Quality Assurance In ISO 9001 Standards

Quality assurance, according to the ISO 9001 Standard, is a way of managing that prevents non-conformance and thus “assures quality”. This is what makes ISO 9001 Standardsdifferent from other standards: it is a management standard, not a product standard. It goes beyond product standardisation: it is standardising not what is made but how it is made.

To use the ISO 9001 standards to dictate and control how organisations work was to extend the role of standards to new territory. To take such a step we might have firstly established that any such requirements worked — that they resulted in ways of working which improved performance. Yet the plausibility of this Standard, and the fact that those who had an interest in maintaining it were (and still are) leading opinion, prevented such enquiries. In simple terms the Standard asks managers to say what they do, do what they say and prove it to a third party. ISO 9000 (2008) paragraph 1: “The requirements specified are aimed primarily at achieving customer satisfaction by preventing non-conformity at all stages from design through servicing.” To put it another way, the Standard asserts that preventing non-conformance achieves customer satisfaction. But does it? Of course it matters to customers that a product works. But there is no guarantee that the Standard will ensure even that.

Furthermore, customers take a total view of an organisation — how easy it is to do business with — in respect of all things of importance to each and every customer. ISO 9000 requires managers to “establish and maintain a documented quality system as a means of ensuring that product conforms to specified requirements”. Loosely translated this is “say what you do”. Management is supposed to “define and document its policy for quality . . . including its commitment to quality”. What management would not declare its commitment to quality? But would they know what it means? Would they argue (as they should) that quality management is a different and better way to do business, or would they believe that ISO 9001 Standardswill take care of quality?

The ISO 9000 Standards encourages managers to think of “quality” and “business as usual” as separate and distinct. It helps managers avoid the revelation that quality means a wholly different view of management. Instead, the organisation “shall appoint a management representative who, irrespective of other responsibilities, shall have defined authority and responsibility” [for ISO 9000]. At a practical level this means only one executive might decide he or she had better learn a thing or two about quality.

However, would being responsible for ISO 9001 standards lead to learning about quality or simply enforcing the ISO 9000 regime in an organisation? Key to the regime is auditing. The Standard requires organisations to conduct internal quality audits to “verify whether quality activities comply with planned arrangements”. This can be loosely translated as “do you do as you say?” and the purpose of the audit is to see that you do. It was not until the 1994 review that the words were changed to “quality activities and related results”. It was a Standard which was rooted in the philosophy of inspection: fifteen years after its initial promulgation the promoters sought to extend the focus to results. But results or improvements assessed by what means? Inspection. By the time the Standard was adopted world-wide, quality thinking had moved a long way from the philosophy of inspection. It is now understood, at least by a few, that quality is achieved through managing the organisation as a system and using measures which enable managers to improve flow and reduce variation (which we explore in chapters 5 and 7).

The defenders argue that there is nothing stopping a company having ISO 9000 and implementing methods for managing flow and reducing variation, but where are such companies? Few of the companies we researched, formally and informally, knew anything about this thinking. The Standard does not talk about it; moreover, the Standard effectively discourages managers from learning about it by representing quality in a different way. According to ISO 8402 (quality vocabulary), quality is: “The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs.” Everything we have learned about ISO 9000 suggests that the people who created this definition were thinking about the things which need to be controlled, those things which “bear on its ability . . .”. The builders of the Standard assumed that customer needs would be listed in contractual agreements between the supplier and customer. ISO 9000 has a “make” logic — procedures for “how you do what you do” — and a “control” logic — check to see that it is done. It is a relic of the era when contractual agreements were perceived to be an important device for regulating the behaviour of suppliers.

In these ways, ISO 9000 standards encouraged “planning for quality”. Planning for quality sounds plausible, but it assumes many things: that the plan is the right plan, that it is feasible, that people will “do it”, that performance will improve. It is an approach which, paradoxically, leads to poor decisions. Planners of quality systems, guided by ISO 9000 standards , start with a view of how the world should be as framed by the Standard. Understanding how an organisation is working, rather than how someone thinks it should, is a far better place from which to start change of any kind.

ISO 9000 Standards Video Clip On Youtube

ISO 9000 Standards - ISO 9000 Standard Software
The term ISO9000 Standards refers to a set of quality management standards. ISO9000 currently includes three quality standards: ISO 9000:2005, ISO 9001:2000, and ISO 9004:2000. ISO 9001:2000 presents requirements, while ISO 9000:2005 and ISO 9004:2000 present guidelines. All of these are process standards (not product standards).

ISO 9001 Standard 's purpose is to facilitate international trade by providing a single set of standards that people everywhere would recognize and respect.

The ISO 9001 Standards apply to all kinds of organizations in all kinds of areas. Some of these areas include manufacturing, processing, servicing, printing, forestry, electronics, steel, computing, legal services, financial services, accounting, trucking, banking, retailing, drilling, recycling, aerospace, construction, exploration, textiles, pharmaceuticals, oil and gas, pulp and paper, petrochemicals, publishing, shipping, energy, telecommunications, plastics, metals, research, health care, hospitality, utilities, pest control, aviation, machine tools, food processing, agriculture, government, education, recreation, fabrication, sanitation, software development, consumer products, transportation, design, instrumentation, tourism, communications, biotechnology, chemicals, engineering, farming, entertainment, horticulture, consulting, insurance, and so on.

What is ISO 9000 Standards?

What is ISO 9000 Standards?

Preparing ISO 9000 Standards Quality Manual

Preparing ISO 9000 Standards Quality Manual

Identifying and Recording Design Changes In ISO 9000 Standards

Identifying and Recording Design Changes In ISO 9000 Standards

The documentation for design changes in ISO 9000 Standards should comprise the change proposal, the results of the evaluation, the instructions for change and traceability in the changed documents to the source and nature of the change. You will therefore need:
- A Change Request form which contains the reason for change and the
results of the evaluation – this is used to initiate the change and obtain
approval before being implemented.
- A Change Notice that provides instructions defining what has to be changed this is issued following approval of the change as instructions to the owners of the various documents that are affected by the change.
- A Change Record that describes what has been changed – this usually forms part of the document that has been changed and can be either in the form of a box at the side of the sheet (as with drawings) or in the form of a table on a separate sheet (as with specifications).
Where the evaluation of the change requires further design work and possibly experimentation and testing, the results for such activities should be documented to form part of the change documentation.
At each design review a design baseline should be established which identifies the design documentation that has been approved. The baseline
should be recorded and change control procedures employed to deal with any changes. These change procedures should provide a means for formally
requesting or proposing changes to the design. For complex designs you may prefer to separate proposals from instructions and have one form for proposing design changes and another form for promulgating design changes after approval. You will need a central registry to collect all proposed changes and provide a means for screening those that are not suitable to go before the review board, (either because they duplicate proposals already made or because they may not satisfy certain acceptance criteria which you have prescribed). On receipt, the change proposals should be identified with a unique number that can be used on all related documentation that is subsequently produced. The change proposal needs to:
- Identify the product of which the design is to be changed
- State the nature of the proposed change identify the principal requirements, specifications, drawings or other design documents which are affected by the change
- State the reasons for the change either directly or by reference to failure
reports, nonconformity reports, customer requests or other sources
- Provide for the results of the evaluation, review and decision to be
recorded

Revision Of Documents In ISO 9000 Standards

Revision Of Documents In ISO 9000 Standards

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 9001.

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 standard 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.

Revision Of Documents In ISO 9000 Standards

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.

Establishing Quality Objectives In ISO 9000 Standards

Establishing Quality Objectives In ISO 9000 Standards

The ISO 9000 Standard requires that top management ensure that quality objectives are established.

ISO 9001 defines quality objectives as results sought or aimed for related to quality. It also suggests that these

objectives be based on the quality policy and be specified at different levels in the organization, being

quantified at the operational level. As with quality policy the details will be addressed later and here we

will focus on what it means to establish qualityobjectives and how they relate to other objectives.

As the quality policy equates to the corporate policy, it follows that quality objectives equate to corporate objectives. All of the organization’s objectives should in some way serve to fulfil requirements of customers and other interested parties. It is also interesting to note that inISO 9001, the term requirement is defined as a need or expectation that is stated, customarily implied or obligatory. While an investor may not specify a requirement for growth in share value, it would certainly be an expectation. While an employee does not express requirements for salary increases when profits rise, it would certainly be an expectation and while society has no way other than to protest or invoke the law to impose its desires upon an organization, it certainly has the power to make organization’s comply and even change the law in extreme cases. So quality objectives do equate to corporate objectives.

Management needs to ensure that the objectives are established as a basis for action. All work serves an objective and it is the objective that stimulates action.

The reason for top management setting the objectives is to ensure that everyone channels their energies in a positive direction that serves the organizations purpose and mission.

For an objective to be established it has to be communicated, translated into action and become the focus of all achievement. Objectives are not wish lists. The starting point is the purpose and mission statement and the factors

identified as affecting the ability of the organization to accomplish its mission. It is in these areas the organization needs to excel and therefore they become the focus for action and consequently the setting of objectives. Although ISO 9001 suggests that the quality objectives should be based on the quality policy, it is more likely to be current performance, competition and opportunities arising from new technology that drive the objectives.

An objective is a result that is aimed for and is expressed as a result that is to be achieved. Objec-

tives are therefore not policies. The requirement should also not be interpreted as applicable only to

organizational functions and levels. Objectives are required at levels within the organization not levels

within the organization structure. This is clarified by the requirement for objectives to include those

needed to meet requirements for product. There are therefore five levels at which control and improve-

ment objectives need to be established:

Corporate level where the objectives are for the whole enterprise to enable it to fulfil its vision

Process level where the objectives are for specific processes to enable them to fulfil corporate goals

Product or service level where the objectives are for specific products/services or ranges of products/services to enable them to fulfil or create customer needs and expectations

Departmental or function level where the objectives are for an organizational component to enable it to fulfil corporate goals Personal level where the objectives are for the development of individual competency

A management system is not a static system but a dynamic one and if properly designed and implemented can drive the organization forward towards world class quality. All managerial activity is concerned either with maintaining performance or with making change. Change can retard or advance performance. That which advances performance is beneficial. In this regard, there are two classes of quality objectives, those serving the control of quality

(maintaining performance) and those serving the improvement of quality (making beneficial change).

maintain or to prevent from deteriorating. To maintain your performance and your position in the market you will have to continually seek improvement.

Remaining static at whatever level is not an option if your organization is to survive. Although you will be striving for improvement it is important to avoid slipping backwards with every step forwards. The effort needed to prevent

regression may indeed require innovative solutions. While to the people working on such problems, it may appear that the purpose is to change the status quo, the result of their effort will be to maintain their present position not raise it to higher levels of performance. Control and improvement can therefore be perceived as one and the same thing depending on the standards being aimed for and the difficulties in meeting them.

The statements of objectives may be embodied within business plans, product development plans, improvement plans, process descriptions and even procedures.

Achievable objectives do not necessarily arise from a single thought even when the policies provide a framework. There is a process for establishing objectives.

At the strategic level, the subjects that are the focus for setting objectives are the factors that affect the organization’s ability to accomplish its mission – the critical success factors such as marketing, innovation, human resources,

physical and financial resources, productivity and profit. There may be other factors such as the support of the community, of unions, of the media as certain businesses depend on continued support from society. Customer needs, regulations, competition and other external influences shape these objectives and cause them to change frequently. The measures arise from an analysis of current performance, the competition and there will emerge the need for either improvement or control. The steps in the objective setting process are as follows:

Identifying the need

Drafting preliminary objectives

Proving the need to the appropriate level of management in terms of:

whether the climate for change is favourable

the urgency of the improvement or controls

the size of the losses or potential losses

the priorities

Identifying or setting up the forum where the question of change or control is discussed Conducting a feasibility study to establish whether the objective can be achieved with the resources that can be applied Defining achievable objectives for control and improvement

Communicating the objectives

The standard does not require that objectives be achieved but it does require that their achievement be planned and resourced. It is therefore prudent to avoid publishing objectives for meeting an unproven need and which has not

been rigorously reviewed and assessed for their feasibility. It is wasteful to plan for meeting objectives that are unachievable and it diverts resources away from more legitimate uses.

Objectives are not established until they are understood and therefore communication of objectives must be part of this process. Communication is incomplete unless the receiver understands the message but a simple yes or no is not an adequate means of measuring understanding. Measuring employee understanding of appropriate quality objectives is a subjective process. Through the data analysis carried out to meet the requirements of clause 8.4 you will have produced metrics that indicate whether your quality objectives are being achieved. If they are being achieved you could either assume your employees understand the quality objectives or you could conclude that it doesn’t matter. Results alone are insufficient evidence. The results may have been achieved by pure chance and in six months time your performance may have declined significantly. The only way to test understanding is to check the decisions people make. This can be done with a questionnaire but is more effective if one checks decisions made in the work

place. Is their judgement in line with your objectives or do you have to repeatedly adjust their behaviour?

For each objective you should have a plan that defines the processes involved in its achievement. Assess these processes and determine where critical decisions are made and who is assigned to make them. Audit the

decisions and ascertain whether they were contrary to the objectives. A simple example is where you have an objective of decreasing dependence upon inspection. By examining corrective actions taken to prevent recurrence of

nonconformities you can detect whether a person decided to increase the level of inspection in order to catch the nonconformities or considered alternatives.

Any person found increasing the amount of inspection has clearly not understood the objective.

ISO 9000 Standards – Quality Management Principles

ISO 9000 Standards – Quality Management Principles
A quality management principle is defined by ISO/TC 176 as a comprehensive and fundamental rule or belief, for leading and operating an organization, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all other interested parties. Eight principles have emerged as fundamental to the management of quality.

All the requirements of ISO 9001:2008 are related to one or more of these principles. These principles provide the reasons for the requirements and are thus very important. The quality management principles can be listed as below:

1. Customer focus
Organizations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.
The customer focus principle is reflected in ISO 9000 Standards through the requirements addressing:
a. Communication with the customer
b. Care for customer property
c. The determination of customer needs and expectations
d. Appointment of a management representative
e. Management commitment

2. Leadership
Leaders establish unity of purpose and direction for the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.
The leadership principle is reflected in ISO 9000 Standards through the requirements addressing:
a. The setting of objectives and policies
b. Planning
c. Internal communication
d. Creating an effective work environment

3. Involvement of people
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.
The involvement of people principle is reflected in ISO 9000 Standards through the requirements addressing:
a. Participation in design reviews
b. Defining objectives, responsibilities and authority
c. Creating an environment in which people are motivated
d. Internal communication
e. Identifying competence needs

4. Process approach
A desired result is achieved more efficiently when related resources and activities are managed as a process.
The process approach principle is reflected in ISO 9000 Standards through the requirements addressing:
a. The identity of processes
b. Defining process inputs and outputs
c. Providing the infrastructure, information and resources for processes to
function

5. System approach to management
This principle is expressed as follows:
Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.
The system approach principle is reflected in ISO 9001 through the requirements addressing:
a. Establishing, implementing and maintaining the management system
b. Interconnection, interrelation and sequence of processes
c. The links between processes
d. Establishing measurement processes

6. Continual improvement
This principle is expressed as follows:
Continual improvement of the organization’s overall performance should be a permanent objective of the organization.
The continual improvement principle is reflected in ISO 9000 Standards through the requirements addressing:
a. Improvement processes
b. Identifying improvements
c. Reviewing documents and processes for opportunities for improvement

7. Factual approach to decision making
This principle is expressed as follows:
Effective decisions are based on the analysis of data and information.
The factual approach principle is reflected in ISO 9000 Standards through the requirements addressing:
a. Reviews, measurements and monitoring to obtain facts
b. Control of measuring devices
c. Analysis to obtain facts from information
d. Records for documenting the facts
e. Approvals based on facts

8. Mutually beneficial supplier relationships
This principle is expressed as follows:
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
The mutually beneficial supplier relationships principle is reflected in ISO 9000 Standardsthrough the requirements addressing:
a. Control of suppliers
b. Evaluation of suppliers
c. Analysis and review of supplier data

ISO 9000 Standards – Document Approval

ISO 9000 Standards – Document Approval

The ISO 9000 Standards requires that documents be approved for adequacy prior to issue.

Approval prior to issue means that designated authorities have agreed the document before being made available for use. Whilst the term ade-
quacy is a little vague it should be taken as meaning that the document is judged as fit for the intended purpose. In a paper based system, this means approval before the document is distributed. With an electronic system, it means that the documents should be approved before they are published or made available to the user community.

The ISO 9000 Standards document control process needs to define the process by which documents are approved. In some cases it may not be necessary for anyone other than the approval authority to examine the documents. In others it may be necessary to set up a panel of reviewers to solicit their comments before approval is given.
It all depends on whether the approval authority has all the information
needed to make the decision and is therefore ‘competent’. One might think that the CEO could approve any document in the organization but just because a person is the most senior executive does not mean he or she is competent to perform any role in the organization.

Users should be the prime participants in the approval process so that the
resultant documents reflect their needs and are fit for the intended purpose. If the objective is stated in the document, does it fulfil that objective? If it is stated that the document applies to certain equipment, area or activity, does it cover that equipment, area or activity to the depth expected of such a document? One of the difficulties in soliciting comments to documents is that you will gather comment on what you have written but not on what you have omitted. A useful method is to ensure that the procedures requiring the document specify the acceptance criteria so that the reviewers and approvers can check the document against an agreed standard.

To demonstrate documents have been deemed as adequate prior to issue,
you will need to show that the document has been processed through the
prescribed document approval process. Where there is a review panel, a simple method is to employ a standard comment sheet on which reviewers can indicate their comments or signify that they have no comment. During the drafting process you may undertake several revisions. You may feel it
necessary to retain these in case of dispute later, but you are not required to do so. You also need to show that the current issue has been reviewed so your comment sheets need to indicate document issue status.