ISO 9000 Standard

ISO 9001 Standard Quality Manual Template

2012-02-04T19:29:00.000-08:00

The quality manual is the necessary cornerstone for any business venturing out on the ISO 9001:2008 accreditation route as it exhibits top management’s determination to managing an useful quality management system. The quality manual is a type of most essential document which provides the right impression to clients, staff, inspectors and all the parties interested in your company, about your company’s efforts to satisfy all their clientele’s needs. People through your company will relate to it whenever they prefer to find the big picture of the system, or exactly what guidelines have been organized. You can save your valuable time and hard earned money with the quality manual template we offer you. If you really compile the quality manual, you will easily comprehend and apply ISO 9001:2008, which is one of the best methods to do so.By reading by the needs one-by-one and assigning each prerequisite a specific document, process or technique that exists within your company, you will get that over half of the demands have already been resolved. Quality manual makes the relation, between the process and the documents, an official one. Format and content Write your quality manual to ensure that it works for you, for your company and also the manner you work, it is totally your selection however generally make sure that it supports your organisation’s targets. The quality manual should not contain any confidential or proprietary information as it should be readily available to third party auditors and customers. You should also ensure that a clear distinction is made between the contents of the quality manual and the procedures. The quality manual identifies the intention of top management for the operation of the quality management system, whilst the operations explain how these kind of purposes are integrated. There are three things that must be included in the quality manual:

1. The probability of the quality management system such as details of the validation of any exclusions

2. For quality management system, the procedures should be standard or should be mentioned in them

3. A explanation of the discussion between the procedures of the quality management system Who will use your Quality Manual and why?

In general, the clients and the prospective customers need it in order to know how your company system meets their requirements. If your quality manual includes two pages, it may not motivate trust that your system is strong enough to be an useful quality management system. Customers and Clients want assurance that you know how to plan, implement, and control the processes that affect their products or service delivery. The third party inspectors will b interested to know how your company meets their standard needs and also if perhaps the quality management system is useful in accomplishing your organization’s targets. Auditors will use the quality manual as a guide to help out discover and also form the purpose facts that they have to find in exhibition of your company’s compliance with the standard. Internal inspectors can review and inspect their own company for their needs rather than referring to standard documents from external sources. Management ought to be able to determine, from the manual, how the numerous processes and also systems have interaction, and at a high level what policies and methods have been established to maintain and control the processes and systems . The quality manual is usually presented to fresh recruits to familiarize themselves with the organization’s quality management system and also the manuals are often used as an in-house training resource. Most importantly, your quality manual ought to not sit on a dirty shelf or be hidden in an obscure position on the computer network; it is an active and powerful document that requires coverage in order for it to grow and also improve. Please click on the links below to learn more about Quality Manual Templates and view some free examples.

Read more on ISO 9001 Standard at http://www.iso9001store.com

ISO 14001 Certification

2011-11-28T06:01:00.000-08:00

ISO 14001 certification is primarily concerned with the approach of Environmental Management System. Keeping in mind the growing worldwide concerns regarding the living environment, we have come up with expertise in providing certification services.Certification to the internationally recognised EMS standard, ISO 14001 from an accredited and reputable provider is becoming a preferred choice for organisations looking to demonstrate their environmental credentials.

What is ISO 14001?

ISO 14001 is the internationally recognised standard for the environmental management of businesses. It prescribes controls for those activities that have an effect on the environment. These include the use of natural resources, handling and treatment of waste and energy consumption.

Implementing an Environmental Management System is a systematic way to discover and control the effects your company has on the environment. Cost savings can be made through improved efficiency and productivity. These are achieved by detecting ways to minimise waste and dispose of it more effectively and by learning how to use energy more efficiently. It verifies compliance with current legislation and makes insurance cover more accessible.

Advantages of ISO 14001 certification:

* Environmental legal liability.
* Improved corporate image; strategic investment; improved regulatory relations.
* Improving the quality of the environment.
* Assuring commitment to manage and improve environment
* Reducing incidents that may be detrimental to working in the long run and causing liability
* Conserve natural resources and energy and help in getting the required legal consent
* Sharing environmental solutions and improving industry and government relationship
* Evaluates system performance through management review and correct management system deficiencies.

The ISO 14001 certification provided by OSS, offers quality control system defines the organisation, responsibilities, objectives and procedures used to assure quality and reliability of products and services. The policies of the ISO 9001:2008 quality control program should be implemented and maintained at all levels of the business operation and be accessible to all employees.

The ISO 14000 standardization series establishes standards, guidelines, and policies governing correct environmental management by certified organizations. ISO 14001 is, thus far, the most recognized of the ISO 14000 series, as well as the sole ISO standard that can be certified. In an era of environmental consciousness, this certification is crucial for a business or corporate entity to remain competitive in not only a national market, but the international market.

Wide acceptance- ISO certification is recognised in more than 120 countries and is the logical choice for any organisation involved in international business or committed to quality.

The certification process is undertaken by a third party uninvolved in any way with the organization seeking certification. A sizable number of certification organizations, known as auditors, will provide materials, mentoring, and monitoring to ensure that organizations recognize and comply with the various management guidelines. Once the standards have been met, the auditing organization will certify the applicant organization as ISO 14001-compliant.

OSS is considered as a professional organisation which holds some of the highly qualified individuals in the pool, serving for a wide range of areas by providing customer preferred and efficient certification services. The company toils for rendering a complete suite of consulting services and training in the field of Quality Management and Environmental Management to the organisation across all the industries verticals for building a progressing and profitable organisation by creating competitive advantage in the market.

Read more on ISO 14001 Standard at http://www.e-wia.com

ISO 9001 Standard Quality Manual Template

2011-08-03T06:21:00.000-07:00

The quality manual is the necessary cornerstone for any business venturing out on the ISO 9001:2008 accreditation route as it exhibits top management’s determination to managing an useful quality management system. The quality manual is a type of most essential document which provides the right impression to clients, staff, inspectors and all the parties interested in your company, about your company’s efforts to satisfy all their clientele’s needs. People through your company will relate to it whenever they prefer to find the big picture of the system, or exactly what guidelines have been organized. You can save your valuable time and hard earned money with the quality manual template we offer you. If you really compile the quality manual, you will easily comprehend and apply ISO 9001:2008, which is one of the best methods to do so.By reading by the needs one-by-one and assigning each prerequisite a specific document, process or technique that exists within your company, you will get that over half of the demands have already been resolved. Quality manual makes the relation, between the process and the documents, an official one. Format and content Write your quality manual to ensure that it works for you, for your company and also the manner you work, it is totally your selection however generally make sure that it supports your organisation’s targets. The quality manual should not contain any confidential or proprietary information as it should be readily available to third party auditors and customers. You should also ensure that a clear distinction is made between the contents of the quality manual and the procedures. The quality manual identifies the intention of top management for the operation of the quality management system, whilst the operations explain how these kind of purposes are integrated. There are three things that must be included in the quality manual:

1. The probability of the quality management system such as details of the validation of any exclusions

2. For quality management system, the procedures should be standard or should be mentioned in them

3. A explanation of the discussion between the procedures of the quality management system Who will use your Quality Manual and why?

In general, the clients and the prospective customers need it in order to know how your company system meets their requirements. If your quality manual includes two pages, it may not motivate trust that your system is strong enough to be an useful quality management system. Customers and Clients want assurance that you know how to plan, implement, and control the processes that affect their products or service delivery. The third party inspectors will b interested to know how your company meets their standard needs and also if perhaps the quality management system is useful in accomplishing your organization’s targets. Auditors will use the quality manual as a guide to help out discover and also form the purpose facts that they have to find in exhibition of your company’s compliance with the standard. Internal inspectors can review and inspect their own company for their needs rather than referring to standard documents from external sources. Management ought to be able to determine, from the manual, how the numerous processes and also systems have interaction, and at a high level what policies and methods have been established to maintain and control the processes and systems . The quality manual is usually presented to fresh recruits to familiarize themselves with the organization’s quality management system and also the manuals are often used as an in-house training resource. Most importantly, your quality manual ought to not sit on a dirty shelf or be hidden in an obscure position on the computer network; it is an active and powerful document that requires coverage in order for it to grow and also improve. Please click on the links below to learn more about Quality Manual Templates and view some free examples.

Read more on ISO 9001 at http://www.iso-9001-store.com

Why Quality System Training Is Important In ISO 9001 Standards?

2011-05-24T05:37:00.000-07:00

Quality system design is an essential foundation for successful quality management, but quality systems training – for all employees – maybe the key to successful implementation and maintenance.

For most life science companies, maintaining a quality system has become a way of life. However, it probably isn’t these companies’ quality systems that keep their products and services afloat.

Yes, the manner in which a quality system is designed is duly important but the reality of the situation is that many quality system designs can work equally well in the same (or similar) environments. For example, one life science company may implement a well-known and highly recommended quality system design (ISO 9001 for example) and find great success while another very similar company may implement the same system and fail miserably.

The ability to get company employees to “buy into” a quality system is likely to make a big difference in a “pass or fail” quality system trial even, when a well known quality system design has been implemented. Whether it is change control, CAPA management, internal audits, customer complaints management, document control or deviations management, every company employee needs to know the following regarding his or her company’s quality system:

What the quality system policies are (at least those that will directly or indirectly affect him or her);
What the company’s objectives are in relation to the quality system policies, especially those objectives which the employee may be contributing to directly or indirectly;
What the company’s plans are to achieve those objectives especially those plans that will directly or indirectly affect the employee involved.

Every company should also take steps towards the testing of every employee’s comprehension of policies, objectives and plans related to quality system management. Measuring comprehension does NOT infer that a written exam be administered to employees. Perhaps simple observation from employee supervisors will be sufficient to determine whether one employee has a sufficient grasp of the policies objectives and plans that he or she should be aware of.

According to the FDA’s guidance document: Quality Systems Approach to Pharmaceutical cGMP Regulations, “Policies, objectives, and plans under a modern quality system provide the means by which senior managers articulate their vision of and commitment to quality to all levels of the organization.”¹

The FDA guidance also states that “senior management should incorporate a strong commitment to quality into the organizational mission.”²This of course can be accomplished by writing a “commitment to quality statement” in the company’s organizational mission. However, without training, employees are unlikely to care about or even think about quality management ideals and expectations.

To remedy this common dilemma, quality managers need to consider taking the following steps:

Ask Questions – Quality managers need to take time to talk, and most importantly, ask questions of every employee involved in quality. Well thought out questions regarding quality will at the very least get employees considering the endeavors they are involved in.
Delegate – More and more, quality is becoming less of a department and more of a group effort. That may seem scary for quality professionals but the reality is that delegation to numerous people (and/or departments) – combined with consistent follow through – always results in better business and better relationships between those who lead and those who follow.
A Quality Example – If quality managers don’t take quality seriously then it is less likely that other department employees will take the time to contribute to a company “quality cause.”

In short, quality management system may at times seem complex but it’s actually like most managerial responsibilities – primarily a people process.

Visit http://www.iso9001store.com for moure information.

ISO 9000 Document Control Procedures

2011-02-05T04:17:00.001-08:00

The ISO 9000 Standard requires that a documented procedure be established to define

the controls needed.

This requirement means that the methods for performing the various activities required

to control different types of documents should be defined and documented.

Although the standard implies that a single procedure is required, should you choose

to produce several different procedures for handling the different types of documents

it is doubtful that any auditor would deem this noncompliant. Where this might be

questionable is in cases where there is no logical reason for such differences

and where merging the procedures and settling on a best practice would

improve efficiency and effectiveness.

Documents are recorded information and the purpose of the document

control process is to firstly ensure the appropriate information is available

where needed and secondly to prevent the inadvertent use of invalid

information. At each stage of the process are activities to be performed that

may require documented procedures in order to ensure consistency and

predictability. Procedures may not be necessary for each stage in the process.

Every process is likely to require the use of documents or generate documents

and it is in the process descriptions that you define the documents that need to

be controlled. Any document not referred to in your process descriptions is

therefore, by definition, not essential to the achievement of quality and not

required to be under control. It is not necessary to identify uncontrolled

documents in such cases. If you had no way of tracing documents to a

governing process, a means of separating controlled from uncontrolled may

well be necessary.

The procedures that require the use or preparation of documents should also

specify or invoke the procedures for their control. If the controls are unique to

the document, they should be specified in the procedure that requires the

document. You can produce one or more common procedures that deal with

the controls that apply to all documents. The stages in the process may differ

depending on the type of document and organizations involved in its

preparation, approval, publication and use. One procedure may cater for all the

processes but several may be needed.

The aspects you should cover in your document control procedures, (some

of which are addressed further in this chapter) are as follows

Planning new documents, funding, prior authorization, establishing need

etc.

- Preparation of documents, who prepares them, how they are drafted,

conventions for text, diagrams, forms etc.

- Standards for the format and content of documents, forms and diagrams.

- Document identification conventions.

- Issue notation, draft issues, post approval issues.

- Dating conventions, date of issue, date of approval or date of distribution.

- Document review, who reviews them and what evidence is retained.

- Document approval, who approves them and how approval is denoted.

- Document proving prior to use.

- Printing and publication, who does it and who checks it.

- Distribution of documents, who decides, who does it, who checks it.

- Use of documents, limitations, unauthorized copying and marking.

- Revision of issued documents, requests for revision, who approves the

request, who implements the change.

- Denoting changes, revision marks, reissues, sidelining, underlining.

Amending copies of issued documents, amendment instructions, and

amendment status.

- Indexing documents, listing documents by issue status.

- Document maintenance, keeping them current, periodic review.

- Document accessibility inside and outside normal working hours.

- Document security, unauthorized changes, copying, disposal, computer

viruses, fire and theft.

- Document filing, masters, copies, drafts, and custom binders.

- Document storage, libraries and archive, who controls location, loan

arrangements.

- Document retention and obsolescence.

With electronically stored documentation, the document database may provide

many of the above features and may not need to be separately prescribed in

your procedures. Only the tasks carried out by personnel need to be defined in

your procedures. A help file associated with a document database is as much

a documented procedure as a conventional paper based procedure.

Document Review In ISO 9000 Standards

2011-02-05T04:15:00.000-08:00

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.

Revision Of Documents In ISO 9000 Standards

2011-02-05T04:14:00.002-08:00

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.

Revision Of Documents In ISO 9000 Standards

2011-02-05T04:14:00.001-08:00