. Identify Project Responsibilities.

3. Train Employees on ISO 9001

4. Perform a Gap Analysis

5. Prepare a Project Plan

6. Document Your System

7. Implement the QMS in Your Organization

8. Audit Your QMS

9. ISO 9001:2008 Registration Audit

10. Certification

11. Maintain and improve your management system


ISO 9

001 - 2008

• The quality of something can be determined by comparing

a set of inherent characteristics with a set of requirements.

If those inherent characteristics meet all requirements, high

or excellent quality is achieved.

• The customers' perception of the value of the suppliers' work output

• The properties of products and/or services that are valued by the

consumer.

• A degree of excellence.

• The rate of what has been achieved of the process requirements.

Quality

Q


ISO 9

001 - 2008

Document

Document

information and its supporting medium

for examples:

paper

magnetic

electronic or optical computer disc

photograph

master sample


ISO 9

001 - 2008

Quality control is a set of activities intended to ensure that

quality requirements are actually being met.

Quality assurance is a set of activities intended to establish

confidence that quality requirements will be met.

QC & QA

Quality control is the fulfilling quality requirements

Quality assurance is the providing confidence that quality

requirements will be fulfilled


ISO 9

001 - 2008

Policy

A procedure is a way of carrying out a process or activity.

According to ISO 9000, procedures may or may not be

documented. However, in most cases, ISO 9001 expects

you to document your procedures.

Policy & Procedure


ISO 9

001 - 2008

Mission

Statement explains why an organization exists. It

defines its reason for being

Vision

Describes what it wants to be and how it wants to be

seen by interested parties.

Mission & Vision


ISO 9

001 - 2008An audit is an evidence gathering process. Audit evidence is

used to evaluate how well audit criteria are being met.

There are three types of audits: first-party, second-party, and

third-party audits. First-party audits are internal audits. Second

and third party audits are external audits.

A self-assessment is a comprehensive and systematic review of an

organization’s overall maturity and is used to help achieve and

sustain organizational success.

Audit & Assessment


ISO 9

001 - 2008

Preventive action

Action to eliminate the cause of a potential nonconformity

or other undesirable potential situation

Corrective action

Action to eliminate the cause of a detected nonconformity

or other undesirable situation

Preventive action &Corrective action


ISO 9

001 - 2008

Is a set of interrelated or interacting elements that

organizations use to direct and control how quality policies

are implemented and quality objectives are achieved.

such as:

satisfying the customer's quality requirements.

Quality management system


ISO 9

001 - 2008

Organize our thinking

How can ISO help us?

A 1- Develop your process.

2. Document your process.

3. Implement your process .

4. Maintain your process.

5. Monitor your process .

6. Measure your process .

7. Analyze your process.

8. Control your process .

9. Improve your process .

Q what is the steps for a good process?


ISO 9

001 - 2008Is a comprehensive and fundamental rule for leading and operating an organisation, aimed at continually

improving performance over the long term by focusing on customers while addressing the needs of all other stake holders".

Quality Management Principles

1. Customer-Focused Organisation

2. Leadership

3. Involvement of People

4. Process Approach

5. System Approach to Management

6. Continual Improvement

7. Factual Approach to Decision Making

8. Mutually Beneficial Supplier Relationships.


ISO 9

001 - 2008"Organisations depend on their customers and therefore should understand current

and future customer needs, meet customer requirements .

Principle 1 - Customer-Focused Organisation

Steps in application of this principle are ...

1. Understand customer needs and expectations for

products, delivery, price.

2. Communicate these needs and expectations

throughout the organisation.

3. Measure customer satisfaction & act on results.

4. Manage customer relationships


ISO 9

001 - 2008 “Leaders should create and maintain the internal environment in which people can become

fully involved in achieving the organisation's objectives."

Principle 2 - Leadership


1. Be proactive and lead by example.

2. Establish a clear vision of the organisation's future.

3. Provide people with the required resources and freedom

to act with responsibility.

4. Build trust and eliminate fear.

5. Consider the needs of all stake holders including

customers, owners, people, suppliers and society .

6. Educate, train and coach people.

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ISO 9

001 - 2008"People at all levels are the essence of an organisation and their full involvement

enables their abilities to be used for the organisation's benefit".

Principle 3 - Involvement of People

Steps in application of this principle are...

1. Accept ownership and responsibility to solve problems.

2. Freely share knowledge & experience in teams.

3. Improve the way of representing the organisation to

customers, local communities .

4. Help people derive satisfaction from their work.

5. Make people to be part of the organisation.


ISO 9

001 - 2008

"A desired result is achieved more efficiently when related resources and activities are

managed as a process."

Principle 4 - Process Approach


1. Identify and measure the inputs and outputs of the process.

2. Evaluate possible risks, and impacts of processes on customers,

suppliers and other stake holders of the process.

5. Establish clear responsibility, authority, and accountability for

managing the process.

6. Identify internal and external customers, suppliers and other

stake holders of the process,


ISO 9

001 - 2008 "Identifying, understanding and managing a system of interrelated processes for a given

objective improves the organisation's effectiveness .

Principle 5 - System Approach to Management


1. Define the system by identifying or developing the

processes that affect a given objective.

2. Structure the system to achieve the objective in the

most efficient way.

3. Continually improve the system through measurement

and evaluation.

4. Estimate the resource requirements .


ISO 9

001 - 2008

"Continual improvement should be a permanent objective of the organisation."


1. Apply the basic improvement concepts.

2. Continually improve the efficiency and effectiveness of all processes.

3. Promote prevention based activities.

4. Provide every member of the organisation with appropriate education and

training, on the methods and tools of continual improvement .

5. Establish measures and goals to guide and track improvements.

Principle 6 - Continual Improvement


ISO 9

001 - 2008

"Effective decisions are based on the analysis of data and information."


1. Take measurements and collect data and information relevant to the

objective.

2. Ensure that the data and information are sufficiently accurate, reliable

and accessible.

3. Analyze the data and information using valid methods.

4. Understand the value of appropriate statistical techniques.

5. Make decisions and take action based on the results of logical analysis

balanced with experience and intuition.

Principle 7 - Factual Approach to Decision Making


ISO 9

001 - 2008 "An organisation and its suppliers are interdependent, and a mutually beneficial

relationship enhances the ability of both to create value."


1. Identify and select key suppliers.

2. Create clear and open communications.

3. Initiate joint improvement of products and processes.

4. Jointly establish a clear understanding of customers' needs.

5. Share information and future plans.

6. Recognise supplier improvements and achievements.

Principle 8 - Mutually Beneficial Supplier Relationships


ISO 9001 – 2008 Standard


ISO 9

001 - 2008

Clause headings:

ISO 9001:2008 Standard

0. Introduction

1. Scope

2. Normative Reference

3. Terms and Definitions

4. Quality Management System

5. Management Responsibility

6. Resource Management

7. Product Realization

8. Measurement, Analysis and Improvement


ISO 9

001 - 2008

What does the term "ISO" stand for?

The term ISO stands for the International Organization for

Standardization. You would reasonably assume that it ought

to be IOS, but it isn't. Apparently, the term ISO was chosen

(instead of IOS),

because iso in Greek means equal, and ISO

wanted to convey the idea of equality - the idea that they

develop standards to place organizations on an equal

footing.

Introduction


ISO 9

001 - 2008

What are the ISO 9000 standards ?

The ISO 9000 standards are a collection of formal International

Standards, Technical Specifications, Technical Reports, Handbooks and

web based documents on Quality Management.

ISO 9001 is NOT a product Standard - it contains no product

requirements. It is a series of generic requirements for quality

management systems.

ISO 9001 - 2008


ISO 9

001 - 2008

People in the organization will benefit by:

Better working conditions

Increased job satisfaction

Improved health and safety

Improved stability of employment

Owners and investors will benefit by:

Increased return on investment

Improved operational results

Increased market share

Increased profits

Why is ISO 9001 Important?


ISO 9

001 - 2008

Suppliers and partners will benefit by:

Stability

Growth

Partnership and mutual understanding

Society will benefit by:

Fulfillment of legal and regulatory requirements

Improved health and safety

Reduced environmental impact

Increased security

Why is ISO 9001 Important?


ISO 9

001 - 2008

(Company ) has developed and implemented this quality

management system to demonstrate its ability to

consistently provide product that meets customer and

statutory and regulatory requirements, and to address

customer satisfaction through the effective application of

the system, including continual improvement and the

prevention of nonconformity.

1.Scope


ISO 9

001 - 2008

For undated references, the latest edition of the normative

document referred to applies. ISO 9000: 2005 Quality

Management System –Fundamentals and Vocabulary.

2.Normative Reference


ISO 9

001 - 2008

“Supplier” and “Vendor” are synonymous and refer

to the external source used to acquire purchased

products by (Company Name).

3.Terms and Definitions

The terms and definitions of iso 9000 will applied


ISO 9

001 - 2008

4.1 General requirements

4.Quality Management System

the organization establish, documented,

implemented and maintained a quality management

system and continually improved its effectiveness in

accordance with the requirements of this

International Standard.


ISO 9

001 - 2008

4.2 Documentation requirements

4.2.1 General

4.2.2 Quality manual

4.2.3 Control of documents

4.2.4 Control of quality records

QMS


ISO 9

001 - 2008

The quality management system documentation shall include:

1. documented statements of a quality policy and quality objectives.

2. a quality manual .

3. documented procedures required by this International Standard .

4. documents needed by the organization to ensure the effective

planning, operation and control of its processes.

5. records required by this International Standard.

Document requirements


ISO 9

001 - 2008 Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008.

The documented quality policy has to be controlled according to the requirements of clause

4.2.3.

Note: Organizations that are revising their quality policy for the first time, or in order to meet

the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3

(c), (d) and (g).

Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008.

These documented quality objectives are also subject to the document control requirements

of clause 4.2.3.

1- Statements of Policy and quality objectives


ISO 9

001 - 2008

document specifying the quality management

system of an organization

2- Quality manual


ISO 9

001 - 2008

What does Quality Manual Include?

The Quality manual includes the following

It fully describes the scope of QMS.

It completely explains each and every requirement of the ISO 9001 Standard

It contains complete detail and explanation of exclusions .

It contains references for the quality procedures used to describe all the QMS processes

A flow chart represent the series and interaction of your key business processes.

The organization's quality policies which shows that the organization is strictly committed to

quality


ISO 9

001 - 2008Following are the primary uses of the quality manual

To communicate management's expectations for quality to the organization

To reveal the organization conformity with ISO 9001 requirements

To serve as a measure for compliance to management's expectations for:

Internal audits

ISO Registrar audits

Customer audits

Primary Uses of Quality Manual


ISO 9

001 - 2008

Procedure is the specified way to carry out an activity or a process

ISO 9001:2008 specifically requires the organization to have “documented procedures” for the

following six activities:

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

3- Documented procedures


ISO 9

001 - 2008 Process maps, process flow charts and/or process descriptions

Organization charts

Specifications

Work and/or test instructions

Documents containing internal communications

Production schedules

Approved supplier lists

Test and inspection plans

Quality plans

4- Documents needed by the organization


ISO 9

001 - 20085.6.1 Management reviews

6.2.2 e) Education, training, skills and experience

7.1 d) Evidence that the realization processes and resulting product fulfill requirements

7.2.2 Results of the review of requirements related to the product and actions arising from

the review

7.3.2 Design and development inputs relating to product requirements

7.3.4 Results of design and development reviews and any necessary actions

7.3.5 Results of design and development verification and any necessary actions

7.3.6 Results of design and development validation and any necessary actions

7.3.7 Results of the review of design and development changes and any necessary actions

7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations

5- Records required by ISO 9001 - 2008


ISO 9

001 - 20087.5.2 d) As required by the organization to demonstrate the validation of processes where the resulting

output cannot be verified by subsequent monitoring or measurement

7.5.3 The unique identification of the product, where traceability is a requirement

7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use

7.6 a) Basis used for calibration or verification of measuring equipment where no international or national

measurement standards exist

7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to

requirements

7.6 Results of calibration and verification of measuring equipment

8.2.2 Internal audit results and follow-up actions

8.2.4 Indication of the person(s) authorizing release of product.

8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained

8.5.2 e) Results of corrective action

8.5.3 d) Results of preventive action

Cont.


ISO 9

001 - 2008

Documents

information and its supporting medium

for examples:

paper

magnetic

electronic or optical computer disc

photograph

master sample

4.2.3 Control of Documents


ISO 9

001 - 2008

A record is a type of document. Which provide evidence that

activities have been performed or results have been achieved.

Records management addresses six key issues:

identification

storage

protection

retrieval

retention

disposition

4.2.4 Control of quality record


ISO 9

001 - 2008

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 communication

5.6 Management review

5.6.1 General

5.6.2&3 Review input & output

5.Management Responsibility


ISO 9

001 - 2008Top management is committed to the development and implementation of the quality

management system and continually improves its effectiveness by:

communicating to (Company Name) the importance of meeting customer as well as statutory

and regulatory requirements,

establishing a quality policy,

establishing quality objectives,

conducting management reviews, and

ensuring the availability of resources

Management commitment


ISO 9

001 - 2008


1. Understand customer needs and expectations for products, delivery, price, dependability,

2. Ensure a balanced approach among customers and other stake holders (owners, people,

suppliers, local communities and society at large) needs and expectations.

3. Communicate these needs and expectations throughout the organisation.

4. Measure customer satisfaction & act on results, and

5. Manage customer relationships.

Customer focus


ISO 9

001 - 2008

6.1 Provision of resources

6.2 Human resources

6.2.1 General

6.2.2 Competence, training and awareness

6.3 Infrastructure

6.4 Work environment

6.Resource Management


ISO 9

001 - 20086.1 Provision of resources

(Company Name) determines and provides the resources needed

to implement and maintain the quality management system and continually improve its

effectiveness, and

to enhance customer satisfaction by meeting customer requirements.

Provision of resources


ISO 9

001 - 20086.2.1 General

Personnel performing work affecting conformity to product requirements are competent on the

basis of appropriate education, training, skills and experience.

6.2.2 Competence, training, and awareness

determines the necessary competence for personnel performing work affecting conformity to

product requirements,

where applicable, provides training or takes other actions to achieve the necessary competence,

evaluates the effectiveness of the actions taken,

ensures that its personnel are aware of the relevance and importance of their activities and how

they contribute to the achievement of the quality objectives, and

maintains appropriate records of education, training, skills and experience .

Supporting Documentation QOP-62-01 Competence, Training, and Awareness

Human resources


ISO 9

001 - 2008The organization shall determine, provide and maintain the infrastructure needed to achieve

conformity to product requirements.

buildings, workspace and associated utilities,

process equipment (both hardware and software), and

supporting services (such as transport, or communication, or information systems).

Infrastructure


ISO 9

001 - 20086.4 Work environment

set of conditions under which work is performed

NOTE Conditions include physical, social, psychological

and environmental factors (such as temperature).

Company determines and manages the work

environment needed to achieve conformity to product

requirements.

Work environment


ISO 9

001 - 20087.1 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&3 Design and development inputs &output

7.3.4 Design and development review

7.3.5&6 Design and development verification &validation

7.3.7 Control of design and development changes

7.Product Realization


ISO 9

001 - 20087.4 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 Identification and traceability

7.5.4 Customer property

7.5.5 Preservation of product

7.6 Control of monitoring and measuring equipment

7.Product Realization


ISO 9

001 - 20088.1 General

8.2 Monitoring and measurement

8.2.1 Customer satisfaction

8.2.2 Internal audit

8.2.3&4 Monitoring and measurement of processes & product

8.3 Control of nonconforming product

8.4 Analysis of data

8.5 Improvement

8.5.1 Continual improvement

8.5.2 Corrective action

8.5.3 Preventive action

8.Measurement, Analysis and Improvement


Steps to getting ISO 9001


ISO 9

001 - 2008

Steps to ISO 9001 Certification

1. Learn About ISO 9001

2. The cost of the project.

3. Identify Project Responsibilities.

4. Train Employees on ISO 9001

5. Perform a Gap Analysis

6. Prepare a Project Plan

7. Document Your System

8. Implement the QMS in Your Organization

9. Audit Your QMS

10. ISO 9001:2008 Registration Audit

11. Certification

12. Maintain and improve your management system


ISO 9

001 - 2008

Learn About ISO 9001

Step 1

NO. Activity Who When How How Long

1ISO

purchaseMr. Farzad On line One day

2Study the

requirements

ISO Project Manager

Review One week

3

Study the requirement

sSteering team Action plan

Two meeting/

weekTwo weeks


ISO 9

001 - 2008

The cost of the project

1. The consultant cost.

2. Hiring some peoples.

3. Training cost.

4. Infrastructure and documentation.

5. Software and format.

6. Registration and certificate cost.

Step 2


ISO 9

001 - 2008

Identify Project Responsibilities

1. Top management

2. Project manager.

3. Management representative.

4. Internal Auditors.

5. Steering team.

6. task team.

7. Infrastructure.

Step 3


ISO 9

001 - 2008Establish the quality policy.

Ensure that quality objectives are established at all relevant levels of the organization.

Ensure availability of resources.

Ensure that the planning of the quality system is carried out to meet the requirements of the

standard and the quality objectives.

Ensure that responsibilities, authorities and their interrelation are defined and

communicated.

Ensure that appropriate communication is established within the organization and

effectiveness of the quality management system is communicated.

Responsibilities of Top Management


ISO 9

001 - 2008

Choose your PM

1. The Project Manager completes the Training.

2. The Project Manager prepares a Project Plan.

3. Management and the Project Manager identify an ISO 9001 Steering Team.

4. The Project Manager and others conduct a Gap Analysis with the Gap

Analysis Checklist.

5. Revise processes and procedures and train those within your organization

Project manager


ISO 9

001 - 2008

Choose your MR

1. The standard requires that the MR must be "a member of

management" serving primarily as the "eyes" and "ears" of top

management.

2. The MR primarily provides feedback( report) to top management on

the effectiveness of the quality management system.

3. Ensuring that processes needed for the quality management system are

established, implemented and maintained.

4. Ensuring the promotion of awareness of customer requirements

throughout the organization.

Management representative (MR)


ISO 9

001 - 2008

Choose your auditors team

1. Trained internal auditors for your audit program.

2. Auditing each area of your facility once or twice a year,

3. A general guidance number is 10% of the total number of employees; a company with 50

employees would train 5 auditors.

4. Look for employees that have a strength in investigating issues and that are good

communicators.

5. The better people skills the auditors have, the smoother your audits will be performed.

Internal Auditors


ISO 9

001 - 2008

Choose your Steering team

Management must identify a steering team for the project. It

should be made up of managers from different areas of the

organization.

The purpose of the team will be to assign resources and

responsibilities for the project as well as providing

leadership for the project.

A team led by top management that will coordinate and lead

the implementation project

Steering team


ISO 9

001 - 2008

1. Identify team members for each procedure.

2. Assign target start date and completion date for each team.

3. Identify training needs for employees and schedule training sessions for ISO 9001:2008

4. Meet on a regular basis to evaluate progress, answer questions for the teams and

evaluate resource needs for the

implementation.

5. Review and approve procedures as they are finalized.

6. Evaluate and choose a Registrar

Steering team responsibility


ISO 9

001 - 2008

Choose your Task teams

The Task Team is led by a member of the Steering Team.

A Task Team is set-up for each Quality System Procedure that

needs to be developed.

Task team (quality team)


ISO 9

001 - 2008

1. Review the “Implementation Steps” to the group

2. Review Responsibilities of the ISO 9001:2008 Steering Team

3. Review procedure that the team will be responsible for.

4. Review the section of the Gap Analysis that applies to the team.

5. Determine resources required for completion of the tasks.

Task team responsibility


ISO 9

001 - 2008

The organization shall determine, provide and maintain the

infrastructure needed to achieve conformity to product

requirements. Infrastructure includes, as applicable

1. buildings, workspace and associated utilities.

2. process equipment (both hardware and software).

3. supporting services (such as transport, or communication,

or information systems).

Infrastructure


ISO 9

001 - 2008

Train Your Organization

1. Top management.

2. Project manager.

3. Internal Auditors.

4. Steering team.

5. task team.

6. All employees.

Step 4


ISO 9

001 - 2008Define the knowledge and skill needed for each employee to conduct their job.

Deliver training or other learning activities to develop the required knowledge and skill.

Provide a way to prove whether the training was effective (test for understanding)

Ensure employee awareness of how their activities contribute to the quality objectives. They

should understand the relevance and importance of their role.

Keep training records and records of employee education, skills and experience.

Management Overview


ISO 9

001 - 2008ALL of the employees in an organization so they understand the importance of ISO 9001 and

their role in meeting the requirements.

The course will educate them on:

What is an ISO 9001 Quality Management System?

Why is our company involved with ISO 9001?

What does ISO 9001 require?

How does it impact me and how can I impact quality?

What and why are people auditing?

Employee Awareness


ISO 9

001 - 2008

Perform a Gap Analysis

Consider the start of your project as the date of the Gap Analysis.

Before conducting the Gap Analysis:

1. Identify one or more people to conduct the Gap Analysis; it is

helpful if they have some quality experience or audit experience.

2. Print the Gap Analysis Checklist.

3. Schedule the Gap Analysis, and communicate to all employees what

is being done, and why.

Step 5


ISO 9

001 - 2008

Perform a Gap Analysis

Schedule the Gap Analysis

NO. Activity Who When How How Long

1

2

3

UMTFZCO Gamal A. Hamid

ISO 9

001 - 2008

Question YES NO N/A Auditor Remarks

1 Do you identify the requirements that your customers want you to comply with?

2 Do you identify your customers' product requirements?

3 Do you identify your customers' delivery requirements?

4 Do you identify your customers' post-delivery requirements?

5 Do you identify warranty requirements?

6 Do you identify maintenance requirements?

Gap analysis check list

76

Chick list more than 50 pages and coves all the company activitiesFor example:


ISO 9

001 - 2008

ISO 9001 Gap Analysis Report

Summarize the audit findings in the form of a task list.

You will usually identify several categories of tasks.

Processes that comply with the standard and are documented.

Processes that comply with the standard and must be documented.

Processes that do not comply with the standard and must be redesigned.

Processes required by the standard that are not currently in place.

Gap analysis Report


ISO 9

001 - 2008

Prepare a Project Plan

ISO 9001 Step-by-Step Workbook

The Team Approach

Gantt chart

Step 6


ISO 9

001 - 2008

1- Prepare Your Organization

2- Develop Your ISO 9001 Quality Management System (QMS)

3- Implementation and ISO 9001 Registration

ISO 9001 Step-by-Step Workbook


ISO 9

001 - 2008 Task 1: Management Describe your company

Task 2: Management Choose your ISO Management System

Task 3: Management Obtain the latest ISO 9001 standard

Task 4: Management Select the Management Rep & Steering Team

Task 5: ISO Steering Team Prepare an Organizational Chart

Task 6: ISO Steering Team Establish the Quality Team

Task 7: Quality Team Conduct First Team Meeting

Task 8: ISO Steering Team Formulate the Quality Policy / Objectives

Task 9: ISO Steering Team State the scope of the QMS

Task 10: Quality Team/ Identify applicable regulations ISO Steering Team

1- Prepare Your Organization


ISO 9

001 - 2008 Task 11: Quality Team Identify/Describe processes/Prepare process flow diagrams

Task 12: ISO Steering Team Provide Communication Tools

Task 13: Quality Team Conduct a Preliminary Assessment –c/list

Task 14: ISO Steering Team Assign Improvement Actions for QMS

Task 15: ISO Steering Team Provide ISO 9001 training-Exercises A--F

Task 16: ISO Steering Team Manage the Implementation Project

Task 17: ISO Steering Team Complete Project Timing Chart

Task 18: ISO Steering Team Collect Existing Documents

Task 19: ISO Steering Team Perform financial study of costs and benefits

Task 20: ISO Steering Team Reconfirm the ISO 9001 Decision

Task 21: ISO Steering Team Promote and practice teamwork

2- Develop Your ISO 9001 Quality Management System (QMS)


ISO 9

001 - 2008 Task 22: Obtain and Review a Model for a QMS Manual

Task 23: Use the Model as a Template to generate QMS documentation

Task 24: Implement the Quality Management System

Task 25: Conduct Internal Audit of the QMS

Task 26: Conduct the Management Review

Task 27: Select a Certification Body to register the QMS

Task 28: Receive Certification and Celebrate

3- Implementation and ISO 9001 Registration


ISO 9

001 - 2008A Gantt chart is a graphical representation of the duration of tasks

against the progression of time.

A Gantt chart is a useful tool for planning and scheduling projects.

And helpful when monitoring a project's progress.

Action plan (Gantt chart)


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ISO 9

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Document Your System

How Much Documentation Do You Need?

Importance of Document Control

ISO 9001 QMS Templates

Step 7


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Clause 4.2.1 General explains that the quality management system

documentation shall include:

1. documented statements of a quality policy and quality

objectives;

2. a quality manual

3. documented procedures required by this International Standard

4. documents needed by the organization to ensure the effective

planning, operation and control of its processes, and

5. records required by this International Standard;

Document requirements


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Establish a documented procedure to:

Approve documents for adequacy prior to issue

Review, update as necessary, and re-approve documents

Identify the changes and current document revision status

Make relevant documents available at points of use

Ensure the documents remain legible and readily identifiable

Identify external documents and control their distribution

Prevent obsolete documents from unintended use

Apply suitable identification if obsolete documents are retained

Documents control


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Implement the QMS in Your Organization

Training on New Procedures

Training of Internal Auditors

Step 8


ISO 9

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Everyone in your organization should be performing processes following your documented

procedures and work instructions, complying with the QMS requirements.

Make improvements to the processes

Many of these procedures may be new to your organization, or have changed significantly

during your ISO 9001 project. Now that they are actually in use, you will most likely find areas

that can be improved. Make improvements using the Corrective and Preventive Action

process and the document revision process

Training on New Procedures


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Training Objectives:

Fully understand and successfully interpret the ISO 9001:2008 requirements

Understand how to audit using the process approach

Ask audit questions that get results

Identify and document nonconformities

Qualify additional staff to conduct internal audits

Gain knowledge to help manage a successful ISO 9001:2008 implementation project

Provide professional credentials to internal auditors

Provide critical knowledge for staff and management

Training of Internal Auditors


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Audit Your QMS

Conduct Internal Audits

Corrective/Preventive Action

Step 9


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During an internal audit you will compare your quality system

against the requirements of the standard.

You will select a group of internal auditors from within your

company to perform the audits.


Schedule internal audits to cover all areas of the organization

before your Registration Audit. Allow time to take corrective

action on any findings.

A robust and effective internal audit program is one of the best

tools to finding and correcting shortcomings in the QMS before

your Registration Audit.



ISO 9

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Your corrective action procedure must explain how you:

review non-conformance and customer complaints

decide the cause of the problem

decide an appropriate course of action to stop the problem recurring

put the plan into action

ensure that the action has solved the problem

Corrective Action


ISO 9

001 - 2008Preventive action is a pro-active procedure ie dealing with the problem BEFORE it happens.

Your preventive action procedure must explain how you:

review potential problems

decide the potential cause of the problem

decide an appropriate course of action to stop the problem occurring

put the plan into action

ensure that the preventive action has solved the potential problem

Preventive Action


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ISO 9001:2008 Registration Audit

Selecting a Registrar

When to select a Registrar

Registration Costs

Choosing a Registrar

Registrar Questionnaire

Recommended Registrars

Step 10


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Typical ISO Registration Process

1- Registration

2- Initial assessment

3- Certification audit

4- Surveillance audits

5- Reassessments

6- Certificate


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Step 11 Certification


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Maintain and improve your management system

Step 12


Thank you

ISO 9001

Education

Transcript of ISO 9001