Conduct Initial Status Survey In ISO 9001 Standards

Conduct Initial Status Survey In ISO 9001 Standards

ISO 9001 does not require duplication of effort or redundant system. The goal of ISO 9001 is to create a quality management system that conforms to the standard. This does not preclude incorporating, adapting, and adding onto quality programs already in place. So the next step in the implementation process is to compare the organization’s existing quality management system, if there is one — with the requirements of the standard (ISO 9001:2008).

For this purpose, an organization flow chart showing how information actually flows (not what should be done) from order placement by the customer to delivery to this customer should be drawn up. From this over-all flow chart, a flow chart of activities in each department should be prepared.

With the aid of the flow charts, a record of existing quality management system should be established. A significant number of written procedures may already be in place.

Unless they are very much out of date, these documents should not be discarded.

Rather, they should be incorporated into the new quality management system.

Documents requiring modification or elaboration should be identified and listed. This exercise is some times referred to as ” gap analysis”. During these review processes, wide consultation with executives and representatives of various unions and associations within the organization is required to enlist their active cooperation.

In the review process, documents should be collected, studied and registered for

further use, possibly after they have been revised. Before developing new quality

management system documentation, you need to consider with which quality

requirements or department you should start. The best is to select an area where

processes are fairly well organized, running effectively and functioning satisfactorily.

The basic approach is to determine and record how a process is currently carried out.

We can do this by identifying the people involved and obtaining information from them during individual interviews. Unfortunately, it often happens that different people will give different, contradicting versions of a process. Each one may refer to oral instructions that are not accurate or clear. This is why the facts are often not described correctly the first time around, and have to be revised several times.

Once it has been agreed how to describe the current process, this process has to be adapted, supplemented and implemented according to the requirements of the quality standard (ISO 9001:2008). This requires organizational arrangements, the drawing up of additional documents and possible removal of existing documentation (e.g. procedures, inspection/test plans, inspection/test instructions) and records (e.g. inspection/test reports, inspection/test certificates).

In introducing a quality management system, the emphasis is on the improvement of the existing processes or the re-organization of processes.

In general, the steps to follow are the following:

a. Ascertain and establish the following:

What is the present operation/process? What already exists?

b. Analyze the relevant sections of the quality standard – ISO 9001:2008:

What is actually required?

c. If necessary, supplement and change operational arrangements in accordance

with the standard, develop documents and records, and describe operations/

processes:

What is the desired operation/process?

The gap analysis can be done internally, if the knowledge level is there. Or a formal pre-assessment can be obtained from any one of a large number of ISO 9001 consulting, implementing, and registration firms.

ISO 9001 Standards – Quality Management Principles

ISO 9001 Standards – Quality Management Principles

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

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

1. Customer focus
Organizations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.
The customer focus principle is reflected in ISO 9001 Standards through the requirements addressing:
a. Communication with the customer
b. Care for customer property
c. The determination of customer needs and expectations
d. Appointment of a management representative
e. Management commitment

2. Leadership
Leaders establish unity of purpose and direction for the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.
The leadership principle is reflected in ISO 9001 Standards through the requirements addressing:
a. The setting of objectives and policies
b. Planning
c. Internal communication
d. Creating an effective work environment

3. Involvement of people
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.
The involvement of people principle is reflected in ISO 9001 Standards through the requirements addressing:
a. Participation in design reviews
b. Defining objectives, responsibilities and authority
c. Creating an environment in which people are motivated
d. Internal communication
e. Identifying competence needs

4. Process approach
A desired result is achieved more efficiently when related resources and activities are managed as a process.
The process approach principle is reflected in ISO 9001 Standards through the requirements addressing:
a. The identity of processes
b. Defining process inputs and outputs
c. Providing the infrastructure, information and resources for processes to
function

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

6. Continual improvement
This principle is expressed as follows:
Continual improvement of the organization’s overall performance should be a permanent objective of the organization.
The continual improvement principle is reflected in ISO 9001 Standards through the requirements addressing:
a. Improvement processes
b. Identifying improvements
c. Reviewing documents and processes for opportunities for improvement

7. Factual approach to decision making
This principle is expressed as follows:
Effective decisions are based on the analysis of data and information.
The factual approach principle is reflected in ISO 9001 Standards through the requirements addressing:
a. Reviews, measurements and monitoring to obtain facts
b. Control of measuring devices
c. Analysis to obtain facts from information
d. Records for documenting the facts
e. Approvals based on facts

8. Mutually beneficial supplier relationships
This principle is expressed as follows:
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
The mutually beneficial supplier relationships principle is reflected in ISO 9001 Standardsthrough the requirements addressing:
a. Control of suppliers
b. Evaluation of suppliers
c. Analysis and review of supplier data

ISO 9001 Standards – Retention Of Records

ISO 9001 Standards – Retention Of Records

It is important that records are not destroyed before their useful life is over.
There are several factors to consider when determining the retention time for records.
The duration of the contract – some records are only of value whilst the contract is in force.
The life of the product – access to the records will probably not be needed for some considerable time, possibly long after the contract has closed. On defence contracts the contractor has to keep records for up to 20 years and
for product liability purposes, in the worst-case situation (taking account of
appeals) you could be asked to produce records up to 17 years after you made the product.
The period between management system assessments – assessors may wish to see evidence that corrective actions from the last assessment were taken. If the period of assessment is three years and you dispose of the evidence after 2 years, you will have some difficulty in convincing the assessor that you corrected the deficiency.
You will also need to take account of the subcontractor records and ensure
adequate retention times are invoked in the contract.
Where the retention time is actually specified can present a problem. If you
specify it in a general procedure you are likely to want to prescribe a single
figure, say 5 years for all records. However, this may cause storage problems – it may be more appropriate therefore to specify the retention times in the procedures that describe the records. In this way you can be selective.
You will also need a means of determining when the retention time has
expired so that if necessary you can dispose of the records. The retention time doesn’t mean that you must dispose of them when the time expires – only that you must retain the records for at least that stated period. Not only will the records need to be dated but the files that contain the records need to be dated and if stored in an archive, the shelves or drawers also dated. It is for this reason that all documents should carry a date of origin and this requirement needs to be specified in the procedures that describe the records. If you can rely on the selection process a simple method is to store the records in bins or computer disks that carry the date of disposal.
While the ISO 9001 requirement applies only to records, you may also need to retain tools, jigs, fixtures, test software – in fact anything that is needed to repair or reproduce equipment in order to honour your long-term commitments.
Should the customer specify a retention period greater than what you
prescribe in your procedures, special provisions will need to be made and this is a potential area of risk. Customers may choose not to specify a particular time and require you to seek approval before destruction. Any contract that requires you to do something different creates a problem in conveying the requirements to those who are to implement them. The simple solution is to persuade your customer to accept your policy. You may not want to change your procedures for one contract. If you can’t change the contract, the only alternative is to issue special instructions. You may be better off storing the records in a special contract store away from the normal store or alternatively attach special labels to the files to alert the people looking after the archives.

Develop Quality Management System Documentation In ISO 9001 Standards

Develop Quality Management System Documentation In ISO 9001 Standards
Documentation is the most common area of non-conformance among organizations wishing to implement ISO 9000 quality management systems. As one company pointed out: “When we started our implementation, we found that documentation was inadequate. Even absent, in some areas. Take calibration. Obviously it’s necessary, and obviously we do it, but it wasn’t being documented. Another area was inspection and testing. We inspect and test practically every item that leaves here, but our documentation was inadequate”.
Documentation of the quality management system should include:
1. Documented statements of a quality policy and quality objectives,
2. A quality manual,
3. Documented procedures and records required by the standard ISO 9001:2008, and
4. Documents needed by the organization to ensure the effective planning, operation and control of its processes.

Quality documentation is generally prepared in the three levels indicated below that follows. Use ISO 10013:1995 for guidance in quality documentation.

Level A: Quality manual
States the scope of the quality management system, including exclusions and details of their justification; and describes the processes of the quality management system and their interaction. Generally gives an organization profile; presents the organizational relationships and responsibilities of persons whose work affects quality and outlines the main procedures. It may also describe organization’s quality policy and quality objectives.

Level B: Quality management system procedures
Describes the activities of individual departments, how quality is controlled in each department and the checks that are carried out.

Level C: Quality documents (forms, reports, work instructions, etc.)
1. Work instructions describe in detail how specific tasks are performed; include drawing standards, methods of tests, customer’s specifications, etc.
2. Presents forms to be used for recording observations, etc.

What is ISO 9001 Standard

What is ISO 9001 Standard?

Outsourced Processes In ISO 9001 Standards

Outsourced Processes In ISO 9001 Standards

One of the changes in ISO 9001:2008 is clarification of the role of outsourced processes in a quality management system. Guidance on ‘Outsourced processes’ helps clarify the intent and shows the linkage between Clause 4.2, where outsourced processes appear, and the purchasing controls in clause 7.4.
An outsourced process is a process that the organization needs for its quality management system and is performed by an external party. This party could be another company, a corporate service, another division, etc.
The organization needs to ensure the outsourced process is conducted in accordance with ISO 9001:2008 and other requirements of the quality management system. This brings in the purchasing controls of 7.4. The service may not be purchased in the traditional sense of a monetary transaction. The guidance document explains that the controls in clause 4.2 and 7.4 apply. For example, a “no charge” service from a corporate head office requires documentation of supplier selection and, most importantly, control.
The guidance document addresses two important cases and gives guidance on the appropriate level of control. The cases are:
• The organization has the competence and ability to carry out a process, but chooses to outsource it (for commercial or other reasons).
• The organization does not have the competence to carry out the process itself, and chooses to outsource it.

Demonstrating conformity with ISO 9001:2008

Demonstrating conformity with ISO 9001:2008

For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.
Organizations may be able to demonstrate conformity without the need for extensive documentation.
To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines “objective evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”
Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d)
Planning of product realization, and clause 8.2.4

Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.
Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.

Transition from ISO 9001:2000 to ISO 9001:2008

Transition from ISO 9001:2000 to ISO 9001:2008
This reference guide was developed to help you understand the nature of the changes to the ISO 9001 standard.
Clause Change/Emphasis Not Auditable
0.1 General – Added language emphasizing statutory and regulatory requirements are a concern as it relates to products for this international standard.
0.4 Compatibility with Other Management Systems Standards - Emphasis was added on the consideration given to ISO 14001:2004 to ensure that the standards are compatible.
1.1 General
1.2 Application – “Statutory” was added in certain paragraphs to ensure the user is aware that these requirements must be taken into consideration. Additional notes were added to explain that where the word “product” appears, it refers to every stage of its existence, from raw material received to the final product being shipped to the customer.
2. Normative Reference – Reference to ISO 9000 (vocabulary and concepts) was updated to refer to the current revision (i.e. ISO 9000:2005).
3. Terms and Definitions – The supplier/organization/customer model was removed. These relationships, in reality, are not always linears.
The Auditable RequirementsClause Change/Emphasis4.1In 4.1 a, “identify” was replaced with “determine” to emphasize that an organization must give careful consideration to what processes are needed in order to fulfill requirements.A link is drawn to 7.4 in the additional note. This was done to show that the supplier approval, evaluation, and re-evaluation process is where evidence of controlled outsourced processes should be demonstrated.4.2.1References to records and documents were consolidated.Also, the organization can require records not specified in this international standard that are created and maintained.4.2.3Clarification is given to the requirement for outsourced documents. Only those needed for the planning and operation of the QMS need to be controlled. This could exclude documents related to occupational health and safety since ISO 9001 contains requirements only concerned with product (see 0.1).4.2.4Rephrased, but no additional clarifications or emphasis added. Editorial change only.5.5.2The management representative must be from the organization’s management. This would exclude consultants and other individuals external to the organization (e.g. a management representative from the corporate entity). The purpose of this is to ensure that this individual, entrusted with the responsibilities of championing the quality management system, is not “out of touch” with the organization.6.2.1The boundaries of competence only extend to individuals who impact product conformity. However, this does not just include those who are directly involved in production. The decisions made by management affect product conformity; therefore, they must be competent as well.
6.2.2If said personnel have not yet attained the competence needed to perform the assigned job, then the organization must provide training or some other remedy to ensure that competence is achieved. The organization must also have a mechanism to ensure that personnel have been evaluated based on how well they demonstrate their knowledge and skill (i.e. competence). It is not enough to merely provide training or consider an individual’s experience. The organization must prove to itself that this person can, in fact, perform.6.3Infrastructure also includes databases and information technology.6.4Emphasis is added in a note to highlight that the concept of “work environment” only extends to product quality.7.1 c“Measurement” is added.7.2.1“Post-delivery activity” is clarified in a note with examples.7.3.1A note emphasizes that design verification, validation, and review are different from one another and serve different purposes. Design review is where the organization evaluates if the design can meet requirements and if any changes need to be made. Design verification is where the organization has ensured that requirements have been met (e.g. is the widget blue and is it hexagonal?). Design validation is where the organization proves that the design can perform as required.However, the records of design verification, validation, and review do not have to be separate.7.3.3Production and service provisions also extend to how product is preserved, handled, etc., to ensure product conformity. See 7.5.1Design outputs must include requirements related to preservation. See 7.5.5.
7.5.2Notes were added to give examples of the types of processes where this requirement would apply along with a statement that service organizations should have additional considerations in the planning stages when deficiencies and conformity are not likely to be identified prior to delivery.7.5.3Product status must be identified throughout product realization, not just the final product. See 1.2.7.5.4Wording was modified to add clarity, but the intent of the requirement has not changed.7.5.5Again, emphasis is added that care must be given to preserving the product regardless of where it falls in the realization process.7.6An obsolete reference to another ISO document was replaced.The definition of “monitoring and measuring devices” has been clarified to include equipment and devices that are purposed for monitoring and measuring, regardless of their original or intended purpose.An additional note regarding software was added.8.2.2Document and record requirements were reworded and their placement modified to improve clarity.The reference to the auditing guidance document was updated (i.e. ISO 19011).
8.2.3Wording was modified to emphasize that correction and corrective actions are not only to be taken to preserve the conformity of the product, but also to preserve the quality management system. For example, internal rejection/scrap rates could show evidence that the organization is preserving product conformity and is taking intermediate action to prevent bad product from being shipped to their customers; however, it could also be a sign that the organization is not efficient since the higher rejection/scrap rates are undesirable.A note was added to clarify the meaning of “suitable methods” related to planning, monitoring and measurement processes. Suitability should be determined based on risk and the impact that nonconformity would have on the product or process.8.2.4Product can be released to other internal processes despite planned arrangements not being satisfactorily completed as long as it conforms prior to release to the customer. This relaxes requirements on intermediate inspection results and records.8.3Actions taken against nonconforming product must be proportional to its impact or potential impact. See 8.2.3 related to impact considerations for monitoring and measurement.This would mean that in the planning stages of a product, the organization needs to customize responses to nonconforming products based on the risk or potential risk to the organization.This requirement existed in ISO 9001:2000; however, its location has changed.
8.5.2Nonconformity can have multiple causes (“cause”; i.e. a singular reason, was used in the 2000 version); therefore, the organization must consider this when conducting root cause analysis.Also, it is not enough to simply review corrective action and ensure that procedures were changed, personnel have been re-trained, and that processes were amended. The organization must review whether or not the action(s) taken were effective; i.e. did they successfully eliminate the nonconforming condition?8.5.3Similar to the new emphasis on the effectiveness of corrective action, the organization must also document whether or not the preventive action(s) taken were effective in eliminating the risk of nonconformity.

ISO 9001 Standards Requirement – Product Realization

ISO 9001 Standards Requirement – Product Realization
Planning of Product RealizationPlan 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 requirementsNeed for processes, documents, and resourcesVerification, validation, monitoring, measurement, inspection, and test activitiesCriteria for product acceptanceRecords as evidence the processes and resulting product meet requirements
Customer-Related Processes
Determination of Requirements Related to the ProductDetermine 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 productAny 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 definedResolve any requirements differing from those previously expressedEnsure its ability to meet the requirementsMaintain 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 CommunicationDetermine and implement effective arrangements for communicating with customers on:Product informationInquiries, contracts, or order handling (including amendments)Customer feedback (including customer complaints)

ISO 9001 Standards Requirements – Design and Development

Design and Development PlanningPlan and control the product design and development. This planning must determine the:Stages of design and developmentAppropriate review, verification, and validation activities for each stageResponsibility and authority for design and developmentThe interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.
Design and Development InputsDetermine product requirement inputs and maintain records. The inputs must include:Functional and performance requirementsApplicable statutory and regulatory requirementsApplicable information derived from similar designsRequirements essential for design and developmentReview these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.
Design and Development OutputsDocument the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:Meet design and development input requirementsProvide information for purchasing, production, and serviceContain or reference product acceptance criteriaDefine essential characteristics for safe and proper useBe approved before their release
Design and Development ReviewPerform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:Evaluate the ability of the results to meet requirementsIdentify problems and propose any necessary actionsThe reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.
Design and Development VerificationPerform design and development verification in accordance with planned arrangements to ensure the output meets the design and development input requirements. Maintain the results of the verification and subsequent follow-up actions.
Design and Development ValidationPerform validation in accordance with planned arrangements to confirm the resulting product is capable of meeting the requirements for its specified application or intended use, where known. When practical, complete the validation before delivery or implementation of the product. Maintain the results of the validation and subsequent follow-up actions.
Control of Design and Development ChangesIdentify design and development changes and maintain records. Review, verify, and validate (as appropriate) the changes and approve them before implementation. Evaluate the changes in terms of their effect on constituent parts and products already delivered. Maintain the results of the change review and subsequent follow-up actions.

Reasons a Company Becomes Certified in ISO 9001 Standards

ISO 9000 certification or registration can be an expensive process. A company must consider the reasons and promised benefits for going through this process. If a company decides to seek certification, they should consider making sure their suppliers are certified or at least compliant to the ISO 9000 standards.
Major reasonsIn the early 1990s, companies seemed to be jumping on the certification bandwagon without seriously considering the rationale for doing so. Often they did so because competitors or “everybody else” is getting registered. Today companies seriously look at the reasons and benefits for becoming registered.
The major reasons that company leadership or management decides to seek ISO 9000 certification are to gain continued or increased business and to maintain effective operations.
Improved businessA company can maintain a relationship with customers, as well as get increased business through complying to the ISO 9000 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.
Finally, some companies want to become certified, so they can advertise that fact and give the impression of being better than their competitors.
You have seen ads with a logo stating the company is certified at some ISO 9000 level. It apparently gives those companies a leg up on competitors not registered.
Again, this seemed more important in the 1990s, but you don’t see that many companies using ISO 9000 certification as an advertising tool.
ISO 9000 is supposed to make sure your business is run in an orderly manner that will assure continued success.
One would think that a goal such as being run effectively and able to deliver goods consistently and reliably would also be desirable for a company’s own operation. Surprisingly, many companies do not consider that as a goal.

Process Approach In ISO 9001 Standards

Process Approach In ISO 9001 Standards
The process approach was introduced into ISO 9001 with the year 2000 version of the standards.Prior versions used an element approach. The document Guidance on the concept and use of the process approach for management systems describes to process approach and offers an implementation paradigm.1. Identification of processes of the organization1.1. Define the purpose of the organization1.2. Define the policies and objectives of the organization1.3. Determine the processes in the organization1.4. Determine the sequence of the processes1.5. Define process ownership1.6. Define process documentation2. Planning of a process2.1. Define the activities within the process2.2. Define the monitoring and measurement requirements2.3. Define the resources needed
2.4. Verify the process and its activities against its planned objectives3. Implementation and measurement of the process4. Analysis of the process5. Corrective action and improvement of the process ImplementationThis document explains the process used to evaluate changes to the 2008 version. In particular, it explains the revision process and illustrates the impact vs. benefit analysis used to evaluate potential changes.In addition to the guidance documents, ISO maintains a web site with “official interpretations” of ISO 9001. Currently, these interpretations only include ISO 9001:2000, but, because the changes to the 2008 version were limited, they are valuable.Consider a common question. An organization needs a documented procedure for preventive action (8.5.3), and must keep records of the results of preventive action (8.5.3.d). One of the interpretation requests asks, “Does sub-clause 8.5.3 a) require organizations to demonstrate, with objective evidence in the form of records, that they have undertaken actions to determine the existence of ‘potential nonconformities and their causes’?” The answer is “No”.Auditing PracticesThe ISO 9001 Auditing Practices Group maintains a website9 with guidance and information on auditing ISO 9001 quality management systems. It is an informal group of quality management system (QMS) experts, auditors, and practitioners drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF).The website, primarily aimed at QMS auditors, consultants, and quality practitioners, is an online source of papers and presentations on auditing a QMS and reflect the process based approach.The website contains almost forty guidance documents with practical advice ranging from “How to audit top management processes” to “The role and value of the audit checklist”.

ISO 9000 and ISO 14000 in plain language

Both “ISO 9000” and “ISO 14000” are actually families of standards which are referred to under these generic titles for convenience. Both families consist of standards and guidelines relating to management systems, and related supporting standards on terminology and specific tools, such as auditing (the process of checking that the management systemconforms to the standard).
ISO 9000 is primarily concerned with “quality management“. In the everyday context, like “beauty”, everyone may have his or her idea of what “quality” is. But, in the ISO 9000 context, the standardized definition of quality refers to all those features of a product (or service) which are required by the customer. “Quality management” means what the organization does to ensure that its products or services satisfy the customer’s quality requirements and comply with any regulationsapplicable to those products or services.
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.
In addition, both ISO 9000 and ISO 14000 require organizations that implement them to improve their performance continually in, respectively, quality and environmental management.
Both ISO 9000 and ISO 14000 concern the way an organization goes about its work, and not directly the result of this work. In other words, they both concern processes, and not products – at least, not directly. Nevertheless, the way in which the organization manages its processes is obviously going to affect its final product.
In the case of ISO 9000, the efficient and effective management of processes is, for example, going to affect whether or not everything has been done to ensure that the product satisfies the customer’s quality requirements. In the case of ISO 14000, the efficient and effective management of processes is going to affect whether or not everything has been done to ensure a product will have the least harmful impact on the environment, at any stage in its life cycle, either by pollution, or by depleting natural resources.
However, neither ISO 9000 nor ISO 14000 are product standards. The management system standards in these families state requirements for what the organization must do to manage processes influencing quality (ISO 9000) or the processes influencing the impact of the organization’s activities on the environment (ISO 14000). In both cases, the philosophy is that management system requirements are generic. No matter what the organization is or does, if it wants to establish a quality management system or an environmental management system, then such a system has a number of essential features which are spelled out in the relevant ISO 9000 or ISO 14000 standards.

ISO 9001 Standards In General

ISO 9001 Standards In General
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by— its business environment, changes in that environment, or risks associated with that environment,— its varying needs,— its particular objectives,— the products it provides,— the processes it employs,— its size and organizational structure.It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying theassociated requirement.This International Standard can be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer, statutory and regulatory requirements applicable to theproduct, and the organization’s own requirements.The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.

ISO 9001 – Compatibility with other management systems

ISO 9001 – Compatibility with other management systems
ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently.ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, for certification, or for contractual purposes. It focuses on the effectiveness of the qualitymanagement system in meeting customer requirements.ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organizations overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.
During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community.This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financialmanagement or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible foran organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard.

Certification In ISO 9001 Standards

Certification In ISO 9001 Standards
Certification involves an independent assessment of your quality system to confirm that it meets the requirements of ISO 9001. You will need to design, document and implement your own quality system. The system will need to cover all the requirements of the ISO 9001 standard. Many certification bodies will not conduct a formal assessment until the system has been operating for at least three months. Your quality system cannot be audited until you have generated documentary evidence to show that you are meeting the standard. To find a certification body with relevant experience in your sector and accreditation from the United Kingdom Accreditation Service (UKAS). Certification by a non-UKAS accredited body is likely to lead to credibility problems with your customers. Arrange a visit from the certification body’s auditors. UKAS prohibits auditors from acting as consultants. They will not tell you how to meet the standard but can offer advice. They will seek objective evidence that you are complying with each of the clauses of the ISO 9001 standard. The auditors will tell you of any shortcomings in your system. If you satisfy the standard, the auditors put your name forward for certification. You will be required to correct these problems within a specified timeframe. You can also be certificated if the auditors only identify a small number of ‘minor’ problems. Once you are certificated, you can display the certification body’s logo, and if the body is UKAS-accredited, the UKAS ‘tick and crown’ symbol (consult UKAS about exceptions to this rule). If the auditors identify more serious ‘major’ problems, you will be required to correct these before certification. These surveillance visits normally take place twice a year at agreed dates. All certification bodies are required to revisit registered companies to ensure they still meet the requirements of the standard. You will be given time to deal with any minor or major problems which are identified before any action is taken to withdraw your certificate.

ISO 9000 family of standards and SMEs

ISO 9000 family of standards and SMEs
The ISO 9000 quality management system is generic in nature and applicable to all companies, regardless of the type and size of the business, including small and medium enterprises (SMEs), and they are applicable to all categories of products, whether hardware, software, processed materials or services. ISO 9001:2008 specifies what is required to be done by an organization but does not indicate how it should be done, thus giving the enterprise a lot of flexibility to run its business.
It is simple to use, clear in language and easily understandable. The new standard is also appropriate for small companies, as it does not demand the type of paper bureaucracy needed for the implementation of the 1994 version. Only six documented procedures are now required and need for other procedures/documents can be decided by the company. Companies will, however, be required to provide objective evidence that the QMS has been effectively implemented. A small company may find it appropriate to include the description of its entire QMS within a single Quality Manual, including all the documented procedures required by the standard.
The process-based approach given in the new standard will tend to ensure that systems are documented and implemented in a manner that suits a SME’s own way of doing business. This approach makes it easier for SMEs to implement, instead of just taking over an artificial structure of QMS imposed from outside. It will also be easier for SMEs managed by their owners to demonstrate “top management commitment” towards QMS. Furthermore, in a SME, it is easier to ensure effective internal communication, better utilization of resources, people clearly understanding their roles and responsibilities, etc.
The new standard has included a provision for deciding on the applicability of
certain product realization processes included in section 7 of the standard. For example, if the SME has no responsibility for the design and development of the product it provides, the SME may say so, giving the reasoning behind it, in the Quality Manual; the certification body, being satisfied that this corresponds, would then award it certification to ISO 9001:2008. Similarly, other product realization processes such as purchasing, product identification and traceability, control of measuring devices may also be excluded if these are not applicable for the type of products or services being provided by the company.
It is also possible that SMEs may not have adequate in-house expertise or there may be other constraints to perform all processes on their own. In such cases, the new standard also permits the outsourcing of any of the QMS processes, providing the company has control over such processes. The nature of this control will depend on the nature of the outsourced or subcontracted processes and the risk involved. For example, the design and development process may be subcontracted to an expert or a specialized agency, inspection/verification of goods purchased may be subcontracted to an inspection agency, internal audit of QMS can be outsourced, etc. However, overall responsibility for ensuring control on all outsourced processes as per requirements of the standard would remain with the company’s management.

Management Principles Of ISO 9001 Standards

Management Principles Of ISO 9001 Standards
ISO 9000 is based on eight management principles:
• Customer focus, resulting in meeting customer requirements and striving to exceed them;
• Leadership, aiming to create an internal environment in which people are fully involved;
• Involvement of people who are the essence of an organization;
• Process approach, resulting in improved efficiency to obtain desired results;
• System approach to management, leading to improved effectiveness and efficiency through identification, understanding and management of interrelated processes;
• Continual improvement, which becomes a permanent objective of the organization;
• Factual approach to decision-making, based on the analysis of data and information; and
• Mutually beneficial supplier relationships, based on an understanding of their interdependence.
ISO 9000 encourages the adoption of the process approach to manage an organization. There are five main areas considered for the revised process model in ISO 9000:
• Quality management system
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis and improvement.

Benefits Of Obtaining ISO 9000 Certification

Benefits Of Obtaining ISO 9000 Certification
Implementing a quality management system brings internal benefits to most organizations, as well as opening up opportunities vis-à-vis the outside world.
Internal benefits to the company include:
• improved customer focus and process orientation within the company;
• improved management commitment and decision-making;
• better working conditions for employees;
• increased motivation of employees;
• reduced cost of internal failures (lower rates of rework, rejection, etc.) and external failures (fewer customer returns, replacements, etc.); and last but not least,
• continual improvement of the quality management system.
The following external benefits are generated:
• customers are more confident that they will receive products conforming to their requirements, which in turn results in higher customer satisfaction;
• an improved image of the company;
• more aggressive publicity, as customers can be informed of the benefits of their doing business with a company that manages the quality of its outputs;
• more confidence that the company’s products meet relevant regulatory
requirements;
• better objective evidence to defend product liability charges if such are brought by customers.
Refer http://www.iso9001-standard.us for more information.

Implementing A Quality Management System

Implementing A Quality Management System
An ISO 9000:2008 quality management system can be implemented by following the steps detailed as follows:
1. Evaluate the organization’s need/goals for implementing a QMS Need may arise from repeated customer complaints; frequent warranty returns; delayed deliveries; high inventories; frequent production hold-ups; and high level of rework or rejection of products or services.
At this stage, identify the goals which you would like to achieve through a QMS, such as customer satisfaction, increased market share, improved communications and morale in the organization, greater efficiency and profitability, etc. Another objective in implementing a QMS may be a demonstration of compliance through third party certification, which may be requested by an important client or required for enlisting as a supplier to large companies, e.g., original equipment manufacturers (OEMs).
2. Obtain information about the ISO 9000 family
The persons identified for initiating the development of an ISO 9000 QMS need tounderstand the requirements of ISO 9001:2008 as read with ISO 9000:2000 and ISO 9001:2008.
Supporting information such as quality management principles, frequently asked questions (FAQs), guidance on clause 1.2 (application) of ISO 9001:2008, guidance on documentation requirements of ISO 9001:2008 and other brochures are available free of charge on the ISO web site;
3. Appoint a consultant, if necessary
If, within the organization, you do not have adequate competence to develop a QMS, you may appoint a consultant. Before doing so, it is good to check his/her background; knowledge about the product realization processes of your organization; and experience in helping other organizations to achieve their stated goals, including certification.
Carry out a cost-benefit analysis of hiring a consultant and agree the scope of his/her work in writing. It is also possible to appoint a consultant only for the training of key staff; the latter can then carry out further training and development of the system.
4. Awareness and training
Raise awareness about QMS requirements amongst all personnel performing activities that affect quality. Plan for and provide specific training on how to develop Quality Manuals; on procedures; on QMS planning; on how to identify and implement improvement processes; and on how to audit compliance with the QMS, etc.
The Institute of Quality Assurance (IQA), the American Society for Quality (ASQ)and the International Auditor and Training Certification Association (IATCA) can provide lists of training organizations.
5. Gap analysis
Evaluate gaps between your existing quality management system and the QMS requirements of ISO 9001. Prepare how to bridge these gaps, including by planning for any additional resources required. Gap analysis may be carried out through selfassessment or by the external consultant.
6. Product realization processes
Review clause 7 of ISO 9001:2008 relating to “Product realization” to determine how the requirements apply or do not apply to your company’s QMS.
The processes covered by this clause include:
• Customer-related processes
• Design and development
• Purchasing
• Production and service provision
• Control of measuring and monitoring devices
Note that if your company is not responsible for preparing the design of your product, you can exclude the requirement for “design and development” from your QMS and explain the reasons for doing so in your Quality Manual.
7. Staffing
Decide on the responsibilities of the persons who will be involved in developing and documenting the QMS, including the appointment of a management representative who will oversee the implementation of the QMS. Establishing a project Steering Committee may also prove useful to oversee progress and provide resources wherever required.
8. Planning a time frame
Prepare a complete plan to close the gaps identified in Step 5 to develop the QMS processes. In the plan, include activities to be performed, resources required, responsibilities and an estimated completion time for each activity. Clauses 4.1 and
7.1 of ISO 9001:2008 provide information that should be used when developing the plan. The total time required for each phase (planning, documentation, implementation and evaluation) depends on the extent of the gaps in your existing QMS.
9. Draft a Quality Manual
In your Quality Manual;
• Include how the QMS applies to the products, processes, locations and departments of the organization;
• Exclude any requirement with justification for doing so as decided in step 6
above;
• Refer to or include documented procedures for QMS;
• Describe the interaction between the processes of the QMS, e.g., the interaction between product realization processes and other management, measurement and improvement processes; and
• Draft the quality policy and quality objectives for the organization.
The staff concerned in the organization should review the Quality Manual and the documented procedures so that their comments and suggestions can be taken into account before the Quality Manual and procedures are approved for issue and use.
The effective date of implementation should also be decided.
10. Carry out internal audits
During the phase of implementation of some three to six months after the documentation has been written, the trained auditors should carry out one or two internal audits covering all activities for the QMS, and concerned management should take corrective action on the audit findings without delay. Wherever required, revise the manuals, procedures and objectives. After each internal audit, the top management should review the effectiveness of the system and provide necessary resources for corrective actions and improvements.
11. Apply for certification
On satisfactory completion of Step 10, and if your company decides to obtain third party certification, you can make an application for certification to an accredited certification body. The certification audit process is explained section VII.
12. Conduct periodic evaluations
After certification, the organization should periodically conduct internal audits to review the effectiveness of the QMS and see how it can be “continually improved”. The organization should evaluate periodically if the purpose and goals (see Step 1) for which the QMS was developed are being achieved, including its continual improvement.

ISO 9001 Standards – Management Review

ISO 9001 Standards – Management Review
Review the quality management system at planned intervals to:- Assess possible opportunities for improvementEnsure a suitable, adequate, and effective system

- Evaluate the need for any changes to the system
- Consider the need for changes to the quality policy and objectives
Maintain records of the management reviews.
Inputs for management review must include information on:
- Results of audits
- Customer feedback
- Process performance and product conformity
- Status of preventive and corrective actions
- Follow-up actions from earlier reviews
- Changes that could affect the quality system
- Recommendations for improvement
Outputs from the management review must include any decisions and actions related to:
- Improvement of the effectiveness of the quality management system and its processes
- Improvement of product related to customer requirements
- Resource needs

ISO 9001 Standards – Design and Development

ISO 9001 Standards - Design and Development
Plan and control the product design and development. This planning must determine the:Identify problems and propose any necessary actions
- Stages of design and development
- Appropriate review, verification, and validation activities for each stage
- Responsibility and authority for design and development
The interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.
NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.
Determine product requirement inputs and maintain records. The inputs must include:
- Functional and performance requirements
- Applicable statutory and regulatory requirements
- Applicable information derived from similar designs
- Requirements essential for design and development
Review these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.
Document the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:
- Meet design and development input requirements
- Provide information for purchasing, production, and service
- Contain or reference product acceptance criteria
- Define essential characteristics for safe and proper use
- Be approved before their release
Perform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:
- Evaluate the ability of the results to meet requirements
- The reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.

ISO 9001 Standards – Control of Measuring and Monitoring Equipment

ISO 9001 Standards - Control of Measuring and Monitoring Equipment
Determine the monitoring and measurements to be made, and the required equipment, to provide evidence of product conformity. Use and control the monitoring and measuring devices to ensure that measurement capability is consistent with monitoring and measurement requirements.
Where necessary to ensure valid results:
- Calibrate and/or verify the measuring equipment at specified intervals or prior to use
- Calibrate the equipment to national or international standards (or record other basis)
- Adjust or re-adjust as necessary
- Identify the measuring equipment in order to determine its calibration status
- Safeguard them from improper adjustments
- Protect them from damage and deterioration
Assess and record the validity of prior results if the device is found to not conform to requirements. Maintain records of the calibration and verification results.
Confirm the ability of software used for monitoring and measuring for the intended application before its initial use (and reconfirmed as necessary).
NOTE: Confirming the ability of software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.
For More Information Please Visit http://www.iso9001-standard.us

ISO 14001:2004 Standards Contents

ISO 14001:2004 Standards
ISO 14000 is a series of international standards on environmental management. It provides a framework for the development of an environmental management system and the supporting audit programme.
The main thrust for its development came as a result of the Rio Summit on the Environment held in 1992.
ISO 14000 is an Environmental Management System (EMS), which requires that an organization consider the environmental aspects of its products and services.
Iso14000 approach forces you to take a hard look at all areas of your business that has an environmental impact.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
ISO 14000 is an Environmental Management System (EMS) who’s purpose is:
· A management commitment to pollution prevention.
· An understanding of the environmental impacts (reducing) of an organization’s activities.
A commitment (pollution prevention) to employees, neighbors and customers
ISO 14001 is the corner stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System against which an organization can be certified by a third party.
The environment cannot be protected by our convictions or goodwill alone. Efforts to protect the environment must be planned, coordinated and organized into a system, such as ISO 14001.
ISO14001 requires an Environmental Policy to be in existence within the organisation, fully supported by senior management, and outlining the policies of the company, not only to the staff but to the public. The policy needs to clarify compliance with Environmental Legislation that may effect the organization and stress a commitment to continuous improvement. Emphasis has been placed on policy as this provides the direction for the remainder of the Management System.
Those companies who have witnessed ISO9000 Assessments will know that the policy is frequently discussed during the assessment, many staff are asked if they understand or are aware of the policy, and any problems associated with the policy are seldom serious. The Environmental Policy is different, this provides the initial foundation and direction for the Management System and will be more stringently reviewed than a similar ISO9000 policy. The statement must be publicised in non-technical language so that it can be understood by the majority of readers. It should relate to the sites within the organisation encompassed by the Management System, it should provide an overview of the company’s activities on the site and a description of those activities. A clear picture of the company’s operations.
The preparatory review and definition of the organization’s environmental effects is not part of a ISO14001 Assessment, however examination of this data will provide an external audit with a wealth of information on the methods adopted by the company. The preparatory review itself should be comprehensive in consideration of input processes and output at the site. This review should be designed to identify all relevant environmental aspects that may arise from existence on the site. These may relate to current operations, they may relate to future, perhaps even unplanned future activities, and they will certainly relate to the activities performed on site in the past (i.e. contamination of land).
The initial or preparatory review will also include a wide-ranging consideration of the legislation which may effect the site, whether it is currently being complied with, and perhaps even whether copies of the legislation are available. Many of the environmental assessments undertaken already have highlighted that companies are often unaware of ALL of the legislation that affects them, and being unaware, are often not meeting the requirements of that legislation.
The company will declare its primary environmental objectives, those that can have most environmental impact. In order to gain most benefit these will become the primary areas of consideration within the improvement process, and the company’s environmental program. The program will be the plan to achieve specific goals or targets along the route to a specific goal and describe the means to reach those objectives such that they are real and achievable. The Environmental Management System provides further detail on the environmental program. The EMS establishes procedures, work instructions and controls to ensure that implementation of the policy and achievement of the targets can become a reality. Communication is a vital factor, enabling people in the organisation to be aware of their responsibilities, aware of the objectives of the scheme, and able to contribute to its success.
As with ISO9000 the Environmental Management System requires a planned comprehensive periodic audit of the Environmental Management System to ensure that it is effective in operation, is meeting specified goals, and the system continues to perform in accordance with relevant regulations and standards. The audits are designed to provide additional information in order to exercise effective management of the system, providing information on practices which differ to the current procedures or offer an opportunity for improvement.
In addition to audit, there is a requirement for Management Review of the system to ensure that it is suitable (for the organization and the objectives) and effective in operation. The management review is the ideal forum to make decisions on howe to improve for the future.
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. Organizations who are currently registered to ISO 14001:1996 will have an 18-month transition period to register to ISO 14001:2004.

ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System

ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System (QMS)
- An Romania Perspective
The assurance of quality of the delivered products and services has always represented the main goal of any organisation which wants to be on the market. The concept of „quality” is larger than in the past, referring also to management aspects. Thus, the quality of products and services does not represent only a goal, but a consequence of the quality of the whole managerial activities, workers, and even a quality of partnerships. Modern industrial reorganisations are usually realised through the strategies of quality management, due to the fact that these are able to release the continuous and substantial improvements of the economical agents’ performances.
Within such a frame, one possibility for an organisation to maintain and to gain new positions on a market is to design, to implement and to certificate a Quality Management System (QMS), system through which all processes are controlled.
The Romanian pharmaceutical market is currently restricted as volume and value compared to other countries in the region. Joining the European Union and future improvement of living conditions will mean increase of pharmaceutical expenses per person, considering the fact that the demand for pharmaceutical products (medication) is not influenced by the evolution of prices. After 1990, foreign manufacturers have become interested in the increasing potential of Romania, a country of 22 million inhabitants with a very low intake of drugs per person, due to the low living standard. They have penetrated the market through direct import companies, through license agreements, acquisitions and privatizations.
Romanian manufacturers have tried to shift their direction towards export, but the barrier represented by the Good Manufacturing Practice (GMP – for production) and ISO 9001:2000 standards (for distribution) has stopped their penetration of new markets. Their exports mainly targeted Russia, Moldova and former socialist countries. Without norms of this kind, also known as standards, today’s international trade would be inconceivable because every product would have to be checked in keeping with individual criteria. Norms, therefore, create comparability.
Nowadays, the external market has, for several companies, the same importance as the domestic one. The conquest of external market is essential because it brings currency, improves commercial balance, creates new working places and promotes the managerial or technological know-how transfer.
ISO 9000 is a generic name given to a family of standards developed to provide a framework around which a quality management system can be effectively implemented. These standards were developed mainly to facilitate commercial relationships and to increase the confidence of consumers in the capability of a supplier to constantly satisfy the requirements of products and services quality.
The paper presents some advantages achieved by implementation of Quality Management System in pharmaceutical industry, namely S.C. X Company S.A from Tirgu-Mures, one of the most important producer and distributor of pharmaceutical products in Romania.
Using a proven management system combined with ongoing external validation, enables the X Company to continually renew its strategies, domestic and external operations and service level. To this respect, the paper presents the main steps in implementing the Quality Management System within this organisation and some benefits of the registration such as increasing domestic sales, but most off all, the penetration and increasing sales on external markets.
The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines related to quality management systems and related supporting standards.
ISO 9001:2000 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.
The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects. Implementing a Quality Management System within an organisation needs to be a decision of top management. The objective of the quality system needs to be clearly defined so that the system can be effective. The design and implementation of quality management system will vary depending on the type, size and products of the organisation and should be used in conjunction with the ISO 9000:2000 standards. Implementing a Quality Management System is not that difficult as it seems, the key is planning and commitment. How complex or simple the QMS is depends entirely on the organisation and what the objectives are. It can be a simple guide to the organisation policy and procedures, or it can document every task and procedure. It really depends on how much risk is involved and how much control is required.
The documentation of QMS involves:
1. The policy to refer to quality, the objectives of quality and the book of quality (Quality Management System)
2. Management Responsibility
3. Resource Management
4. Product Realisation
5. Measurements, Analysis and Improvement
A well managed quality system will have impact on:
1. customer loyalty and repeat business
2. market share
3. operational efficiencies
4. flexibility and ability to respond to market opportunities
5. effective and efficient use of resources
6. cost reductions
7. competitive advantages

ISO 9001 Standards – Documented Procedures

ISO 9001 Standards – Documented Procedures

The standard requires the management system documentation to include documented procedures required by ISO 9001 Standards.
ISO 9000 defines a procedure as a specified way to carry out an activity or a process. This definition is ambiguous because an activity is on a different scale than a process. Process outputs are dependent upon many factors of which activities are but one. An activity is the smallest unit of work. Several activities accomplish a task and several tasks reflect the stages in a process but there is more to a process than a series of tasks. This definition also esults in a belief that procedures are documented processes but this too is inaccurate. Procedures tell us how to proceed don‘t need to produce any others. The specific procedures required are:

(a) A documented procedure for document control
(b) A documented procedure for the control of records
(c) A documented procedure for conducting audits
(d) A documented procedure for nonconformity control
(e) A documented procedure for corrective action
(f) A documented procedure for preventive action
These areas all have something in common. They are what the authors of the early drafts of ISO 9000 :2008 referred to as system procedures ? they apply to the whole system and are not product, process or customer specific although it is not uncommon for customers to specify requirements that would impact these areas. Why procedures for these aspects are required and not for other aspects of the management system is unclear but it seems that the authors of ISO 9000 felt these were not processes ? a conclusion I find difficult to justify.
They are certainly not business processes but could be work processes. However, there is another message that this requirement conveys. It is that procedures are not required for each clause of the standard. Previously, countless organizations produced a manual of 20 procedures to match the 20 elements of ISO 9001. Some limited their procedures to the 26 procedures cited by the standard and others produced as many as were necessary to respond to the requirements.
Document control is a work process or a number of work processes because the inputs pass through a number of stages each adding value to result in the achievement of defined objectives. These are the acquisition, approval, publication, distribution, storage, maintenance, improvement, and disposal stages. These are not tasks but processes that achieve defined objectives and involve both physical, financial and human resources. Within these processes are tasks, each of which may require documented procedures as they are initiated.
Control of records is also a work process similar to document control. There are the preparation, storage, access, maintenance and disposal stages. This is not one uninterrupted flow but a life cycle. There is not one task but several performed at different times for different reasons.
Auditing is certainly a process with a defined objective. Without the provision of competent personnel and a suitable environment, audits will not achieve their objectives no matter how many times the procedure is implemented.
Nonconformity control like records control is a work process for the same reasons. The sequence of tasks is not in the form of an uninterrupted sequence. The sequence of stages may be identification, documentation, segregation, review, remedial action and disposal but this is not a continuous sequence. There are breaks and different procedures may apply at each stage depending on what it is that is nonconforming.
There is little merit in having one corrective action procedure when the source of problems that require corrective action is so varied. One Corrective Action Form might be appropriate but its application will be so varied that it is questionable whether one size fits all. Presenting top management with a nonconformity report because it has been detected that the organization charts are not promptly updated following a change, will not motivate them into action. Corrective action forms part of every process rather than being a separate process. It is unreasonable to force all actions aimed at preventing the recurrence of problems through one process. Many problems are prevented from recurring not by following a procedure, but by the designer, the producer, supplier, manager remembering they had a problem last time and doing it differently the next ? i.e. they learn from their mistakes. No forms filled in, no procedures followed ? just people using their initiative ? this is why corrective action is part of every process operation.
Preventive action remains one of the most misunderstood requirements of ISO 9001 because it is mistaken for corrective action but more on this. There is even less justification for one preventive action procedure because the source of potential problems is so varied. Preventive actions are taken in design, in planning, in training and in maintenance under the name of FMEA, Reliability Prediction, Quality Planning, Production Planning, Logistic Planning, Staff Development, Equipment Maintenance ? preventive actions are built into these processes and similar to corrective action are part of every process design.

Demonstrating conformity with ISO 9001:2008

Demonstrating conformity with ISO 9001:2008
For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.
Organizations may be able to demonstrate conformity without the need for extensive documentation.
To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines “objective
evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”
Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d)
Planning of product realization, and clause 8.2.4 Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.
Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.

Guidance on Clause 4.2 of ISO 9001:2008

Guidance on Clause 4.2 of ISO 9001:2008
The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of the general documentation requirements of the International Standard.
a) Documented statements of a quality policy and objectives:
Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented quality policy has to be controlled according to the requirements of clause 4.2.3.
Note: Organizations that are revising their quality policy for the first time, or in order to meet the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g).
Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented quality objectives are also subject to the document control requirements of clause 4.2.3.
b) Quality Manual:
Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS
A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.
Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.
The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.
c) Documented procedures:
ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities:
4.2.3 Control of documents
4.2.4 Control of records
8.2.2 Internal audit
8.3 Control of nonconforming product
8.5.2 Corrective action
8.5.3 Preventive action
These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3 Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (for example, corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (for example, internal audits). Both are acceptable.
Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures (particularly those relating to product realization processes) to implement an effective QMS.
Other organizations may require additional procedures, but the size and/or culture of the organization could enable these to be effectively implemented without necessarily being documented. However, in order to demonstrate compliance with ISO 9001:2008, the organization has to be able to provide objective evidence (not necessarily documented) that its QMS has been effectively implemented.
d) Documents needed by the organization to ensure the effective planning, operation and control of its processes:
In order for an organization to demonstrate the effective implementation of its QMS, it may be necessary to develop documents other than documented procedures. However, the only documents specifically mentioned in ISO 9001:2008 are:
- Quality policy (clause 4.2.1.a)
- Quality objectives (clause 4.2.1.a)
- Quality manual (clause 4.2.1.b)
There are several requirements of ISO 9001:2008 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples
may include:
- Process maps, process flow charts and/or process descriptions
- Organization charts
- Specifications
- Work and/or test instructions
- Documents containing internal communications
- Production schedules
- Approved supplier lists
- Test and inspection plans
- Quality plans
All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or 4.2.4, as applicable
e) Records:
Examples of records specifically required by ISO 9001:2008 are presented in Annex B.
Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system.
Requirements for the control of records are different from those for other documents, and all records have to be controlled according to those of clause 4.2.4 of ISO 9001:2008.