ISO 9000 Standards

• ISO 9001: 2008 Quality management systems — Requirements is intended for use in any organization regardless of size, type or product (including service). It provides a number of requirements which an organization needs to fulfill to achieve customer satisfaction through consistent products and services which meet customer expectations. It includes a requirement for continual (i.e., planned) improvement of the Quality Management System, for which ISO 9004:2004 provides many hints.

This is the only implementation for which third party auditors can grant certification. It should be noted that certification is not described as any of the ‘needs’ of an organization as a driver for using ISO 9001 but does recognize that it may be used for such a purpose.

• ISO 9004:2000 Quality management systems - Guidelines for performance improvements covers continual improvement. This gives you advice on what you could do to enhance a mature system. This document very specifically states that it is not intended as a guide to implementation.

There are many more standards in the ISO 9001 series, many of them not even carrying “ISO 9000” numbers. For example, some standards in the 10,000 range are considered part of the 9000 group: ISO 10007: 1995 discusses configuration management, which for most organizations is just one element of a complete management system. The emphasis on certification tends to overshadow the fact that there is an entire family of ISO 9000 standards… Organizations stand to obtain the greatest value when the standards in the new core series are used in an integrated manner, both with each other and with the other standards making up the ISO 9000 family as a whole.

Note that the previous members of the ISO 9000 series 9002 and 9003 have been integrated into 9001. In most cases, an organization claiming to be “ISO 9000 registered” is referring to ISO 9001.

ISO 9001 Scope of Software Quality

The ISO 9001 standard has 20 clauses (4.1 to 4.20) that lay down guidelines for the development of quality assurance systems. These guidelines define the essential features of the software quality management system and suggest controls and methods that allow the software to meet customer needs.

The steps that have to be taken to set up the ISO 9001 standard are :

1. A commitment to quality by the highest level of management of the organization and necessary resource allocation. Understanding quality requirements for organizing the work.

2. Identifying procedures to develop the software and to test whether it can meet customer needs in a defined time.

3. Acceptance of software by customer.

4. Delivery and installation.

5. Maintenance.

6. Support activities, namely, documentation control, maintenance of detailed records , and training.

7. Non-conformity control and corrective action these steps when implemented through a set of procedures will make the company eligible for ISO 9001. ISO 9001 gives a detailed explanation for each clause, which requires compliance for a company to become eligible for ISO 9001 certification. If all the above steps are fully executed, then clauses 4.1 to 4.20 of 4.20 of ISO 9001 are taken care of.

ISO 9001 does not recommend standard formats but demands execution of these steps.

ISO 9001 Checklist

Quality Policy (4.0 of ISO 9001)

The management shall define the quality policy and ensure all concerned understand this policy. The policy document should be signed by the CEO and be displayed at prominent places.

Management Review (4.1 to ISO 9001)

The quality system adopted to satisfy the requirements for this information standard shall be reviewed periodically to ensure continuity, suitability, and effectiveness. The company shall appoint a management representative with the responsibility to ensure that ISO guidelines are implemented.

Quality System Procedure (QSP) (4.2 of ISO 9001)

The company shall establish a OSP and maintain a documented quality system as a means of ensuring that it confirms to the specified requirements of ISO.

(a) Preparation of documented quality system procedures and instructions.

(b) Effective implementation of these procedures.

Broadly, QAS includes the following:

• QA manual
• Management procedures
• Technical work instructions

Contract Review (4.3 of ISO 9001)

The company shall establish a procedure for contract review and coordination of activities:

• Contractual requirements are adequately defined and documented
• Procedure to resolve any deviation
• Ensure capability to meet contractual requirement
• Records of contract review are maintained

Design control (4.4 of/ so 9001)

Establish and maintain procedures to control and verify the design to ensure that specified requirements are met. The points to be covered are

• Identification of design consideration
• Design methodology
• Use of past design experience
• Inclusion of design experience
• Inclusion of design Inputs requirements
• Design verification
• Design changes

Documnt control (4.5 0f ISO 9001)

• Design documents
• Planning documents
• Procedural documents
• Reference documents
• Document master list and its revision log
• The organization for documentation

Purchasing (4.6 of ISO 9001)

• Hardware, software, tools
• Assessment of sub-contractors
• Verification of supplies

Software Identification and Tracing (4.7 of ISO 9001)

Establish a procedure whereby software can be drilled down to all documentation to trace any information needed. Appropriate numbering, coding and version control numbers should be introduced.

Purchase supplied Product (4.7 of ISO 9001)

The company shall establish a procedure to receive, verify, store and maintain client supplied software/ tools etc. These items are part of the deliverables of the company. If software is found unsuitable it should be returned with resource for rejection.

Process control (4.9 of ISO 9001)

A procedure to ensure that from development to implementation all activities are carried out to meet the quality requirements. The procedure should have following aspects covered through documents:

• Work Instruction
• Monitoring and control of activities
• Approval of processes and hardware and software/ tools etc.
• Workmanship standards

Inspection and testing (4.10 ISO 9001)

Establish a procedure to ensure that resources are as per the required standards. It should cover

• In process inspection and testing
• Final inspection and testing
• Records of testing

Inspection, measuring and testing equipment (4.11 of ISO 9001)

• Establish a procedure to ensure that rules, practices, conventions, tools and techniques agreed upon between the company and customer are adhered to and used in the development

• Software tools, e.g., compilers, editors, database software, steps, communication software internet and Web tools are evaluated earlier for purchase and installation

• Ensure that test plans are evolved for all stages of development

Test status (4.12 of ISO 9001)

Set a procedure to ensure that only tested and quality assured products are dispatched, used or installed.

Control of Non- conforming Products (4.13 0f ISO 9001)

Set up a procedure to ensure that the software not conforming to specified requirements is not dispatched, installed or used by mistake.

Corrective Action (4.14 of ISO 9001)

Set up a procedure to ensure that corrective action is taken to set right non- conforming software.

Handling, Storage and delivery (4.15 ISO 9001)

Ensure that unauthorized persons do not tamper with the software during development and after completion, and as a result, deliver software that has quality problems. Strict controls on access and us of media are necessary to control the quality of outgoing software.

Quality Records (4.16 of ISO 9001)

A procedure should be set to identify and maintain quality records with a clear and unique relation to the software for which it is maintained. There should be a set of guidelines for retention of quality records for future reference in case a dispute arises. The retention period is of mutual convenience and as per contract terms, if any.

Internal quality Audits (4.17 of IO 9001)

A procedure should be in place to audit whether the quality procedures have been complied with. The audit will be scheduled and results reported and corrective action taken as laid down.

Training (4.18 of ISO 9001)

The company will maintain a procedure to identify the training needs of people responsible for quality assurance. The training records will justify the inclusion of personnel in the testing team.

Software Maintenance Service (4.19 0f ISO 9001)

If software includes support and service needs of the customer, then a support procedure should be in place that ensures that this service is effectively carried out.

Statistical Techniques (4.20 of ISO 9001)

A procedure should be in place be in place to verify the needs for statistical techniques that will in turn verify process capability and characteristics. This would be more applicable in process control software.

Advantages of ISO 9000

It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of Litigation. The quality principles in ISO 9000: 2000 are also sound, according to Wade, and Barnes, who says “ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive.” Barnes also cites a survey by LIoyd’s Register Quality Assurance which indicated that ISO 9000 increased net profit, and another by Deloitte Touche which reported that the costs of registration were recovered in three years. According to the Providence Business News, implementing ISO often gives the following advantages:

1. Create a more efficient , effective operation
2. Increase customer satisfaction and retention
3. Reduce audits
4. Enhance marketing
5. Improve employee motivation, awareness, and morale
6. Promote international trade
7. Increase profit
8. Reduce waste and increases productivity

However, a broad statistical study of 800 Spanish companies found that ISO 9000 registration in itself creates little improvement because companies interested in it have usually already made some type of commitment to quality management and were performing just as well before registration.

In today’s service sector driven economy, more and more companies are using ISO 9000 as a business tool. Through the use of properly stated quality objectives, customer satisfaction surveys and a well-defined continual improvement program companies are using IO 9000 processes to increase their efficiency and profitability.

Problems of ISO 9001

A common criticism of ISO 9001 is the amount of money, time and paperwork required for registration. According to Barnes, “Opponents claim that it is only for documentation. Proponents believe that if a company has documented its quality systems, then most of the paperwork has already been completed.”

According to Seddon, ISO promotes specification, control, and procedures rather than understanding and improvement. Ade argues that IO 9000 is effective as a guideline, but that is promoting it as a standard “helps to mislead companies into thinking that certification means better quality, [undermining] the need for an organization to set its own quality standards“. Reliance on the specifications of ISO 9001 does not guarantee a successful quality system.

The standard is seen as especially prone to failure when a company is interested in certification before quality. Certifications are in fact often based on customer contractual requirements rather than a desire to actually improve quality. “ If you just want the certificate on the wall, chances are, you will create a paper system that doesn’t have much to do with the way you actually run your business,’” said ISO’s Roger Frost. Certification by an independent auditor is often seen as the problem area, and according to Barnes, “has become a vehicle to increase consulting services.” In fact, ISO itself, advises that ISO 9001 can be implemented without certification, simply for the quality benefits that can be achieved.

Another problem reported is the competition among the numerous certifying bodies, leading to a softer approach to the defects noticed in the operation of the Quality system of a firm.

Capability Maturity Model Integration(CMMI)

CMMI is a collection of best practices that met the needs of organizations in different areas of interest. A collection of best practices that cover a particular area of interest is called a CMMI model.

Capability maturity model Integration (CMMI) in software engineering and organizational development is a process improvement approach that provides organizations with the essential elements for effective process improvement. It can be used to guide process improvement across a project, a division, or an entire organization. CMMI helps integrate traditionally separate organizational functions. Set process improvement goals and priorities, provide guidance for quality processes, and provide a point of reference for appraising current processes.

CMMI currently addresses three areas of interest:

(1) Product and service development --- CMMI for development (CMMI DEV),
(2) Service establishment, management, and delivery --- CMMI for Services (CMMI SVC), and
(3) Product and service acquisition ---- CMMI for Acquisition (CMMI ACQ).

CMMI was developed by a group of experts from industry, government, and the Software Engineering Institute (SEI) at carnage Mellon University. CMMI models provide guidance for developing or improving processes that meet the business goals of an organization. A CMMI model may also be used as a framework for appraising the process maturity of the organization.

Depending on the CMMI constellation (acquisition, services, development), you use, the process areas it contains will vary. Key process areas are the areas that will be covered by covered by the organization’s processes. The table below lists the process areas that are present in all CMMI constellations. This collection of sixteen process areas is called the CMMI Model framework, or CMF.

CMMI Model Framework(CMF)

Capability Maturity model Integration (CMMI) Model framework (CMF)

Abbreviation		Name		Area		Maturity Level
REQM		Requirements Management		Engineering		2
PMC		Project Monitoring and Control		Project Management		2
PP		Project Monitoring and Control		Project Management		2
CM		Configuration Management		Support		2
MA		Measurement and Analysis		Support		2
PPQA		Process and product Quality Assurance		Support		2
OPD		Organizational Process Definition		Process Management		3
OPF		Organizational Process Focus		Process Management		3
OT		Organizational Training		Process Management		3
IPM		Integrated Project Management		Project Management		3
RSKM		Risk Management		Project Management		3
DAR		Decision analysis and resolution		Support		3
OPP		Organizational Process Performance		Process Management		4
QPM		Quantitative Project Management		Project Management		4
OID		Organizational Innovation and Deployment		Process Management		5
CAR		Casual Analysis and Resolution		Support		5

CMMI Representation

CMMI enables you to approach process improvement because it provides the latest best practices for product and service development and maintenance. The CMMI best practices enable organizations to do the following:

• More explicitly link management and engineering activities to their business objectives

• Expand the scope of and visibility into the product lifecycle and engineering activities to ensure that the producer or service meets customer expectations

• Incorporate lessons learned from additional areas of best practice (e.g., measurement, risk management, and supplier management)

• Implement more robust high maturity practices

• Address additional organizational functions critical to their products and services

• More fully comply with relevant ISO standards

CMMI Appraisal

CMMI Benefits

Levels of the Capability Maturity model

There are five levels defined along the continuum of the CMM, and, according to the SEI: “Predictability, effectiveness, and control of an organization’s processes are believed to improve as the organization moves up these five levels. While not rigorous, the empirical evidence to date supports this belief.”

Level 1 Initial

It is characteristic of processes at this level that they are (typically) undocumented and in a state of dynamic change, tending to be driven in an ad hoc, uncontrolled and reactive manner by users or events. This provides a chaotic or unstable environment for the processes.

Level 2 – Managed

It is characteristic of processes at this level that some processes are repeatable, possibly with consistent results. Process discipline is unlikely to be rigorous, but where it exists it may help to ensure that existing processes are maintained during times of stress.

Level 3 – Defined

It is characteristic of processes at this level that there are sets of defined and documented standard processes established and subject to some degree of improvement over time. These standard processes are in place (i.e., they are the AS-IS processes) and used to establish consistency of process performance across the organization.

Level 4- Quantitatively Managed

It is characteristic of processes at this level that, using process metrics, management can effectively control the AS IS process (e.g., for software development). In particular, management can identify way to adjust and adapt the process to particular projects without measurable losses of quality or deviations from specifications. Process capability is established from this level.

Level 5- Optimizing

It is a characteristic of processes at this level that the focus is on continually improving process performance through both incremental and innovative technological changes/ improvements.

At maturity level 5, processes are concerned with addressing statistical common causes of process (for example, shifting the mean of the process performance) to improve process performance. This would be done at the same time as maintaining the likelihood of achieving the established quantitative process improvement objectives.

Six Sigma

Six Sigma is one of the most popular quality methods lately. It is the rating that signifies “best in class,” with only 3.4 defects per million units or operations (DPMO). Its concept works and results in remarkable and tangible quality improvements when implemented wisely. Today, Six Sigma processes are being executed in a vast array of organization and in a wide variety of functions.

Fueled by its success at large companies such as Motorola, General electric, Sony, and Allied Signal, the methodology is proving to be much than just a quality initiative. Why are these large companies embracing Six Sigma? What makes this methodology different from the others?

The goal of Six Sigma is not to achieve six sigma levels of quality, but to improve profitability. Prior to Six Sigma, improvements brought about by quality programs, such as Total Quality Management (TOM) and ISO 9000, usually had no visible impact on a company’s net income. In general, the consequences of immeasurable improvement and invisible impact caused these quality programs gradually to be.

Six Sigma was originally developed as a set of practices designed to improve manufacturing processes and eliminate defects, but its application was subsequently extended to other types of business processes as well In Six Sigma, a defect is defined as anything that lead to customer dissatisfaction.

• Six Sigma stands for six standard deviation from mean (sigma is thee Greek letter used to represent standard deviation in statistics).

• Six Sigma methodologies provide the techniques and tools to improve the capability and reduce the defects in any process.

• Six Sigma strives for perfection. It allows for only 3.4 defects per million opportunities ( or 99.999666 percent accuracy)

• Six Sigma improves the process performance decrease variation and maintains consistent quality of the process output. This leads to defect reduction and improvements in profits, product quality and customer satisfaction.

• Six Sigma incorporates the basic principles and techniques used in business, statistics and engineering.

• The objective of Six Sigma principle is to achieve zero defects products/ process. It allows and engineering.

• The objective of Six Sigma principle is to achieve zero defects products/ process. It allows 4.4 defects per million opportunities.

Features that St Six Sigma

Apart from previous quality improvement initiatives include—

• A clear focus on achieving measurable and quantifiable financial returns from any Six Sigma project.

• An increased emphasis on strong and passionate management leadership and support.

• A special infrastructure of “ Champions, “ “ Master black Belts, “ “black Belts, “ etc. to lead and implement the Six Sigma approach.

• A clear commitment to making decisions on the basis of verifiable data, rather than assumptions and guesswork.

Sigma Levels

• 1 sigma = 690, 000 DPMO= 31% efficiency
• 2 sigma = 308,000 DPMO= 69.2% efficiency
• 3 sigma = 66,800 DPMO= 93.32% efficiency
• 4 sigma= 6,210 DPMO = 99.379 % efficiency
• 5 sigma = 230 DPMO = 99.977 % efficiency
• 6 sigma = 3.4 DPMO = 99.9997 % efficiency

Copyright © 2015 Mbaexamnotes.com         Home | Contact | Projects | Jobs