Contents Of ISO 14001 Standards

The ISO 14000 family addresses various aspects of environmental management. The very first two standards, ISO 14001:2004 and ISO 14004:2004 deal with environmental management systems (EMS). ISO
14001:2004 provides the requirements for an EMS and ISO 14004:2004 gives general EMS guidelines.

The newly revised ISO 14001:2004 specifies the requirements for an environmental management system (EMS), which provides a framework for an organization to control the environmental impacts of its activities, products
and services, and to continually improve its environmental performance. It applies to those environmental aspects which the organization can control and over which it can be expected to have an influence. It does not itself state
specific environmental performance criteria.

ISO 14001:2004 is applicable to any organization that wishes to:
• implement, maintain and improve an environmental management system
• assure itself of its conformance with its stated environmental policy
• demonstrate such conformance to others
• seek certification/registration of its environmental management system by an external organization
• make a self-determination and self-declaration of conformance with this international standard.

All the requirements in this standard can be incorporated into any environmental management system. Having been revised, the improved ISO 14001 is now expected to bring the benefits of implementing an EMS to more businesses than ever. The standard is now easier to understand and use and has more detailed checklists for inputs and outputs from the management review and has increased compatibility to ISO 9001.

Key Elements Of ISO 14001:2004
• Environmental policy
Develop a statement of your organizations commitment to the environment. Use this policy as a framework for planning and action.
An environmental policy is top managements declaration of its commitment to the environment. This policy should serve as the foundation for your EMS and provide a unifying vision of environmental concern by the entire organization. Given its importance, your policy should be more than just flowery prose.

Since it serves as the framework for setting environmental objectives and targets, the policy should be brought to life in your plans and deeds. Everyone in the organization should understand the policy and what is expected of them in order to achieve the organizations objectives and targets.
Your policy should reflect three key commitments, including a commitment to continual improvement. While this does not mean that you must improve in all areas at once, the policy should drive your organizations efforts to continually improve environmental management (and the improved performance that results from these efforts).

What is ‘Root Cause Analysis’ In ISO 9001 Standards?

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

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

What is ‘Root Cause Analysis’ In ISO 9001 Standards?

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

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

Certification Of ISO 14001

Certification Of ISO 14001

International Organization for Standardization (ISO) is functioning from Geneva in Switzerland as a worldwide federation of national standards organizations. The mission of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing corporation in the spheres of intellectual, scientific, technological and economic activity. ISO’s works result in international agreements which are published as international agreements which are published as international standards.

ISO 9000

Previous version of ISO 9000 (1994) emphasize on documents and document control. But as per new standard the extent of documentation can differ from company to company in a simplified manner.

ISO 9000 system requires records at relevant stages which provide data for continual improvement and can be used for legacy as a data bank.

ISO 14000

ISO 14000, the environmental management system family of standards, was formally published by the International Organization for Standardization (ISO) on September 2, 1996. ISO 14001 is the conformance standard within the ISO 14000 series. After extensive groundwork, the revised version of ISO 14001 was released on 15th of November 2004. ISO 14001:2004 will replace ISO 14001:1996 after a transition period of 18 months, ending on 14th May 2006, and will become the basis for the certification procedure for environmental management. All ISO 14001:1996 certificates will be rendered invalid on 15th May 2006

Since 1996 the ISO 14001 has formed the basis for structuring, implementation, review and further development of environmental management systems. It lays down the applicable demands for organizations of all kinds and sizes as well as for diverse geographical, cultural and social conditions. The overall objective is to promote environmental protection and the prevention of environmental stress in harmony with economic, social and political requirements.

OHSAS 18001 is an Occupation Health and Safety Assessment Series for health and safety management systems. It is intended to help an organizations to control occupational health and safety risks (OH&S). The importance of managing Occupational Health and Safety is recognized by all interested parties – employers, employees, customers, suppliers, insurers,shareholders, the community, contractors, and regulatory agencies. It enables an organization to control occupational health and safety risks risks and to improve performance.

Certification Of ISO 14001

Certification Of ISO 14001

International Organization for Standardization (ISO) is functioning from Geneva in Switzerland as a worldwide federation of national standards organizations. The mission of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing corporation in the spheres of intellectual, scientific, technological and economic activity. ISO’s works result in international agreements which are published as international agreements which are published as international standards.

ISO 9000

Previous version of ISO 9000 (1994) emphasize on documents and document control. But as per new standard the extent of documentation can differ from company to company in a simplified manner.

ISO 9000 system requires records at relevant stages which provide data for continual improvement and can be used for legacy as a data bank.

ISO 14000

ISO 14000, the environmental management system family of standards, was formally published by the International Organization for Standardization (ISO) on September 2, 1996. ISO 14001 is the conformance standard within the ISO 14000 series. After extensive groundwork, the revised version of ISO 14001 was released on 15th of November 2004. ISO 14001:2004 will replace ISO 14001:1996 after a transition period of 18 months, ending on 14th May 2006, and will become the basis for the certification procedure for environmental management. All ISO 14001:1996 certificates will be rendered invalid on 15th May 2006

Since 1996 the ISO 14001 has formed the basis for structuring, implementation, review and further development of environmental management systems. It lays down the applicable demands for organizations of all kinds and sizes as well as for diverse geographical, cultural and social conditions. The overall objective is to promote environmental protection and the prevention of environmental stress in harmony with economic, social and political requirements.

OHSAS 18001 is an Occupation Health and Safety Assessment Series for health and safety management systems. It is intended to help an organizations to control occupational health and safety risks (OH&S). The importance of managing Occupational Health and Safety is recognized by all interested parties – employers, employees, customers, suppliers, insurers,shareholders, the community, contractors, and regulatory agencies. It enables an organization to control occupational health and safety risks risks and to improve performance.

ISO 9001 Standard Quality Manual Template

ISO 9001 Standard Quality Manual Template

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.

Costs and resources Of ISO 9001 Standards

Costs and resources Of ISO 9001 Standards

The largest cost of ISO 9001 is the involvement of company employees. The ‘ownership’ created by involving employees in designing the quality system maximises the chances of them accepting it. Reducing this cost by minimising employee involvement is a false economy. The next largest cost will be for designing and developing the system. This needs to be led by someone with experience in this particular field. You may have someone within your own organisation who has carried out this role, perhaps with a former employer. Your Business Link may offer free or subsidised advice and training, and will be able to provide names of approved consultants. Grants for work in this area tend to be directed through Business Links. Different areas have different grants, which depend on local conditions. A typical grant may cover up to 50 per cent of the cost of an approved consultant. Certification fees are around £800 for the smallest companies. Overall costs depend upon company size and the number of locations involved. Ask certification bodies for quotes for initial audits and surveillance visits. Many will give an all-inclusive price, including surveillance visits for three years. Typically, special rates will depend on how long the assessment is likely to take and what the company’s turnover is. Ask your certification body if it offers special rates for small companies. The standard requires that companies have trained internal auditors to conduct audits on the system. An internal audit can provide an effective means of monitoring the system and identifying areas for improvement. For further details, contact the International Register of Certificated Auditors.

ISO 9001 Quality Policy

ISO 9001 Quality Policy

The standard requires the quality policy to be appropriate to the purpose of the organization.

The purpose of an organization is quite simply the reason for its existence and as Peter Drucker so eloquently put it there is only one valid definition of business purpose: to create a customer”(Drucker, Peter F., 1977)2 . In ensuring that the quality policy is appropriate to the purpose of the organization, it must be appropriate to the customers the organization desires to create. It is therefore necessary to establish who the customers are, where the customers are, what they buy or wish to receive and what these customers regard as value. As stated above, the quality policy is the corporate policy and such policies exist to channel actions and decisions along a path that will fulfil the organization’s purpose and mission. A goal of the organization may be the attainment of ISO 9001 certification and thus a quality policy of meeting the requirements of ISO 9001 would be consistent with such a goal, but goals are not the same as purpose as indicated in the box to the right. Clearly no organization would have ISO 9001 certification as its purpose because certification is not a reason for existence – an objective maybe but not a purpose.

Policies expressed as short catchy phrases such as “to be the best” really do not channel actions and decisions. They become the focus of ridicule when the organization’s fortunes change. There has to be a clear link from mission to quality policy.

Policies are not expressed as vague statements or emphatic statements using the words may, should or shall, but clear intentions by use of the words ‘we will’

– thus expressing a commitment or by the words ‘we are, we do, we don’t, we have’ expressing shared beliefs. Very short statements tend to become slogans which people chant but rarely understand the impact on what they do. Their virtue is that they rarely become outdated. Long statements confuse people because they contain too much for them to remember. Their virtue is that they not only define what the company stands for but how it will keep its promises.

In the ISO 9001 definition of quality policy it is suggested that the eight quality management principles be used as a basis for establishing the quality policy.

One of these principles is the Customer Focus principle. By including in the quality policy the intention to identify and satisfy the needs and expectations of customers and other interested parties and the associated strategy by which this will be achieved, this requirement would be fulfilled. The inclusion of the strategy is important because the policy should guide action and decision. Omitting the strategy may not ensure uniformity of approach and direction.

The standard requires that the quality policy include a commitment to comply with requirements and continually improve the effectiveness of the quality management system.

A commitment to comply with requirements means that the organization should undertake to meet the requirements of all interested parties. This means meeting the requirements of customer, suppliers, employees, investors, owners and society. Customer requirements are those either specified or implied by customers or determined by the organization and these are dealt with in more detail under clauses 5.2 and 7.2.1. The requirements of employees are those covered by legislation such as access, space, environmental conditions, equal opportunities and maternity leave but also the legislation appropriate to minority groups such as the disabled and any agreements made with unions or other representative bodies. Investors have rights also and these will be addressed in the investment agreements. The requirements of society are those obligations resulting from laws, statutes, regulations etc.

An organization accepts such obligations when it is incorporated as a legal entity, when it accepts orders from customers, when it recruits employees, when it chooses to trade in regulated markets and when it chooses to use or process materials that impact the environment.

The effectiveness of the management system is judged by the extent to which it fulfils its purpose. Therefore improving effectiveness means improving the capability of the management system. Changes to the management system that improve its capability i.e its ability to deliver outputs that satisfy all the interested parties, are a certain types of change and not all management system changes will accomplish this. This requirement therefore requires top management to pursue changes that bring about an improvement in performance.

IMPLEMENTATION GUIDANCE FOR ISO 9001:2008

IMPLEMENTATION GUIDANCE FOR ISO 9001:2008

This Implementation Guidance has been developed to assist users in understanding the issues that need to be considered during the co-existence period between ISO 9001:2000 and ISO 9001:2008.

While the changes between ISO 9001:2000 and ISO 9001:2008 are expected to have a limited impact on users, some arrangements regarding implementation are needed.

Note: To reflect the limited scope of the changes the term “implementation” is now being used to make a clear distinction with the former “transition” from ISO 9001:1994 to ISO 9001:2000, when there were significant changes throughout the standard.

A wide diffusion of this implementation guidance is recommended, in particular the comparison table between ISO 9001:2008 and ISO 9001:2000, given in Annex B to ISO 9001:2008.

ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.

Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008 No new requirements were introduced in this edition but, in order to benefit from the clarifications of ISO 9001:2008, users of the former version will need to take into consideration whether the clarifications introduced have an impact on their current interpretation of ISO 9001:2000, as changes may be necessary to their QMS In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.

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

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

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

- the results of an extensive worldwide “User Feedback Survey on ISO 9001 and ISO 9004″ by ISO/TC 176/SC 2/WG 18 and similar national surveys.

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

The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO14001:2004.

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

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

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

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

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

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

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

- No additional training required or minimal training required

- No effects on current certifications

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

- Provides clarity

- Increases compatibility with ISO 14001.

- Maintains consistency with ISO 9000 family of standards.

- Improves translatability.

ISO 9001 Standards Requirement – Product Realization

ISO 9001 Standards Requirement – Product Realization

Planning of Product Realization
Plan and develop the processes needed for product realization. Keep the planning consistent with other requirements of the quality management system and document it in a suitable form for the organization. Determine through the planning, as appropriate, the:
Quality objectives and product requirements
Need for processes, documents, and resources
Verification, validation, monitoring, measurement, inspection, and test activities
Criteria for product acceptance
Records as evidence the processes and resulting product meet requirements

Customer-Related Processes

Determination of Requirements Related to the Product
Determine customer requirements:
Specified for the product (including delivery and post-delivery activities)
Not specified for the product (but needed for specified or intended use, where known)
Determine:
Statutory and regulatory requirements applicable to the product
Any additional requirements considered necessary by the organization

Review of Requirements Related to the Product
Review the product requirements before committing to supply the product to the customer in order to:
Ensure product requirements are defined
Resolve any requirements differing from those previously expressed
Ensure its ability to meet the requirements
Maintain the results of the review, and any subsequent follow-up actions. When the requirements are not documented, they must be confirmed before acceptance.
If product requirements are changed, ensure relevant documents are amended and relevant personnel are made aware of the changed requirements.
NOTE: In some situations, such as internet sales, a formal review is impractical for each order. Instead, the review can cover relevant product information such as catalogs or advertising material.

Customer Communication
Determine and implement effective arrangements for communicating with customers on:
Product information
Inquiries, contracts, or order handling (including amendments)
Customer feedback (including customer complaints)

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Establishing Quality Policy In ISO 9000 Standards

Establishing Quality Policy In ISO 9000 Standards

The standard requires that top management establish

the quality policy.

ISO 9001 defines a quality policy as the overall

intentions and direction of an organization related to

quality as formally expressed by top management. It

also suggests that the policy be consistent with the

overall policy of the organization and provide a

framework for setting quality objectives. Further-

more ISO 9001 advises that the eight quality manage-

ment principles be used as a basis for forming the quality policy. The quality

policy can therefore be considered as the values, beliefs and rules that guide

actions, decisions and behaviours. A value may be ‘integrity’ and expressed as:

We will be open and honest in our dealings with those inside and outside the

organization. A rule may be ‘confidentiality’ and expressed as Company

information shall not be shared with those outside the organization. Both these are

also beliefs because it might be believed that deceiving people only leads to

failure in the long run. It might also be believed that disclosing confidential

information fuels the competition and will drive the organization out of

business. Both values guide actions, decisions and behaviours and hence may

be termed policies. They are not objectives because they are not achieved – they

are demonstrated by the manner in which actions and decisions are taken and

the way your organization behaves towards others.

The detail of quality policy will be addressed later. What is important in this

requirement is an understanding of why a quality policy is needed, what is

required to establish a quality policy and where it fits in relation to other

policies.

Defining the purpose or mission of the business is one thing but without

some guiding policies, the fulfilment of this mission may not happen unless

effort is guided in a common direction. If every manager chooses his or her

direction, and policies, the full potential of the organization would not be

realized. A shared vision is required that incorporates shared values and

shared policies.

The purpose of corporate policies is to influence the short and long-term

actions and decisions and to influence the direction in which the mission will

be fulfilled. If there were policies related to the organization’s customers, they

could be fulfilled at the expense of employees, shareholders and society. If

there were policies related to profit, without other policies being defined, profit

is positioned as a boundary condition to all actions and decisions. Clearly this

may not direct the organization towards its mission.

As stated above, the quality policy is the corporate policy and such policies

exist to channel actions and decisions along a path that will fulfil the

organization’s purpose and mission. A goal of the organization may be the

attainment of ISO 9001 certification and thus a quality policy of meeting the

requirements of ISO 9001 would be consistent with such a goal, but goals are not

the same as purpose as indicated in the box to the right. Clearly no organization

would have ISO 9000 certification as its purpose because certification is not a

reason for existence – an objective maybe but not a purpose.

Policies expressed as short catchy phrases such as “to be the best” really do

not channel actions and decisions. They become the focus of ridicule when the

organization’s fortunes change. There has to be a clear link from mission to

policy.

Policies are not expressed as vague statements or emphatic statements using

the words may, should or shall, but clear intentions by use of the words ‘we will’

– thus expressing a commitment or by the words ‘we are, we do, we don’t, we

have’ expressing shared beliefs. Very short statements tend to become slogans

which people chant but rarely understand the impact on what they do. Their

virtue is that they rarely become outdated. Long statements confuse people

because they contain too much for them to remember. Their virtue is that they

not only define what the company stands for but how it will keep its

promises.

In the ISO 9001 definition of quality policy it is suggested that the eight

quality management principles be used as a basis for establishing the policy.

One of these principles is the Customer Focus principle. By including in the

quality policy the intention to identify and satisfy the needs and expectations

of customers and other interested parties and the associated strategy by which

this will be achieved, this requirement would be fulfilled. The inclusion of the

strategy is important because the policy should guide action and decision.

Omitting the strategy may not ensure uniformity of approach and direction.

The standard requires that top management establish the quality policy.

ISO 9001 defines a quality policy as the overall intentions and direction of an organization related to quality as formally expressed by top management. It also suggests that the policy be consistent with the overall policy of the organization and provide a framework for setting quality objectives. Furthermore ISO 9001 advises that the eight quality management principles be used as a basis for forming the quality policy. The quality policy can therefore be considered as the values, beliefs and rules that guide actions, decisions and behaviours. A value may be ‘integrity’ and expressed as:

We will be open and honest in our dealings with those inside and outside the organization. A rule may be ‘confidentiality’ and expressed as Company information shall not be shared with those outside the organization. Both these are also beliefs because it might be believed that deceiving people only leads to failure in the long run. It might also be believed that disclosing confidential information fuels the competition and will drive the organization out of business. Both values guide actions, decisions and behaviours and hence may be termed policies. They are not objectives because they are not achieved – they are demonstrated by the manner in which actions and decisions are taken and the way your organization behaves towards others.

The detail of quality policy will be addressed later. What is important in this requirement is an understanding of why a quality policy is needed, what is required to establish a quality policy and where it fits in relation to other policies.

Defining the purpose or mission of the business is one thing but without some guiding policies, the fulfilment of this mission may not happen unless effort is guided in a common direction. If every manager chooses his or her direction, and policies, the full potential of the organization would not be realized. A shared vision is required that incorporates shared values and shared policies.

The purpose of corporate policies is to influence the short and long-term actions and decisions and to influence the direction in which the mission will be fulfilled. If there were policies related to the organization’s customers, they could be fulfilled at the expense of employees, shareholders and society. If there were policies related to profit, without other policies being defined, profit is positioned as a boundary condition to all actions and decisions. Clearly this may not direct the organization towards its mission.

As stated above, the quality policy is the corporate policy and such policies exist to channel actions and decisions along a path that will fulfil the organization’s purpose and mission. A goal of the organization may be the attainment of ISO 9001 certification and thus a quality policy of meeting the requirements of ISO 9001 would be consistent with such a goal, but goals are not the same as purpose as indicated in the box to the right. Clearly no organization would have ISO 9000 certification as its purpose because certification is not a reason for existence – an objective maybe but not a purpose.

Policies expressed as short catchy phrases such as “to be the best” really do not channel actions and decisions. They become the focus of ridicule when the organization’s fortunes change. There has to be a clear link from mission to policy.

Policies are not expressed as vague statements or emphatic statements using the words may, should or shall, but clear intentions by use of the words ‘we will’ – thus expressing a commitment or by the words ‘we are, we do, we don’t, we have’ expressing shared beliefs. Very short statements tend to become slogans which people chant but rarely understand the impact on what they do. Their virtue is that they rarely become outdated. Long statements confuse people because they contain too much for them to remember. Their virtue is that they not only define what the company stands for but how it will keep its promises.

In the ISO 9001 definition of quality policy it is suggested that the eight quality management principles be used as a basis for establishing the policy.

One of these principles is the Customer Focus principle. By including in the quality policy the intention to identify and satisfy the needs and expectations of customers and other interested parties and the associated strategy by which this will be achieved, this requirement would be fulfilled. The inclusion of the strategy is important because the policy should guide action and decision.

Omitting the strategy may not ensure uniformity of approach and direction.

ISO 9000 Standards – Document control procedures

ISO 9000 Standards – Document control procedures
The ISO 9000 Standards 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 ISO 9000 standards 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.

Create a Documented Implementation Plan In ISO 9000 Standards

Create a Documented Implementation Plan In ISO 9000 Standards

Once the organization has obtained a clear picture of how its quality management system compares with the ISO 9001:2008 standard, all non-conformances must be addressed with a documented implementation plan. Usually, the plan calls for identifying and describing processes to make the organization’s quality management system fully in compliance with the standard.

The implementation plan should be thorough and specific, detailing:

a. Quality documentation to be developed

b. Objective of the system

c. Pertinent ISO 9001:2008 section

d. Person or team responsible

e. Approval required

f. Training required

g. Resources required

h. Estimated completion date

These elements should be organized into a detailed chart, to be reviewed and

approved. The plan should define the responsibilities of different departments and personnel and set target dates for the completion of activities. Once approved, the Management Representative should control, review and update the plan as the implementation process proceeds.

Typical implementation action plan is shown in Figure 2. Use ISO 10005:1995 for guidance in quality planning.

ISO 9001 Standards Check List

ISO 9001:2008 include these checklists as follows:

1. ISO 9001 General Requirements

Has the organization established, documented, implemented and maintained a quality management system in accordance with the requirements of ISO 9001?

2. General Documentation Requirements
Does the quality management system documentation include documented procedures and records required ensuring effective operation and control of its processes?

3. Quality Manual
Has a quality manual been established and maintained that includes:

4. Control of Documents
Are documents required for the quality management system controlled?

5. Control of Records
Have records been established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system?

6. Management Commitment
How has top management demonstrated commitment to the development and improvement of the quality management system?

7. Quality Policy
Organization has top management ensured that the quality policy:

8. System Planning
1. Quality Objectives
a. What are the quality objectives that have been established at relevant functions and levels within the organization?

9. Responsibility, authority and Communication
Responsibility, authority and Communication Audit Checklist
1. Responsibility and authority

10. Resource Management
Resource Management Audit Checklist

1. Provision of resources

11. Planning of Product/Service Realization
Planning of Product/Service Realization Audit Checklist
Is planning of the realization processes consistent with the other requirements of the organization’s quality management system?

12. Management Review
Management Review Audit Checklist
1. General checklist
a) Does the top management review the quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness?

13. Product review
Determination of Requirements Related to the Product (7.2.1)

14. Design and Development Planning and Design and Development Inputs
What is the design and development planning methodology described in the design procedure?

15. Design and Development Outputs Audit
Are the outputs of the design and/or development process documented in a manner that enables verification against the design and/or development inputs?

16. Design and Development Review Audit
Are systematic reviews of design and/or development conducted at suitable stages?

17. Design and/or Development Verification
Is design and/or development verification performed to ensure the output meets the design and/or development inputs?

18. Design and/or Development Validation
Is design and/or development validation performed to confirm that resulting product is capable of meeting the requirements for the intended use?

19. Control of Design and Development Changes
Are design and/or development changes identified, documented, and controlled?

20. Purchasing Process
Does the organization control its purchasing processes to ensure purchased product conforms to requirements?

21. Purchasing Information
Do purchasing documents contain information describing the product to be purchased?

22. Verification of Purchased Product
Have the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements been established and implemented?

23. Control of Production and Service
Are the production and service provision planned and carried out under controlled conditions including:

24. Validation of Processes for Production and Service Provision
Have processes where deficiencies may become apparent only after the product is in use or the service has been delivered been validated?

25. Identification and Traceability
Is the product identified by suitable means throughout product realization?

26. Customer Property
How does the organization exercise care with customer property while it is under the
organization’s control or being used by the organization?

27. Preservation of Product
Is conformity of product preserved during internal processing and delivery to the intended destination?

28. Audit Checklist of Control of Measuring and Monitoring Devices
Has the organization determined the monitoring and measurement to be undertaken and the monitoring and measurement devices needed to provide evidence of conformity of product to determined requirements?

29. Customer Satisfaction
Are measurement and monitoring activities needed to assure conformity and achieve improvement been identified and included in the product quality plan?

30. Internal Audit Checklist
Are periodic internal quality audits conducted to determine whether the quality management system has been effectively implemented and maintained?

31. Monitoring and Measurement of Processes
Are suitable methods applied for monitoring and where applicable, measurement of the quality management system processes necessary to meet customer requirements?

32. Monitoring and Measurement of Product
Are product characteristics monitored and measured to verify that product requirements are met?

33. Control of Nonconforming Product Checklist
Is nonconforming product identified and controlled to prevent unintended use or delivery?

34. Analysis of Data
Is appropriate data determined, collected and analyzed to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can
be made?

35. Corrective Action
How is corrective action taken to eliminate the cause of nonconformities in order to prevent recurrence?

36 Continual Improvement
Are processes necessary for the continual Improvement of the quality management system planned and managed?

37. Preventive Action
Has the organization determined actions to eliminate the causes of potential nonconformities in order to prevent occurrence?

These checklists also called ISO 9000 audit checklist.