ISO 9001 Standard - ISO 9001 Standards

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Origin Of ISO 9000 Standards

The standard requires companies to write an ISO 9000 quality manual that defines how each requirement of the rather broad ISO 9001:2008 standard is applied at the company. In a sense, the ISO 9000 quality manual is a company specific version of the standard.

While writing the quality manual represents a big hurdle for most companies, the ISO 9001:2008 standard requires further details in form of ISO 9000 quality procedures, a quality policy and quality objectives. Most companies make the mistake of creating various different documents to meet these requirements; however, this usually is the beginning of a cumbersome and bureaucratic ISO 9000 quality system.
Tip: Combine the different documentation requirements (i.e., quality manual, procedures, corporate policy and objectives) as much as possible into one comprehensive manual. This reduces repetition and bureaucracy, and it saves time implementing the quality system.

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Implementing ISO 9000 Quality Management System

Implementation of ISO 9000 affects the entire organization right from the start. If pursued with total dedication, it results in ‘cultural transition’ to an atmosphere of continuous improvement.
The process of implementing ISO 9000 depends on:
a. The sophistication of your existing quality program,
b. The size of your organization, and
c. The complexity of your process.

The 14 essential steps, briefly described below, are to be followed through in order to implement ISO 9000 quality management system successfully.
Step 1: Top management commitment
Step 2: Establish implementation team
Step 3. Start ISO 9000 awareness programs
Step 4: Provide Training
Step 5. Conduct initial status survey
Step 6: Create a documented implementation plan
Step 7. Develop quality management system documentation
Step 8: Document control
Step 9. Implementation
Step 10. Internal quality audit
Step 11. Management review
Step 12. Pre-assessment audit
Step 13. Certification and registration
Step 14: Continual Improvement

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What Is ISO 14000 Environmental Management System

ISO 14000 is primarily concerned with Environmental Management. In plain language, this means what the organization does to minimize harmful effects on the environment caused by its activities.

Improving the environmental performance of corporations is one way of limiting environmental damage. Environmental management systems (EMS’s), such as ISO 14001, provide a framework for organizations that wish to effectively manage their environmental affairs. Implementing an EMS that conforms to the ISO 14001 standard may help businesses integrate environmental values into their operations.

An EMS can be described as a program of continuous environmental improvement that follows a defined sequence of steps drawn from established project management practice and routinely applied in business management. In simple terms these steps are as follows:
• Review the environmental consequences of the operations.
• Define a set of policies and objectives for environmental performance.
• Establish an action plan to achieve the objectives.
• Monitor performance against these objectives.
• Report the results appropriately.
• Review the system and the outcomes and strive for continuous improvement.
Not every system will present these steps in exactly the same way, but the basic principles are clear and easily understandable.

The ISO 14000 series is a series of standards for different aspects of environmental management. A number of these standards relating to environmental management systems have been adopted formally by the members of the ISO, while others are in different stages of preparation.

ISO 14000 is a group of standards covering the following areas:
•Environmental Management Systems (14001,14002, 14004)
•Environmental Auditing (14010, 14011, 14012)
•Evaluation of Environmental Performance (14031)
•Environmental Labeling (14020, 14021, 14022, 14023, 14024, 14025)
•Life-Cycle Assessment (14040, 14041,14042, 14043)

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ISO 9001 Standards – Quality Manuals

ISO 9001 is a quality management system (QMS) created and maintained by the International Organization for Standardization (ISO), the largest developer of international standards in the world. QMS systems are meant to provide organizations with a formal framework for process improvements and quality standards. The system provides a set of procedures that covers all key processes to ensure they are effective. It also provides a methodology for record-keeping, checking for defects and continuous improvement and maintenance of these functions.

- Provide resources needed to support process operations, monitoring and the management review process.

- Transform and maintain physical workspaces, equipment, hardware, software, utilities and support services needed to meet requirements.

- Develop a system to review transportation (if any), communication and information services for sharing data relating to ISO 9001 standards.

- Provide adequate training for management reviewers (MRs) and internal auditors. They should have the right experience, education and skills needed to ensure that competence requirements are being met.

- Keep a record of the review process. This includes corrective and preventive action procedures.

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ISO 9001:2008 Draft Changes

ISO 9001:2008 Draft Changes

0.1 Changes here are a statement about whom and where the standard is including any statutory requirements and have the same scale as any customer or regulatory requirements. It’s also clarified that these requirements are restricted to those applicable to the product.

0.4 There is a comment that state that the new standard is made due consideration to ISO 14001:2004.

1.1 &1.2 Statutory requirements had been referred in connection with purchased products and product realization. Second note explains that a statutory requirement can be a legal requirement.

After so many years of auditions the long last debate had been settled. Statutory legal requirements and statutory requirements are obliged to the purchasing processes. It was always an open area that no one had the correct answer: is your supplier must follow the law or not? Apparently yes.

2Normative reference – the ISO 9000 is now replaced by ISO 9000:2005.

3The explanations about what is a customer and what is an organization and what is a supplier had been removed.

4.1 Clause a – The word “determine” is replacing the “identify”

A note had been added stating that a purchased processes are regarded as purchasing products and another note that demand that these processes would be controlled as far as products.

4.2.1 Slight change of words but when you examine the change you realize the meaning is the same.

Note 2 was changed – a single document may include requirements for more than one procedure and requirements of one procedure may appear in more than one document.

It’s about time. A lot of headaches are vowed to be save. If your audit was one of the old school and demanded everything by the book – now you may combine two quality procedures to one document: Job description and training for example or you can split one document into two. How ever it is suitable for you as long as you provide the requirements.

4.2.3 A clarification that external documentation is considered while it is part of the quality management system.

5.1 Clause a – the word “statutory” had been added.

5.5.2 An addition for a requirement that the management representative would be a member of the organization’s management.

That addition puts all external consultants at risk – you can no longer be the

management representative. That sets a whole new line of form and documentations for you to develop in order that the external consultants would be considered as a management representative.

6.2.2Clause b –”provide training or take other actions to satisfy these needs” changed to “where applicable training needs to be provided to achieve the necessary competence”

Clause c – you must ensure that the training is with competence rather than if it was an effective training.

It all goes back to defining .You defined what is necessary now you must provide it nothing is new.

On one hand it is an improvement. The training must be reviewed before. But I think it’s not such an improvement. Instead of testing your employees if they got anything of the training you must now check the training itself before.

6.3 Clause c – information systems are included.

6.4 A new note: noise, humidity, temperatures are part of a working environment.

7.1 Clause c – measurement had been added to the activities.

7.2.1

Clause a – change of words – not of the meaning.

Clause c – the word ‘applicable’ replaces ‘related’.

Clause d – change of words – not of meaning.

A note has been added to explain what is the meaning of “post delivery activities”.

7.3.1 A note had been added clarifying that design review, verification and

validation are separated processes but they might be conducted together.

7.3.3

A change of words.

A note had been added clarifying what is included in “preservation of product”.

7.5.3 A requirement added specifying that product traceability must be included throughout the product realization.

That actually means that the product must be identified not only on the shelves after or between, but also throughout the realization process. Is pacticable? Only time will tell…

7.5.4

A change of words in the requirement to inform the customer of any problem

regarding his property.

The note had been amended that also personal data is included as customer’s

property.

7.5.5

A change of words:

from “conformity of” to “in order to maintain conformity to requirements”.

7.6

A change of words: from “devices” to “equipment”.

The reference to paragraph 7.2.1 had been removed.

Clause c – from “be identified to enable the”

to ” identification to enable their”.

Changes in the notes:

Note 1 – the reference to ISO 100012-2 had been removed.

Note 3 – explanation about when configuration of computer must be applied when the computer is used for monitor and measurements processes.

That means that from now on a computers that provides any kind of measurements services is considered a monitoring and measuring device. How can one calibrate a computer? Ask the supplier or your system administrator. They will know better than anyone. But you would have to prove it has been done.

8.2.1

A note had been added to suggest some means of conducting customer satisfaction evaluation.

8.2.2

Requirements for the audit evidence and results had been added and also that the management is responsible for ensuring preventive and corrective action to be taken.

The reference to the ISO 10011 is changed to ISO 19011.

8.2.3

A change of words:

“to ensure conformity of the product” had been removed.

A note had been added to clarify that the organization should determine the type of the monitoring and measuring according to the processes and how will this affect the quality management system.

8.2.4

A change of word:

“maintain evidence of conformity with acceptance criteria” had been removed but it is still a requirement.

8.3

An addition Clause d – specify how to deal with a nonconforming product that was discovered after delivery – but actually there nothing new only that they moved it to a new clause.

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.