Introduction of the Resource Person

Engr. Bilal Haider Lecturer Institute of Chemical Engg. & Tech. University of the Punjab, Lahore
Qualification: B.Sc. Engg. (Chem.), MS (TQM), Lead Assessor ISO 17025, 9000 PNAC & NA

Professional Affiliations: Professional Trainings:

ISO/IEC 17025 Assessor Course, Norwegian Accreditation (Norway) IRCA Qualified ISO 9000 Auditor National Quality Award Assessor (NQAA) Course organized by Asian Productivity Organization (APO), Japan. Evaluation of Measurement Uncertainty, Norwegian Accreditation (Norway) ISO 17020 General criteria for the operation of various types of bodies performing inspection organized by PNAC

Discussion Topics
Introduction Evolution

to Quality and Standardization

of Quality Management System (ISO 9000) Management System - Requirements (ISO 9001:2008)

Quality

Introduction to Quality and Standardization

What is Quality after all?

Quality!

Fitness for use Juran

Conformance to requirements Crosby

Customer satisfaction/delight Deming

Degree to which a set of inherent characteristics fulfils requirements - ISO 9000:2000

Customer Satisfaction
Degree to which the customers requirements have been fulfilled

Performance
Satisfaction = Expectation

< 1 - Dissatisfaction = 1 - Satisfaction > 1 - Delight

Standardization
The process of developing and agreeing upon Standards.

Aims of Standardization

Fitness for purpose Interchangeability Variety reduction Compatibility Guarding against factors that affect the health and safety of consumers Environmental protection Better utilization of resources Better communication and understanding Better communication and understanding Removal of trade barriers

Standard?
Standards are documented agreements containing technical specifications or precise criteria to be used consistently as a guideline of characteristics, to ensure that materials, products, processes and services are fit for their intended purpose.

TYPES OF STANDARDS
Vocabulary standards: Glossaries, signs and symbols; A few examples are Paper Vocabulary, List of Equivalent Terms Used in the Plastic Industry, Vocabulary for the Refractory Industry and Vocabulary of Information Processing.
Measurement standards: Material measure or physical property that defines or reproduces the unit of measurement of a base or derived quantity. Such as units of measures; The seven basic units of the SI system e.g. meter, Kg, Ampere etc. Product standards: Cover specifications for dimensions, performance, health, safety, environmental protection and documentation; Standards for inspection, test methods and analysis. Management Standards: Standards that focus on organization, such as for logistics, maintenance, inventory management, quality management, project management and production management such as ISO 9000, ISO 14000, ISO 17025, SA 8000, HACCP etc.

Attributes of a standard
A standard generally has three attributes:
1. 2. 3.

Level: such as at the company, national or international level. Subject: such as engineering, food, textile or management. Aspect: such as specification, testing and analysis, packaging and labeling (more than one aspect may be covered in a single standard: a standard may include specification of items such as the product, its sampling and inspection, related tests and analysis, packaging and labeling).

For example the term Pakistan Standard Specification of Biscuits, means that the standard is a national standard (level), in the food area (subject), and provides specifications (aspect) for the biscuits.

Infrastructure for Standardization in Pakistan

ILAC IAF

Legal framework in Pakistan

Accreditation Board PNAC Standards Institute PSQCA

ISO BIPM OIML

An institution for training and monitoring Auditors

System certifiers..

System auditors

System consultants

Laboratory accreditation ISO 17025

NPSL

HACCP

ISO14000

ISO 9000

LABORATORIES

Microbe

Chemical

Textile

Legal metrology

TESTING SERVICES
Factory metrology lab Trade transaction

ENTERPRISES

Renowned Standardization Bodies

ISO ASTM DIN EN IEC BSI International Organization for Standardization American Society for Testing and Materials Deutsches Institut fr Normung European Norms International Electrotechnical Commission British Standards Institute

Certification
1.

2. 3.

Means Compliance with a standard or specification (e.g. Systems or Product Standards). May be general in the scope of recognition Considers total business .

Accreditation
1. 2. 3.

It means recognition of competence in a specific area and scope. Its scope is highly specific. Evaluates people, skills and knowledge.

Evolution of Quality Management System ISO 9001:2008

1987 1994 2000 First Published ISO 9001, 9002 & 9003 First revision ISO 9001, 9002 & 9003 Second revision - ISO 9001

2008

Third revision ISO 9001

Quality Management System

Management System to direct & control an organization with regard to quality.

Quality management Principles

1. Customer focus 2. Leadership 3. Involvement of people 4. Process Approach 5. System approach to management 6. Continuous Improvement 7. Factual approach to decision making 8. Mutually beneficial supplier relationships

Quality Management Principle No.1

Customer Focus

Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations. Application of this principle is reflected in ISO 9001:2008 clauses 5.2, 7.2.3 and 8.2.1

Customer Focus...
Application of this principle involves : Researching and understanding customer needs and expectations. Ensuring that the objectives of the organization are linked to customer needs and expectations. Communicating customer needs and expectations throughout the organization. Measuring customer satisfaction and acting on the results Systematically managing customer relationships. Ensuring a balanced approach between satisfying customers and other interested parties (such as owners, employees, suppliers, financiers, local communities and society as a whole)

Quality Management Principle No.2 Leadership

Leaders

establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organizations objectives.

This principle is reflected in ISO 9001:2008 clauses 5.3, 5.4, 5.5, 6.1, 6.2

Leadership...
Application of this principle involves: Considering the needs of all interested parties including customers, owners, employees, suppliers, financiers, local communities and society as a whole. Establishing a clear vision of the organizations future. Setting challenging goals and targets. Creating and sustaining shared values, fairness and ethical role models at all levels of the organization. Establishing trust and eliminating fear. Providing people with the required resources, training and freedom to act with responsibility and accountability. Inspiring, encouraging and recognizing peoples contributions.

Quality Management Principle No.3

Involvement of people

People at all levels are essence of an organization and their full involvement enables their abilities to be used for the organizations benefit. This principle is reflected in ISO 9001:2008 clauses 5.3(d) and 6.2.

Involvement of people...

Application of this principle involves: People understanding the importance of their contribution and role in the organization. People identifying constraints to their performance. People accepting ownership of processes and problems and their responsibility for solving them.

Involvement of people...

People evaluating their performance against their personal goals and objectives. People actively seeking opportunities to enhance their competence, knowledge and experience. People freely sharing knowledge and experience. People openly discussing problems and issues.

Quality Management Principle No.4

Process Approach

A desired result is achieved more efficiently when activities and related resources are managed as a process. This principle is reflected in almost all clauses of ISO 9001

Process Approach...

Application of this principle involves:

Systematically defining the activities necessary to obtain a desired result. Establishing clear responsibility and accountability for managing key activities. Analyzing and measuring of the capability of key activities.

Process Approach...

Identifying the interfaces of key activities within and between the functions of the organization. Focusing on the factors - such as resources, methods, and materials - that will improve key activities of the organization. Evaluating risks, consequences and impacts of activities on customers, suppliers and other interested parties.

Quality Management Principle No.5

System approach to management

Identifying, understanding and managing inter-related processes as a system contributes to the organizations effectiveness and efficiency in achieving its objectives. This principle is reflected in ISO 9001:2008clauses 4.1& 4.2.

System approach to management...

Application of this principle involves: Structuring a system to achieve the organizations objectives in the most effective and efficient way. Understanding the inter-dependencies between the processes of the system. Structured approaches that harmonize and integrate processes.

System approach to management...

Proving a better understanding of the roles and responsibilities necessary for achieving common objectives and thereby reducing crossfunctional barriers. Understanding organizational capabilities and establishing resource constraints prior to action. Targeting and defining how specific activities within a system should operate. Continually improving the system through measurement and evaluation.

Quality Management Principle No.6

Continual Improvement

Continual improvement of the organizations overall performance should be a permanent objective of the organization. This principle is reflected in ISO 9001 clause 8.5.

Continual Improvement...

Application of this principle involves: Employing a consistent organization-wide approach to continual improvement of the organizations performance. Providing people with training in the methods and tools of continual improvement.

Continual Improvement...

Making continual improvement of products, processes and systems an objective for every individual in the organization. Establishing goals to guide, and measures to track, continual improvement. Recognizing and acknowledging improvements.

Quality Management Principle No.7

Factual approach to decision making

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

This principle is reflected in ISO 9001:2008 clauses 5.4.1, 5.6.2, 7.3 and 8.4

Factual approach to decision making

Application of this principle involves: Ensuring that data and information are sufficiently accurate and reliable. Making data accessible to those who need it. Analyzing data and information using valid methods. Making decisions and taking action based on actual analysis, balanced with experience and intuition

Quality Management Principle No.8

Mutually beneficial supplier relationships

An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value. This principle is reflected in ISO 9001:2008 clause 7.4

Mutually beneficial supplier relationships

Application of this principle involves: Establishing relationships that balance short-term gains with long-term considerations. Pooling of expertise and resources with partners. Identifying and selecting key suppliers. Clear and open communication.

Mutually beneficial supplier relationships

Sharing information and future plans. Establishing joint development and improvement activities. Inspiring, encouraging and recognizing improvements and achievements by suppliers.

ISO 9000 standards

Three important standards in the family of ISO 9000 International Standard are:

ISO 9000: Concepts, Principles, Fundamentals and Vocabulary ISO 9001: Sets the QMS Requirements to be met ISO 9004: Provides guidance for Continual improvement of organizations overall performance

ISO 9001:2008

Internationally accepted management standard that has become a world benchmark for good management practice Generic standard i.e. any industry sector viz. manufacturing or service (education, hospitals, hotels, banks, transport, accountancy, etc.) can use it. Any type (private, public, government enterprise, etc) and any size of enterprise can use it (big, small or tiny)

PDCA Methodology
Plan
Act

Do

check

Model of Process based Quality Management System Continual Improvement of the quality management system
R E Q U I R E M E N T S S A T I S F A C T I O N

C U S T O M E R

Management responsibility

Resource management

Measurement, analysis & improvement

Product realization

C U S T O M E R

Product

ISO 9001:2008
Quality Management System - Requirements 1.0 Scope 2.0 Normative References 3.0 Terms and Definitions 4.0 Quality Management System Requirements 5.0 Management Responsibility 6.0 Resource Management 7.0 Product Realization 8.0 Measurement, Analysis & Improvement

Quality Management System - 1 4.1 General Requirements a) Identification of the processes for the QMS b) Determine the sequence of these processes c) Determine criteria for effective operation & control of these processes d) Ensure the availability of resources e) Monitor, measure (where applicable) and analyze these processes f) Implement actions necessary for achieving planned results and continual improvement

Quality Management System - 2

4.2

Documentation Requirements - 1

4.2.1 General The QMS Documentation shall include: a) Quality Policy & Quality Objectives b) Quality Manual c) Documented procedures and records required by this Standard d) Documents needed for planning, operation and control of processes e) Records required by this Standard

Quality Management System - 3

4.2

Documentation Requirements - 2

4.2.2 Quality Manual a) Scope of QMS / Justification of the Exclusions b) Documented procedures or reference to them c) Description of interaction between the processes of the QMS

Quality Management System - 4

4.2

Documentation Requirements - 3

4.2.3 Control of documents Establish documented procedure to define method to: a) Approve documents b) Review, update and re-approve documents c) Identify the revision status / changes d) Ensure availability of relevant versions at point of use e) Ensure documents are legible and readily identifiable f) Identification and Control the external documents g) Identification and Control of obsolete documents

Quality Management System - 5

4.2

Documentation Requirements - 4

4.2.4 Control of records a) Establish / Maintain records to demonstrate conformity to this International Standard b) Keep records legible, readily identifiable and retrievable c) Establish documented procedure for identification, storage, protection, retrieval, specify retention time and their disposition

Documentation Requirements

Clause 4
Documents Quality manual Flow chart of major processes and their interaction Document control procedure Record control procedure. Description of out sourced services and their control procedure. Records Document updating records Disposal of quality records

Management Responsibility - 1 5.1 Management Commitment

a) Communication to the organization the importance of meeting customer, statutory and regularity requirements b) Establish Quality Policy & Quality Objectives c) Conducting Management Reviews d) Ensuring the availability of resources
5.2 Customer Focus Determine and meet the customer requirements for enhancing customer satisfaction

Management Responsibility - 2 5.3 Quality Policy a) Is appropriate to the purpose of the organization b) Includes a commitment to comply with and continually improve the QMS c) Provides framework of establishing and reviewing Quality Objectives d) Is communicated and understood within organization e) Is reviewed for continuing suitability

Management Responsibility - 3 5.4 Planning - 1

5.4.1 Quality Objectives a) Needed to meet the requirements of the product are established at relevant functions within the organization

b) Are measurable and consistent with the Quality Policy

Management Responsibility - 4 SMART Objectives

Specific Measurable Achievable Results orientated Time bound

Management Responsibility - 5 5.4 Planning - 2

5.4.2 Quality Management System Planning Top Management shall ensure that a) Planning is done for meeting the requirements of this standard (4.1) and Quality Objectives

b) Integrity of the QMS is maintained when changes to QMS are planned and implemented

Management Responsibility - 6
5.5 Responsibility, Authority and Communication - 1
5.5.1 Responsibility and Authority Are defined and communicated 5.5.2 Management Representative The Management Shall appoint a Management Representative responsible to : a) Ensure that processes for QMS are established, implemented and maintained b)
c)

Reporting to top management on performance of QMS and any need for improvement
Ensure the promotion of awareness of customer requirements throughout the organization

Management Responsibility - 7
5.5 Responsibility, Authority and Communication - 2

5.5.3 Internal Communication Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of quality management system.

Management Responsibility - 8 5.6 Management Review - 1 5.6.1 General The management shall review the QMS at planned intervals to ensure its continued suitability, adequacy and effectiveness The review shall include : a) Assessing opportunities for improvement and need for changes to the QMS b) Review of the Quality Policy and Quality Objectives Records of the reviews must be kept

Management Responsibility - 9 5.6 Management Review - 2 5.6.2 Review Inputs The Inputs shall include information on: a) Results of audits b) Customer feedback c) Process performance and product conformity d) Status of preventive and corrective action e) Follow-up actions from previous management review f) Changes which could affect the QMS g) Recommendations for improvement

Management Responsibility - 10 5.6 Management Review - 3

5.6.3 Review Outputs The Outputs shall include any decisions and actions on: a) Improvement of the effectiveness of quality management system and processes, b) Improvement of product related to customer requirements c) Resources needs

Documentation Requirements

Clause 5 Documents Quality objectives at organizational and functional level. Organization structure and responsibilities of management representative and key functionaries whose job affects product quality. Description of internal communication channel. ( This could be specified in quality manual) Procedure for management review Records Evidence of quality planning Record of management review

Resource Management - 1 6.1 Provision of Resources

The Organization shall determine and provide resources needed to : a) Implement and maintain the QMS and continually improve its effectiveness b) Enhance customer satisfaction by meeting customer requirements.

Resource Management - 2 6.2 Human Resources

6.2.1 General Competent persons should perform work effecting quality 6.2.2 Competence, awareness and training a) Determine the necessary competence for the personnel performing work effecting quality b) Provide training and take action to satisfy these needs c) Evaluate the effectiveness of the action taken d) Ensure that its personnel are aware of relevance and importance of their activities and how they contribute to the achievement of the quality objectives e) Maintain appropriate records of education, training, skills and experience

Resource Management - 3 6.3 Infrastructure

The organization shall determine, provide and maintain the infrastructure needed to achieve product conformity, it includes: a) Building, workplace and associated utilities b) Process equipment (both hardware and software) c) Supporting services(such as transport or communication)

Resource Management - 4 6.4 Work Environment

The organization shall determine and manage the work environment needed to achieve conformity to product requirements

Documentation Requirements

Clause 6 Documents Specific requirement of qualification and competence of personnel Procedure for identifying training needs and yearly training plan List of special facilities or work environments affecting quality Procedure for maintenance of buildings equipment and facilities Record Record of training and experience of personnel Maintenance record

Product Realization - 1

7.1

Planning of Product Realization

Organization shall plan and develop the processes needed for product realization, while considering the Following factors as appropriate: a) Quality objective and requirements for the product b) Need to establish processes, documents, and provide resources specific to the product c) Required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance d) Records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4)

Product Realization - 2

7.2

Customer Related Processes - 1

7.2.1 Determination of requirements related to the product

The organization shall determine: a) Requirements specified by customer including (delivery conditions & post Delivery activities) b) Requirements not stated but necessary for the intended use, where known c) Statutory & regulatory requirements related to product d) Any additional requirement determined by the organization

Product Realization - 3

7.2

Customer Related Processes - 2

7.2.2 Review of Requirements Related to the Product Review following before the acceptance of contract : a) b) c) Product requirements are defined Contract or order requirements differing from those previously expressed are resolved The organization has the ability to meet the defined requirements.

Results of the reviews must be maintained Any change in requirements is communicated to all

Product Realization - 4

7.2

Customer Related Processes - 3

7.2.2 Customer Communication

The organization shall define and implement Effective arrangements for communicating with customers in relation to : a) Product information b) Enquiries, contracts or order handling, including amendments, and c) Customer feedback, including customer complaints

Product Realization - 5

7.3

Design and Development - 1

7.3.1 Design and Development Planning

Organization shall determine the a) Design and development stages, b) Review, verification and validation that are appropriate to each design and development stage, and c) Responsibilities and authorities for design and development Planning output shall be updated, as appropriate, as the design and development progresses

Product Realization - 6 7.3 Design and Development - 2

7.3.2 Design and Development Inputs Inputs related to product requirements including following shall be determined, a) Functional and performance requirements, b) Applicable statutory and regulatory requirements, c) Where applicable, information derived from previous similar design, and d) Other requirements essential for design and development

The requirements must be complete, unambiguous and not in conflict in each other
The requirements must be reviewed for adequacy and records must be maintained

Product Realization - 7

7.3

Design and Development - 3

7.3.3 Design and Development Outputs The design and development outputs shall: a) Meet the input requirements for design and development b) Provide appropriate information for purchasing, production and for services provision c) Contain or reference product acceptance criteria d) Specify the characteristics of the product that are essential for its safe and proper use

Product Realization - 8

7.3

Design and Development - 4

7.3.4 Design and Development Review Reviews by representatives of the functions concerned shall be performed in accordance with planned arrangements (see 7.3.1) to : a) Evaluate the ability of the results of design and development to meet requirements, and

b) Identify any problems and propose necessary actions. Records of reviews and any necessary actions shall be maintained

Product Realization - 9 7.3 Design and Development - 5

7.3.5 Design and development verification Verification shall be performed in accordance with planned arrangements (7.3.1) to ensure that design and development outputs have met the design and development input requirements. Records of the results and any actions shall be maintained.

Product Realization - 10 7.3 Design and Development - 6 Validation shall be performed in accordance with planned arrangements (7.3.1) to ensure that Resulting product is capable of meeting requirements for intended use, where known. Where practicable, validation shall be completed prior to the delivery or implementation of the product Records of the results and any actions shall be maintained.

7.3.6 Design and development validation

Product Realization - 11 7.3 Design and Development - 7

7.3.7 Control of design and development changes

The changes will be reviewed, verified and validated as appropriate and approved before implementation. The review for change shall include evaluation of the effects of the change on constituent parts and product already delivered. Records of the changes and any actions shall be maintained.

Product Realization - 12

7.4

Purchasing - 1

7.4.1 Purchasing Process The organization shall ensure that purchased product conforms to specified purchase requirements

The type and extent of control applied shall be dependent upon the effect on the final product

Product Realization - 13

7.4

Purchasing - 2

7.4.2 Purchasing Information Purchasing information shall describe the purchased product, including where appropriate: a) Requirement for approval of product, procedures, process and equipment Quality management system requirements

b) Requirement for qualification of personnel c)

Product Realization - 14

7.4

Purchasing - 3

7.4.3 Verification of the Purchased Product Establish and implement the inspection activities necessary for ensuring conformance of purchased product to purchase information. Where verification at the suppliers premises is required by organization / customer, it shall be indicated so in the purchase information.

Product Realization - 15

7.5

Production and Service Provision - 1

7.5.1Control of Production and Service Provision Production and service provision shall be carried out under controlled conditions, as applicable: a) Availability of information that describes the characteristics of the product, b) Availability of work instructions, as necessary, c) Use of suitable equipment, d) Availability and use of monitoring and measuring devices, e) Implementation of monitoring and measurement, and f) Implementation of release, delivery and post-delivery activities.

Product Realization - 16

7.5

Production and Service Provision - 2

7.5.2Validation of processes for production and service provision Validation of process shall be done where the resulting output cannot be verified by subsequent monitoring or measurement, the following shall be addressed: a) Defined criteria for review and approval of the processes b) Approval of equipment and qualification of personnel c) Use of specific methods and procedures d) Requirements for records e) Revalidation

Product Realization - 17 7.5 Production and Service Provision - 3

7.5.3Identification and Traceability

Identification of product by suitable means throughout product realization Identification of the product status with respect to the monitoring and measurement requirements Where traceability is required the organization shall control and record the unique identification of the product

Product Realization - 18

7.5

Production and Service Provision - 4

7.5.4Customer Property

The organization shall a) Identify, verify, protect customer property and safeguard

b) In case of loss, damage or unsuitable for use customer must be informed

c) Records must be maintained

Product Realization - 19

7.5

Production and Service Provision - 5

The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packing, storage and protection. Preservation shall also apply to the constituent parts of product

7.5.5Preservation of Product

Product Realization - 20
7.6 Control of Monitoring and Measuring Equipments
The equipments Shall be: a) Calibrated or verified at specific intervals, or prior to use, against measurement standards traceable to international or national measurement standards, where no such standards exist, the basis used for calibration or verification shall be recorded

b) Adjusted or re-adjusted as necessary

c) Identified to enable the calibration status to be determined d) Safeguarded from adjustments that would invalidate the measurement result e) Protected from damage and deterioration during handling, maintenance and storage f) Records shall be maintained

Documentation Requirements Clause 7 Documents Quality plan or other documents showing how quality is planned in products/projects Method of capturing customer requirements Review of orders or contracts to assess capability to meet customers requirements Specifications for companys products Procedure for design and development Specifications for purchased materials

Documentation Requirements Clause 7 contnd.. Documents Procedure for selection and approval of suppliers Procedure for review of suppliers performance Procedure for verification of purchased products and dealing with non conforming supplies. Procedures or work instruction for critical processes. Procedure for assessing process capability and approval of processes. Qualification of operators and processes where quality cannot be verified after work is finished.

Documentation Requirements Clause 7 contd Documents Procedure for maintenance of critical equipment. Procedure for identification and traceability of materials (where required). Inspection and testing plans/instructions. Procedure for showing inspection/test status of materials/equipment. Procedure for calibration measuring devices. Procedure for handling customer property. Procedure for preservation, packaging and storage of product.

Documentation Requirements Clause 7 Records Contract review of major contracts Design review record Results of design verification/validation Inspection results of purchased materials. Record of qualification of operators and processes where output cannot be assessed for non conformity. Inspection and testing records Record of rework and rejection Calibration record of measuring devices. Record of damaged or lost customer property (where applicable).

Measurement, Analysis and Improvement - 1

8.1

General

Organization must plan and implement the monitoring measurement, analysis and improvement processes needed to : a) Demonstrate conformity of the product b) Ensure conformity of the QMS c) Continually improve the effectiveness of QMS

Determine applicable method including Statistical Techniques and extent of their use

Measurement, Analysis and Improvement - 2

8.2

Monitoring & Measurement - 1

8.2.1 Customer Satisfaction

Establish a method for obtaining and using the information about customer perception as to whether the organization has met customer requirements

Measurement, Analysis and Improvement - 3 8.2 Monitoring & Measurement - 2

8.2.2 Internal Audit Documented procedures Shall be established and internal audits shall be conducted at regular intervals to determine whether the QMS : a) Conforms to standard and other requirements determined by organization b) Is effectively implemented and maintained Audit shall be: 1. Planned, Criteria / Scope / Frequency and method be defined. 2. Selection / conduct of audit shall ensure impartiality 3. Follow-up activities shall be performed 4. Records shall be maintained

Measurement, Analysis and Improvement - 4

8.2

Monitoring & Measurement - 3

Apply methods for monitoring and where applicable measurement of QMS processes. Methods shall demonstrate the ability of the processes to achieve the planned results. In case planned results are not obtained Corrective / Preventive actions must be taken to ensure the conformity to the product.

8.2.3 Monitoring and measurement of processes

Measurement, Analysis and Improvement - 5

8.2
8.2.4

Monitoring & Measurement - 4

Monitoring and measurement of product

Monitor the characteristics of the product at appropriate stages in accordance with planned arrangements (see 7.1) Evidence of conformity and acceptance criteria must be defined. No product or service delivery shall not proceed until the planed arrangement are satisfactorily completed and approved by authorized person. Records shall also be maintained.

Measurement, Analysis and Improvement - 6

8.3 Control of Nonconforming Product - 1

The nonconforming products must be identified and controlled to prevent unintended use or delivery. Documented procedure stating responsibility and authority to deal with nonconforming products shall be defined.

Measurement, Analysis and Improvement - 7

8.3 Control of Nonconforming Product - 2

The organization shall deal with nonconforming products by : a) Taking action to eliminate the detected non conformity b) Authorizing its use, release / acceptance under concession by relevant authority if allowed by customer. c) Take action to prevent its original intended use Records and actions taken shall be recorded. Incase of rework product shall be re-verified Incase the product has been delivered appropriate actions shall be taken

Measurement, Analysis and Improvement - 8 8.4 Analysis of Data

a) b) c)

d)

Determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the QMS can be made. Analysis of data shall provide information relating to: Customer Satisfaction (see 8.2.1) Conformity of product requirements (see 7.2.1) Characteristics and trends of processes and and products including opportunities of Corrective action Suppliers

Measurement, Analysis and Improvement - 9

8.5

Improvement - 1

8.5.1 Continual Improvement

The organization shall continually improve the effectiveness of QMS through the use of : Quality Policy Quality Objectives, Audit Results Analysis of data, Corrective and Preventive Actions Management Review

Measurement, Analysis and Improvement - 10

8.5

Improvement - 2

8.5.2 Corrective Action

Corrective actions shall be taken to eliminate causes of nonconformities to prevent their recurrence. Documented procedure shall be established to define requirements for: a) Reviewing nonconformities (including customer complaints) b) Determining the causes of nonconformities c) Evaluating the need for action to ensure that nonconformities do not recur

Measurement, Analysis and Improvement - 11

8.5

Improvement - 3

d) Determining and implementing action needed

e) Records of the action taken results f) Reviewing corrective action taken

Measurement, Analysis and Improvement - 12 8.5 Improvement - 4

8.5.3 Preventive Action

Preventive actions shall be taken to eliminate causes of potential nonconformities to prevent their occurrence. Documented procedure shall be established to define requirements for: a) Determining potential nonconformities and their causes b) Evaluating the need for action to prevent occurrence of nonconformities c) Determining and implementing action needed

Measurement, Analysis and Improvement - 13 8.5 Improvement - 5

d) Records of results action taken

e) Reviewing preventive action taken

Documentation Requirements Clause 8 Documents Procedure for measurement and monitoring of processes for effective control. Methods for use of statistical techniques for process control and data analysis for improvement. Procedure for inspection and release of final product. Procedure for dealing with non conforming product and use of material under concession. Procedure for monitoring customer satisfaction and dealing with customer complaints.

Documentation Requirements Clause 8 contnd.. Documents Procedure of internal audit of QMS, along with check list. Procedure for corrective and preventive action. Procedure for collection and analysis of data for effectiveness and improvement of QMS. Records Process monitoring data and corrective action taken for process control Record of product non conformities and products accepted on concession.

Documentation Requirements Clause 8 contnd.. Records Data analysis and activities for continual improvement. Result of internal audits and follow up action. Data on customer feedback and action taken on customer complaints.

No body
Can Achieve

QUALITY
Without

Thank you !!!