THE ISO 9000 STANDARDS

MUHAMMAD USMAN ZUBAIR 2010-ME-29

MARCH 20, 2013

DEPARTMENT OF MECHAINCAL ENGINEERING, UCE&T

THE ISO 9000 STANDARDS

First issued in 1987 and then revised in 1994. The ISO standard (Quality Management & Quality assurance standards). The ISO standard 9000 has permanently influenced the way manufacturing companies conduct business in world trade and was become the world standard for quality .

ISO 9000: In Depth:

ISO is not an acronym ISO is a name used for International organization for standardization The ISO was formed in 1947 in Geneva, Switzerland ISO 9000 is a European Standard

The organization has two stated objectives:

1. To promote development of standardization to facilitate International exchange of goals and services. 2. To promote cooperation in intellectual, scientific, technological and economic activity.

Parts of ISO 9000?

ISO 9000 is composed of 5 different but related parts: ISO 9000, 9001, 9002, 9003, 9004 ISO 9000 and 9004 are guidelines, while ISO 9001, 9002 and 9003 are the categories in which a company may apply for certification.

The ISO 9000 series includes the following standards. ISO 9001:
Quality system Model for quality assurance in Design / Development, production, Installation & Servicing.

ISO 9002:
Quality system Model for quality assurance in production & Installation.

ISO 9003:
Quality system Model for quality assurance in final inspection & test.

ISO 9004:
Quality management & Quality system elements guidelines. Depending on the extent to & company fails to meet the requirements of the standard registration may or may not recommended at that time. The audit team does not advice or consults with the company on how to fix the discrepancies but merely describe the nature of non-compliance.

Periodic Audits Are Required To Maintain Certification:

The certification process can take from six months to a year or more, & can cost tens of thousands of dollars; Cost depends on the companys size, number of plants & product line. Registration may be sought generally for ISO 9001 or ISO 9002 and some companies have registration up to ISO 9003. The ISO 9004 standard is simply and guideline and model or basis for registration. For certification a companys plants are visited and audited by accredit and independent third party teams to certify that the standards 20 key elements are in place and functioning properly.

Six Essential Elements of a Successful Registration Effort:

1. 2. 3. 4. 5. 6. Senior Management Commitment to the Effort Appropriate ISO 9000 Training An Effective Management Review Process Documentation of the Quality System An Effective Internal Auditing System An Effective Corrective Action Process

ISO 9001:2000 Breakdown

Introduction
a) Process Approach: This standard promotes a process approach for development, implementation, and improving system effectiveness, as well as enhancing customer satisfaction by meeting customer requirements Emphasizes the importance of Understanding and meeting of the requirements The need to consider processes in terms of added value b) ISO 9001 and ISO 9004 have been developed as a consistent pair designed to complement one another, but can be used independently; different scopes, but similar structure

1. SCOPE:
A. General B. Application All requirements of ISO 9001 are considered generic and are intended to be applicable to all organization, regardless of type, size and product

2. Normative Reference
a) Reference standard b) ISO 9000: 2005 Quality Management Systems- Fundamentals and vocabulary. c) 2008 version is not available. d) ISO 9004: 2005 (2008 is not available)

3. Terms & Definitions

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a) Terms and definitions are to be reviewed b) The terms to describe the supply chain: c) 2000 Standard: d) SUPPLIER ORGANIZATION CUSTOMER e) (Interested Parties) f) 1994 Standard: g) SUBCONTRACTOR SUPPLIER CUSTOMER h) Wherever the term product occurs, it can also mean service.

4. Quality Management System

a) General requirements Organization establishes, documents, implements, maintains, and continually improves QMS The organization shall; determine the processes needed and their application throughout the organization Determine the sequence and interaction of processes

b) Documentation requirement i. General requirement QMS documentation shall include; Quality Policy and Quality Objectives Quality Manual ii. Quality manual The Quality Manual shall be established and maintained, including The scope of QMS, with details of and justifications for any exclusions Control of documents Documented procedures shall be established to define the controls needed for the: Approval for adequacy prior to issue, Review, update and re-approve documents, Control of quality records Records shall remain legible, readily identifiable, and retrievable Records shall be established to define the controls needed for the:

iii.

iv.

Identification, Storage,

5. Management Responsibility
a) Management commitment Top Management shall provide evidence of its commitment to the development and implementation of the QMS and continually improving its effectiveness by; Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, Establishing the Quality Policy, b) Customer focus Top management shall ensure customer needs and expectations are determined and met with the aim of enhancing customer satisfaction c) Quality policy Top management shall ensure that the Quality Policy: Is appropriate to the purpose of the organization, Includes commitment to comply with requirements and continually improve the effectiveness of the QMS, d) Planning i. Quality objectives Top management shall ensure that quality objectives, including those needed to meet requirements for product are established at relevant functions and levels within the organization. These quality objectives shall be measurable and consistent with the Quality Policy. ii. Quality management system planning Top Management shall ensure that the planning for the QMS is carried out to meet the requirement

e) Responsibility, authority & communication i. Responsibility and authority Top management shall ensure that the responsibilities and authorities are defined and communicated within the organization. ii. Management representative
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Top management appoints a member of the organizations management who shall have responsibility & authority that includes: Ensuring processes for QMS are established, implemented and maintained,

iii.

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

f) Management Review Top management shall review the organizations QMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness Management Review shall include assessing opportunities for improvement and the need for changes to the QMS, including the Quality Policy and Quality Objectives. g) Review input Includes audit results, customer feedback,

h) Review output The output from the Management Review shall include any decisions and actions related to: Improvement of the effectiveness of the QMS and its processes, Improvement of product related to customer requirements, and

6. Resource Management
a) Provision of resources The organization shall determine and provide the resources needed to: implement, maintain and continually improve the effectiveness of the quality management system

b) Human resources
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i.

General Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience Competence, awareness & training The organization shall: determine the necessary competence for personnel performing work affecting product quality, where applicable provide training or take other actions to achieve the necessary competence Infrastructure The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable; Buildings, workspace and associated utilities Process equipment (both hardware and software), and

ii.

iii.

iv.

Work environment Determine and manage the work environment needed to achieve conformity to product requirements

7. Product Realization
a) Planning of product realization The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the QMS In planning product realization, the organization shall determine the following, as appropriate: Quality objectives and requirements for the product; The need to establish processes and documents and to provide resources specific to the product.

b) Determination of requirements related to the product

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i.

Review of requirement related to the product Organization shall review the requirements related to the product. This review shall be conducted prior to the organizations commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that: Product requirements are defined, Contract or order requirements differing from those previously expressed are resolved, and

ii.

Customer communication Determine and implement effective arrangements for customer communication in relation to: Product information Enquiries, contracts or order handling (including amendments)

c) Design & development i. Design & development planning During the design and development planning, the organization shall determine The design and development stages, The review, verification and validation that are appropriate to each design and development stage, and ii. Design & development input Inputs relating to product requirements shall be determined and records maintained. These inputs shall include: iii. Functional and performance requirements, Applicable statutory and regulatory requirements,

Design & development review At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements Evaluate the ability of results of design and development to meet requirements, and Identify any problems and propose necessary actions

iv.

Design & development verification Verification shall be performed in accordance with planned arrangements to ensure design and development outputs have satisfied the design and development input requirements

v.

Design & development validation control of design & development changes Design and development validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting requirements for the specified application or intended use where known.

8. Purchasing
a) Purchasing process Suppliers shall be evaluated and selected based on their ability to supply to the organizations requirements; Criteria for selection, evaluation and re-evaluation must be established Records of this evaluation shall be maintained b) Purchasing information Information shall describe the product to be purchased including (as appropriate): Approval requirements for product, procedures, processes, equipment Qualification requirements of personnel

c) Verification of purchased product The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. d) Production & service provision i. Control of production & service provision Provisions for production and service shall be carried out under controlled conditions including: ii. Availability of information describing product characteristics Availability of work instructions as necessary

Validation of processing for product & service provision

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Demonstrate that the processes have the ability to achieve the desired results Establish arrangements for these processes including: Defined criteria for review and approval of processes Equipment approval and personnel qualification

iii.

Identification & traceability Where appropriate, the organization shall identify product by suitable means throughout product realization The organization shall identify product status with respect to monitoring and measuring requirements

iv.

Customer property Exercise care and identify, verify, protect and safeguard customer property for use or incorporation into product while under control of organization

v.

Preservation of product The organization shall preserve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation shall include identification, handling, storage and protection. Preservation shall also apply to the constituent parts of a product.

e) Control of monitoring & measuring devices The organization shall determine the monitoring and measurement to be taken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements

9. Measurement Analysis and Improvement

a) General Processes for monitoring, measurement, analysis and improvement shall be planned and implemented to: Demonstrate conformity to product requirements Ensure conformity of QMS b) Monitoring
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i.

ii.

Customer satisfaction As one of the measurements of the performance of the QMS, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined Internal audit The organization shall conduct internal audits at planned intervals to determine whether the QMS Conforms to the planned arrangements to the requirements of ISO9001 and to the QMS requirements of the organization, and

iii.

Monitoring & measurement of process The organization shall apply suitable methods for monitoring and, where applicable, measurement of the QMS processes. These methods shall demonstrate the ability of the processes to achieve planned results.

iv.

Monitoring & measurement of product The organization shall monitor and measure characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with planned arrangements. Evidence of conformity with acceptance criteria shall be maintained.

c)

Control of nonconforming product The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery Where applicable the organization shall deal with Nonconforming by one or more of the following ways: Taking action to eliminate the detected nonconformity; Authorizing use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; Analysis of data

d)

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Determine, collect and analyze appropriate data to demonstrate suitability and effectiveness of QMS and the opportunities to improve it Analysis shall provide information relating to: Customer satisfaction Conformity to product requirements

e)

Improvement i. Continual improvement Effectiveness of QMS shall be continually improved through use of the Quality Policy, quality objectives, audit results, data analysis, corrective and preventive actions, and management review. ii. Corrective action Action shall be taken to eliminate the causes of nonconformities in order to prevent recurrence and shall be appropriate to the effects of the nonconformities encountered Procedure shall be documented to define requirements for: iii. Reviewing nonconformities (including customer complaints) Determining causes of nonconformities

Preventive action Action shall be determined to eliminate the causes of potential nonconformities in order to prevent occurrence. Preventive actions shall be appropriate to the effects of the potential problems Procedure shall be established to define requirements for: Determining potential nonconformities and their causes Evaluating need for action to prevent occurrence of nonconformities

NOTE:
The ISO 9000 Standard is product certification. It is a quality process certification. Companies established their own criteria practices for quality, however, documented quality system must be in compliance with the ISO 9000 standard.

ISO 14000---EMS---Introductions & Planning

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The ISO 14000 is a family of standards first published in Sep-1996 pertaining to international EMS (Environmental Management System)

What is EMS?
A continual cycle of Planning, Implementing, Reviewing, and Improving the processes and action actions that an organization undertakes to meet its environmental obligations. Continual Improvement: Enhancing your EMS to better your overall Environmental Performance

ISO 14000; Environment Management System:

Does your organization needs an EMS Is your organization required to comply with environenmtntal laws and regulations (It concern the way an organizational activities effect the environment throughout the life of its products).

Activities:
a) May lie to the internal or external to the organization b) Range from production to the ultimate dispose of the product after its useful life c) Include effects on the environment such as pollution, waste generation, noise, depletion. (A rapidly increasing number of companies in many countries have been obtaining certificates for this standard)

Section. I: Guidelines for environmental Auditing.

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Section. II: Environmental Assessment. Section, III: Environmental label and declaration.

EMS:
An effective EMS is built on TQM concepts. Most EMS models [Including ISO 14000] are built on the PLAN, DO, ACT, CHECK [PDCA] cycle. Applying ISO 14000 and to initiate and sustain EMS effort, top management must communicate to all employees the importance of : Making the environment an organizational priority [Thinking of an effective environmental management as fundamental to the organizations survival] Integrating Environmental Management throughout the Organization.[thinking about the environment as part of product/service and process development and delivery among other activities]

Key Elements of EMSISO 14000:

ISO 14001 is widely accepted international standard for EMS that focuses on continual improvement. Companies may be asked to demonstrate conformance with ISO 14001 as a condition of doing business in some markets & The standard is consistent with the key elements found in many EMS models, including the European Unions eco management and audit scheme.

Key Elements of EMSISO 14000A snapshot:

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Environmental Policy Environmental AspectsIdentify Products, Activities / services attributing to environment Legal and other requirements. Objectives & Targets Environmental Management ProgramPlan Actions necessary to achieve above objectives. Structure and Responsibility. Training, Awareness and competence. EMS documentation Document Control Operational Control Emergency preparedness & Response Monitoring & Measurement NC & Corrective and Preventive actions Records EMS audit Management Review.

Prevention of Pollution Hierarchy:

Source Reduction In- Process Recycling Other Recycling Treatment & Recovery Control Mechanism

Typical Example of EMS policy:

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We will comply with the environmental laws & regulations and will strive to secure fundamental reforms that will improve our environmental effectiveness and reduce our cost of compliance. We will consider environmental factors and the acquisition and use and disposal cost when making Planning, Purchasing, and operating Decisions. We will monitor Environmental Performance through regular evaluation. Manage Land Water, wild Life and forest recourses in environmentally sensitive manner. Use energy efficiently throughout our operations and support the efficient use of coal, wood, & electricity. Reuse and recycle whenever and wherever possible. Use environmentally preferred materials. Clean up residual pollution from past operations in cost effective manner.

THE QS 9000 STANDARD

The QS was first established in August 1994. Chrysler, Ford, General Motors jointly developed this standard. Prior to the development of QS 9000 Each of the big three automotive industries had its own standard for quality system requirement. The February 1995 edition of QS 9000 has three sections.

Section. I: Contain all the 20 clauses of ISO 9001 Section. II: Production part approval process continuous improvement Section. III: Customer specific requirements existing QS 9000 registration are
continuously approved to comply with the new edition of QS 9000.

Goal:
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The goal for Quality System Requirements QS-9000 is the development of fundamental quality systems that provide for continuous improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.

Purpose:
QS-9000 defines the fundamental quality system expectations of Chrysler, Ford, General Motors, Truck Manufacturers and other subscribing companies for internal and external suppliers of production and service parts and materials. These companies are committed to working with suppliers to ensure customer satisfaction beginning with conformance to quality requirements, and continuing with reduction of variation and waste to benefit the final customer, the supply base, and themselves.

Approach:
QS-9000 is a harmonization of Chryslers Supplier Quality Assurance Manual, Fords Q101 Quality System Standard, and General MotorsNAO Targets for Excellence, with input from the Truck Manufacturers. ISO 9001:1994 Section 4 has been adopted as the foundation for QS-9000 and is printed in Section I in italic type. Interpretations and supplemental quality system requirements have been harmonized and are printed in normal type. While other companies may adopt this document, Chrysler, Ford, and General Motors retain full control over the content except for ISO 9001:1994, of which copyright remains with the International Organization for Standardization.

QS-9000 implementation and registration:

The conformance to QS-9000 quality systems requirements is generally verified by third party audit by a customer approved QS-9000 registrar [14]. In rare occasion a second party audit by the customers auditor is allowed. It should be noted that many exist ing requirements of automakers such as Statistical Process Control (SPC), Advanced Product Quality Planning (APQP), Failure Mode Effect Analysis (FMEA), etc., and requirements of the programs such as Chryslers Supplier Quality Assurance, General Motors NAO Targets of Excellence, Fords Q-101 Quality Systems Standard, and of other programs are still prevailing under QS-9000 requirements

QS-9000 third party registrars and accreditation bodies:

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QS-9000 third party registrars are an independent company who are accredited by a national accreditation body to verify compliance with QS-9000 Quality Systems Requirement through a third party independent audit. They maintain a register of names of the companies who have achieved QS-9000 registration through them. Accreditation body for registrar is either chartered or appointed by the government of the country where it is located. For example, in the United Kingdom, all registrars must be accredited by the National Accreditation Council for Certification Bodies (NACCB) which must issue certificates with the Crown Stamp of the NACCB.

The cost of QS-9000 registration:

Using the preliminary pre-assessment audit findings and the implementation schedule as guidelines, the cost of QS-9000 registration may be estimated. Without a preliminary audit, it is extremely difficult, to estimate the cost of QS-9000 registration. A medium size company of 200 employees may spend anywhere between $50,000 to $150,000 towards QS-9000 registration which exclude any training and preparation costs. There are too many variables with too many parameters to consider when estimating the cost of QS-9000 registration.

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