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 ³General 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) 


Introduction to Quality and Standardization .

What is Quality after all? .

ISO 9000:2000    .Quality«!  µFitness for use¶ ± Juran µConformance to requirements¶ ± Crosby µCustomer satisfaction/delight¶ ± Deming µDegree to which a set of inherent characteristics fulfils requirements¶ .

Delight .Dissatisfaction = 1 .Satisfaction > 1 .Customer Satisfaction ³ Degree to which the customer¶s requirements have been fulfilled ´ Performance Satisfaction = Expectation < 1 .

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 .

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.

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 ³Pakistan 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 für Normung European Norms International Electrotechnical Commission British Standards Institute .

Systems or Product Standards).Certification 1. 2. May be general in the scope of recognition Considers total business . Means Compliance with a standard or specification (e. 3. .g.

Its scope is highly specific.Accreditation 1. 2. Evaluates people. It means recognition of competence in a specific area and scope. skills and knowledge. 3. . specific.

Evolution of Quality Management System ± ISO 9001:2008
1987 1994 2000 2008 First Published ± ISO 9001, 9002 & 9003 First revision ± ISO 9001, 9002 & 9003 Second revision - ISO 9001 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

2. should meet customer requirements and strive to exceed customer expectations. 7. Application of this principle is reflected in ISO 9001:2008 clauses 5.Quality Management Principle No.3 and 8.1 .2.1 Customer Focus  Organizations depend on their customers and therefore should understand current and future customer needs.2.

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

5.Quality Management Principle No.3. 5. 5. This principle is reflected in ISO 9001:2008 clauses 5. 6.1.2 .2 Leadership  Leaders establish unity of purpose and direction of the organization. 6.4. They should create and maintain the internal environment in which people can become fully involved in achieving the organization¶s objectives.

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

This principle is benefit. 9001: .3(d) and 6.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 organization¶s benefit. reflected in ISO 9001:2008 clauses 5.2.

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

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

This principle is reflected in almost all clauses of ISO 9001 . process.Quality Management Principle No.4 Process Approach A desired result is achieved more efficiently when activities and related resources are managed as a process.

Process Approach.. Application of this principle involves: involves: Systematically defining the activities necessary to obtain a desired result. activities. activities.  Establishing clear responsibility and accountability for managing key activities.  Analyzing and measuring of the capability of key activities. result..  .

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

2.1& 4.5 System approach to management Identifying. 9001:2008clauses . This principle is reflected in objectives.Quality Management Principle No. understanding and managing inter-related interprocesses as a system contributes to the organization¶s effectiveness and efficiency in achieving its objectives. ISO 9001:2008clauses 4.

 Understanding the inter-dependencies between the interprocesses of the system.  Structured approaches that harmonize and integrate processes. . system.. way.System approach to management. processes. Application of this principle involves: involves:  Structuring a system to achieve the organization¶s objectives in the most effective and efficient way..

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

.6 Continual Improvement Continual improvement of the organization¶s overall performance should be a permanent objective of the organization.Quality Management Principle No.5. organization. This principle is reflected in ISO 9001 clause 8.

Continual Improvement. . performance...  Providing people with training in the methods and tools of continual improvement. improvement. Application of this principle involves: involves:  Employing a consistent organization-wide approach organizationto continual improvement of the organization¶s performance.

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

4 . This principle is reflected in ISO 9001:2008 clauses 5. 5. and 8.6.7 Factual approach to decision making Effective decisions are based on the analysis of data and information.Quality Management Principle No.1.

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

Quality Management Principle No. This principle is reflected in ISO 9001:2008 9001: clause 7.8 Mutually beneficial supplier relationships An organization and its suppliers are interinterdependent and a mutually beneficial relationship enhances the ability of both to create value. value.4 .

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

 .  Establishing joint development and improvement activities. encouraging and recognizing improvements and achievements by suppliers.Mutually beneficial supplier relationships Sharing information and future plans.  Inspiring. suppliers. activities. plans.

Fundamentals and Vocabulary ISO 9001: Sets the QMS Requirements to be met ISO 9004: Provides guidance for Continual improvement of organization¶s overall performance   .ISO 9000 standards Three important standards in the family of ISO 9000 International Standard are: are:  ISO 9000: Concepts. Principles.

hotels. government enterprise. any industry sector viz. public. accountancy. etc) and any size of enterprise can use it (big.) can use it. banks. manufacturing or service (education. transport. small or tiny)   . hospitals. Any type (private. etc.ISO 9001:2008  Internationally accepted management standard that has become a world benchmark for good management practice Generic standard i.e.

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 .

0 Quality Management System Requirements 5.0 Product Realization 8.ISO 9001:2008 Quality Management System .0 Scope 2.0 Terms and Definitions 4.0 Management Responsibility 6.0 Resource Management 7.Requirements 1.0 Measurement. Analysis & Improvement .0 Normative References 3.

Quality Management System .1 4. measure (where applicable) and analyze these processes f) Implement actions necessary for achieving planned results and continual improvement .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.

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.2 4.2 Documentation Requirements . operation and control of processes e) Records required by this Standard .2.1 4.Quality Management System .

2.2 Documentation Requirements .3 4.2 4.Quality Management System .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 .

2.4 4.2 Documentation Requirements . update and re-approve documents rec) 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 .3 Control of documents Establish documented procedure to define method to: a) Approve documents b) Review.3 4.Quality Management System .

protection.2. specify retention time and their disposition .5 4.Quality Management System . storage.4 4. retrieval.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.2 Documentation Requirements .

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 .

1 5.Management Responsibility . statutory and regularity requirements b) Establish Quality Policy & Quality Objectives c) Conducting Management Reviews d) Ensuring the availability of resources 5.1 Management Commitment a) Communication to the organization the importance of meeting customer.2 Customer Focus Determine and meet the customer requirements for enhancing customer satisfaction .

2 5.Management Responsibility .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 .

4 Planning .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 .1 5.Management Responsibility .3 5.

4 SMART Objectives Specific Measurable Achievable Results orientated Time bound .Management Responsibility .

4 Planning .4.2 5.Management Responsibility .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 .5 5.

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 .2 Management Representative The Management Shall appoint a Management Representative responsible to : a) Ensure that processes for QMS are established.Management Responsibility .6 5.1 5.1 Responsibility and Authority Are defined and communicated 5.5.5 Responsibility. Authority and Communication .5.

7 5.5. Authority and Communication .2 5. .5 Responsibility.Management Responsibility .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.

8 5.1 General The management shall review the QMS at planned intervals to ensure it¶s continued suitability.6 Management Review . 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 .1 5.6.Management Responsibility .

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 .2 5.Management Responsibility .9 5.6 Management Review .

b) Improvement of product related to customer requirements c) Resources needs .3 Review Outputs The Outputs shall include any decisions and actions on: a) Improvement of the effectiveness of quality management system and processes.6 Management Review .3 5.10 5.6.Management Responsibility .

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

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. .

skills and experience .1 General Competent persons should perform work effecting quality 6.2. 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.2.2 Human Resources 6.Resource Management . training.2 Competence.2 6.

Resource Management . workplace and associated utilities b) Process equipment (both hardware and software) c) Supporting services(such as transport or communication) . provide and maintain the infrastructure needed to achieve product conformity.3 6. it includes: a) Building.3 Infrastructure The organization shall determine.

4 6.4 Work Environment The organization shall determine and manage the work environment needed to achieve conformity to product requirements .Resource Management .

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 .

documents. 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 4.4) . while considering the Following factors as appropriate: a) Quality objective and requirements for the product b) Need to establish processes.1 Planning of Product Realization Organization shall plan and develop the processes needed for product realization.2. monitoring. validation.1 7. and provide resources specific to the product c) Required verification.Product Realization .

2 Customer Related Processes .2.1 7. where known c) Statutory & regulatory requirements related to product d) Any additional requirement determined by the organization .2 7.Product Realization .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.

3 7.2 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.Product Realization .2 Customer Related Processes .2 7.2. Results of the reviews must be maintained Any change in requirements is communicated to all .

2 Customer Communication The organization shall define and implement Effective arrangements for communicating with customers in relation to : a) Product information b) Enquiries. including amendments. including customer complaints .Product Realization .4 7.2.3 7.2 Customer Related Processes . and c) Customer feedback. contracts or order handling.

1 Design and Development Planning Organization shall determine the a) Design and development stages. b) Review. as appropriate.3.5 7.1 7.Product Realization .3 Design and Development . and c) Responsibilities and authorities for design and development Planning output shall be updated. verification and validation that are appropriate to each design and development stage. as the design and development progresses .

Product Realization . and d) Other requirements essential for design and development The requirements must be complete.2 Design and Development Inputs Inputs related to product requirements including following shall be determined.3 Design and Development . b) Applicable statutory and regulatory requirements. unambiguous and not in conflict in each other The requirements must be reviewed for adequacy and records must be maintained .6 7.2 7. c) Where applicable. information derived from previous similar design.3. a) Functional and performance requirements.

3 7. 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 .3 Design and Development .Product Realization .3.7 7.3 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.

Product Realization .3 Design and Development .4 7.1) to : a) Evaluate the ability of the results of design and development to meet requirements. and b) Identify any problems and propose necessary actions.3.4 Design and Development Review Reviews by representatives of the functions concerned shall be performed in accordance with planned arrangements (see 7.8 7. Records of reviews and any necessary actions shall be maintained .3.

3 Design and Development .3.5 Design and development verification Verification shall be performed in accordance with planned arrangements (7.1) to ensure that design and development outputs have met the design and development input requirements.9 7. .Product Realization .3. Records of the results and any actions shall be maintained.5 7.

Where practicable.6 Design and development validation . where known.3. 7.Product Realization .10 7.6 Validation shall be performed in accordance with planned arrangements (7.3. validation shall be completed prior to the delivery or implementation of the product Records of the results and any actions shall be maintained.1) to ensure that Resulting product is capable of meeting requirements for intended use.3 Design and Development .

. The review for change shall include evaluation of the effects of the change on constituent parts and product already delivered.Product Realization .7 Control of design and development changes The changes will be reviewed.7 7.3 Design and Development . verified and validated as appropriate and approved before implementation.11 7.3. Records of the changes and any actions shall be maintained.

4 Purchasing .12 7.1 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 .4.1 7.Product Realization .

2 Purchasing Information Purchasing information shall describe the purchased product.Product Realization .13 7. procedures. including where appropriate: a) Requirement for approval of product.4.2 7.4 Purchasing . process and equipment Quality management system requirements b) Requirement for qualification of personnel c) .

it shall be indicated so in the purchase information. Where verification at the supplier¶s premises is required by organization / customer.4.4 Purchasing .14 7.3 7.3 Verification of the Purchased Product Establish and implement the inspection activities necessary for ensuring conformance of purchased product to purchase information. .Product Realization .

Product Realization . e) Implementation of monitoring and measurement. d) Availability and use of monitoring and measuring devices. as applicable: a) Availability of information that describes the characteristics of the product.1Control of Production and Service Provision Production and service provision shall be carried out under controlled conditions.5 Production and Service Provision .5. delivery and post-delivery activities. c) Use of suitable equipment. .1 7. as necessary.15 7. b) Availability of work instructions. and f) Implementation of release.

Product Realization .5.5 Production and Service Provision .16 7.2Validation 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 .2 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 .3 7.5 Production and Service Provision .17 7.Product Realization .

5 Production and Service Provision .Product Realization . verify. damage or unsuitable for use customer must be informed c) Records must be maintained .4 7.5. protect customer property and safeguard b) In case of loss.18 7.4Customer Property The organization shall a) Identify.

5 Production and Service Provision .19 7. This preservation shall include identification.5Preservation of Product .5.5 The organization shall preserve the conformity of product during internal processing and delivery to the intended destination.Product Realization . handling. Preservation shall also apply to the constituent parts of product 7. storage and protection. packing.

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.Product Realization . where no such standards exist. maintenance and storage f) Records shall be maintained .6 Control of Monitoring and Measuring Equipments The equipments Shall be: a) Calibrated or verified at specific intervals. against measurement standards traceable to international or national measurement standards.20 7. or prior to use.

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 customer¶s requirements Specifications for company¶s products Procedure for design and development Specifications for purchased materials .

. 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 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.

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

Inspection and testing records Record of rework and rejection Calibration record of measuring devices.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 damaged or lost customer property (where applicable). Record of qualification of operators and processes where output cannot be assessed for non conformity. .

Measurement. Analysis and Improvement . 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 .1 8.1 General Organization must plan and implement the monitoring measurement.

2 Monitoring & Measurement .1 8.2.Measurement.2 8. Analysis and Improvement .1 Customer Satisfaction Establish a method for obtaining and using the information about customer perception as to whether the organization has met customer requirements .

2 8.2. Planned. 2. Records shall be maintained . Follow-up activities shall be performed 4.Measurement. Selection / conduct of audit shall ensure impartiality 3. Analysis and Improvement .3 8.2 Monitoring & Measurement . Criteria / Scope / Frequency and method be defined.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.

2 Monitoring & Measurement . In case planned results are not obtained Corrective / Preventive actions must be taken to ensure the conformity to the product. Methods shall demonstrate the ability of the processes to achieve the planned results. 8.3 Monitoring and measurement of processes .4 8.3 Apply methods for monitoring and where applicable measurement of QMS processes. Analysis and Improvement .2.Measurement.

1) Evidence of conformity and acceptance criteria must be defined. Analysis and Improvement .2. .Measurement.2 8. No product or service delivery shall not proceed until the planed arrangement are satisfactorily completed and approved by authorized person.4 Monitoring & Measurement . Records shall also be maintained.4 Monitoring and measurement of product Monitor the characteristics of the product at appropriate stages in accordance with planned arrangements (see 7.5 8.

Analysis and Improvement . Documented procedure stating responsibility and authority to deal with nonconforming products shall be defined.Measurement.1 The nonconforming products must be identified and controlled to prevent unintended use or delivery.3 Control of Nonconforming Product .6 8. .

2 The organization shall deal with nonconforming products by : a) Taking action to eliminate the detected non conformity b) Authorizing its use. Incase of rework product shall be re-verified Incase the product has been delivered appropriate actions shall be taken . c) Take action to prevent its original intended use Records and actions taken shall be recorded. Analysis and Improvement .7 8.Measurement. release / acceptance under concession by relevant authority if allowed by customer.3 Control of Nonconforming Product .

Analysis of data shall provide information relating to: Customer Satisfaction (see 8.1) Conformity of product requirements (see 7.4 Analysis of Data a) b) c) d) Determine.2.Measurement.1) Characteristics and trends of processes and and products including opportunities of Corrective action Suppliers .2. Analysis and Improvement . 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.8 8.

9 8. Corrective and Preventive Actions Management Review .1 Continual Improvement The organization shall continually improve the effectiveness of QMS through the use of : Quality Policy Quality Objectives.1 8.Measurement.5. Audit Results Analysis of data. Analysis and Improvement .5 Improvement .

2 8. Analysis and Improvement .10 8.5. 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.2 Corrective Action Corrective actions shall be taken to eliminate causes of nonconformities to prevent their recurrence.5 Improvement .

11 8.Measurement.5 Improvement .3 d) Determining and implementing action needed e) Records of the action taken results f) Reviewing corrective action taken . Analysis and Improvement .

4 8.3 Preventive Action Preventive actions shall be taken to eliminate causes of potential nonconformities to prevent their occurrence.5.12 8.5 Improvement .Measurement. Analysis and Improvement . 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.5 d) Records of results action taken e) Reviewing preventive action taken .13 8.5 Improvement . Analysis and Improvement .

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

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

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

No body Can Achieve QUALITY Without U .

Thank you !!! .

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