Course title : Lead Auditor,

ISO 9001:2008

Quality Management System

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HopLun

Background

The International Organization for Standardization (ISO) was founded in Geneva in 1947. The original Purpose of the organization was to provide standardization of technical specifications for products traded in the International market place. The term “ISO” is a word derived from the Greek “isos,” meaning “equal.” Over 150 countries are members of ISO, and there are more than 10,000 ISO standards used worldwide. These Standards determine how various products and services are produced, and include standards for instance : Film speed. Thickness of credit cards. Compact disc format. Screw thread number.

Standardization has served an important role in promoting quality and compatibility of products on a global basis

Background

ISO 9001 is the world’s most popular Quality Management System(QMS) standard and its is all about keeping customers satisfied. Whatever sector the company operates in, from manufacturing to services, Whoever followed the principles of quality management system against this ISO standard has been benefited from more efficient ways of working, better cost control and fast and more effective implementation of new working practices.

What it means

Lay out the processes needed by the company, and have them in sequence , making sure that they are effective.

The management of the company have to be committed to putting in ISO and have to set quality objectives that can be measured. It should be focused on customer satisfaction, and communicate this to all employees.

Defining responsibilities and plan a management meeting to assess how you are doing and where you need to improve.

Providing resources and support.

Model of a process-based Quality Management System

“PDCA”

The methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly described as follows

Plan: Establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies.

Do: Implement the processes.

Check: Monitor and measure processes and product against policies, objectives and requirements for the product and report the results.

Act: Take actions to continually improve process performance.

8 Principles of ISO 9001 Standard

Customer focus

Leadership

Involvement of people

Process approach

System approach to management

Continual improvement

Factual approach to decision making

Mutually beneficial supplier relationship

The concept of exclusions

All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Therefore, an organization should consider whether all the requirements of the standard are relevant to its activities, based on the nature of the organization itself, its products, and the processes it uses to meet customer, statutory and regulatory requirements. In addition, the organization should take into account any commitments it has made in its Quality Policy and Objectives and how these could affect the need to undertake particular realization processes. All of these can affect the scope of the organization’s QMS.

The exclusions could be : Clause 7.3 Design and Development. Clause 7.5.4 Customer Property. Clause 7.6 Control of Monitoring And Measuring Equipments .

4. Quality Management System.

4.1. General Requirements.

Preparing documents is all about standardizing the way you do things through

policies, procedures , instructions, flow diagrams, forms etc. Does the company have a repeatable controlled system where records are maintained to prove compliance. In short “say what you do and do what you say” – and prove it!

Documentation provides proof of requirements, thus providing a common source

for reference. It also makes communication more reliable and removes the need

for repeating and remembering verbal instructions.

Its all about how does the job get done when you are not around!

4.2 Documentation Requirements.

4.2.1 General Quality Management System documentation shall include:

Documented statements of a Quality Policy and Quality Objectives.

A Quality Manual.

Documented procedures required by this International Standard :

a) Control of document.

b) Control of quality record.

c) Internal quality record .

d) Control on non conforming product.

e) Corrective and preventive action.

Documents needed by the organization to ensure the effective planning, operation and control of its processes.

Records required by this International Standard :

a) Minutes of meeting review.

b) Training report.

c) Record of design input.

d) Calibration report.

e) Internal Audit result.

4.2.2 Quality Manual

Quality Manual format and structure is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS

A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.

Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.

The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3 :

a) Scope of the quality management system b) Details and justification for any exclusions c) Procedures or references to the procedures d) Description of interaction between processes

4.2.3 Control of Documents

Control the documents required by the Quality Management System. Records are a special type of document and must be controlled as required by clause 4.2.4.

Establish a documented procedure to:

1) Approve documents for adequacy prior to issue. 2) Review, update as necessary, and re‐approve documents.

3) Identify the changes and current document revision status.

4) Make relevant documents available at points of use.

5) Ensure the documents remain legible and readily identifiable.

6) Identify external documents and control their distribution.

7) Prevent obsolete documents from unintended use.

8) Apply suitable identification if obsolete documents are retained.

4.2.4 Control of Record

Establish and control records as evidence of conformity to requirements and to demonstrate the effective operation of the quality management system.

Establish a documented procedure to define the controls needed for record:

1) Identification

2) Storage

3) Protection

4) Retrieval

5) Retention

6) Disposition

Keep records legible, readily identifiable, and retrievable

5. Management Responsibility

The management of the company have to be committed to putting it in

ISO. They have to set Quality Objectives that can be measured, focused

on customer satisfaction, and communicate this to all employees. Define

responsibilities and plan a management meeting to assess how they are

doing and where they need to improve. It shows that implementing ISO is a management initiative and will be supported right through the company.

5.1 Management Commitment

Providing evidence of management commitment to develop and implement the Quality Management System, as well as, continually improve its effectiveness by:

1) Expressing the importance of meeting requirements.

2) Establishing the Quality Policy and Quality Objectives.

3) Conducting management reviews.

4) Ensuring the availability of necessary resources.

5.2 Customer Focus

Its all about ensuring customer requirements are determined and met in order to

improve customer satisfaction. And the top management need to understand customer’s current and future needs to meet customer requirements and strive to exceed customer expectations. This really involves the monitoring of customer perception. It does not mean that you have to send questionnaires to your customers. There are many different ways of monitoring perception. The organization can use methods relevant to its business.

5.3 Quality Policy

The top management must have to ensure the Quality Policy is:

1) Appropriate to the purpose of the organization.

2) Focused on meeting requirements and continual improvement.

3) Used as a framework for Quality Objectives.

4) Communicated and understood at appropriate levels.

5) Reviewed for continuing suitability.

5.4 Planning

5.4.1 Quality Objectives

The top management shall establish Quality Objectives to meet product requirements at the relevant functions and levels within the organization. The Quality Objectives must have to be measurable and consistent with the Quality Policy.

5.4.2 Quality Management System Planning

The top management shall ensure that planning for the quality management system:

a) Meets the general requirements (4.1), as well as, Quality Objectives (5.4.1)

b) Maintains the system integrity when changes are planned and

implemented.

5.5 Responsibility, Authority, and Communication

5.5.1 Responsibility and Authority

Responsibilities and authorities Must have to be defined and communicated within the organization.

5.5.2 Management Representative

A member of the management must have to be appointed who has the responsibility and authority to:

a) Ensure the needed processes are established, implemented, and maintained.

b) Report to top management on Quality Management System performance.

c) Report to top management on any need for improvement.

d) Ensuring the promotion of awareness of customer requirements .

The responsibility of a management representative can include being the liaison with external parties on matters relating to the Quality Management System.

5.5.3 Internal Communication Appropriate communication processes must has to be established and carried out within the organization regarding the effectiveness of the system.

5.6 Management Review 5.6.1 General The Quality Management System must have to be reviewed at planned intervals to: a) Ensure a suitable, adequate, and effective system b) Assess possible opportunities for improvement c) Evaluate the need for any changes to the system d) Consider the need for changes to the quality policy and objectives Records of the management reviews must have to be maintained as well .

5.6.2 Review Input

Inputs for management review must include information on:

a) Results of audits.

b) Customer feedback.

c) Process performance and product conformity.

d) Status of preventive and corrective actions.

e) Follow‐up actions from earlier reviews.

f) Changes that could affect the quality system.

g) Recommendations for improvement.

5.6.3 Review Output

Outputs from the management review must include any decisions and

actions related to:

a) Improvement of the effectiveness of the Quality Management

System and its processes.

b) Improvement of product related to customer requirements.

c) Resource needs.

6. Resource Management

6.1 Provision of Resources

All necessary resources must have to be determined and provided to:

a) Implement and maintain the Quality Management System.

b) Continually improve the effectiveness of the system.

c) Enhance customer satisfaction by meeting customer requirements.

Resources are looked at in three ways: people, infrastructure and work environment.

6.2.1 General

This part deals with the people who work for the company every day and have a quality impact on the product or service. All employees need to have appropriate education, training and skills, and be competent to do their job. A method is also needed to show that these trainings are effective.

Failure to train personnel may result in mistakes, & poor decisions. We cannot expect staff to do their job properly if they are not trained to do so.

6.2.2 Competence, Training, and Awareness

The organization must:

Determine the competency needs for personnel.

Provide training (or take other actions) to achieve the necessary competence.

Evaluate the effectiveness of the actions taken.

Inform employees of the relevance and importance of their activities.

Ensure they know their contribution to achieving quality objectives.

Maintain education, training, skill, and experience records.

6.3 Infrastructure

We must need to identify and maintain those processes and equipment

that make the product or provide the service. When we take on a contract we need to provide and maintain all the necessary equipment to deliver

the end result or to achieve product conformity. Infrastructure includes:

Buildings, workspace, and associated utilities.

Process equipment (both hardware and software).

Supporting services (such as transport, communication, or information

systems).

6.4 Work Environment

Here we must have to look at the conditions under which work is being performed including : Physical. Environmental . Noise . Temperature. Humidity. Lighting. Weather .

We must have to ensure that those are appropriate for meeting customers’ requirements. Again, we must need to ensure that this is reviewed regularly. It’s important that the environment in which we make the product or provide the service is controlled. Improvements in work environmental conditions create a positive quality culture, more satisfied workers, and thus a more satisfied customer.

7. Product Realization

7.1 Planning of Product Realization

We need to create processes that turn the idea into a finished product or service. This needs to be planned so we ensure we can achieve our objective. We need to understand just what are the quality requirements of the product or service, and provide a method to make, measure, and prove that the finished product or service does in fact meet what we set out to do. In planning product realization, the organization shall determine the following :

1) Quality objectives and product requirements.

2) Need for processes, documents, and resources.

3) Verification, validation, monitoring, measurement, inspection, and test activities.

4) Criteria for product acceptance.

5) Records as evidence the processes and resulting product meet requirements.

A document specifying the processes of the Quality Management System (including the product realization processes), and the resources to be applied to a specific product, project or contract, can be referred to as a Quality Plan.

7.2 Customer-related processes

This is much more focused on the detailed requirements that the customer

actually requested.

7.2.1 Determination of Requirements Related to the Product

Determine customer requirements:

1) Specified for the product (including delivery and post‐delivery activities- like

warranty provision, contractual obligations such as maintenance services, and

supplementary services such as recycling or final disposal).

2) Not specified for the product (but needed for specified or intended use, where known).

3) Statutory and regulatory requirements applicable to the product.

4) Any additional requirements considered necessary by the organization.

7.2.2 Review of Requirements Related to the Product

We must have to review the product requirements before committing to supply the product to the customer in order to:

a) Ensure product requirements are defined.

b) Resolve any requirements differing from those previously expressed.

c) Ensure its ability to meet the requirements.

Records of the results of the review and actions arising from the review(any

subsequent follow‐up actions) must have to be maintained. When the

requirements are not documented, they must be confirmed before acceptance. If

product requirements are changed, ensure relevant documents are amended and relevant.

7.2.3 Customer Communication

Determine and implement effective arrangements for communicating with customers on:

1) Product information.

2) Inquiries, contracts, or order handling (including amendments).

3) Customer feedback (including customer complaints)

# 7.3 Design and development #

Firstly the organization must have to confirm that they actually design the

products they make. If they do, then there is a step by step design process they

must have to follow. In simple terms they are defining a method where, by the

customer requirements are put into suitable designs so that it is made correctly.

Careful documentation is required here and maintaining all records especially

change control, authorization and .ommunication. The organization must have to

Plan and control the product design and development. This planning must

determine the:

1) Stages of design and development.

2) Appropriate review, verification, and validation activities for each stage.

3) Responsibility and authority for design and development.

7.3.2 Design and Development Inputs

Determine product requirement inputs and maintain records. The inputs

must include:

1) Functional and performance requirements.

2) Applicable statutory and regulatory requirements.

3) Applicable information derived from similar designs.

4) Requirements essential for design and development.

5) Reviewing these inputs for adequacy.

6) Resolving any incomplete, ambiguous, or conflicting

requirements.

7.3.3 Design and Development Outputs

Document the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:

1) Meet design and development input requirements.

2) Provide information for purchasing, production, and service.

3) Contain or reference product acceptance criteria.

4) Define essential characteristics for safe and proper use.

6) Be approved before their release

Information for production and service can include details for product preservation.

7.3.4 Design and Development Review

It is all about Performing systematic reviews of design and development at suitable stages in

accordance with the planned arrangements (7.3.1) to:

1) Evaluate the ability of the results to meet requirements

2) Identify problems and propose any necessary action.

The reviews must include representatives of the functions concerned with the stage being

reviewed. Maintain the results of reviews and subsequent follow‐up actions.

7.3.5 Design and Development Verification

Performing design and development verification in accordance with planned

arrangements (7.3.1) to ensure the output meets the design and development

input requirements. Maintain the results of the verification and subsequent follow‐up actions.

7.3.6 Design and Development Validation

Performing validation in accordance with planned arrangements (7.3.1) to

confirm the resulting product is capable of meeting the requirements for its

specified application or intended use, where known. When practical, complete the

validation before delivery or implementation of the product. Maintain the results of the

7.3.7 Control of Design and Development Changes

Identifying design and development changes and maintain records. Review, verify,

and validate (as appropriate) the changes and approve them before

implementation. Evaluate the changes in terms of their effect on constituent parts

and products already delivered. Maintain the results of the change review and subsequent follow‐up actions .

7.4 Purchasing

7.4.1 Purchasing Process

We must have to ensure that the material we purchase, is in fact suitable for it’s

intended purpose. This includes assessing the suppliers. We need to make sure

that our purchase orders clearly specify what we need, and also we have a

method to confirm it meets this requirement when received. Remember we are a customer too, and in order for us to meet our customer requirements we must

have to ensure that the material purchased is what was intended, and have a

method to monitor and control this. The quality of what we receive will directly

affect our customers.

We must have to evaluate and select suppliers based on their ability to supply

product in accordance with the our requirements. Criteria for selection,

evaluation and re-evaluation shall be established. Records of the results of

evaluations and any necessary actions arising from the evaluation must have to be maintained.

7.4.2 Purchasing Information

We must have to ensure the purchasing information, contains information describing the product to be purchased, including the requirements for:

1) Approval of product, procedures, processes, and equipment.

2) Qualification of personnel.

We must have to ensure the adequacy of the specified requirements before communicating the information to the supplier.

Also include Quality Management System requirements in the purchasing information.

7.4.3 Verification of Purchased Product

We must have to establish and implement the inspection or other necessary

activities for ensuring the purchased products meets the specified purchase

requirements. If we or our customer proposes to verify the product at the

supplier location, we must have to state the intended verification arrangements

and method of product release in the purchasing information.

7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision

We must have to plan and carry out production and service provision under controlled conditions to include, as applicable:

1) Availability of product characteristics information.

2) Availability of work instructions, as necessary.

3) Use of suitable equipment.

4) Availability and use of monitoring and measuring equipment.

5) Implementation of monitoring and measurement activities

6) Implementation of product release, delivery, and post‐delivery activities.

7.5.2 Validation of Processes for Production and Service Provision

We must have to validate any production or service provision where subsequent

monitoring or measurement cannot verify the output. This validation includes

processes where deficiencies may become apparent only after product use or

service delivery. Demonstrate through the validation the ability of processes to

achieve the planned results. Establish validation arrangements including, as applicable:

1) Criteria for process review and approval.

2) Approval of equipment.

3) Qualification of personnel.

4) Use of defined methods and procedures.

5) Requirements for records.

6) Re‐validation.

7.5.3 Identification and Traceability

Identify, where appropriate, the product by suitable means during product

realization. Identify the product status with respect to monitoring and

measurement requirements throughout product realization. Where traceability is

a requirement, control the unique identification of the product and maintain records.

7.5.4 Customer Property

This could be material, equipment or intellectual property supplied by the customer to be used in your process. We must have to put extra care and ensure it is identified and protected throughout the process. If we loose, damage or find it is unsuitable then we must have to inform the customer and keep records of this.

This clause just ensures that we look after customer property, and have a method to report any damage etc to the customer. It helps in keeping the confidentiality and a very positive customer relationship.

7.5.5 Preservation of Product

Preserving the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation includes:

1) Identification.

2) Handling.

3) Packaging.

4) Storage.

5) Protection.

7.6 Control of Measuring and Monitoring Equipment

Sometimes better known as “calibration” . this clause ensures that the measuring equipment we use to measure the product or service is adequate to meet the customer requirements and is safeguarded from unintended use. Also the equipment is checked at frequent intervals to confirm it is in specification. If a problem is found then there must be a way to review product already measured using the device. To maintain the consistent measurement capability against the requirements we must have to ensure to :

1) Calibrate and/or verify the measuring equipment at specified intervals or prior to use.

2) Calibrate the equipment to national or international standards (or record other basis).

3) Adjust or re‐adjust as necessary.

4) Identify the measuring equipment in order to determine its calibration status.

5) Safeguard them from improper adjustments.

6) Protect them from damage and deterioration.

We must have to assess and record the validity of prior results if the device is found to not conform to requirements. Maintain records of the calibration and verification results .

We must have to confirm the ability of software used for monitoring and measuring for the intended application before its initial use (and reconfirmed as necessary).

8. Measurement, Analysis, and Improvement

8.1 General

Plan and implement the monitoring, measurement, analysis, and improvement processes needed to:

1) Demonstrate conformity to product requirements.

2) Ensure conformity of the system.

3) Continually improve effectiveness.

Determine through planning the need for, and use of, applicable methods, including statistical techniques, as well as, the extent of their use.

8.2.1 Customer Satisfaction

This is all about how the customer perceives our product and service. Just because a customer has not complained about the product or service does not mean they are satisfied. We must have to come up with a way to monitor the customer and use this data to improve the relationship. Monitoring customer perception can

include obtaining input from sources such as customer satisfaction surveys,

customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, and dealer reports.

8.2.2 Internal Audit

Conducting internal audits at planned intervals to determine if the Quality Management System:

a) Conforms to planned arrangements (see 7.1).

b) Conforms to requirements of ISO 9001.

c) Is effectively implemented and maintained. The organization must:

1) Plan the audit program.

2) Consider the status and importance of the audited areas.

3) Consider the results of prior audits.

4) Define the audit criteria, scope, frequency, and methods.

5) Select and use impartial and objective auditors (not audit their own work).

Establishing a documented procedure to address responsibilities and requirements to:

1) Plan audits and conduct audits.

2) Establish records and report results.

3) Maintain records of the audits and their results.

Ensuring management of the audited areas takes actions without undue delay to eliminate detected non conformities and their causes. Verify through follow‐up actions the implementation of the action and report the results.

8.2.3 Monitoring and Measurement of Processes

We must have to apply suitable methods for monitoring and, where applicable,

measurement of the Quality Management System processes. These methods shall

demonstrate the ability of the processes to achieve planned results. When

planned results are not achieved, correction and corrective action must have to be taken, as appropriate.

8.2.4 Monitoring and Measurement of Product

We must have to set criteria to measure the key characteristics of the product or

service. This ensures that the requirements have been met from the initial plan.

This should be done at appropriate stages. We need to provide evidence of these

checks, and record the final check and person who does final release. Before we

ship any product or complete a service, we have to be satisfied that it meets its

intended purpose and all the checks and balances have been done.

8.3 Control of Nonconforming Product

We must have to ensure that any nonconforming product is being identified and

controlled to prevent its unintended use or delivery. A documented procedure

must have to be established to define the controls and related responsibilities and

authorities for dealing with nonconforming product. Where applicable, the

nonconforming product has to be dealt by one or more of the following ways:

1) Take action to eliminate the detected nonconformity.

2) Authorize its use, release, or acceptance by concession.

3) Take action to preclude its original intended use or application.

4) Take action appropriate to the effects, or potential effects, of the

nonconformity when nonconforming product is detected after delivery or use has started.

Maintain records of the nature of the nonconformity, and any subsequent actions,

(including any concessions). When the nonconformity is corrected, re‐verify it to

show conformity.

8.4 Analysis of Data

Determine, collect, and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system, as well as, evaluate where continual improvement of the effectiveness of the quality management system can be made. Include in the analysis the data generated by monitoring and measuring activities and from other relevant sources. Analyze this data to provide information on:

1) Customer satisfaction (see 8.2.1).

2) Conformity to product requirements (see 8.2.4).

3) Characteristics and trends of processes and products, including

opportunities for preventive action (see 8.2.3, 8.2.4, and 8.5.3)

4) Suppliers (see 7.4)

8.5 Continual Improvement

8.5.1 Continual Improvement

One of the most important elements of this Quality Management System is the

area of continuous improvement, and the use of corrective and preventative

action reports. These are used both to correct a known problem, but also to

prevent their occurrence. Continual improvement effects of Quality Management System through:

1) Quality policy.

2) Quality objectives.

3) Audit results.

4) Analysis of data.

5) Corrective and preventive action.

6) Management review.

8.5.2 Corrective Action

We must have to take corrective action to eliminate the causes of nonconformities

and prevent recurrence. Corrective action must have to be appropriate to the

effects of the problem. A documented procedure has to be established a for

corrective action that defines requirements to:

1) Review nonconformities (including customer complaints).

2) Determine the causes of nonconformities.

3) Evaluate the need for actions to prevent recurrence.

4) Determine and implementing the needed action.

5) Maintain records of the results of the action taken.

6) Review the effectiveness of corrective action taken.

8.5.3 Preventive Action

We must have to determine the action to eliminate the causes of potential

nonconformities in order to prevent their occurrence. We must have to ensure

that preventive actions are appropriate to the anticipated effects of the potential

problem. Again a documented procedure has to be established for preventive

action to define requirements to:

1) Determine potential nonconformities and their causes.

2) Evaluate the need for actions to prevent occurrence.

3) Determine and implementing the needed action.

4) Maintain records of the results of the action taken.

5) Review the effectiveness of preventive action taken.

PREPARED BY : MOHAMMED ENAMUL KABIR.

Thank You

For Your Patience