ISO 9001 Standards Document control procedures

ISO 9001 Standards Document control procedures
The ISO 9001 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 9001 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.

ISO 9001 Standards Document control procedures

ISO 9001 Standards Document control procedures
The ISO 9001 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 9001 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.

ISO 9001 Standards – Quality Policy and Objectives

ISO 9001 Standards – Quality Policy and Objectives

A ISO 9001 Standards quality policy and its corresponding quality objectives are established to direct the organization towards two specific goals of a quality management system:

-Provision of products – goods and services – that meet customer and applicable legal requirements, and

- Enhancement of customer satisfaction

The quality policy and the objectives are also a means of controlling the quality management system’s processes. Simply, if you want to control a process, assign an objective to it (or more) and make sure it is aligned to the quality policy, then monitor and measure the process’ performance against the assigned objective. You need to provide adequate resources to the process to ensure that it is capable of achieving the objective. You continually improve the whole process by upgrading the objective, make corrective and preventive actions or introduce innovation to it. Corrective action addresses an undesirable situation’s cause in order to prevent its recurrence. Preventive action, by contrast, addresses the probable cause of a potentially undesirable situation. This is what the quality policy and objectives are supposed to do. They provide focus, direction and control.

The quality objectives need to be consistent with the quality policy and the commitment to continual improvement, and their achievement needs to be measurable. The achievement of quality objectives can have a positive impact on product quality, operational effectiveness and financial performance and thus on the satisfaction and confidence of interested parties. When an organization has established a quality policy and a set of operational objectives, this means the only thing left to do is to design or plan the necessary processes or tasks that can realize those objectives. Therefore, the processes determine if the objectives will be met in full, partially or not at all. This is where the ISO 9001 standard play a critical role in specifying the required processes and the operating criteria. This is what ISO 9001 is all about. It even specifies criteria for the policy and the objectives.

A quality policy needs to satisfy the following requirements:

• It is appropriate to the purpose of the organization,
• It includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
• It provides a framework for establishing and reviewing quality objectives,
• It is communicated and understood within the organization, and
• It is reviewed for continuing suitability

Quality objectives must be established in order to enable the organization to comply with requirements and continually improve the effectiveness of the quality management system. Quality objectives must achieve four things:

• Enable the organization to meet customer requirements
• Enable the organization to enhance customer satisfaction
• Enable the organization to comply with all legal requirements applicable to the product
• Continually contribute to the effectiveness of the quality management system

Therefore, when you are in the meeting room with your management brainstorming on the appropriate objectives, have these four points in mind.

ISO 9001:2000 requires that management periodically review changes to both the policy and objectives. An organization’s objectives must be measurable and its processes designed to meet those objectives. An organization’s overall business goals, quality objectives and quality policy are all interrelated and must work together to achieve business improvement. To do this, it’s necessary to understand which processes are key to achieving business goals and align those processes with the quality objectives. It means aligning business goals, quality objectives and process measures to create real improvement. And it means using process mapping. Process mapping involves more than just flow charting. Among other things, it can manage and improve processes by illustrating process measures as well as process flows and interactions. One process-mapping method begins by involving the people who work in the process. Another entails mapping the process as is, taking action to improve it and then preparing a final map of the improved process.

Process owners are directly responsible for the attainment of the objectives. They must be given adequate resources, including competent human resources. They need to review the objectives periodically to ensure the key performance indicators are heading towards their objectives on schedule. If not, they need to initiate corrective actions and if the risks of non-achievement are visible, take preventive actions to control them and steer the KPI’s back on course.

Examples of quality objectives:

• Production rejects <>
• Machine breakdown <>
• Returned products = 0/mth
• Purchasing >95% on-time delivery
• Inventory damage = 0/mth

Conclusion: ISO 9001 requires that the quality management system achieves its objectives in order to realize the quality policy.

ISO 9001 Standards – Quality Policy and Objectives

ISO 9001 Standards – Quality Policy and Objectives

A ISO 9001 Standards quality policy and its corresponding quality objectives are established to direct the organization towards two specific goals of a quality management system:

-Provision of products – goods and services – that meet customer and applicable legal requirements, and

- Enhancement of customer satisfaction

The quality policy and the objectives are also a means of controlling the quality management system’s processes. Simply, if you want to control a process, assign an objective to it (or more) and make sure it is aligned to the quality policy, then monitor and measure the process’ performance against the assigned objective. You need to provide adequate resources to the process to ensure that it is capable of achieving the objective. You continually improve the whole process by upgrading the objective, make corrective and preventive actions or introduce innovation to it. Corrective action addresses an undesirable situation’s cause in order to prevent its recurrence. Preventive action, by contrast, addresses the probable cause of a potentially undesirable situation. This is what the quality policy and objectives are supposed to do. They provide focus, direction and control.

The quality objectives need to be consistent with the quality policy and the commitment to continual improvement, and their achievement needs to be measurable. The achievement of quality objectives can have a positive impact on product quality, operational effectiveness and financial performance and thus on the satisfaction and confidence of interested parties. When an organization has established a quality policy and a set of operational objectives, this means the only thing left to do is to design or plan the necessary processes or tasks that can realize those objectives. Therefore, the processes determine if the objectives will be met in full, partially or not at all. This is where the ISO 9001 standard play a critical role in specifying the required processes and the operating criteria. This is what ISO 9001 is all about. It even specifies criteria for the policy and the objectives.

A quality policy needs to satisfy the following requirements:

• It is appropriate to the purpose of the organization,
• It includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
• It provides a framework for establishing and reviewing quality objectives,
• It is communicated and understood within the organization, and
• It is reviewed for continuing suitability

Quality objectives must be established in order to enable the organization to comply with requirements and continually improve the effectiveness of the quality management system. Quality objectives must achieve four things:

• Enable the organization to meet customer requirements
• Enable the organization to enhance customer satisfaction
• Enable the organization to comply with all legal requirements applicable to the product
• Continually contribute to the effectiveness of the quality management system

Therefore, when you are in the meeting room with your management brainstorming on the appropriate objectives, have these four points in mind.

ISO 9001:2000 requires that management periodically review changes to both the policy and objectives. An organization’s objectives must be measurable and its processes designed to meet those objectives. An organization’s overall business goals, quality objectives and quality policy are all interrelated and must work together to achieve business improvement. To do this, it’s necessary to understand which processes are key to achieving business goals and align those processes with the quality objectives. It means aligning business goals, quality objectives and process measures to create real improvement. And it means using process mapping. Process mapping involves more than just flow charting. Among other things, it can manage and improve processes by illustrating process measures as well as process flows and interactions. One process-mapping method begins by involving the people who work in the process. Another entails mapping the process as is, taking action to improve it and then preparing a final map of the improved process.

Process owners are directly responsible for the attainment of the objectives. They must be given adequate resources, including competent human resources. They need to review the objectives periodically to ensure the key performance indicators are heading towards their objectives on schedule. If not, they need to initiate corrective actions and if the risks of non-achievement are visible, take preventive actions to control them and steer the KPI’s back on course.

Examples of quality objectives:

• Production rejects <>
• Machine breakdown <>
• Returned products = 0/mth
• Purchasing >95% on-time delivery
• Inventory damage = 0/mth

Conclusion: ISO 9001 requires that the quality management system achieves its objectives in order to realize the quality policy.

ISO 9001 Standards & ISO 14001 Standards

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
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 ISO 14001:2004.

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.

Quality In ISO 9001 Standards

The Eight Dimensions of Quality

1. Performance

2. Reliability

3. Durability

4. Serviceability

5. Aesthetics

6. Features

7. Perceived Quality

8. Conformance to Standards

Terminology

Every product possesses a number of elements that jointly describe what the user or consumer thinks of us as quality. These parameters are often called quality characteristics. Sometimes these are called critical-to-quality (CTQ) characteristics. Quality characteristics may be of several types:

1. Physical: length, weight, voltage, viscosity

2. Sensory: taste, appearance, color

3. Time Orientation: reliablility, durability, serviceablity.

Since variability can only be described in statistical terms, statistical methods play a central role in quality improvement efforts. In the application of statistical methods to quality engineering, it is fairly typical to classify data on quality characteristics as either attributes or variables data. Variables data are usually continuous measurements, such as length, voltage, or viscosity. Attributes data, on the other hand, are usually discrete data, often taking the form of counts. We will describe statistical-based quality engineering tools for dealing with both types of data.

The Eight Dimensions of Quality1. Performance2. Reliability3. Durability4. Serviceability5. Aesthetics6. Features7. Perceived Quality8. Conformance to StandardsTerminologyEvery product possesses a number of elements that jointly describe what the user or consumer thinks of us as quality. These parameters are often called quality characteristics. Sometimes these are called critical-to-quality (CTQ) characteristics. Quality characteristics may be of several types:1. Physical: length, weight, voltage, viscosity2. Sensory: taste, appearance, color3. Time Orientation: reliablility, durability, serviceablity.Since variability can only be described in statistical terms, statistical methods play a central role in quality improvement efforts. In the application of statistical methods to quality engineering, it is fairly typical to classify data on quality characteristics as either attributes or variables data. Variables data are usually continuous measurements, such as length, voltage, or viscosity. Attributes data, on the other hand, are usually discrete data, often taking the form of counts. We will describe statistical-based quality engineering tools for dealing with both types of data.

ISO 9000 Softwares

ISO 9000 Softwares

1. ISO 9000 Software – ISO 9000 Document Control Software

The concept of document control is integral to ISO 9000. Specifically ISO 9001: 2000, requires the establishment of a document control system that stores and manages documents relating to implementing, maintaining, and continually improving a quality management system. Within the context of ISO 9000, a quality system must be documented and quality records must be maintained. Document control helps ensure effective operation and facilitates better decision-making, by providing a vehicle for employees, customers, and partners to access controlled documentation from any location at anytime.

For high-tech companies that adhere to ISO 14000 environmental management standards, document control procedures are equally necessary to help them continuously improve their environmental management system.

The ISO 9000 Document Control Software is developed & designed to control the ISO 9000 Quality Manual, Operating Procedure, Forms & Documents digitally. System will track the all ISO 9000 Documents by ISO Document No. through out the system.

The ISO 9000 Document Control Software Provides:-

Tracking of Documents- Provides secure tracking of all your ISO 9000 Quality Manual, Operating Procedure & Forms & Documents in any format either in Microsoft Word, Excel, PDF or etc.
Efficiency Document Control- It’s uniquely qualified to be the focal point of a quality management system because it can handle all types of documents regardless of the software used to create them. It provides a secure and centralized document control repository that makes search and retrieval easy during inspections and audits.
Revision Control- Tracking of Document revisions, approval & Release Date. Manually Tracking down any revision on the ISO 9000 document activity is difficult . The ISO 9000 Document Control Software will help to keep track the numbers of revision have been carried out, and also maintain the various revision copies of the documents.
Multiple File Location – System will be able to keep track the directories & folder where the original location is saved.
Centralize Of Document Control – Do not worry about the various department is getting the correct edition of the documents, because all documents have been managed by a centralize software. Document reviews are conveniently scheduled and documented.
Security:System provide User Right Control module which enable System Administrator to define the access right to authorized users and activity allowed.
2. ISO 9000 Software – ISO 9000 Audit Control Software

The ISO 9000 Audit Control Softwarewere designed to handle all aspects of an internal or external audit programme, from planning audits to the follow-up of corrective actions against deficiencies found.

The Control Software increases the accountability and efficiency of your internal/external audits by developing core processes with clearly defined audit plans, step-by-step procedures, and standardized auditor roles and responsibilities. It will help to put you to the right path toward developing a well-organized ISO9001:2000 internal /external audit system.

The ISO 9000 Audit Control Software Provides:-

Audit Schedule – maintains the audit schedule, checklist preparation and all audit info.
Track Non-Conformance – System will help to track all non-conformances found during the audit, including actions & verification.
Corrective Action Report (CAR) – Update of the corrective action.
Security: System provide User Right Control module which enable System Administrator to define the access right to authorized users and activity allowed.