What is the history of ISO 9001

The Previous Standards
If you track the history of ISO 9001 standards, the first initiative can be traced back to 1959, when Department of Defense published its MIL-Q-9858 Standard.
This MIL Q-9858 has been revised into NATO APQP Standards in 1969. Then the Civil Version is initiated by BSI, and published the BS 5179 guidance standards in 1974. Further this is revised into BS 5750 series of requirements Standards in 1979.
The First Version of ISO-9001 : ISO Started to work on these standards in 1981 and finally published the first version of ISO 9001:1987 retaining the same structure as BS 5750, in 1987.  This Standard has three different versions ISO 9001, ISO 9002, ISO 9003.
ISO 9001:1987 – Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.
ISO 9002:1987 – Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.
ISO 9003:1987 – Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.
The emphasis in this version tended to be placed on conformance with procedures rather than the overall process of management—which was the actual intent.
The Version ISO 9001:1994 : ISO published this version in 1994 and the major change is that it emphasizes Quality Assurance via preventive actions, instead of just checking the final product. The requirement of documented procedures is also emphasized even though this is same in the previous version.
The Version of 2000 :  ISO 9001:2004 is significantly different from the previous versions. the most important of this is the emphasis on process management. Also this version demands the involvement of top management,review of process performance, continual improvements to the quality system, monitoring of Customer satisfaction etc.
Another significant change is the integration of ISO9001, ISO 9002 and ISO 9003 into a single standard and calling it ISO 9001.There is a provision to exclude some clauses of design and development if the company is not involved in these activities.
The Version of 2008 : Released in Feb 2008, this version only introduces clarifications to ISO 9001:2000 and some clarifications to improve compatibility with ISO 14000:2004. These changes are included in the ISO 9001:2008.

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Originally posted 2011-04-08 04:00:00.

What is ISO standard

ISO (International Organization of Standardization) is the worlds largest developer and publisher of International Standards or ISO standard
Note: ISO is often wrongly called as International Standards Organization. This is wrong. It is not an abbreviation. This is a word from Latin meaning Equal. The background goes that ISO is a multi Language organization. to avoid confusion between languages, the Latin word is chose. Irrespective of Language, the name of the organization is ISO.
The Headquarters of this organization is located Geneva, Switzerland. It is not a Government Organization. It is a association of 160 national Standards Organizations and they are called as “member bodies”. Though ISO is non governmental, Its members may be part of their National Government. The most representative organization of the country is chosen as a member of the organization, and only one from each country can become a member. See the list of members Here.
There are other members called as Correspondent Members and Subscriber Members.
The role of ISO is limited to specify the requirements for products, Services, good conformity assessment, Managerial and organizational practices. ISO is not involved in certification nor has any control over the certification business.
The standards developed by ISO are designed to be implemented worldwide.
The most popular of ISO Standards are ISO 9000 Family on Quality Management Systems and ISO 14000 Family on Environmental Management Systems.
ISO 9000 forms basis for many other industry specific Standards like TS16949 for automobile Industry, ISO 17025 for Laboratories and AS 9100 for Aviation Industry. 
These are few examples of industry specific Standards only.
Also ISO has provided standards for Various Processes too. There are specific Standards for processes such as Risk Management, Configuration management Etc.
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Originally posted 2011-03-19 04:21:00.

What is Standard

If you go by the dictionary, the word standard is defined as the following in the popular dictionaries
Oxford defines ‘Standard’ as a level of quality or attainment:a required or agreed level of quality or attainment:something used as a measure , norm, or model in comparative evaluations:used or accepted as normal or average:
Merriam-Webster’s defines ‘Standard’ as Set up and established by authority as a rule for the measure of quantity, weight, extent, value, or quality
The Standards are developed by various organizations. Most Nations have their own standardization bodies. The standards are mainly under two categories. Product Standards and industry Standards.

Product Standards

Product Standards define the minimum requirements for a product to be called as a standard product. These are normally defined by the statutory authorities such as Bureau on Indian Standards (BIS). Each of the product will have its own standard defined and  the product is marked.

Industry Standards

Industry Standards are based on the requirements of the industry. The most acceptable Standards are developed by ISO (International organization for Standardization). Out of the 18000+ standards developed by ISO, ISO 9000 family is the most widely used. All most all activities are covered by ISO.

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Originally posted 2011-03-19 02:54:00.

What is Quality?

I know i am opening the can of worms again on trying to define as what is quality. This discussion is as old as the term quality. We are still unable to define if this is  a noun or an adjective.
This is a term which has a variety of definitions. In fact if you ask 10 people in a group  and get ready for at least 15 unique answers.
If you look at the popular dictionaries you will find the following definitions
Oxford Dictionary : 1. the standard of something as measured against other things of a similar kind; the degree of excellence of something: 2. a distinctive attribute or characteristic possessed by someone or something:
Merriam-Webster’s : 1. A peculiar and essential character 2. an inherent feature 3. A degree of excellence 4. A distinguishing attribute.
These definitions are not of help if you are looking as a quality professional.
Also the Gurus on this subject define it differently Now let us see what the Gurus on the subject matter say.
Anon  “Common sense set down on paper”
Joseph M. Juran: “Fitness for use.” Fitness is defined by the customer.
“Quality” means those features of products which meet customer needs and thereby provide customer satisfaction”
“Quality” means freedom from deficiencies-freedom from errors”
Subir Chowdhury: “Quality combines people power and process power.”
Philip B. Crosby: “Conformance to requirements.”
Robert Pirsig: “The result of care.”
Genichi Taguchi, with two definitions:

a. “Uniformity around a target value.” The idea is to lower the standard deviation in outcomes, and to keep the range of outcomes to a certain number of standard deviations, with rare exceptions.
b. “The loss a product imposes on society after it is shipped.” This definition of quality is based on a more comprehensive view of the production system.

Peter Drucker: “Quality in a product or service is not what the supplier puts in. It is what the customer gets out and is willing to pay for.”
W. Edwards Deming: concentrating on “the efficient production of the quality that the market expects,”
Gerald M. Weinberg: “Value to some person”.
let us see what other say on this
ISO 9000: “Degree to which a set of inherent characteristics fulfills requirements.”
Six Sigma: “Number of defects per million opportunities.”
American Society for Quality: “A subjective term for which each person has his or her own definition. In technical usage, quality can have two meanings: a. The characteristics of a product or service that bear on its ability to satisfy stated or implied needs; b. A product or service free of deficiencies.”
JAA (Joint Aviation Authorities – Currently EASA) : “The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs” 
Now let me attempt my own
“Quality can be defined as the best and continuous effort of an organization or individual, to prove their capabilities to meet the expectations of those who are interested in it”
I tried to cover many of the definitions above. The interested parties can be the Organization themselves, their customers, the regulators everybody is interested parties.
I covered the needs by using the word “to meet the expectations”. customer wants value for money, or safety organization expects Profits, less defects, no complaints etc. the regulators want compliance and conformance.

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Originally posted 2011-03-18 17:09:00.

Risk Management – II – Risk Occurrence and Response

The Picture above depicts typical response needed for the occurrence of Risk at various project stages and impact on the Project Goal.risk management Before getting in to the response needed, few definitions here.

Risk – An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative result. This is typically a likely future event based on various project variables and not yet occurred. The impact is not being experienced yet.
Risk Mitigation – Risk Mitigation plan include the
techniques followed to avoid, reduce and control the chance of occurrence of the likely future event called risk. These may include changes to the requirements, actions to reduce the occurrence such as assignment of more responsibilities etc.

Contingency Plan – A contingency plan is essentially the planned actions in the event of failure of mitigation. All efforts are put on the reduce the chance of occurrence, but the despite best efforts, the risk may occur. The contingency plan depicts, the course of action when the risk occurs. This is essentially the plan B.
Issue Management – Issue is an event or condition that has already occurred and has negligible or little impact on the goals. The impact is negligible as a work around possible and the project goal can still be achieved. The issue management will depict the actions to be taken in these condition to bring normalcy to the program.

Risk Management  is the collective term used to describe the actions taken to avoid the risk or decrease the impact of the risk

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Originally posted 2014-02-23 11:11:00.

Introduction to Configuration Management

Configuration Management and standards

Configuration Management gives the identifiably and traceability of a product at various stages of the product life. The requirements specific to configuration management are specified in various standards and Models with minor variations.

  • A Level 2 Process Area for CMMI – Configuration Management (CM)
  • Clause 7.2 of AS 9100 Rev C- Configuration Management
  • Clause 7.5.3 of ISO 9001:2008 – Identification and Traceability
  • A specific standard to deal with Configuration Management – ISO 10007

CM Process

Configuration Management process is broadly described in ISO 10007 which calls for the following steps of configuration management. These steps will help the organization to make sure the product released is of right configuration and in case of any errors, the exact point of error is traced. Also, this will help to improve the product, based on various stages.

CM Planning

A documented configuration management plan outlining the procedures being used to manage the configuration, and describe the roles and responsibilities to manage the configuration. This plan shall be documented, controlled and approved. Wherever possible, the plan must refer to the organizational procedures.

Configuration Identification

A list of configurable items shall be selected based on various factors such as statutory and regulatory requirements, product design stages, criticality in terms of risks etc. These items are to be selected based on their management of physical and functional characteristics being managed.

Change control

The changes to the configuration items must be controlled and documented. The process and records for changes shall include justification for change, evaluation of consequences of changes, and approval of changes. This changes shall always be base lined at periodic changes to the physical and functional characteristics of the product.

Configuration status accounting

The configuration status accounting activities throughout the life cycle of the product to support and enable an efficient configuration management process. Ideally, at any point of time, the product configuration is the last baseline and the changes done after the baseline.

Configuration audit

Periodic audits are to be conducted on the configuration based on the documented procedures, to make sure the product meets the configuration requirements are not. generally two types of configuration audits are conducted.
Physical configuration Audit :  To make sure that the product is meeting the physical characteristics as specified in the product configuration information
Functional configuration audit : To make sure that the product has achieved the functional performance as defined in the product configuration information
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Originally posted 2013-12-08 17:49:00.

Risk Management II – Benefits of Risk Management Program

The earlier article on Risk Management is Risk Management I – A proactive approach to resolve future root causes and their potential consequences.

Purpose of a Risk Management Plan
Risk management program helps the organization to deal with potential occurrences.  It defines the approach and attitude towards risks. This program helps in
  1. identifying what are those risks the organization is ready to accept.
  2. The plan to deal with those unacceptable risks
  3. defines the main requirements of risk mitigation plan.
 The risk Management program helps the organization in the following ways:
  • To identify risks and prepare an action plan to deal with the risk
  • To reduce occurences and impacts of risk
  • To understand significance/severity of risks
  • To promote organizational behaviors focused on risk management
  • To increase effectiveness of product and service delivery to customer
  • Create a process for who, what, when, where, how and how much.
  • Maintain information on historic issues.
  • Capitalize on historic issues to prevent future issues.
  • Bring out hidden risk knowledge, so it can be managed.

Benifits of Risk Management Program

  • Encourage proactive management
  • Be aware of the need to identify and treat risk throughout the organization
  • Improve the identification of threats
  • Comply with relevant legal and regulatory requirements and international norms
  • Improve financial reporting and governance
  • Improve stakeholder confidence and trust
  • Establish a reliable basis for decision-making and planning
  • Improve organizational controls
  • Effectively divide and use resources for risk treatment / handling
  • Improve operational effectiveness and efficiency;
  • Cost of risk management is typically less than the cost of issue management
  • Enhance health and safety performance
  • Enhance environmental protection
  • Minimize losses and improve loss prevention
  • Minimize the cost and efforts in managing incidents
  • Improve organizational learning and resilience
  • Increase the likelihood of achieving goals

The most important benefit of the risk mitigation program is that it gives the organization a future visibility. It deals with future events and not manage the current issues. The organization will be ready to face the realization of the risk. This gives a state of readiness against the potential consequences

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Originally posted 2013-10-27 17:48:00.