ISO 9001 Standand Procedure

ISO 9001 Standard - ISO 9001 Standards

2012-01-01T04:16:00.001-08:00

ISO 9001 Standard - ISO 9001 Standards

Implementing ISO 9001 Standards

2011-10-09T06:16:00.001-07:00

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

How to Get an ISO 14001 Accreditation

2011-10-09T06:15:00.002-07:00

If you are someone who is looking into getting an ISO 14001, then you may be wondering exactly why it is that you have to get this accreditation. First, you have to understand that ISO stands for the International Organisation of Standardisation. This is a series of standards that have been developed with a singular level of guidance for all companies to measure up to. The particular 14001 deals with the requirements that you will need to have in order to measure up to the environmental standards that have been set forth by the ISO.

While you do not necessarily have to get the ISO 14001 accreditation to operate your business, it is something you can do to prove to your clients and customers that you are doing your part to help out with the environment. However, you may be confused on how to go about getting this important accreditation, but it is not as difficult to attain as you might think, and most businesses should be able to get the certification within a year of the application. You should know that they will want to make sure that you have been following some form of environmental standards for at least three months prior to your application. To do this you can write an environmental review of your company’s environmental impact as it is in its current operating state. You will then want to make sure that you provide this information when you send off your initial paperwork to begin the overall process.

In order to help prove that your company is doing its part to be environmentally aware you will have to go through an initial audit once the application has been filled out and filed. After the audit has been completed you will get a list of issues that the auditor feels you need to resolve before you can be certified for the ISO 14001. You will need to work on and correct these issues before the second audit is conducted, and they will give you a time period (usually three to six months) when they will return to check on your progress.

When the second audit occurs they will once again assess the overall business and then they will address the issues that were laid out in the previous audit. If everything goes well then your company will have proven that they are doing what they can to meet the standard set forth in ISO 14001, and they will then receive accreditation. However, this is not the end of the process. Even though you are now recognised as having environmentally conscious policies that are congruent with the international standards, you will have to go through periodic audits every three years to make sure that you are still operating correctly. Not only this, but every three months partial aspects of your company will be analysed to see that they are still working within the standards as well. As long as you remain within the compliance terms you will continue to receive your ISO 14001 certification.

Is Green Business Really Environmentally Sustainable ?

2011-10-09T06:15:00.001-07:00

Is Green Business Really Environmentally Sustainable ?

Green Business is about a good management of a range of issues including reduced carbon footprint and good energy management but also including a broader environmental sustainability, within a practical environmental management system. The most effective system is ISO 14001. Many other approaches are less than effective

There is a wide variety of concepts that are understood by some as environmental management systems or EMS and this varies in different industries. The concept has evolved over time. Essentially the name says it all – A system to enable the business owner or manager to manage environmental problems both real and potential.

Owners and managers setting out to have a green business do not always achieve their aim of environmental sustainability and may not even include reduced carbon footprint and good energy management.

Many industry groups have developed industry wide simplistic programs that they call EMS that actually miss the S for system and some really only have a checklist approach that is based on an “average” or “typical” business in that industry. So effectively they also miss much of the environment. Many do not really involve any management either. Some are very superficial in the way that they select the environmental aspects they manage because they have been drawn up to be generic and cut out the need for the business owner to stop and think. In this case it is difficult to understand how any process of continual improvement can result.

One of these programs are as simple as a checklist, or what many involved call a “tick and flick” exercise. These are barely even educational for the business owner and have no ongoing benefits like reduction of costs or legal protection.

Even where the business owners and or managers spend a lot of time filling in forms and communicating with neighbours, there is often a real lack of understanding of how to identify and varied environmental risks in an individual businesses and why these need to be manage. They can easily miss things and even find they are risking legal implications in areas that are not typical and so not covered by the so called system..

An effective management system needs individual businesses to identify and understand what their environmental risks are or may be. These risks need to be managed and there also needs to be a feedback system going into a regularly reviewed system for continual improvement. This can be enhanced with auditing by qualified independent auditors, whether internal or external; although the greatest benefit does come from employing and independent external auditing body such as a certification body.

There were some early ISO 14001 systems that gave the system a bad name because they were based on outdated engineering and military approaches to ISO systems are overly paper heavy and full of jargon. These were not suitable for small business and farms. These systems have given ISO 140001 a bad name in some circles.

Unfortunately many consultants have come from an old style quality management background without any real understanding of or training in the environment. The training to upgrade from quality auditing only involves doing a three day seminar with a minimal assessment by a training organization. Then they audit with a rigid paper based approach and do a serious disservice to both their clients and to the auditing industry.

Small to medium businesses benefit from a simpler approach based on a real understanding of the issues involved and a genuine understanding of risks. Such systems are based on ISO 14001 and have a real emphasis on keeping things simple and minimizing paperwork. These give very real benefits to the businesses involved.

Sample ISO 9001 Internal Auditing Procedure

2011-10-09T06:14:00.000-07:00

1. PURPOSE
The purpose of this procedure is to define the steps that follows in planning, performing, reporting, recording, and following up on internal audits.
conducts internal audits to determine whether the quality management system:
- Conforms to planned arrangements, to the requirements of ISO 9001 and to the quality management system requirements established by (QMS Manual policies, procedures, work instructions, and forms)
- Is effectively implemented and maintained.

2. SCOPE
This procedure applies to all company personnel who are responsible for planning, development, use, and maintenance of the quality management system.

3. DEFINITIONS
None

4. REFERENCES
4.1 Quality Manual,
5. ASSOCIATED DOCUMENTS
5.1 Audit Check List,
5.2 ERC/ERO Procedure,
5.4 Audit Schedule,
5.3 Audit Notebook

6. PROCEDURE
NOTE 1: This procedure is typically initiated about four weeks prior to the execution of an internal audit as called for by ’s audit schedule. The audit schedule is established and maintained by The Quality Assurance Manager.
NOTE 2: Every element in the quality system is audited on a regular basis and at minimum of once per year. Activities are audited more frequently if there are significant changes taking place (i.e., many new hires/high turnover of personnel, modified procedures and work instructions, etc.) or if there is a history of problems in that area.
NOTE 3: Only qualified personnel may perform internal auditing activities. These qualified personnel are classified as internal auditors and have received the following training as a minimum: 1 day training on internal auditing techniques, 1 day training on the ISO 9001 Standard, this training may be performed by previously trained internal auditors.

6.1 AUDIT PLANNING, COORDINATION, AND PREPARATION
6.1.1 The Quality Assurance Manager defines the specific criteria, scope, methods, and objectives for the upcoming internal audit based on the status, maturity, and importance of specific elements in ’s quality system.
Audits shall be carried out to a defined scope and shall be as follows,
a) Planned: as per the internal audit plan
b) Unplanned: arising as a result of,
- Customer complaints
- Following the implementation of actions defined in a corrective action report
- Following the identification of additional or amended procedures for products
NOTE 4: In planning the particular audit, these activities include determining the extent and boundaries of the audit (locations, activities, processes); set of policies, procedures and/or requirements to be audited against; auditing methods; and audit objectives.
6.1.2 The Quality Assurance Manager selects the appropriate auditor to ensure objectivity and impartiality of the audit process.
6.1.3 The Quality Assurance Manager and the auditor review the proposed audit program to ensure that it is consistent with and effective for the defined audit criteria, scope, methods, and objectives.
6.1.4 Prior to the audit date, auditor reviews the appropriate quality system documentation, records of completed corrective and preventive actions, and past audit findings for the activities to be audited, and then develops a checklist covering the quality system elements and activities to be audited.

6.2 INTERNAL QUALITY AUDIT INVESTIGATION

6.2.1 The auditor will contact the personnel in the area being audited at the time indicated on the audit program, and briefly review the audit criteria, scope, methods and objectives with them.
NOTE 5: The checklists only serve as a guide to the auditors, and other areas may be investigated as deemed necessary by the auditors or as requested by the auditee.
6.2.2 When a nonconformance is identified, the auditor presents the nature of the nonconformity and the evidence to the personnel involved for verification, clarification, and addresses any questions or concerns that the personnel may have, as well as to give advice, when requested, regarding any problems which are uncovered.
6.2.3 If the nonconformance is confirmed, then go to step 6.2.5.
6.2.4 If the possible nonconformance requires further clarification the auditor will discuss the situation with the Quality Assurance Manager.
6.2.5 After the facts of the nonconformity are verified (or modified), the auditor either drafts nonconformance statement or documents the necessary information for writing one later.
NOTE 6: The nonconformance statement includes the nature of the nonconformity, the actual evidence obtained, and the nature of the requirement that is not being complied with (i.e., the appropriate ISO 9001 clause number, the appropriate quality system document section/page/paragraph, what the personnel says is the normal practice, contract requirements, statutory regulations, current standards, and any other relevant requirements).

6.3 REPORTING AND FOLLOW-UP
6.3.1 Within 2 weeks of completing the internal audit program, the auditor prepares a brief internal audit report and submits it to The Quality Assurance Manager for review and approval.
NOTE 7: The audit report includes the audit’s criteria, scope, methods and objectives, the names and titles of the audit team members, a summary of general observations (i.e., general degree of compliance and any significant problems encountered), all statements of nonconformities, weaknesses, and/or opportunities for improvement, and verification results for follow-up activities performed during the audit.
6.3.2 The Quality Assurance Manager reviews and approves the internal audit report, and then distributes copies of the report to senior management and the personnel of the audited areas that were directly involved in the audit.
NOTE 8: Any additional comments or observations of the Quality Assurance Manager can be attached to the report, but the auditor’s observations be will not be deleted or modified by The Quality Assurance Manager.
6.3.3 The Quality Assurance Manager request a Engineering Change Request for any nonconformity listed in the Internal Audit Report and for any weaknesses and “opportunities for improvement” identified and documented.
6.3.4 The Quality Assurance Manager updates and maintains the long-range audit schedule based upon the documented results of the audit and the planned corrective and preventive actions.
6.3.5 The Quality Manager shall maintain an audit notebook detailing all internal and external audits carried out.
- Long-range audit schedule
- Internal audit program
- Completed checklists- signed and dated by each auditor
- Audit report

7. REVIEW PROCEDURE
Any suggested improvements or modifications to this procedure are to be passed on to the Quality Assurance Manager for discussion at the next Quality Review Committee meeting.

Revision Of Documents In ISO 9000 Standards

2011-08-19T06:16:00.002-07:00

The ISO 9000 Standard requires that documents be updated as

necessary and re-approved following their review.

Following a document review, action may or may not be necessary. If the

document is found satisfactory, it will remain in use until the next review. If the

document is found unsatisfactory there are two outcomes.

The document is no longer necessary and should be withdrawn from use –

this is addressed by the requirement dealing with obsolescence.

The document is necessary but requires a change – this is addressed by this

requirement.

The standard implies that updating should follow a review. The term update

also implies that documents are reviewed only to establish whether they are

current when in fact document reviews may be performed for many different

reasons. A more appropriate term to update would be revise. Previously the

standard addressed only the review and approval of changes and did not

explicitly require a revision process. However, a revision process is executed

before a document is subject to re-approval.

This requirement responds to the Continual Improvement principle.

It is inevitable that during use a need will arise for changing documents and

therefore provision needs to be made to control not only the original

generation of documents but also their revisions.

The document change process consists of a number of key stages some of

which are not addressed in ISO 9000 Standards.

a. Identification of need (addressed by document review)

b. Request for change (not addressed in the standard)

c. Permission to change (not addressed in the standard)

d. Revision of document (addressed by document updates)

e. Recording the change (addressed by identifying the change)

f. Review of the change (addressed under quality planning)

g. Approval of the change (addressed by document re-approval)

h. Issue of change instructions (not addressed in the standard)

i. Issue of revised document (addressed by document availability)

As stated previously, to control documents it is necessary to control their

development, approval, issue, change, distribution, maintenance, use, storage,

security, obsolescence or disposal and we will now address those aspects not

specifically covered by the standard.

In controlling changes it is necessary to define what constitutes a change to a

document. Should you allow any markings on documents, you should specify

those that have to be supported by change notes and those that do not.

Markings that add comment or correct typographical errors are not changes

but annotations. Alterations that modify instructions are changes and need

prior approval. The approval may be in the form of a change note that details

changes that have been approved.

Anyone can review a document but approved documents should only be

changed/revised/amended under controlled conditions. The document

review will conclude that either a change is necessary or unnecessary. If a

change is necessary, a request for change should be made to the issuing

authorities. Even when the person proposing the change is the same as would

approve the change, other parties may be affected and should therefore be

permitted to comment. The most common method is to employ Document

Change Requests. By using a formal change request it allows anyone to request

a change to the appropriate authorities.

Change requests need to specify:

a. The document title, issue and date

b. The originator of the change request (who is proposing the change, his or her

location or department)

c. The reason for change (why the change is necessary)

d. What needs to be changed (which paragraph, section, etc. is affected and

what text should be deleted)

e. The changes in text required where known (the text which is to be inserted

or deleted)

By maintaining a register of such requests you can keep track of who has

proposed what, when and what progress is being made on its approval. You

may of course use a memo or phone call to request a change but this form of

request becomes more difficult to track and prove you have control. You will

need to inform staff where to send their requests.

On receipt of the request you need to provide for its review by the change

authority. The change request may be explicit in what should be changed or

simply report a problem that a change to the document would resolve.

Someone needs to be nominated to draft the new material and present it for

review but before that, the approval authorities need to determine whether

they wish the document to be changed at all. There is merit in reviewing

requests for change before processing in order to avoid abortive effort. You

may also receive several requests for change that conflict and before processing

you will need to decide which change should proceed. While a proposed

change may be valid, the effort involved may warrant postponement of the

change until several proposals have been received – it rather depends on the

urgency

Ensuring the availability of controlled documents

The ISO 9000 standards requires that relevant versions of applica-

ble documents are available at points of use.

The relevant version of a document is the version

that should be used for a task. It may not be the latest

version because you may have reason to use a

different version of a document such as when

building or repairing different versions of the same

product. Applicable documents are those that are

needed to carry out work. Availability at points of use

means the users have access to the documents they

need at the location where the work is to be

performed. It does not mean that users should possess copies of the documents

they need, in fact this is undesirable because the copies may become outdated

and not withdrawn from use.

This requirement exists to ensure that access to documents is afforded when

required. Information essential for the performance of work needs to be

accessible to those performing it otherwise they may resort to other means

of obtaining what they need that may result in errors, inefficiencies and

hazards.

In order to make sure that documents are available you should not keep them

under lock and key (or password protected) except for those where restricted

access is necessary for security purposes. You need to establish who wants

which documents and when they need them. The work instructions should

specify the documents that are required for the task so that those documents

not specified are not essential. It should not be left to the individual to

determine which documents are essential and which are not. If there is a need

for access out of normal working hours, access has to be provided. The more

copies there are the greater the chance of documents not being maintained so

minimize the number of copies. A common practice is to issue documents to

managers only and not the users. This is particularly true of management

system documents. One finds that only the managers hold copies of the

Quality Manual. In some firms all the managers reside in the same building,

even along the same corridor and it is in such circumstances that one invariably

finds that these copies have not been maintained. It is therefore impractical to

have all the copies of the Quality Manual in one place. Distribute the

documents by location, not by named individuals. Distribute to libraries, or

document control centres so that access is provided to everyone and so that

someone has responsibility for keeping them up to date. If using an intranet,

the problems of distribution are less difficult but there will always be some

groups of people who need access to hard copy.

The document availability requirement applies to both internal and external

documents alike. Customer documents such as contracts, drawings, specifica-

tions and standards need to be available to those who need them to execute

their responsibilities. Often these documents are only held in paper form and

therefore distribution lists will be needed to control their location. If documents

in the public domain are required, they only need be available when required

for use and need not be available from the moment they are specified in a

specification or procedure. You should only have to produce such documents

when they are needed for the work being undertaken at the time of the audit.

However, you would need to demonstrate that you could obtain timely access

when needed. If you provide a lending service to users of copyrighted

documents, you would need a register indicating to whom they were loaned so

that you can retrieve them when needed by others.

A document that is not ready for use or is not used often may be archived.

But it needs to be accessible otherwise when it is called for it won’t be there. It

is therefore necessary to ensure that storage areas, or storage mediums provide

secure storage from which documents can be retrieved when needed. Storing

documents off-site under the management of another organization may give

rise to problems if they cannot be contacted when you need the documents.

Archiving documents on magnetic tape can also present problems when the

tape cannot be found or read by the new technology that has been installed!

Electronic storage presents very different problems to conventional storage and

gives rise to the retention of ‘insurance copies’ in paper should the retrieval

mechanism fail.

Ensuring documents are legible and identifiable

The standard requires documents to remain legible and

readily identifiable.

Legibility refers to the ease with which the informa-

tion in a document can be read or viewed. A

document is readily identifiable if it carries some

indication that will quickly distinguish it from

similar documents. Any document that requires a reader to browse through it

looking for clues is clearly not readily identifiable.

The means of transmission and use of documents may cause degradation

such that they fail to convey the information originally intended. Confusion

with document identity could result in a document being misplaced, destroyed

or otherwise being unobtainable. It can also result in incorrect documents

being located and used.

This requirement is so obvious it hardly needs to be specified. As a general

rule, any document that is printed or photocopied should be checked for

legibility before distribution. Legibility is not often a problem with electron-

ically controlled documents. However, there are cases where diagrams cannot

be magnified on screen so it would be prudent to verify the capability of the

technology before releasing documents. Not every user will have perfect

eyesight! Documents transmitted by fax present legibility problems due to the

quality of transmission and the medium on which the information is printed.

Heat sensitive paper is being replaced with plain paper but many organiza-

tions still use the old technology. You simply have to decide your approach.

For any communication required for reference, it would be prudent to use

photocopy or scan the fax electronically and dispose of the original.

Documents used in a workshop environment may require protection from oil

and grease. Signatures are not always legible so it is prudent to have a policy

of printing the name under the signature. Documents subject to frequent

photocopying can degrade and result in illegible areas.

Although a new requirement, it is unusual to find documents in use that carry

no identification at all. Three primary means are used for document

identification – classification, titles and identification numbers. Classification

divides documents into groups based on their purpose – policies, procedures,

records, plans, etc are classes of documents. Titles are acceptable providing

there are no two documents with the same title in the same class. If you have

hundreds of documents it may prove difficult to sustain uniqueness.

Identification can be made unique in one organization but outside it may not

be unique. However, the title as well as the number is usually sufficient.

Electronically controlled documents do not require a visible identity other than

the title in its classification. Classifying documents with codes enables their

sorting by class.

ISO 14001 Standards Certification

2011-08-19T06:16:00.001-07:00

ISO 14001 Standards Certification

ISO 14001 sets out a system that can be audited and certified. In many cases, it is the issue of certification that is critical or controversial and is at the heart of the discussion about the trade implications.

Certification means that a qualified body (an “accredited certifier”) has inspected the EMS system that has been put in place and has made a formal declaration that the system is consistent with the requirements of ISO 14001.

The standard allows for “self-certification,” a declaration by an enterprise that it conforms to ISO 14001. There is considerable skepticism as to whether this approach would be widely accepted, especially when certification has legal or commercial consequences. At the same time, obtaining certification can entail significant costs, and there are issues relating to the international acceptance

of national certification that may make it particularly difficult for companies in some countries to achieve credible certification at a reasonable cost. For firms concerned about having certification that carries real credibility, the costs of bringing in international auditors are typically quite high, partly because the number of internationally recognized firms of certifiers is limited at present.2

The issue of accreditation of certifiers is becoming increasingly important as the demand increases.

Countries that have adopted ISO 14001 as a national standard can accredit qualified companies as certifiers, and this will satisfy national legal or contractual requirements. However, the fundamental purpose of ISO is to achieve consistency internationally. If certificates from certain countries or agencies are not fully accepted or are regarded as “second class,” the goal will not have been achieved. It is probable that the international marketplace will eventually put a

real commercial value on high-quality certificates, but this level of sophistication and discrimination has not yet been achieved. It is essential to the ultimate success of the whole system that there be a mechanism to ensure that certification in any one country has credibility and acceptability elsewhere.

The ISO has outlined procedures for accreditation and certification (Guides 61 and 62), and a formal body, QSAR, has been established to operationalize the process. At the same time, a number of established national accreditation bodies

heavily involved in ISO have set up the informal International Accreditation Forum (IAF) to examine mechanisms for achieving international reciprocity through multilateral agreements (MLAs). However, these systems are in the early

stages, and many enterprises continue to use the established international certifiers, even at additional cost, because of lack of confidence in the acceptability of local certifiers.

Given the variability in the design of individual EMS and the substantial costs of the ISO 14000 certification process, there is a growing tendency for large companies that are implementing EMS approaches to pause before taking this

last step. After implementing an EMS and confirming that the enterprise is broadly in conformance with ISO 14001, it is becoming routine to carry out a “gap analysis” to determine exactly what further actions would be required to achieve

certification and to examine the benefits and costs of bringing in third-party certifiers.

ISO 14001 Standards Certification

ISO 14001 Standards sets out a system that can be audited and certified. In many cases, it is the issue of certification that is critical or controversial and is at the heart of the discussion about the trade implications.

The standard allows for “self-certification,” a declaration by an enterprise that it conforms to ISO 14001 Standards. There is considerable skepticism as to whether this approach would be widely accepted, especially when certification has legal or commercial consequences. At the same time, obtaining certification can entail significant costs, and there are issues relating to the international acceptance

The issue of accreditation of certifiers is becoming increasingly important as the demand increases.

Countries that have adopted ISO 14001 Standards as a national standard can accredit qualified companies as certifiers, and this will satisfy national legal or contractual requirements. However, the fundamental purpose of ISO is to achieve consistency internationally. If certificates from certain countries or agencies are not fully accepted or are regarded as “second class,” the goal will not have been achieved. It is probable that the international marketplace will eventually put a

stages, and many enterprises continue to use the established international certifiers, even at additional cost, because of lack of confidence in the acceptability of local certifiers.

last step. After implementing an EMS and confirming that the enterprise is broadly in conformance withISO 14001 Standards, it is becoming routine to carry out a “gap analysis” to determine exactly what further actions would be required to achieve

certification and to examine the benefits and costs of bringing in third-party certifiers.

BACKGROUND TO THE ISO 9001:2008 REVISION PROCESS

2011-08-19T06:15:00.000-07:00

BACKGROUND TO THE ISO 9001:2008 REVISION PROCESS

In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.

Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development ofISO 9001:2008 user needs were identified from the following:

-the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004

-feedback from the ISO/TC 176/Working Group on “Interpretations”

-the results of an extensive worldwide “User Feedback Survey on ISO 9001 and

The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.

The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004.

A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:

1) No changes with high impact would be incorporated into the standard;

2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;

3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.

The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:

-No changes or minimum changes on user documents, including records

-No changes or minimum changes to existing processes of the organization

-No additional training required or minimal training required

-No effects on current certifications

The benefits identified for the ISO 9001:2008 edition fall into the following categories:

-Provides clarity

-Increases compatibility with ISO 14001.

-Maintains consistency with ISO 9000 family of standards.

-Improves translatability.

ISO 9001 and occupational health and safety

2011-05-16T06:11:00.002-07:00

Adopting ISO 9001 might lead to improvements in occupational health and safety in a variety of ways. In the process of formally documenting procedures, for example, managers can identify and eliminate hazardous practices and add safety precautions. Moreover, by fostering more focused attention to detail,ISO 9001 adoption can reveal new “win-win” opportunities to improve quality or efficiency and occupational health and safety that were previously obscured by indirect and distributed costs and benefits.

Additionally, processes that provide warning signals and prompt corrective action can forestall serious accidents. Finally, routine auditing and corrective action procedures required by ISO 9001 to address management system failures encourage root-cause analysis that can identify problematic work practices that might otherwise precipitate not only quality failures, but occupational health and safety concerns.

Departments charged with managing quality sometimes also manage health and safety, and companies are increasingly implementing integrated management systems that incorporate all these considerations. Occupational health and safety can be improved by applying the tools of continuous improvement associated with ISO 9001 certification. Employees who know how to identify root causes of quality problems, for example, also have the skills to identify root causes of safety problems.

The high rates of repetition and increased monitoring implicit in the emphasis of ISO 9001 on routinization and standardization of tasks can increase stress and repetitive motion injuries, potentially worsening the safety records of plants with quality program. Moreover, to the extent that the higher equipment utilization associated with ISO 9001 adoption translates into reduced employee downtime, employee fatigue, a major cause of injuries, might be expected to increase. Additionally, new quality management procedures implemented in association with ISO 9001 that add inspection tasks to work processes optimized for production can occasion poor ergonomic conditions that leave employees susceptible to injuries.

Process Approach In ISO 9001 Standards

2011-05-16T06:11:00.001-07:00

The ISO 9001 International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.

For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.

The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”.

An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.

When used within a quality management system, such an approach emphasizes the importance of

a) understanding and meeting requirements,

b) the need to consider processes in terms of added value,

c) obtaining results of process performance and effectiveness, and

d) continual improvement of processes based on objective measurement

Six Sigma Vs ISO 9000

2011-05-16T06:10:00.000-07:00

The debate over whether or not to choose Six Sigma over ISO 9000 is getting more interesting with each passing day. In an attempt to determine which of these is the better of the two, it is highly pertinent to discuss that in the context of applicability of them to industries. And there exists a huge amount of difference between the approaches of these two methodologies in tackling the issues.

Six Sigma – A Critical View

Six Sigma utilizes a multi-faceted approach to doing business with total improvement of the end product being the goal. In doing so, Six Sigma defines and analyzes the processes critically almost always focusing on process improvements. The statistical tools used in Six Sigma help not just in the adoption of processes but are also critical tools of Six Sigma implementation.

Process Development Stages

Let us examine the above statement as applicable to a process for easier understanding. While working on process improvement, the Black Belts break up the original sequence of different events that comprise the entire process and each event is further subdivided internally. This enables the “belts” to take an entirely different view of the process via the entire process as a whole. The powerful statistical tools employed at this stage of evaluation make the picture clearer and help the “belts” to arrive at decisions about the value additions those made to the process by different events.

This principle obviously goes beyond standardizing the processes and setting the pathway for being vigilant about adherence to the Six Sigma methodology. Useless values which have lost meaning make way for more meaningful events and eventually more robust and comprehensive processes. In a Six Sigma environment, customer demands will assume a key role in driving the processes towards aligning all activities with the vision of the leader of the company. The approach is “how to” rather than “what to” deliver.

The ISO 9000 Approach

The ISO approach towards quality management concentrates on standardization of the activities of production. The eight quality principles of ISO 9000, along with its twenty-four requirements outline business processes. The emphasis here is on the control of events in each aspect of doing business by documenting evidence and reports. The eight principles of ISO 9000 include prioritizing customer data, purchasing and quality systems, among other critical aspects. ISO 9000 recognizes each process, whose end goals are the same, as an independent entity. Documented quality requirements typically decide, based on set rules, whether or not a particular process adhered to that standard.

Document and Process Control

Maintenance of quality is achieved by adhering to key process and document control. Operating procedures and process control documents restrict deviations outside the concepts of what you should be doing in every process. What-you-should-be-doing is given emphasis under standard conditions rather than dealing with process improvement.

Stalwarts in industry are examining the possibility of merging the best practices of the two. Several industry leaders have already acknowledged the benefits of using both methodologies to compliment each other. Another view is that, as Six Sigma implementation is what you do within your company (unlike the certification in ISO) the company does not get recognition for achieving successful Six Sigma implementation. However, as long as the culmination of a business activity is defined by both methodologies as retaining and improving the customer base along with maximizing the bottom line, rejection of one in favor of other will be hard to justify.

Introduction To ISO 14001 Standards

2011-02-01T05:47:00.001-08:00

An environmental policy should reflect the vision, intentions, philosophy, values, and beliefs of the organization with respect to the environment. Top management should put a great deal of thought and imagination into developing and crafting the policy, since it will become the code of conduct by which the organization lives and operates. The policy should be practical and inspirational, providing a framework and a compass for business and technical decisions and actions, and at the same time motivate and encourage all personnel in the organization to achieve excellence in environmental performance.

The ISO 14001 Standard specifies several requirements for the development, content, intent, and implementation of an environmental policy:

1. Top management is responsible and accountable for defining the organization’s environmental policy. They must, as a minimum, carefully review, approve, and commit to abiding by an environmental policy that has been developed for their consideration.

2. The policy must completely cover the organization’s (i.e., facility’s) range of operations, including where appropriate, raw material acquisition, transportation, packaging, and shipping of product,as well as all on-site operations that may impact the environment.

3. The policy must contain three core commitments that are ISO 14001 absolute requirements:

(i) A commitment to continual improvement of the EMS and environmental performance.
(ii) A commitment to the prevention of pollution (i.e., this means taking all reasonable steps to eliminate, or at least minimize, pollution).
(iii) A commitment to comply with relevant environmental legislation and regulations, and with other requirements to which the organization subscribes. This means the organization commits to meet local, regional, and national legislated environmental standards.

4. The policy must give direction and a framework for progress through new environmental objectives and targets that will be set during the course of implementing and maintaining the EMS.

5. The policy must be documented, and it must be implemented through the day-to-day functioning of the EMS.

6. The policy must be maintained, meaning kept up to date and relevant to current operations and conditions.

7. The policy must be communicated to all employees. This implies active, intentional efforts by the organization, led by top management, to ensure all employees know about, understand, and apply the principles, ideas, and commitments in the policy.

8. The policy must be made available to the public, i.e., it must be accessible to all members of the public who wish to see it.

In addition to the essential requirements for an environmental policy, other considerations that may be incorporated into the policy include:

Principles of sustainable development, resource renewal, and preservation • of biological diversity

A commitment to use the most effective pollution abatement technology and • equipment, consistent with economic viability of the business (i.e., BEAT – Best Economically Achievable Technology)

Use of environmental performance indicators to quantitatively monitor • progress

Life cycle thinking – consideration of ‘cradle to grave’ impacts of a • product, which would require the organization to assess cumulative environmental impacts from all stages, from design of the product; acquisition of raw materials; processing to finished product; packaging; shipment; end-use; and ultimate re-use, recycle, or disposal.

For all components of this element of the Standard to be brought to fruition, it is essential that there is clear allocation of responsibilities for developing, approving, communicating, disseminating, implementing, maintaining, and when necessary, revising the environmental policy.

Although environmental policy is the first element of ISO 14001, it may be prudent for an organization to defer finalization of the wording of their policy until work has been done to identify the scope of environmental impacts from the operation, and other planning and preliminary preparation for the EMS has been done. This will help to ensure the policy is authentic and appropriate for the organization’s purpose.

Please visit http://www.e-wia.com for more information.

Quality In ISO 9001 Standards

2011-01-17T04:34:00.001-08:00

The Eight Dimensions of Quality

1. Performance

2. Reliability

3. Durability

4. Serviceability

5. Aesthetics

6. Features

7. Perceived Quality

8. Conformance to Standards

Terminology

Every product possesses a number of elements that jointly describe what the user or consumer thinks of us as quality. These parameters are often called quality characteristics. Sometimes these are called critical-to-quality (CTQ) characteristics. Quality characteristics may be of several types:

1. Physical: length, weight, voltage, viscosity

2. Sensory: taste, appearance, color

3. Time Orientation: reliablility, durability, serviceablity.

Since variability can only be described in statistical terms, statistical methods play a central role in quality improvement efforts. In the application of statistical methods to quality engineering, it is fairly typical to classify data on quality characteristics as either attributes or variables data. Variables data are usually continuous measurements, such as length, voltage, or viscosity. Attributes data, on the other hand, are usually discrete data, often taking the form of counts. We will describe statistical-based quality engineering tools for dealing with both types of data.

The Eight Dimensions of Quality1. Performance2. Reliability3. Durability4. Serviceability5. Aesthetics6. Features7. Perceived Quality8. Conformance to StandardsTerminologyEvery product possesses a number of elements that jointly describe what the user or consumer thinks of us as quality. These parameters are often called quality characteristics. Sometimes these are called critical-to-quality (CTQ) characteristics. Quality characteristics may be of several types:1. Physical: length, weight, voltage, viscosity2. Sensory: taste, appearance, color3. Time Orientation: reliablility, durability, serviceablity.Since variability can only be described in statistical terms, statistical methods play a central role in quality improvement efforts. In the application of statistical methods to quality engineering, it is fairly typical to classify data on quality characteristics as either attributes or variables data. Variables data are usually continuous measurements, such as length, voltage, or viscosity. Attributes data, on the other hand, are usually discrete data, often taking the form of counts. We will describe statistical-based quality engineering tools for dealing with both types of data.

Effects of ISO 9001 Implementation

2011-01-17T04:33:00.001-08:00

Overall we can say that a company sought certification primarily to meet internal needs rather than as a response to external market forces. However the first action to be certified seems as a proactive response, we could not see a clear effort in the company to evaluate the actual results of this process.

Despite all, it has been stated that the certification has enabled them to achieve higher quality, productivity thus product reliability and increase in customer satisfaction. From the aspect of cost dimension it was declared that ISO 9001 implementations had moderately positive impacts on cost reductions by the increase in productivity and decreases in spoilage, rework and scrap. A factor affecting the occurrence of previous impacts is careful selection of the appropriate supplier.

Overall the most important impact of certification was stated to be the improvements in the brand image of the company from the viewpoint of their customers. This will also be very advantageous in the retention of existing customers and attraction of new ones. As a result of the synergy between the stated improvements company achieved a significant competitive advantage compared to competitors that are not certified.

Company has neither any application nor any action regarding TQM and quality costs.

Why is ISO 9001:2008 Certification Important?

2010-10-17T05:57:00.001-07:00

Why is ISO 9001:2008 Certification Important?

First of all it provides a system for managers and organizations to achieve excellence and opens the door for American manufacturers and/or service organizations seeking a larger role in both international trade and with other American organizations. Many organizations require their suppliers to be certified or at a minimum to be working toward certification on ISO 9001:2008 to do business.

Consider the facts (source MORI/SGS-ICS) that with ISO 9001 certification:

83% realized improved management control
82% realized improved customer satisfaction
62% said it improved the ability to win work
61% stated a more motivated workforce
60% realized improved productivity
60% saw reduced waste
52% stated it improved marketing
50% had reduced costs
49% realized increased market share

ISO 9000 AND THE CONSTRUCTION INDUSTRY

2010-10-17T05:55:00.000-07:00

ISO 9000 AND THE CONSTRUCTION INDUSTRY

formal quality management system at a construction firm, there has to be direct demands from their customers, whose requirement for quality is essential for doing business. Most of the construction organizations will not enter into the cost and allocation of resources to implement a quality management system unless they will be compensated. There is a general movement towards making implementation of a quality management system a contractual requirement. Small to medium sized organizations can always argue that they ‘operate to a quality system’ although this is not formalized. However, since the existence of such ‘informal’ quality systems are

difficult to justify, the International Standards Organization, (ISO) has come up with ISO 9001 series of standards that are applicable to all organizations irrespective of size or nature of business.

ISO 9000 refers to a set of quality management standards. Standards present an opportunity for an organization to develop a quality management system that meets the requirements specified by ISO 9001:2000, which are

recognized internationally, making the organization competitive. ISO 9001 family of standards is undeniably the most prolific of all formal standards. This could be due to the worldwide applicability standardization and

flexibility with which the standards are associated, even though there are some experts that still question the standards’ applicability in the construction industry. It is important to note that ISO 9001:2000 has replaced ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994, while the old ISO 9002 and ISO 9003 standards have been discontinued.

A formal quality management system has the potential to change attitudes, cultures, and work procedures at any construction firm in a way the organization has never experienced before. In most cases, in order to set up aformal quality management system at a construction firm, there has to be direct demands from their customers,whose requirement for quality is essential for doing business. Most of the construction organizations will not enterinto the cost and allocation of resources to implement a quality management system unless they will becompensated. There is a general movement towards making implementation of a quality management system acontractual requirement. Small to medium sized organizations can always argue that they ‘operate to a qualitysystem’ although this is not formalized.

However, since the existence of such ‘informal’ quality systems aredifficult to justify, the International Standards Organization, (ISO) has come up with ISO 9001 series of standardsthat are applicable to all organizations irrespective of size or nature of business. ISO 9000 refers to a set of quality management standards. Standards present an opportunity for an organization todevelop a quality management system that meets the requirements specified by ISO 9001:2000, which arerecognized internationally, making the organization competitive. ISO 9001 family of standards is undeniably themost prolific of all formal standards. This could be due to the worldwide applicability standardization andflexibility with which the standards are associated, even though there are some experts that still question thestandards’ applicability in the construction industry. It is important to note that ISO 9001:2000 has replaced ISO9001:1994, ISO 9002:1994 and ISO 9003:1994, while the old ISO 9002 and ISO 9003 standards have been discontinued.

ISO’s logo

2010-10-17T05:54:00.000-07:00

ISO’s logo

ISO will not authorize the use of its logo in connection with material publicizing an ISO 9000 or ISO 14000 certification –some examples of such uses are in company letterheads, marketing leaflets, advertisements, and so on. The ISO logo is a registered trademark. ISO does not authorize its logo to be used, either by quality system certification bodies, or by the companies to which the latter issue ISO 9000 certificates. The same applies to ISO 14000 certifications, as these become more widespread. Allowing the ISO logo to be used would give the false impression that ISO carries out certification activities, or has approved or authorized the organization using its logo. These activities are not business functions of ISO.

ISO is not an auditor, assessor, registrar, or certifier of either quality systems or environmental management systems – or, for that matter, of materials, products and services – nor does it endorse any such activities performed by other parties. ISO develops International Standards but, at present, operates no scheme for assessing conformance with them.

Allowing the use of our logo in advertisements or other publicity material would give the impression that ISO has “approved” such a certification – or even carried it out. For the reasons given above, such an impression would be totally misleading.

ISO 9001 and occupational health and safety

2010-10-17T05:53:00.000-07:00

ISO 9001 and occupational health and safety

Process Approach In ISO 9001 Standards

2010-10-17T05:52:00.000-07:00

Process Approach In ISO 9001 Standards

When used within a quality management system, such an approach emphasizes the importance of

a) understanding and meeting requirements,

b) the need to consider processes in terms of added value,

c) obtaining results of process performance and effectiveness, and

d) continual improvement of processes based on objective measurement

Six Sigma Vs ISO 9000

2010-10-17T05:51:00.000-07:00

Six Sigma Vs ISO 9000

Six Sigma – A Critical View

Process Development Stages

The ISO 9000 Approach

Document and Process Control

The Environment For A Healthy Business In ISO 14001 Standards

2010-08-29T05:45:00.000-07:00

The Environment For A Healthy Business In ISO 14001 Standards

Growing scrutiny toward industry’s effects on the environment has made conformance with ISO 14001:2004 – a voluntary, internationally recognized Environmental Management Systems (EMS) standard – more important than ever. As more companies pursue ISO 14001 certification to demonstrate environmental commitment to their customers, shareholders and government agencies, many are discovering the benefits of partnering with Intertek. As one of the first accredited certification bodies, Intertek offers expertise, experience and know-how that no one else can deliver. Your certified EMS can help you reap the benefits of:

Improved overall performance
Your ISO 14001 certified EMS can help make your business more efficient and productive. Lower energy and raw materials use, reductions in waste and pollution, and mitigated risks of accidents and emergency situations translate into greater profitability and productivity.

Expanded market access
Your company’s environmental credibility and commitment to quality are established from day one. It will take less time to demonstrate the effectiveness of your EMS and earn your prospective customers’ trust and confidence, and you’ll enjoy access to markets you might not otherwise penetrate.

Improved corporate image
Your certification demonstrates your company’s commitment to environmental responsibility, fostering improved relationships with the community, shareholders, and governmental and environmental organizations.

Enhanced competitiveness
While helping you to operate more efficiently and profitably, your ISO 14001 certified EMS can instill additional confidence in shareholders, investors, insurers and your customers – making your business the clear choice in a highly competitive market.
Plus, you can maximize your human and financial resources by using your existing Quality Management System (QMS) as a basis for your EMS, taking advantage of the synergies between ISO 9001 and ISO 14001.

Introduction to ISO 9001 Standard Certification

2010-08-29T05:43:00.000-07:00

Introduction to ISO 9001 Standard Certification

Certification is a way to attest, by the intermediary of a third-party certifier, to a company’s ability to provide a service, product or system in accordance with client requirements and regulation requirements. ISO and IEC give the following definition:
Procedure by which a third party gives written assurancethat a product, process or service complies with the requirementsspecified in a benchmark.The ISO 9000 family of standards corresponds to all the management best practices benchmarks as regards quality, which are defined by ISO (the International Organisation for Standardization).
ISO 9000 standards were originally written in 1987, with revisions taking place in 1994 and 2000. Thus, the 2000 version of the ISO 9001 standard, which is part of the ISO 9000 family, is written “ISO 9001:2000?. The ISO 9001:2000 standard mainly focuses on the processes used to produce a service or product, whereas the ISO 9001:1994 standard was mainly focused on the product itself. Here is an overview of all the different standards in the ISO 9000 family:
ISO 9000: “Quality Management Systems – Basic Principles and Vocabulary”. The ISO 9000 standard describes the principles of a quality management system and defines the terminologyISO 9001: “Quality Management Systems – Requirements”. The ISO 9001 standard describes the requirements relative to a quality management system either for internal use or for contractual or certification purposes. Therefore, this standard is a group of requirements that companies must followISO 9004: “Quality Management Systems – Guidelines for Improving Performance”. This standard, which is intended for internal use and not for contractual purposes, focuses particularly on continually improving performanceISO 10011: “Guidelines for auditing quality management and/or environmental management systems”.

Business benefits of ISO 14001 Standards

2010-08-29T05:42:00.000-07:00

Business benefits of ISO 14001 Standards

Any manager will try to avoid pollution that could cost the company a fine for infringing environmental legislation. But better managers will agree that doing only just enough to keep the company out of trouble with government inspectors is a rather weak and reactive approach to business in today’s increasingly environment-conscious world.
There is a better way. The ISO 14000 way. The ISO 14000 standards are practical tools for the manager who is not satisfied with mere compliance with legislation – which may be perceived as a cost of doing business. They’re for the proactive manager with the breadth of vision to understand that implementing a strategic approach can bring return on investment in environmentrelated measures. Implementing an ISO 14000-basedenvironmental management system, and using other tools from the ISO 14000 family, will give you far more than just confidence that you are complying with legislation.
The ISO 14000 approach forces you to take a hard look at all areas where your business has an environmental impact. And this systematic approach can lead to benefits like the following:
a. Reduced cost of waste managementb. Savings in consumption of energy and materialsc. Lower distribution costsd. Improved corporate image among regulators, customers and the publice. Framework for continuous improvement of your environmental performance.
The manager who is “too busy managing the business” to listen to good senseabout environmental management could actually be costing the business plenty. Just think, for example, of the lost opportunities for achieving benefits like those above.
The ISO 14000 standards are management tools that will help your businessachieve environmental goals that go way beyond acquiring a mere “green sheen”.

The ISO 9001 & ISO 14001 Standards and the environment

2010-08-29T05:41:00.000-07:00

The ISO 9001 & ISO 14001 Standards and the environment

The ISO 14000 family of International Standards on environmental management is a relative newcomer to ISO’s portfolio – but enviroment-related standardization is far from being a new departure for ISO.

In fact, ISO has two-pronged approach to meeting the needs of business, industry, governments, non-governmental organizations and consumers in the field of the environment.

On the one hand, it offers a wideranging portfolio of standardized sampling, testing and analytical methods to deal with specific environmental challenges. It has developed more than 350 International Standards (out of a total more
than 12000) for the monitoring of such aspects as the quality of air, water and soil. These standards are means of providing business and government with scientifically valid data on the environmental effects of economic activity.

They also serve in a number of countries as the technical basis for environmental regulations.

ISO is leading a strategic approach by developing environmental management system standards that can be implemented in any type of organization in either public or private sectors (companies, administration, public utilities). To spearhead this strategic approach, ISO establish a new technical commitee, ISO /TC 207, Environmental management, in

1993. This followed ISO’s successful pioneering experience in management system standardization with the ISO 9000 series for quality management.

ISO’s direct involvement in environmental management stemmed from an intensive consultation process, carried out within the framework of a Strategic Advisory Group on Environment (SAGE),set up in 1991, in which 20 countrie, 11 international organizations and more than 100 environmental experts participated in defining the basic requirements of a new approach to environment-related standards.

This pioneering work was consolidated with ISO’s commitment to support the objective of “sustainable development” dicussed at the United Nations Conference on Environment and Development in Rio de Janeiro in 1992.

Today, delegations of business and government experts from 55 countries have participate actively within TC 207,

and another 16 countries have observer status. These delegations are chosen by the national standars institute concerned and they are required to bring to TC 207 a national consensus on issue being addressed by the commitee.

This national consensus is derived from a process of consultation with interested parties.

From its beginning, it was recognized that ISO/TC 207 should have close cooperation with ISO/TC 176, Quality management and quality assurance, in the areas of management systems, auditing and related terminology. Active efforts are under way to ensure compatibility of ISO environmental management and quality management standards, for the benefit of all organizations wishing to implement them.

ISO 9000 Series and Six Sigma

2010-07-14T05:24:00.000-07:00

As of the year 2001, more than 300,000 organizations world-wide have been certified to the ISO 9000 series standards. It embodies a consistent pair of standards, ISO 9001:2000 and ISO 9004:2000, both of which have been significantly updated and modernized. The ISO 9001:2000 standard specifies requirements for a quality management system for which third-party certification is possible, whereas ISO 9004:2000 provides guide- lines for a comprehensive quality management system and performance improvement through Self-Assessment.

The origin and historical development of ISO 9000 and Six Sigma are very different. The genesis of ISO 9000 can be traced back to the standards that the British aviation industry and the U.S. Air Force developed in the 1920s to reduce the need for inspection by approving the conformance of suppliers’ product quality. These standards developed into requirements for suppliers’ quality assurance systems in a number of western countries in the 1970s. In 1987 they were amalgamated into the ISO 9000 series standards.

Independent of ISO 9000, the same year also saw the launch of Six Sigma at Motorola and the launch of Self-Assessment by means of the Malcolm Baldrige National Quality Award in USA. Both Six Sigma and Self-Assessment can be traced back to Walter A. Shewhart and his work on variation and continuous improvement in the 1920s. It was Japanese industry that pioneered a broad application of these ideas from the 1950s through to the 1970s. When variation and continuous improvement caught the attention of some of the American business leaders in the late 1980s, it took the form of the Malcolm Baldrige National Quality Award, on a national level, and of Six Sigma at Motorola.

Some people are wondering if the ISO 9000:2000 series standards make Six Sigma superfluous. They typically refer to clause 8 of ISO 9001: “Measurement, analysis, improvement.”

It requires that companies install procedures in operations for the measurement of processes and data analysis using statistical techniques with the demonstration of continuous improvement . They also partly refer to the ISO 9004:2000 standards that embody guidelines and criteria for Self-Assessment similar to the national quality awards.

The author firmly believes that Six Sigma is needed regardless of whether a company is compliant with the ISO 9000 series. The two initiatives are not mutually exclusive and the objectives in applying them are different. A Six Sigma program is applied in organizations based on its top-line and bottom-line rationales. The primary objective for applying the ISO 9000 series standards is to demonstrate the company’s capability to consistently provide conforming products and/or services. Therefore, the ISO 9000 series standard falls well short of making Six Sigma superfluous.

The ISO 9000 series standards have from their early days been regarded and practiced by industry as a minimum set of requirements for doing business. The new ISO 9000:2000 stan

dards do not represent a significant change to this perspective. Six Sigma on the other hand, aims at world-class performance, based on a pragmatic framework for continuous improvement.

The author believes that Six Sigma is superior in such important areas as rate of improvement, bottom-line and top-line results, customer satisfaction, and top-level management commitment. However, considering the stronghold of ISO 9000 in industry, Six Sigma and ISO 9000 are likely to be applied by the same organization, but for very different purposes.

Improve your performance management with new version of ISO 9001

2010-06-26T21:28:00.000-07:00

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

ISO 9001 Standards Certification

2010-04-28T05:55:00.000-07:00

ISO 9001 Standards Certification

When an organization chooses not to pursue ISO 9001 certification or not to retain the ISO 9001 certificate, it should make no difference to the way the organization is managed. It’s similar to the man who chooses not to take the course examination. He still has the knowledge he has acquired whether or not he takes the exam and gets a certificate. What he cannot do is demonstrate to others that he has reached a certain level of education without having to prove it every time. People who know him don’t care that he didn’t take the exam. It is only those who don’t know him that he will have difficulty convincing.

Audit Of Electronic Documents In ISO 9001 Standards

2010-04-28T05:54:00.000-07:00

Audit Of Electronic Documents In ISO 9001 Standards

Electronic documents that establish management system policies and procedures can be in a variety of file formats depending on the software applications that are utilized by the organization to generate the documents. Electronic file formats include, Text, HTML, PDF, etc. Spreadsheets and databases formats are also considered to be electronic “documents” subject to the control elements of the management system to being audited.

Given the relative ease with which users can now create electronic spreadsheets and other electronic documents, auditors (either internal or external) should ensure that policies governing the controls that apply to management system documentation in-general are also employed for electronic documents through appropriate procedures.

Organizations need to employ suitable and effective methods within the electronic environment for ensuring the adequate review, approval, publication and distribution of its management system documentation. These should be consistent with the methods for the development and modification of electronic documents.

In many cases document control measures may also be standard features of software applications used for their creation. Therefore auditors should understand these application-specific controls to the degree that these are utilized as a basis for conformance to the applicable management system standard.

Given the increased capacity to modify, update, reformat and otherwise improve documents within an electronic-based management system, auditors should pay particular attention to control elements such as document identification and document revision level.

As electronic media facilitates an increased rate of document modifications, auditors should verify that the controls being employed for the management of obsolete documents are considered within the organizations’ document control policies and procedures.

Auditors should verify that electronic-based documentation exists to provide orientation to users with regard to the functional and control aspects associated with electronic documents. Additionally, “Point-of-use” requirements associated with the applicable management system standards will typically be addressed in part by the organization’s document access policies. Auditors should understand the organization’s policies and procedures regarding user privileges as these become important factors for properly realizing the organization’s processes.

External electronic communication with suppliers, customers and other interested parties may involve the exchange of documents. Given that these external documents may contain key parameters that specify the functioning of the organization’s processes, auditors should verify the degree to which these documents are formally introduced and controlled within the electronic-based management system.

Different Between Quality Assurance & Quality Control

2010-04-05T05:09:00.000-07:00

QA: Quality Assurance is the process which are having their eyes on the process to provide the assurity of the quality. like doing the testing at the time of development, giving the review comments and forced the developers to fixed the defects of the requirement, designed, coding and testing phase is the Quality Assurance.

Quality Control: Before delivering the product to make sure that all the documentation are provided, product has meet with the requirement criteria, all the SDLC phase are met with the exit criteria is the Quality control.

Difference between Quality Control and Quality Assurance?

	Quality Control	Quality Assurance
Definition	QC is about checking at the end of some development process (e.g. – a design activity) that we have built quality in i.e. that we have achieved the required quality with our methods.	QA is about having an overall development and management process that provides right environment for ensuring quality of final product.
Description	QC is like testing a module against requirement specification or design document, measuring response time, throughput etc.	QA gives us added assurance that the whole producing or checking process is properly planned and executed and thus maintaining high quality.
What it does	To check that the modern methods of software development are largely designed to ensure right quality is achieved. QC checks that these methods are in place and to discover where they are not then corrections are to be made.	It gives us added assurance that the while producing / checking process is being properly planned and executed and hence is keeping high our chances of producing software of required quality.
Stages	Define features and levels Define feature check procedure Carrying out the check procedure Record the result take and record any corrective action taken.	1. Determination of quality policy through Quality Management System 2. Checking that predetermined Quality control activities are being properly taken care off.
Best carried out on	QC is best carried out on products	QA is best carried out on process.
Phase of implementation	QC should take place at every stage of SDLC.	QA should be done at end of every SDLC i.e. when product building is complete.
Technique	Structured walkthrough, Fagan Techniques are some of QC techniques.	Quality policy defined and generally implemented in the form of Quality Management System is used to carry out QA.

As per ISO 9000 Standards:

Quality Control means – The Operational Techique and activities that are used to fullfill requirements of Quality,

Quality Assurance means – All Those planned and systematic activites implemented already , to provide adequate confidence that an entity will fulfillrequirements of Quality.

The following table can explain in detail:

QC QA

Product Process

Reactive Pro-active

Line Function Staff Function

Find the defects Prevent the defects

e.g.

QC QA

Walkthrough Quality Audit

Testing Defining Process

Inspection Selection of tools

Checkpoint Review Trainings

Step by Step: Leading your company to Successful ISO 9001:2008 Registration

2010-04-05T05:08:00.000-07:00

Step by Step: Leading your company to Successful ISO 9001:2008 Registration

1. ISO 9000 Introduction, a Process approach.

2. Gap Analysis: Schedule the Gap Analysis, Conduction and ISO 9001 Gap Analysis.

3. Prepare a Project Plan: The Team approach, Steering Team, Task Teams.

4. Train employees on ISO 9001: Mamagement Overview, Employee awareness, Keeping them informed.

5. Document your system: How much Documentation do you need, Importance of Documentation control

6. Implement the QMS in your Organization:Training on new procedures, Training of internal auditors.

7. Audit your QMS: Train internal Auditors, Conduct Internal Audits.

8. ISO 9001:2008 Registration Audit: Selecting a Registrar and then go ahead with registration.

Document Review In ISO 9000 Standards

2010-01-18T03:03:00.000-08:00

Document Review In ISO 9000 Standards

The ISO 9000 Standard requires that documents be reviewed.
Previously the implication was that the review was a check by potential users that the document was fit for purpose before it was offered for approval. It
could be construed that for a document to receive approval it must be checked and therefore review and approval in this context are one and the same
and the requirement is in this instance enhanced rather than relaxed.
A review is another look at something. Therefore document review is a task that is carried out at any time following the issue of a document.
This requirement responds to the Continual Improvement principle.
Reviews may be necessary when:
- Taking remedial action (i.e. Correcting an error)
- Taking corrective action (i.e. Preventing an error recurring)
- Taking preventive action (i.e. Preventing the occurrence of an error)
- Taking maintenance action (i.e. Keeping information current)
- Validating a document for use (i.e. When selecting documents for use in connection with a project, product, contract or other application)
- Taking improvement action (i.e. Making beneficial change to the information)
Reviews may be random or periodic. Random reviews are reactive and arise from an error or a change that is either planned or unplanned. Periodic reviews
are proactive and could be scheduled once each year to review the policies, processes, products, procedures, specification etc. for continued suitability. In
this way obsolete documents are culled from the system. However, if the system is being properly maintained there should be no outdated information
available in the user domain. Whenever a new process or a modified process in installed the redundant elements including documentation and equipment
should be disposed of.

ISO 9000 Standards Document control procedures

2009-12-26T04:06:00.000-08:00

ISO 9000 Standards Document control procedures

BACKGROUND TO THE ISO 9001:2008 REVISION PROCESS

2009-12-16T06:57:00.000-08:00

BACKGROUND TO THE ISO 9001:2008 REVISION PROCESS

Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following: