ISO 9001 Standard - ISO 9001 Standards

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General Description of ISO14001 Standards

General Description of ISO14001 Standards
ISO14001 Standards 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 ISO 9000 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.

ISO 9001 Standards Check List

ISO 9001:2008 include these checklists as follows:

1. ISO 9001 General Requirements

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

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

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

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

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

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

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

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

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

10. Resource Management
Resource Management Audit Checklist

1. Provision of resources

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

These checklists also called ISO 9000 audit checklist.

Implementing ISO 9000 Quality Management System

Implementation of ISO 9000 affects the entire organization right from the start. If pursued with total dedication, it results in 'cultural transition' to an atmosphere of continuous improvement.
The process of implementing ISO 9000 depends on:
􀂃 a. The sophistication of your existing quality program,
􀂃 b. The size of your organization, and
􀂃 c. The complexity of your process.

The 14 essential steps, briefly described below, are to be followed through in order to implement ISO 9000 quality management system successfully.
Step 1: Top management commitment
Step 2: Establish implementation team
Step 3. Start ISO 9000 awareness programs
Step 4: Provide Training
Step 5. Conduct initial status survey
Step 6: Create a documented implementation plan
Step 7. Develop quality management system documentation
Step 8: Document control
Step 9. Implementation
Step 10. Internal quality audit
Step 11. Management review
Step 12. Pre-assessment audit
Step 13. Certification and registration
Step 14: Continual Improvement

Develop Quality Management System Documentation In ISO 9000 Standards

Develop Quality Management System Documentation In ISO 9000 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.

ISO 9000 Document Control Procedures

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

the controls needed.

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

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

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

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

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

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

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

improve efficiency and effectiveness.

Documents are recorded information and the purpose of the document

control process is to firstly ensure the appropriate information is available

where needed and secondly to prevent the inadvertent use of invalid

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

may require documented procedures in order to ensure consistency and

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

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

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

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

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

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

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

governing process, a means of separating controlled from uncontrolled may

well be necessary.

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

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

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

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

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

depending on the type of document and organizations involved in its

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

processes but several may be needed.

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

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

Planning new documents, funding, prior authorization, establishing need

etc.

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

conventions for text, diagrams, forms etc.

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

- Document identification conventions.

- Issue notation, draft issues, post approval issues.

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

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

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

- Document proving prior to use.

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

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

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

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

request, who implements the change.

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

Amending copies of issued documents, amendment instructions, and

amendment status.

- Indexing documents, listing documents by issue status.

- Document maintenance, keeping them current, periodic review.

- Document accessibility inside and outside normal working hours.

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

viruses, fire and theft.

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

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

arrangements.

- Document retention and obsolescence.

With electronically stored documentation, the document database may provide

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

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

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

a documented procedure as a conventional paper based procedure.

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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