ISO 9001:2008-RESOURCE MANAGEMENT PROCEDURES Part 2

Posted on September 17, 2011 by isotrainer

The procedures shall also include: -

• Determine the necessary competence for personnel performing work affecting product Quality and Environmental.
• Provide training / others action to satisfy the need.
• Evaluate the effectiveness of the action taken.
• Ensure that all personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the Quality and Environmental Objective.
• Maintain appropriate records of education, training, skills and experience.

9. Each department head is responsible to identify the training needs of their staff in terms of skill, technical expertise and management knowledge.

10. The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirement as applicable.
a) Building, workplace and associated utilities.
b) Process equipment (both hardware and software)
c) Supporting service (transport / communication)

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Management system basics for ISO

Posted on September 17, 2011 by isotrainer

There are important basics for Management system in ISO standards.Management system basically refers to what the organization does to manage its processes, or activities, so that its products or services meet the objectives it has set itself, such as:

* satisfying the customer’s quality requirements,
* complying with regulations, or
* meeting environmental objectives.

Management system standards

Management system standards provide a model to follow in setting up and operating a management system. This model incorporates the features on which experts in the field have reached a consensus as being the international state of the art.

Plan – Do – Check – Act

The Plan – Do – Check – Act (PDCA) cycle is the operating principle of ISO’s management system standards.
Plan, Do, Check, Act

Plan – establish objectives and make plans (analyze your organization’s situation, establish your overall objectives and set your interim targets, and develop plans to achieve them).

Do – implement your plans (do what you planned to).

Check – measure your results (measure/monitor how far your actual achievements meet your planned objectives).

Act – correct and improve your plans and how you put them into practice (correct and learn from your mistakes to improve your plans in order to achieve better results next time).

From time to time ISO have been upgrade from one transition to another transition for newer version of standard.However, the basic is still the same.usually it’s differences is not that significant for us to master it.So, do take note this simple Management system basics.

Posted in ISO 14001:2004, iso 9001:2008, Quality System | Tagged , , | 16 Comments

Top management and Quality and Environmental Policy

Posted on September 16, 2011 by isotrainer

1. The top management shall ensure that the Quality and Environmental Policy: -

a) Is appropriate to the purpose of the Company
b) Includes commitment to comply with requirements and continual improve the effectiveness of the Quality and Environmental Management System.
c) Provides a framework for establishing and reviewing Quality and Environmental Objectives

d) Is understood, communicated and made aware to all levels of the organization
e) Is reviewed for continual suitability

2. In meeting the Quality and Environmental Policy, company shall set annual Quality and Environmental Objectives / Target including those needed to meet requirement for product are establish at relevant functions and levels within the organization explained in the System Maintenance Procedure .

3. Head of Department shall develop the Action Plan, usually at the preceding year (according to company financial year / calendar. It shall be recommended to the Top Management (Managing Director) for approval before making it available to all departments concern.

4. The Quality and Environmental Objectives set shall be measurable, time-bound, challenging and consistent with the Quality and Environmental Policy. These Quality and Environmental Objectives shall be review yearly during the Management Review Meeting to reflect the customer requirement and satisfaction.

5. Company establishes annual environmental objectives and related targets as part of its management review process. New objectives and targets are established each year in the management review held just prior to the initiation of the strategic planning process to allow for incorporation into the strategic plan and to ensure adequate financing of the projects. New objectives are typically proposed by members of the board of management review or by process owners based on the results of the management review and its assessment of environmental management system performance and changing circumstances.

6. These objectives and targets are measurable, where practicable, and consistent with the environmental policy, including the commitments to prevention of pollution, to compliance with applicable legal requirements and with other requirements to which the company subscribes, and to continual improvement.

7. When establishing and reviewing its objectives and targets, company takes into account the legal requirements and other requirements to which the organization subscribes, and its significant environmental aspects. It also considers its technological options, its financial, operational and business requirements, and the views of interested parties. Environmental management programs are established to ensure the achievement objectives and targets once approved. These program(s) include

a. Designation of responsibility for achieving objectives and targets at relevant functions and levels of the organization, and
b. The means and time-frame by which they are to be achieved.

11. The approved objectives and targets are listed in the Environmental Planning Workbook along with their associated management programs (who, what, when). Note that other formats may be used for the management program (e.g. Microsoft Project) if needed. In this case a reference to the alternate plan should appear in the Environmental Planning Workbook.

12. Quality and Environmental Planning shall also be performed to include: -

a) The processes of the Quality and Environmental management system, considering the permissible exclusions
(Refer to Section D of this System Manual)
b) The resources needed (refer to Resource Management Procedure)
c) Continual improvement of the Quality and Environmental Management System.

10. The top management shall ensure that

a) The planning of SM is carried out to meet the requirement in clause 4.1 Internal standard and Quality and Environmental Objectives.
b) The integrity of the SM.

11. All planning shall be documented and retained as per the Control of Record Procedure.

12. The planning shall ensure that any change recommended shall be in a controlled manner and that the integrity of the SM is maintained such change.

Posted in ISO 14001:2004, iso 9001:2008, Management responsibility | Tagged , , , , , , , , , , , , , | 9 Comments

ISO 9001:Management Responsibility

Posted on September 16, 2011 by isotrainer

The Management Review shall cover all inputs and outgoing (e.g. audit results, customer feed back, process performance, and etc.) as well as the output in relation to the improvement initiatives of Quality and Environmental Management System, business processes, product and resources.

A Communication Process Chart shall also be established to identify the communication process.

Finally, all employees have the responsibility to safeguard the environment and their fellow workers by adhering to the policies and procedures associated with the environmental management system and by participating in the identification of environmental performance improvement opportunities wherever possible. Supervisors and management team members have the additional responsibility to support employees in implementing environmental improvement projects.

Posted in iso 9001:2008, Management responsibility, Quality Manual | Tagged , , , | 9 Comments

MANAGEMENT RESPONSIBILITY

Posted on September 15, 2011 by isotrainer

In ISO management responsibility is a very crucial one.Without proper management which distributes plans and execute well, the system will totally failed.In ensuring the effectiveness of the Quality and Environmental Management System implementation, the following procedures and/or standard have been established: -

1.Management Commitment

The top management shall be committed to develop and continually improve the Quality and Environmental Management System by: -
a) Communicating to the organization the importance of meeting Customer, statutory and regulatory requirements.
b) Establishing the Quality and Environmental policy and objectives
c) Conducting management reviews to monitor and initiate action to ensure the effectiveness of the Quality and Environmental Management System.
d) Ensuring the availability of resources.

2.Management shall ensure the availability of resources essential to establish, implement, maintain and improve the environmental management system. Resources include human resources and specialized skills, organizational infrastructure, technology and financial resources

3.Roles, responsibilities and authorities shall be defined, documented and communicated in order to facilitate effective environmental management. Roles, responsibilities and authorities may be documented in job descriptions (major duties), competency matrices (job specific responsibilities) and within local procedures and instructions (task and functional responsibilities). ?

4.In assurance of an effective Quality and Environmental Management System, the Managing Director has appointed the Head of QC Department as the Management Representative assisted by a Management Team / Committee for the establishment, implementation and maintenance of the Quality and Environmental Management System according to ISO 9001:2008 standard requirement and ISO 14001:2004 standard requirement .

5.Company’s Management shall continuously provide adequate resources essential to implement its Quality and Environmental policy, its business operations and to achieve its Quality and Environmental objectives. In effort to ensure resource availability, the Management has also defined the roles and responsibilities of all personnel concerned. An Organization Chart with the relevant functions / departments shall therefore be created to reflect such scope.

Posted in Environmental Manual, Environmental Procedure, ISO 14001:2004, Iso template, Management responsibility | Tagged , , , , , , , , , , , , , , , , , , , | 9 Comments

Procedural Policy for Quality and Environmental manual

Posted on September 15, 2011 by isotrainer

1.The system documentation shall also be controlled as per the requirement of the ISO 9001:2008 and ISO 14001:2004 standard, being that the Document Control Center (DCC) has been set up for the control, issue, change and obsolete status of all Quality and Environmental records.

2.The Department Heads are responsible to ensure that all documents applicable to their Quality and Environmental system are available and maintained at all relevant locations. They are also responsible to ensure that up-to-date formal procedures are implemented, while obsolete documents are promptly removed.

3. The establishment of documented procedures includes
• Approved documents for adequacy prior to use
• Review, up date and re-approve document
• Identified the changes and the current revision status of documents
• Ensure that the relevant versions of applicable documents are available at point of use
• Ensure that document remain legible and readily identify
• Internal or External document are identified and the distribution are controlled
• To stamp “OBSOLETE” to no longer valid / control document

4.Master copies of the Systems Manual and Procedures shall be kept at the Document Control Center. A master list of all controlled documents identifies the latest issues.

5.Company has established process for the Control of Records including:

? Record identification
? Record storage
? Protection
? Retrieval
? Retention period
? Maintenance and disposition

6.Individual department head shall maintain Quality and Environmental Records. Each department is responsible to ensure that the identification, collection, indexing, filling, storage, maintenance and disposition of the respective Quality and Environmental records are implemented according to the system procedure.

7.All Quality and Environmental records shall be legible and identifiable to the product involved. They shall be stored at secure location within the factory premises for use and for reference where and when needed.

8.Records are maintained as per the retention period described in the Quality and Environmental Records Retention Table. Where agreed contractually, Quality and Environmental records shall be made available to customer or his representative for evaluation for an agreed period.

Posted in Environmental Manual, Environmental Procedure, ISO 14001:2004, ISO 9001:2001, iso 9001:2008, Iso template, Quality Manual, Quality System | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , | 9 Comments

Quality and Environmental system Structure

Posted on September 14, 2011 by isotrainer

The structure of this Quality and Environmental system consists of 3 distinct levels:

Level 1
Systems Manual (SM)
The scope of Quality and Environmental Management System and details and justifications for any exclusion.
The documented procedures establish for Quality and Environmental Management System and its reference.
Description of the interaction between the processes of Quality and Environmental Management System.Quality and Environmental policy, company organization, responsibilities and authority.

Level 2
Quality and Environmental System Procedures (SP)
These documents provide guidelines and establish the activities for the implementation of individual activities to meet the Quality and Environmental system out-lined in the System Manual.

Level 3
Supporting document for Quality and Environmental System Procedure
Specifically outline the role of individuals in the system on the particular job or sequence in action is conducted. This includes specifications, drawing, work instruction, job procedure and etc

Posted in Environmental Manual, Environmental Procedure, ISO 14001:2004, iso 9001:2008, Quality System | Tagged , , , , , , , , , , , , , , | 12 Comments

Procedural Policy for Quality and Environmental Manual

Posted on September 14, 2011 by isotrainer

1. The Company has ensured that all Quality and Environmental business operations and processes are documented according to the requirement of the ISO 9001:2008 and ISO 14001:2004. This is to ensure that all processes are implemented effectively and efficiently in a controlled, monitored and systematic approach.

2. The Company assures compliance of its Quality and Environmental system through Quality and Environmental audit assessment and continual improvement to the Quality and Environmental Management System .

Posted in Environmental Manual, ISO 14001:2004, iso 9001:2008, Quality Manual | Tagged , , , | 14 Comments

Quality Management System document needs

Posted on September 13, 2011 by isotrainer

The Quality Management System documentation includes
a. Documented statement of Quality Policy and Quality Objective
b. Quality Manual
c. Documented procedure by International Standard
d. Document to ensure the effectiveness planning, operation and control of processes
e. Record required by International Standard

Posted in iso 9001:2008, Quality Manual | Tagged , , , , | 13 Comments

General ISO 9001 Requirements

Posted on September 13, 2011 by isotrainer

One example on General ISO 9001 Requirements . Company xyz shall manage its business processes as follows: -

a. Identify all processes needed for the Quality Management System and their application trough out the organization.
b. Determine the sequence and interaction of processes.
c. Determine the criteria as well as methods required for effective operation and control of the business processes.
d. Ensuring that the availability of resources and information necessary to support of the operation and monitoring of the processes.
e. Measure, monitor and analyze the processes and implement the necessary actions to achieve planned result and for continual improvement of the processes.

Posted in iso 9001:2008, ISO discussion, Quality Manual | Tagged , , , , , | 13 Comments