Lmi introduction to iso 9000 final vs 25 min

Introduction to ISO 9001:2008

Ludlum Measurements, Inc.Sweetwater, Texas

Since 1962

@ 25 Min..

What is ISO 9000? An Introduction

• The best definition of ISO 9000 is the planning and implementation of the Best Business Practices that meet Customer Requirements, promotes Customer Satisfaction, and insures the Success of the Company.

• Best Business Practices differ from one Company to another, which is why ISO 9000 is a generic Quality Management Standard.

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• For example, the prevailing wisdom of the Electronics Industry has always been to Outsource what you can and to do the one thing you do exceedingly well.

• But the Vision of Ludlum Measurements has always been to do as many phases as it can locally, to control Quality, Price, and to assure itself of an Uninterrupted Supply Chain. For LMI, this is its Best Business Practices.



• The accomplishments of fifty years have been called successful, though there have been challenges from time to time.

• It is ironic, that the greatest challenges we face for the future are the fruits of these successes. As a much larger Company, LMI will find it increasingly difficult to deliver the same individualized service that has gained it Customer Loyalty and Customer Satisfaction.



• It is with this challenge in mind, giving our Customers individualized Service as a large Company, that we seek ISO 9000 Registration at this time.

• Merging the Best Business Practices of Ludlum Measurements with the Best Business Practices presented by the ISO 9000 Standard will produce a Company we already know and a Company that complies with the ISO 9000 Standard at the same time.



• This merger of Practices has to be done with care and with balance. If it is not, the Company we end up with will neither be the Company the Board of Directors wants, nor the Company the ISO 9000 Committee suggested that it becomes.

• Before we review the ISO 9000 Standard, we shall consider some guidance from the ISO 9000 Committee itself, regarding its Requirements as a whole.



• Because many Companies thought ISO wanted a complicated documentation system, they built a system that managed documents, not Quality. ISO clarifies this in their “Guidance on the Documentation Requirements of ISO 9001:2008”:

• “It is stressed that ISO 9001 requires (and always has required) a ‘Documented quality management system’, and not a ‘system of documents’.”



• The ISO Committee not only allows for a flexible system, but one with a minimum of documentation:

• “ISO 9001:2008 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes....”



• In conclusion, then, the ISO 9001 Requirements are designed to put tools into the hands of Management and into the hands of Employees at all levels in the organization.

• These tools are: Planning, Implementation, and Documentation of the Best Business Practices and are designed to meet Customer Requirements, promote Customer Satisfaction, and insure the Success of the Company.


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Introducing ISO 9000

Ludlum Measurements, Inc.

Complications of ISO 9000

• We are about to review a complicated International Standard, with a myriad set of Requirements.

• Take heart! Most of the complications and details are designed to be transparent to most people. The complications and details are behind-the-scenes and they describe the way things are planned and organized. Most of you will deal with just the way things are done. That’s all.


• The ISO 9000 standards are a collection of formal International Standards, Technical Specifications, Technical Reports, Handbooks and web based documents on Quality Management.

• There are 25 documents in the collection altogether.


What are the ISO 9000 standards?

What are the main ISO 9000 standards? ISO 9000:2005 Quality management systems – Fundamentals and vocabulary.

This covers the basics of what quality management systems are and also contains the core language of the ISO 9000 series of standards. A guidance document used for reference to understand terms and vocabulary related to quality management systems.




ISO 9001:2008 Quality management systems – Requirements This is the only ISO9000 standard for which certification can be gained. Intended for use in any organization regardless of size, type or product including service. It provides a number of Quality Management System requirements which an organization needs to fulfil to achieve customer satisfaction. It includes a requirement for the continual improvement.




ISO 9001:2008 Quality management systems – Requirements This is the only ISO9000 standard for which certification can be gained. Intended for use in any organization regardless of size, type or product including service. It provides a number of Quality Management System requirements which an organization needs to fulfil to achieve customer satisfaction. It includes a requirement for the continual improvement.

ISO 9004:2000 Quality management systems - Guidelines for performance improvements. This covers continual improvement, specifically. It also gives you advice on what you could do to enhance a mature system. This standard very specifically states that it is not intended as a guide to implementation.


• The organisation needs to demonstrate its ability to consistently provide product that meets customer and regulatory requirements.

• The organisation must aim to enhance customer satisfaction through the effective application of the quality management system. This includes processes for continual improvement of the system.

What are the ISO 9001 requirements?


What are the Requirements of ISO 9001?

The requirements in ISO 9001 include:a set of procedures that cover all key

processes in a business monitoring processes to ensure they are effectivekeeping adequate recordschecking output for defects, with appropriate and corrective

action where necessaryregularly reviewing individual processes and the quality

system itself for its effectivenessFocus on continual improvement

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What are the ISO 9001:2008 Quality Management System Requirements?

The ISO 9001:2008 Standard consists of the following sections:Section 1: Scope Section 2: Normative Reference Section 3: Terms and definitions Section 4: Quality Management System Section 5: Management Responsibility Section 6: Resource Management Section 7: Product Realization Section 8: Measurement, analysis and improvement


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Quality Management System Highlights


Quality Management System Requirements: Section 4: Quality Management System

Quality Management System Section 4 ISO9001:2008

Section 4.1

Introduction to the Quality Management System

Document Hierarchy

Section 4.2

Documentation Requirements

Customer, Statutory and Regulatory Requirements

Document Control Procedure

Record Control Procedure


ISO 9001:2008 Clause Highlights

Management Responsibility Section 5 ISO9001:2008

Section 5.1 Senior Management Commitment

Section 5.2 Customer Focus

Section 5.3 Quality Policy

Section 5.4Quality Management System Planning

Quality Objectives

Section 5.5

Responsibility, Authority and Communication

Responsibility & Authority

Management Representative

Internal Communication

Section 5.6 Management Review



Quality Management System Requirements: Section 5: Management Responsibility

Quality Management System Requirements:

Section 6: Resource Management

Resource Management Section 6 ISO9001:2008

Section 6.1 Provision of Resources

Section 6.2 Human Resources

Section 6.3 Infrastructure

Section 6.4 Work Environment



Product Realisation Section 7 ISO9001:2008

Section 7.1 Planning of Product Realisation

Section 7.2

Customer Related Processes

Contract Review

Production Planning

Communication

Customer Communication

Authority Communication

Section 7.3 Design and Development

Section 7.4

Purchasing

Purchasing Documents

Supplier Assurance and Approval

Verification of Purchased Materials

Supplier Performance Review

Suppliers and Contractor Communication



Quality Management System Requirements: Section 7: Product Realisation

Quality Management System Requirements: Section 7: Product Realisation

Product Realisation Section 7 ISO9001:2008

Section 7.5

Control of Production and Service Provision

Identification and Traceability

Customer Property

Systems of Preservation of Product

Housekeeping Policy

Cleaning Policy

Pest Control Policy

Control of Visitors and Contractors

Despatch and Distribution

Maintenance

Waste Management

Crisis Management

Section 7.6 Control of Monitoring and Measurement Equipment



Quality Management System requirements: Section 8: Measurement, Analysis and Improvement

Measurement, Analysis and Improvement Section 8 ISO9001:2008

Section 8.1 Measurement, Analysis and Improvement of the Quality Management System

Section 8.2

Monitoring and Measurement

Customer Satisfaction

Internal Audits

Monitoring and Measurement of Processes

Monitoring and Measurement of Product

Section 8.3Control of Non-Conforming Product

Product Recall

Section 8.4 Analysis of Data

Section 8.5

Corrective Action

Preventative Action

Improvement




Quality Management System Documentation: Manuals, Procedures, and

Records

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What are the ISO 9001:2008 Quality Management System Document

Requirements?


The ISO 9001:2008 standard requires a Quality Policy and Procedure Manual

Obsolete Versions

What are the ISO 9001:2008 Quality Management System requirements?

ISO 9001:2008 requires a Quality Policy in the Policy Manual:

•The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality policy is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards. These measureable objectives are documented.

•Procedures are maintained in our Procedure Manual.


What are the ISO 9001:2008 Quality Management System Document

Requirements? ISO 9001:2008 refers specifically to only 6 documented

procedures. But since we design our own instruments, our minimum requirement is 7.

Other documentation may be required in order to manage some processes that are necessary for the effective operation of the quality management system.

This is presently under review by the Quality Assurance Manager, who also manages the ISO 9000 Project.


What are the ISO 9001:2008 Quality Management System Procedure

Requirements?The standard specifies six compulsory procedures, but since

we design our own instruments, we add a seventh:

1. Control of Documents (4.2.3) 2. Control of Records (4.2.4) 3. Design and Development (7.3)4. Internal Audits (8.2.2) 5. Control of Nonconforming Product / Service (8.3) 6. Corrective Action (8.5.2) 7. Preventive Action (8.5.3)



Our Seven Compulsory Procedures:1. Control of Documents (4.2.3)

The ISO 9001:2008 standard requires that we need a documented procedure to control quality documents.

All employees must have access to up-to-date documents and be aware of how to use them.

The use of Company-supplied Documents is mandatory.



Our Seven Compulsory Procedures:2. Control of Records (4.2.4)

The ISO 9001:2008 standard requires that we need to control and maintain Quality Records to provide evidence of conformance to the ISO 9001 Standard.

This Procedure must provide for the identification, storage, retrieval, protection, and retention time, as well as cover the final disposition of Quality Records.



Our Seven Compulsory Procedures:3. Design and Development (7.3)

The ISO 9001:2008 standard requires that we must plan the development of our instruments, document it at various stages, record any changes to it, validate that it’s what the Customer wants and verify that it conforms to requirements. And that it works.



Our Seven Compulsory Procedures:4. Internal Audits (8.2.2)

The ISO 9001:2008 standard requires that we must plan and conduct periodic Internal Audits of the Quality Management System.

Timely Corrective Action must be taken on deficiencies with follow-up actions to verify the Corrective Actions. Internal Audits are reviewed during Management Review.



Our Seven Compulsory Procedures:5. Control of Nonconforming Product / Service (8.3)

The ISO 9001:2008 standard requires that we identify and control Nonconforming Product to prevent its unintended use or delivery to a Customer.

Nonconforming Product must be corrected and be re-verified before use.



Our Seven Compulsory Procedures:6. Corrective Action (8.5.2)

The ISO 9001:2008 standard requires that we take CorrectiveAction to rectify non-conformances. It is a requirement to keeprecords of these activities and monitor their effectiveness.



Our Seven Compulsory Procedures:7. Preventive Action (8.5.3)

The ISO 9001:2008 standard requires that we need to take Preventative Action to eliminate potential causes of problems. It is a requirement to keep records of these activities and monitor their effectiveness.


What are the ISO 9001:2008 Quality Records Requirements?

The ISO 9001:2008 standard has an absolute requirement to maintain the following records:•Management Review Minutes•Training Record •Product Release Record •Design and Development Records

- Results of the review of customer requirements- Design and development inputs - Results of design and development reviews and actions - Results of design and development verification and actions- Results of design and development validation and actions - Results of the review of design and development changes

•Supplier Assessment Record



•Validation Record•Identification and Traceability Record•Register of Customer Property•Calibration Record - Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist - Validity of the previous measuring results when the measuring equipment is found not to conform to requirements - Results of calibration and verification of measuring equipment •Internal Audit Record•Records of Non-conforming Product•Corrective Action Request Form•Preventative Action Request Form



This Wraps up our Brief Overview of the ISO 9001:2008 Quality

Management System Requirements