ISO 9000 Standard

History Of ISO 9001 Standards

Pre ISO 9000
During World War II, there were quality problems in many British industries such as munitions, where bombs were exploding in factories during assembly. The solution adopted to address these quality problems required factories to document their manufacturing procedures and to prove by record-keeping that the procedures were being followed. The standard was BS 5750, and it was known as a management standard because it specified not what to manufacture, but how the manufacturing process was to be managed. In 1987, the British Government persuaded the International Organization for Standardization (ISO) to adopt BS 5750 as an international standard. The international standard was named ISO 9000.

ISO 9000: 1987 Version
ISO 9000:1987 had the same structure as the British Standard BS 5750, with three ‘models’ for quality management systems, the selection of which was based on the scope of activities of the organisation:
• ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organisations 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.
ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards (MIL SPECS), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management—which was likely the actual intent.

ISO 9001 Standard is important because of its orientation. While the content itself is useful and important, the content alone does not account for its widespread appeal.
ISO 9001 Standard is important because of its international orientation. Currently, ISO 9000 is supported by national standards bodies from more than 150 countries. This makes it the logical choice for any organization that does business internationally or that serves customers who demand an international standard of excellence.
ISO 9001 Standard is also important because of its systemic orientation. We think this is crucial. Many people wrongly emphasize motivational and attitudinal factors. The assumption is that quality can only be created if workers are motivated and have the right attitude. This is fine, but it doesnt go far enough. Unless you institutionalize the right attitude by supporting it with the right policies, procedures, records, technologies, resources, and structures, you will never achieve the standards of quality that other organizations seem to be able to achieve. Unless you establish a quality attitude by creating a quality management system, you will never achieve a world-class standard of quality.
Simply put, if you want to have a quality attitude you must have a quality system. This is what ISO recognizes, and this is why ISO 9001 Standard is important.

A quality management system enables you to manage your business processes effectively:

it is much more than a set of rules and procedures. When properly implemented and maintained, a QMS addresses the needs of your organisation and delivers tangible business benefits.

The new version of ISO 9001 has recently been published. One of the main aims of ISO 9001:2008 is to facilitate integration with other standards. Although there are no new requirements as such, there are some key clarifications to be taken into account.

There are three main objectives to the new standard:

Detail, clarify, improve the understanding of ISO 9001:2000 (previous version)

Improve compatibility with ISO 14001:2004 Simplify the way in which ISO 9001 can be integrated with other management system standards (such as OHSAS 18001)

There are no new requirements in the new standard:

The title, scope, and structure of the standard are unchanged

The process approach is confirmed

Compatibility with the latest revision of ISO 14001:2004 is maintained and improved upon

Preservation of the quality management principles included in ISO 9000:2000

There are five main areas to note. The relevant sections of the standard are noted in brackets.

1. A reinforcement of the notion of product conformity

2. Compatibility with other standards is evolving

3. A better understanding of outsourced processes

4. An editorial clarification of some requirements – for instance;

A reinforcement of the notion of product conformity2.3.4.

An editorial clarification of some requirements – for instance;A better understanding of outsourced processesCompatibility with other standards is evolving

• (6.4) work environment, including an explanatory note on work environment giving examples,

to help meet product conformity requirements

• (8.2.1) measurement of customer satisfaction, including a note broadening the scope beyond

satisfaction surveys to include other channels such as customer feedback5.

• (Introduction) the notion of risk

• (5.5.2) appointment of a management représentative

• (6.2.2) assessing the effectiveness of achieving compétence

• (8.5.2 et 3) assessing the effectiveness of corrective and preventive actions?

Some additional explanations regarding the requirements of the standard;An editorial clarification of some requirements – for instance;A better understanding of outsourced processesCompatibility with other standards is evolvingA reinforcement of the notion of product conformity

Implementing ISO 9001 standards

If  you have your own business and now you are looking for ISO 9001 certification for quality standards for business to make your business products more reliable to the customers. To be in the market for any business, it needs quality and for quality any business needs to follow quality standards, so ISO 9001 Standards developed many quality standards as per different -different business areas.

ISO 9001 Standards  is a generic quality standard and can be applied to any organization but before applying it, a process starts with pre-assessment audits and passes through on-going maintenance. The process of implementing ISO 9001 includes identifying, collecting and organizing the information required for certification.

For implementing ISO 9001 standards, any organization needs to hire a consultant because detailed knowledge of ISO standards is essential before successfully applying it. A consultant will analyze your organization structure, your products and their standards and will make a complete plan as per ISO standards for your organization.To hire a consultant is easiest way because they have complete knowledge of ISO standards and they perform various activities like provides class room training to your business employee about ISO 9000 standards

An ISO consultant performs the various activities and explains the course objectives :

• understand the purpose of ISO 9000: 2005, ISO 9001: 2008, ISO 9004: 2000, ISO 19011: 2002 etc. standards and their interrelationship

• describe the purpose of Quality Management Systems and 8 Quality Management Principles

• Interpret the ISO 9001: 2008 in the context of audit

•Plan and conduct an audit in accordance with guidelines as per ISO 19011: 2002, gather objective evidence via various methods and determine conformity to the requirements of Quality Management Systems

• Develop understanding of Roles & Responsibilities of Lead Auditors

Hiring a Consultant is a better and easiest way to implement ISO in your organization

In today’s hectic business environment, it is vital that we are all on the same page, right? But how do we know if we meet those standards? Business owners and executives can avoid the uncertainty, and that’s where ISO 9001 certification comes in.

Standardizing Quality Systems

The ISO, or International Organization for Standardization, was established in 1947 to develop international standards for
everything from electronics to management systems. Having over 13,000 standards currently in place, ISO has created the auditing and certification process known as ISO 9001. This began the drive toward quality standards.

Improving Customer Satisfaction

Companies choose to implement ISO 9001 and get certified because many customers and industries require it. By keeping customers happy, they can increase sales and profitability for their business. And if an area of the company’s program appears to be too bureaucratic and non-value-adding, then it might also be an area for continuous improvement efforts.

Enhancing Company Performance

Both customers and industries alike use ISO certification as a way to evaluate and audit their suppliers and products. Through an independent verification process, customers can gain assurance of their suppliers’ products. And as a supplier becomes certified, the testing requirement is waved, which saves the company both
time and money.

Developing Best Practices

Employed as a “Best Practices” model, ISO 9001 utilizes the philosophy of the “Plan-Do-Check-Act” continuous improvement cycle to achieve requirements. This process approach centers around eight quality management principles used by management as a guide toward improving performance and identifying the main elements
needed in a good quality system:

1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. Systems Approach to Management
6. Continuous improvement
7. Factual Approach to Decision-Making
8. Mutually Beneficial Supplier Relationship

Building Stable Processes

ISO 9001 policies, procedures and forms can provide employers, managers and employees with a systematic and consistent approach to implementing policies, plans, procedures and work routines. Instead of building their own policies and procedures from scratch, some companies prefer to hire professional writers that have already prepared a set of written policies and procedures to help on the way to certification.

Auditing a Company System

In the certification process, an independent registrar will perform an on-site audit of a company’s operations to verify that it complies with the ISO standard. If the business complies, then that company will be registered as ISO 9001 compliant.

Meeting Company and Customer Needs

On the way to certification, a business can meet its ISO needs by:

= Using well-defined processes and procedures to build stable processes
= Training in the audit and certification process
= Continuously improving with ISO 9001 standards

Noticing the Difference

With complete procedures manuals for ISO 9001 Quality Management System, required HR procedures, and an ISO training class, a template like an ISO 9001 Quality Manager Procedures Manual Series can help a business on its way to ISO 9001 certification.
Sometimes the effort can be very great, but companies typically notice a remarkable difference in efficiency and effectiveness after the first year.

What is ‘Root Cause Analysis’ In ISO 9001 Standards?
Suppose you come across a dandelion weed while in your garden. (If you have as little time in the garden as I do, at times you may find too many!) You pull off the head of the dandelion and all the leaves. There – you can’t see it any more.
The question is: does this fix the problem?
To illustrate, let me share some findings from an audit in a type of courier company. They collect & deliver items for their customers, and have contracts with large customers. If any customer complaints arise, the operations manager must respond in writing.
For audit, I chose a sample of complaints from the last 3 months and looked at what they’d done with them.  Most complaints were for late/missed pick-ups or deliveries.
Some sample responses from the manager to the client:
A. This route has too many sites on it, we are looking at changing it.’
B. ‘The entry disappeared from the system. It was re-entered, and the pick-up went ahead the next day.’
C.  ‘The driver was new and didn’t know. He has been spoken to.’  (A week later, the same driver missed another pick-up for the same customer.)  ‘He no longer works for us.’
D. ‘I can only assume this happened while I was on leave, and the supervisor didn’t know he had to respond to your calls urgently.’

And my favourite E: ‘The driver was late because there were delays during the day.’
These responses are typical of just looking at symptoms: pulling off the dandelion leaves. That approach leaves the root of the problem still intact.  Like the dandelion, you can pretty much bank on the fact that it’s going to come up again. And again. And again. Until you do something to find the real cause (or causes). That’s effective root cause analysis, because you get to the root: the real underlying cause.
For example: Why does a route have ‘too many sites’ on it? What does ‘looking at changing it’ mean? Has it been done? If it was changed, did the changes work? If not, when will it be done?  How did that route get ‘too many sites’ on it? And what would stop that happening again, or on another route?
Consider the ‘new’ driver: Why didn’t he know what to do? Had he received the information he needed such as induction and training? If not, why not? Why is ’speaking to’ a driver adequate to prevent recurrence? (it’s not) Has the company reviewed how it selects its drivers? Because the recurrence a week is a strong sign of inadequate cause analysis and ineffective corrective action.
Why Find the Root Cause?
Most organisations are busy and somewhat chaotic. Immediacy often rules. So there’s often a tendency to go for the quick fix – treat the symptom rather than the real, underlying cause. The driver is ’spoken to’, the order ‘re-entered into the system’. But this almost guarantees the same or very similar situation will recur, and have to be dealt with again. And again.
When problems come up in your organisation – which they will – you can choose how to respond. You can look for someone to blame and stop at the symptom (’the driver was new… the supervisor didn’t know… it disappeared from the system’). Quite apart from the damage it causes to personnel relations, this approach isn’t effective.
An organisation with an intelligent approach to quality knows the value of a systematic approach to problems, including root cause analysis. The best question is: What can we learn from this situation?  And then:  How can we apply that learning to improve?
When Should You Use Root Cause Analysis?
If you have or aspire to ISO 9001, you must have a systematic approach to problems: nonconformance, corrective and preventive action. Without it, you’ll find it hard to pick problems for root cause analysis, because they’re often distributed over time (so you don’t realize they recur), or happen to different people (so you don’t realise they recur in your organisation).
Good candidates for root cause analysis are the situations that recur most often, and use the most resources to rectify or those that cause the most damage when they do.
Remove the Root Cause or Not?
After you’ve identified the root cause/s, you have to decide if it’s worth removing the root cause or whether you continue to treat the symptoms.  This isn’t always an easy decision.
It’s often relatively easy to estimate the cost of removing the root cause, but less easy to assess the cost of not doing so. Suppose, for example, a truck breakdown turns out to have been caused by ineffective maintenance by a supplier.  And suppose that supplier costs $10,000 less per year than the other. Superficially, the cost vs savings looks good.
But suppose that also means a truck off the road for at least an extra 5 days a year – and your largest customer got so angry about one too many crucial but failed pick-ups that they don’t renew your contract.  And tell everyone what an unreliable company you are.

How To Write ISO 9001 Standards Procedures?

Step 1
Place the following sub sections into your procedure:
Purpose, Scope, Definitions, Associated Documentation, Responsibility/Authority, Procedure, Record Retention and Attachments. Leave blank spaces between each to add the required information.
Step 2
First, start with the Purpose Section. Describe the reason why the procedure exists. If we use the purchasing procedure as an example the Purpose might read:
“This procedure defines the process for obtaining raw materials and supplies for XYZ Company and the matter with which the requirements of these purchases are flowed down to XYZ Company’s suppliers.”
Step 3
ScopeNext, define the scope of the document. This is to what extent the process will reach within the company. For example:
“This procedure shall include all purchases directly used in the manufacture or processing of XYZ Company’s product.”
Step 4
Next make a list of terms and definitions. These should not be common terms that anyone reading the document should already know; but, should be technical terms that pertain to the procedure or common terms that may have added meaning to the company. For example:
“Supplier – XYZ Company defines a supplier as an approved company that supplies items used to produce and/or manufacture our product. This term does not include companies that supply general office product not used to produce or process XYZ Company’s products.”
In this example the common term supplier has added meaning to XYZ Company that could differ from another company’s definition of supplier. To avoid confusion a definition of the term is listed in the definitions section of the ISO 9001 procedure.
Step 5
Define the supporting document that are needed to create a complete process. If you product calls out t use only approved suppliers it may be nice to reference the supplier management procedure and the approved supplier list; because, they will be needed to complete the purchasing process.
Step 6
Now define the responsibilities and authorities. This is similar to a job description where as it defines the person that will manage and/or carry out the tasks described in the procedure. For example:
“The purchasing manager will be responsible for managing this procedure and coordinating purchases. Managing shall include the implementation and enforcement of this procedure throughout XYZ Company.”
Step 7
Define the procedure. This is the bulk of the procedure and is where the company will define the actual process. This can be detailed or simply call out what work inspection are to be used at each step of the purchasing process. It is important that all the elements of the quality standard that pertain to the procedure are defined in this part of the document. This section is usually broken into subsections. In our “Purchasing Procedure” example this might include “General procedures”, “Purchasing Components and Raw Materials” and “Purchasing Outside Services”. Usually some kind of outline method is used to layout this section.
Step 8
Next is the record retention section. This usually defines the method of controlling records related to this process. Where they will be kept, How long they will be kept, in what type of media for which they will be stored.
Step 9
Finally, the attachments section of the procedure will be defined. This will be references to other procedures, external information sources or other media used to supplement that procedure itself.

Integrating Management Systems Within The ISO 9001 Standards

Today’s free market economies increasingly encourage diverse sources of supply and provide opportunities for expanding markets. Fair competition needs to be based on identifiable, clearly defined common references that are recognised from one country to the next. A standard, internationally recognised, developed by consensus among trading partners, serves as the language of trade. The International Organisation for Standardisation (ISO) has developed around 8?700, mostly technical related standards on this basis. Standards Series such as ISO 9000, ISO 14000 and what is to be known as ISO 18000 and ISO 26000 are Management related. These standards contain generic guidelines for Management Systems in the area of Quality, Environment, Occupational Health & Safety and Human Resources.

ISO is a word derived from the Greek isos, meaning “equal”. ISO 9000 Standards are developed and updated by the International Organisation for Standardisation which has around 150 member bodies. A member body of ISO is the national body “most representative of standardisation in its country”.(eg. Germany – DIN, USA – ANSI, Australia – SAA).
More than 50 countries, as well as the European Community have adopted ISO 9000 which is recognised internationally as a benchmark for measuring quality in a trade context. Since its first issue in 1987, approximately 430?000 companies have been using ISO 9000. Being a standard coming from an organisation that is usually involved in the development of technical standards, ISO 9000 is often regarded as a document that belongs in the hands of a technician exposed to production line quality control. At a closer look, however, ISO 9000 Standard Series provide guidance in the development and application of Management Systems as well as Quality Control in Manufacturing and Administration.

ISO has been developing a number of Management System Guidelines for various aspects of business. The most recent are the ISO 14000 Environmental Management System Guidelines. This is an international standard that will affect business in the near future. ISO 14000 has been designed to integrate with ISO 9000. However, apart from international standards there are local standards a company has to comply with. To remain compliant with local standards, further manuals and/or procedures are required (eg. lifting procedure in a warehouse to satisfy Work Safety requirements). A company may have several Manuals describing its Management Systems (eg. Human Resources, Quality, Security, Health/Safety, Finances). An overall link between the systems is often missing which makes the monitoring and the assessment of effectiveness difficult. Double handling of information, contradicting instructions, high maintenance costs, administrative excess and lack of overall transparency are common results.
ISO 9000 Standard Series for Quality (of) Management Systems provide generic guidance for the development of an overall Management System, ISO 14000 provides guidance for Environmental Management, etc. Transparency and monitoring of all business activities can be achieved by integrating all systems into one.
Complaints that ISO 9000 is paralysing operations and, that it does not reflect reality are usually a result of not clearly understanding how the standard can be properly structured to address the needs of a company. ISO 9000 can be structured by focusing on “best practice” process rather than the standard, by fitting the standard to the process and not the process to the standard. Having recognised this, ISO has been working on a new structure for ISO 9000, called “Vision 2000?, taking a process orientated approach to ensure that “best practice” as well as several standards can be addressed within one system. Focusing on process allows the development of a practical “working document”, providing an effective management tool. Having learned from the past, the trend to Process Orientated Management Systems started about three years ago in Europe and is finding increasing approval from certification bodies.Every company has its own culture and key individuals.
The business environment influences processes in certain ways (eg. employee market, laws, infrastructure, client, etc.)
To ensure competitiveness a company needs to ensure adequate flexibility in their system to effectively respond to changes in the business environment.
An effective system is a lean system that incorporates all necessary functions, controls of activities and “best practice” without being caught up in detail.
An effective system must also be flexible enough to enable the proper controls on outsourcing and sub-contracting of activities (eg. production, administration, service, etc.)

Transition from ISO 9001:2000 to ISO 9001:2008

This reference guide was developed to help you understand the nature of the changes to the ISO 9001 standard.

Clause Change/Emphasis Not Auditable

0.1 General Added language emphasizing statutory and regulatory requirements are a concern as it relates to products for this international standard.

0.4 Compatibility with Other Management Systems Standards – Emphasis was added on the consideration given to ISO 14001:2004 to ensure that the standards are compatible.

1.1 General

1.2 Application Statutory was added in certain paragraphs to ensure the user is aware that these requirements must be taken into consideration. Additional notes were added to explain that where the word product appears, it refers to every stage of its existence, from raw material received to the final product being shipped to the customer.

2. Normative Reference Reference to ISO 9000 (vocabulary and concepts) was updated to refer to the current revision (i.e. ISO 9000:2005).

3. Terms and Definitions The supplier/organization/customer model was removed. These relationships, in reality, are not always linears.

The Auditable Requirements
Clause Change/Emphasis
4.1
In 4.1 a, identify was replaced with determine to emphasize that an organization must give careful consideration to what processes are needed in order to fulfill requirements.
A link is drawn to 7.4 in the additional note. This was done to show that the supplier approval, evaluation, and re-evaluation process is where evidence of controlled outsourced processes should be demonstrated.
4.2.1
References to records and documents were consolidated.
Also, the organization can require records not specified in this international standard that are created and maintained.
4.2.3
Clarification is given to the requirement for outsourced documents. Only those needed for the planning and operation of the QMS need to be controlled. This could exclude documents related to occupational health and safety since ISO 9001 contains requirements only concerned with product (see 0.1).
4.2.4
Rephrased, but no additional clarifications or emphasis added. Editorial change only.
5.5.2
The management representative must be from the organizations management. This would exclude consultants and other individuals external to the organization (e.g. a management representative from the corporate entity). The purpose of this is to ensure that this individual, entrusted with the responsibilities of championing the quality management system, is not out of touch with the organization.
6.2.1
The boundaries of competence only extend to individuals who impact product conformity. However, this does not just include those who are directly involved in production. The decisions made by management affect product conformity; therefore, they must be competent as well.

6.2.2
If said personnel have not yet attained the competence needed to perform the assigned job, then the organization must provide training or some other remedy to ensure that competence is achieved. The organization must also have a mechanism to ensure that personnel have been evaluated based on how well they demonstrate their knowledge and skill (i.e. competence). It is not enough to merely provide training or consider an individuals experience. The organization must prove to itself that this person can, in fact, perform.

Organizations considering the implementation of ISO 14001 often ask if the standard is applicable to safety and health programs as well as environmental issues. We believe that the answer is unequivocally yes.
Not only is ISO 14001 applicable to health/safety programs, it can also provide the same benefits that it makes possible in the environmental area. These include:
Meeting and/or exceeding regulatory requirements, Placing greater attention on significant issues not driven by regulations (establishing a safety culture, raising employee morale), Establishing a commitment to improve and measure performance, and Improving communications between managers and hourly employees.
In addition, using ISO14001 to integrate environmental/safety/health programs into the business system produces other benefits. Measures that reduce environmental incidents can decrease or eliminate worker exposures to hazardous materials. Conversely, increasing awareness of safety practices can focus employees’ attention on environmental concerns. In fact, the success of health, safety, and environmental programs often hinges on worker understanding, attitude, and commitment. The corporate culture must change to make these matters a natural part of each employee’s approach to his or her work.
The ISO 14001 standard assumes that such cultural transformation occurs through employee involvement and responsibility from the bottom up, not via dictates from the top. That assumption, and other concepts present in ISO 14001, is applicable to health and safety. Therefore, it’s reasonable to consider the use of the standard in an integrated approach that can bring about change for all three. Some organizations have done so, and many others will eventually see the wisdom of employing ISO 14001 for that purpose.
How can ISO 14001 be useful for health and safety when it was intended to address the environmental aspects of organizations? These three areas are so linked that a management standard for one can have equal applicability to the others. The reason ISO 14001 was not specifically aimed at health and safety had more to do with professional parochialism and the politics of international standards writing than with any concern about the logic of doing so. InISO 14001, the only acknowledgement that it could be useful for health and safety appears in the introduction, which recommends its use to those who may need to apply the standard to those areas. No other specific references appear in the document, because the standard’s developers felt that health and safety professionals would eventually develop their own version of ISO 14001. This new version has not emerged, and the likelihood of it happening anytime soon is rather low, because current stakeholders’ views militate against it.