ISO 9001 Standard - ISO 9001 Standards

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ISO 9001 Equipment Maintenance Procedure

The purpose of this ISO 9001 Standards procedure is to regulate the planning and inspecting maintenance of equipments and machines while implementing process of production industry. The maintenance is to minimize and prevent from unexpected incidents caused by machines influencing the plan and schedule of production.

This procedures include steps as follows:

1. Need of equipment maintenance:

Due to the fact is that maintenance of machines and equipments is very important to the implementation of production industry, so the need of machines maintenance is set up to eliminate and prevent from unexpected incidents by machines and equipments that may affect to the plan and progress of production.

2. Making list of equipments

All machines and equipments that are working are conforming to requirements of production. The maintenance will coordinate with other Heads of departments (HODs) to make a list of each equipment for checking, preparing to replace, or repairing to submit to Technical department for approval.

3. Making a schedule of investigation:

Based on the machines and equipments that are using and depending the capacities and purposes of specialized equipments, the maintenance will make a schedule of investigation accordingly identifying the machines that serve requirements of practical products and give schedule of maintenance periodically or regularly maintained according to frequency of using.

4. Implementation of Investigation:

Based on plan of investigation, the maintenance department will investigate machines and equipment and record clearly:

o The duration of time used
o The duration of time maintained previously
o Trouble shootings earlier.
o Status of machines and equipments.
o Need repairing, replacing or maintenance.

5. Making schedule of maintenance:

After investigation and examination, the maintenance department will review the frequency of using of each machine so as to make a schedule of specific maintenance for each kind of machine and equipment.

o After identifying purpose and the importance of each machine in production, the maintenance department will make a schedule of maintenance for each of equipment as regulated by designers.

6. Material estimate:

Once having schedule of maintenance or repair, the maintenance will inspect to identify the causes leading trouble shootings, make a material estimate request to supply accessories of the equipment that need repairing at definite time. At the same time, there will be supervision and inspection from Head of department where machines or equipments are used.

7. Implementation:

Once having made material estimate and provided, Maintenance Department carry out repair based on the plan of maintenance and approval for repair. After the maintenance is finished, the maintenance will coordinate with the using department to make a report of inspection and evaluating quality of equipment and machines to put into operation and stating clearly about status of equipments that are replaced.

8. Updating files:

When finishing maintenance and repair, the maintenance Dept. will file each of machine whose accessories are repaired and for how long they can work as well as make a file for each machine.

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ISO 9001 Standards

ISO 9001 Standards

ISO 9001 Standards is a written set of rules (a Standard) published by an international standards writing body (International Organization for Standardization. The rules define practices that are universally recognized and accepted for assuring that organizations consistently understand and meet the needs of their customers.
ISO 9000 is also highly generic. Its principles can be applied to any organization providing any product or service anywhere in the world.
Since meeting customer needs is one of the (many) definitions of quality, ISO 9001 Standards is often called a quality system or a quality management system. But the rules, referred to as requirements, go beyond quality matters as they are traditionally understood. The requirements fall roughly into the following types:

a. Requirements that help assure that the organizations output (whether product, service, or both) meets customer specifications. (Making, and keeping, them happy.)

b. Requirements that assure that the quality system is consistently implemented and verifiable. (We must actually do what we say we are supposed to do. This must be verifiable via independent, objective
audit.)

c. Requirements for practices that measure the effectiveness of various aspects of the system. (In God we trust; all others bring data.)

d. Requirements that support continuous improvement of the companys
ability to meet customer needs. (We cannot sit still. We must strive to get better all the time, because customers change, and competitors gain strength.)

Nothing in ISO 9000 is new. The first edition, published by ISO in 1987, was drawn almost word for word from a British quality system standard. It in turn evolved from a long succession of written quality system specifications that had their ultimate origin in the defense and arms industries. Most of the practices required by ISO 9000 have been in use in industries of various kinds for decades. One intent of ISO 9001 is to simplify things for organizations. ISO 9001 strives to harmonize the sometimes conflicting, sometimes redundant quality programs that have traditionally been imposed by major corporations on their suppliers. (Note, however, that ISO 9000 is not meant to supersede customer, legal, or regulatory requirements.)

Very often, major customers require or strongly suggest that their suppliers implement ISO 9001 systems. Equally often, such customers require independent verification that suppliers are meeting the equirements.

So third-party registration bodies audit suppliers, confirm compliance to the ISO 9001 standards, and register the suppliers. It does not stop there. To stay registered, suppliers must undergo periodic (often semi-annual) surveillance audits, also carried out by their registration body.

Implementing an ISO 9001 quality system is neither cheap, nor easy. How costly and difficult it can be depends on:

a. The level of commitment of senior management. (The single most important factor.)

b. Where you are when you start. If you have already implemented a disciplined, documented quality system, you will have a less difficult time migrating to ISO 9001. (But that does not mean you will waltz to registration, either.)

c. Whether your company (or any part of it) is design responsible or not.

d. How much time you have. If you are under the customers gun and have merely months to get the job done, the process will be highly stressful.

e. The physical size and configuration of your company.

The bottom line is this. ISO 9001 Standards is a comprehensive set of rules—a business system, really—that can cause the way your organization runs to profoundly change, almost always for the better. Yet, because it is often customer-mandated, many suppliers regard ISO 9001 as just another hoop to jump through to keep our customers happy.

They see their choice as swallow hard, pony up, and jump through the hoops; or walk away from the customer. What many do not fully appreciate is that implementing ISO 9001Standards —expensive, exhausting, and annoying as it can be—can also have the salutary effect of improving the performance of your organization. Not just at first, but on an ongoing basis.

What Is ISO 9001 Standards

What is ISO 9001 Standards?
ISO 9001 is a set of interrelated ideas, principles and rules and
could therefore be considered a system in the same way that we refer to the
metric system or the imperial system of measurement. ISO 9001 is both an
international standard and until year 2008, was a family of some 20
international standards. As a standard, ISO 9001 was divided into 4 parts with
part 1 providing guidelines on the selection and use of the other standards in
the family. The family of standards included requirements for quality
assurance and guidelines on quality management. Some might argue that none
of these are in fact standards in the sense of being quantifiable. The critics
argue that the standards are too open to interpretation to be standards
anything that produces such a wide variation is surely an incapable process
with one of its primary causes being a series of objectives that are not
measurable. However, if we take a broader view of standards, any set of rules,
rituals, requirements, quantities, targets or behaviours that have been agreed
by a group of people could be deemed to be a standard. Therefore by this
definition, ISO 9001 is a standard.

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.

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.

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.

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.

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.

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.
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Quality Planning

Whenever the term “product” is used within the ISO 9001 standard, it refers to both tangible goods and intangible services. The ISO 9001 standard is meant to be generic which means that it is suitable for all kinds of organization, whether commercial or otherwise. The purpose of the quality management system model that is being propagated by the standard is the fulfillment of customer requeirements and expectations in order to induce high levels of customer satisfaction. An unsatisfied customer is essentially a customer whose requirements or needs, and expectations of the level of services being granted upon him/her have not been met. We are all customers because we buy products all the time. So we know what it means to be a dissatisfied customer. The common reaction is to never to go back to that seller and look for other alternatives. A successful organization is one which understands what it takes to meet customer requirements in order to satisfy their needs and expectations. A specific process is thus necessary to resolve any customer complaint or dispute. This process should be geared towards satisfying the customer’s needs and expectations. The parameters of this process should be referenced from the terms of the sale and purchase. This is why it is necessary to review the customer’s requirements before committing to the sales contract. It is necessary that the customer understands what he/she is paying for and it is equally necessary for the organization to understand what it is supposed to deliver. When your organization has these processes in place, then the only thing to do next is to continually measure the effectiveness and subsequently take actions to continually improve the whole process.

ISO 9001 registration or certification

ISO 9001 registration or certification

Registration is documented and objective evidence that an organization’s quality system meets the requirements of ISO 9000.
Certification is a term often used interchangeably with registration.
In the context of ISO 9001, they mean the same thing. Registration isthe technically correct term for verification of compliance to standards of quality systems. Certification usually applies to verification of the quality of products (as opposed to quality systems).
Registration is carried out by independent companies called registrars.These companies are:- Wholly independent.- Accredited by a recognized international accreditation body.- Selected, and paid, by you.
Registration can cover:- The sole location of a single-location organization.- Multiple locations of a multi location organization.- Only certain parts of a multi location organization (under certain conditions).- Separate locations under separate certificates. (This is a more costly approach.)The registration body audits your quality system against the requirements of ISO 9001. It reports its findings in writing. These findings may (and usually do) include noncompliances . Major noncompliances must be closed out prior to official registration.
When this has been done, the registration body:- Lists the organization’s name in its book of registered companies—in effect, registers the organization in its book.- Issues a certificate to the registered organization. This registration includes:— Identity of the organization.— Location(s) covered by the registration.— A list of products/services supplied by the registered locations.— Revision date of the Standard.— Registration effective dates.— Name and location of registrar.
Most registrars limit registrations to three years. After that, youmust renew your registration by undergoing another complete systems audit. Some registrars do not use the renewal approach. They simply keep checking the system via surveillance audits.
Whichever the scheme, the organization, to keep registration, must undergo a surveillance assessment every so often. Six months is the typical interval. Some registrars offer annual surveillance schemes (notrecommended except for firms with exceptionally well-implemented quality management systems). Surveillance assessments are scheduled events (there is no such thing as a “surprise” surveillance audit). Only part of the quality system is checked at each surveillance. Usually, theregistrar does not disclose what part will be assessed until the day of theassessment, although some registrars will tell you everything up front.The entire quality system is usually checked via surveillance audits overthe course of three years.
There is no way to “fail” a surveillance assessment, just as there is no way to “fail” a registration audit—except by refusing to implement corrective action required by the registrar. Normally,registrars allow adequate time, but corrective actions must be done in a timely and agreed upon manner to keep registration.One final note: As mentioned, each registrar publishes a list ofthe firms it has registered to ISO 9000.

Goal and Scope of an ISO 9001 quality system

Goal and Scope of an ISO 9001 quality system
The ISO 9001 Standards states its goal in two blunt words: customer satisfaction.How do we achieve customer satisfaction? By meeting customer requirements.The quality management system (QMS) helps us to do this by:
a. Applying the system. Actually using it. Putting it at the heart of our organization.
b. Continually improving the system. The QMS is never done. After all, customer requirements do not stand still—they evolve and grow tougher.So we have to improve continually in order to survive.
(The guidance document, ISO 9004: 2000, sets a compatible and in some respects more ambitious goal: “improving the processes of an organization to enhance performance.”) Prevention of nonconformity. Prevention is the key term here: prevention,rather than detection. Quality management has long since evolved away from the old “inspect quality in” approach.Prevention is cheaper, more effective, and more protective of the customer. Detection is also a different mindset. It requires a very high degree of process orientation, upstream thinking, and relentless analysis.To what types of organizations does the Standard apply? All types. The requirements “are generic and applicable to all organizations,regardless of type and size.” A compliant QMS can be implementedby any organization, producing any product or service,anywhere in the world.Within the organization, the impact of the requirements and the QMS are similarly broad. The Standard “applies to the activities of organizations from the identification of customer requirements, through all quality management system processes, to the achievement of customer satisfaction.” Every activity within the organization that impacts the process of creating customer satisfaction is affected by the requirements of the ISO 9001 Standards.

ISO 9001 Standards

ISO 9001 Standards
ISO 9001 is a written set of rules (a “Standard”) published by an internationalstandards writing body (International Organization for Standardization. The rules define practices that are universally recognized and accepted for assuring that organizations consistently understand and meet the needs of their customers.ISO 9001 is also highly generic. Its principles can be applied to any organization providing any product or service anywhere in the world.Since meeting customer needs is one of the (many) definitions of quality, ISO 9001 is often called a quality system or a quality management system. But the rules, referred to as requirements, go beyond quality matters as they are traditionally understood. The requirements fall roughly into the following types:
a. Requirements that help assure that the organization’s output (whether product, service, or both) meets customer specifications. (Making, and keeping, them happy.)
b. Requirements that assure that the quality system is consistently implemented and verifiable. (We must actually do what we say we are supposed to do. This must be verifiable via independent, objectiveaudit.)
c. Requirements for practices that measure the effectiveness of variousaspects of the system. (In God we trust; all others bring data.)
d. Requirements that support continuous improvement of the company’sability to meet customer needs. (We cannot sit still. We must strive to get better all the time, because customers change, and competitors gain strength.)
Nothing in ISO 9001 is new. The first edition, published by ISO in 1987, was drawn almost word for word from a British quality system standard. It in turn evolved from a long succession of written quality system specifications that had their ultimate origin in the defense and arms industries. Most of the practices required by ISO 9001 have been in use in industries of various kinds for decades. One intent of ISO 9001 is to simplify things for organizations. ISO 9001 strives to harmonize the sometimes conflicting, sometimes redundant quality programs that have traditionally been imposed by major corporations on their suppliers. (Note, however, that ISO 9001 is not meant to supersede customer, legal, or regulatory requirements.)
Very often, major customers require or strongly “suggest” that their suppliers implement ISO 9001 systems. Equally often, such customers require independent verification that suppliers are meeting the equirements.
So third-party registration bodies audit suppliers, confirm compliance to the ISO 9001 standard, and register the suppliers. It does not stop there. To stay registered, suppliers must undergo periodic (often semi-annual) surveillance audits, also carried out by their registration body.
Implementing an ISO 9001 quality system is neither cheap, nor easy. How costly and difficult it can be depends on:
a. The level of commitment of senior management. (The single most important factor.)
b. Where you are when you start. If you have already implemented a disciplined, documented quality system, you will have a less difficult time migrating to ISO 9001. (But that does not mean you will waltz to registration, either.)
c. Whether your company (or any part of it) is “design responsible” or not.
d. How much time you have. If you are under the customer’s gun and have merely months to get the job done, the process will be highly stressful.
e. The physical size and configuration of your company.
The bottom line is this. ISO 9001 is a comprehensive set of rules—a business system, really—that can cause the way your organization runs to profoundly change, almost always for the better. Yet, because it is often customer-mandated, many suppliers regard ISO 9001 as “just another hoop to jump through to keep our customers happy.”
They see their choice as swallow hard, pony up, and jump through the hoops; or walk away from the customer. What many do not fully appreciate is that implementing ISO 9001—expensive, exhausting, and annoying as it can be—can also have the salutary effect of improving the performance of your organization. Not just at first, but on an ongoing basis.

Backgroup And Future Of ISO 9001:2008

ISO 9001 serves as the basis for benchmarking an organization's quality management system. Quality management should not be confused with terms such as quality assurance" or quality control. Quality management measures the overall management function in determining the organization's quality policy, its objectives, and its responsibilities, as well as the quality policy implementation through means such as quality assurance and quality control. Quality assurance measures all planned and systematic activities implemented within the organizations quality system. Quality control is the operational techniques and activities used to fulfil quality requirements (e.g., meeting a customer's specifications or requirements for a given product or service). Revision of the ISO 9000 standards has been under discussion for a number of years. Soon after the 1994 revisions, ISO Technical Committee 176 began the task of overcoming the standard's manufacturing bias while, at the same time, overcoming other persistent criticisms that the standard did not adequately cover all aspects of the QMS. The development of ISO 9001:2000 has been a particularly interesting process to behold. It is an object lesson in consensus building. ISO Technical Committee 176, with the participation of various national standards bodies, has actually managed to overcome criticisms from apparently opposite directions and written a document that appears to be acceptable to the great majority of ISO's member bodies. The manufacturing industry criticized the older versions of ISO 9001 for its failure to include a large range of quality management requirements in the standard. Some manufacturing industries considered ISO 9001 to be so inadequate that they developed their own expanded, industry-specific versions of the ISO 9001 standard. ISO was also criticized by non-manufacturing industries for catering to the manufacturing industries. Everything about the older versions of ISO 9001 seemed overwhelmingly rooted in a manufacturing environment. The ISO technical committee found itself in a dilemma and then found a way out. ISO 9001:2000 appears to have actually reached a satisfactory compromise in which the language is generic enough to be applicable to industries other than manufacturing yet specific enough to satisfy the particular concerns of the manufacturing industry. As far as actual implementation of the new standard was concerned, ISO Technical Committee 176 recommended that implementation of ISO 9001:2000 could begin as early as the fourth quarter of 1999 -- one full year in advance of the standard's scheduled publication. The ISO technical committee made this recommendation because ISO works through a lengthy consultative process to achieve a consensus. Once a consensus was obtained (in early 1999), further changes became improbable.

Quality Standards ISO 9001:2008

Quality Standard were developed to assist companies control quality and maintain a high standard of customer satisfaction. Quality has become a lot more than that, quality standards can assist your company with good management practices, reduce risk and increase profit margins.
A good quality system should not be written just to satisfy the accreditation process, but should be written with the company’s business practices in mind and to enhance procedures and policies to ensure sound operation.
The principles of the ISO Quality System can be applied to every company, regardless of its size, type or industry. Having a good quality system in place will ensure that your products, services are of the highest standards, your customers are happy and the future of your organisation is heading in the right direction.
What is ISO?ISO is the International Organization for Standardization, based in Switzerland it was established in 1947 to develop common international standards. It has members from over 140 countries worldwide, comprising of .
ISO published its first standards in 1987 and revised in 1994. ISO 9000 refers to the set of quality management standards. The 1994 standards are known as ISO9001. A new set of standards were released in November 2001, these are known as ISO 9001:2000. The transition from an existing ISO 9001 standard to a ISO 2000 standard can be achieved relatively easily. If you are starting a new Quality Management System, it would be best to use the new ISO 2000 standards.
What is the difference between ISO 9000 and ISO 14000?ISO 9000 is primarily concerned with quality management. In plain English this means anything that affects a product or service required by a customer and what that organisation does to ensure that a certain standard of quality is achieved and maintained.
ISO 14000 is primarily concerned with the environment. In plain English, what an organisation does to manage the impact of its activities on the environment.