Introduction to ISO9001:2008 презентация

including a quality policy, core processes, objectives, procedures, and records
Control documents - Ensure that right documents are being used at the right time by the right people
Create and maintain records of the system - Identify records and keep them as evidence of performance and conformity with standards

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

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– Fundamentals and vocabulary.
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 9004:2000 Quality management systems - Guidelines for performance improvements. Covers continual improvement. This 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.

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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.

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include:
a set of procedures that cover all key
processes in a business
monitoring processes to ensure they are effective
keeping adequate records
checking output for defects, with appropriate and corrective action where necessary
regularly reviewing individual processes and the quality system itself for effectiveness
Focus on continual improvement

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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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from our Manual

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ISO 9001:2008 Clause Our Procedure

our Manual

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ISO 9001:2008 Clause Our Procedure

our Manual

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ISO 9001:2008 Clause Our Procedure

our Manual

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ISO 9001:2008 Clause Our Procedure

our Manual

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ISO 9001:2008 Clause Our Procedure

Improvement from our Manual

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www.9001manual.com

ISO 9001:2008 Clause Our Procedure

refers specifically to only 6 documented procedures (See next Slide).
Other documentation may be required by an organization in order to manage the processes that are necessary for the effective operation of the quality management system.
This will vary depending on the size of the organization, the kind of activities in which it is involved and their complexity. Our small business manual covers all the basic clauses of ISO 9001:2008 with 9 procedures/documents our ISO9001:2008 is much more detailed and has 30 documents. Both include 14 records.

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www.9001manual.com

six compulsory documents:
Control of Documents (4.2.3)
Control of Records (4.2.4)
Internal Audits (8.2.2)
Control of Nonconforming Product / Service (8.3)
Corrective Action (8.5.2)
Preventive Action (8.5.3)
In addition to these ISO 9001:2008 requires a Quality Policy and Quality Manual

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six compulsory documents:
Control of Documents (4.2.3)

The ISO9001:2008 standard requires that
an organization needs 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.

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six compulsory documents:
Corrective Action (8.5.2)
The ISO9001:2008 standard requires that you take Corrective Action to rectify non-conformances. It is a
requirement to keep records of these activities
and monitor their effectiveness.
Preventive Action (8.5.3)
The ISO9001:2008 standard requires that you
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.

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a Quality Policy and Quality 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.
Your procedures will be maintained in your Quality Manual.

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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 relating to product requirements
- 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
* All of these records are provided in our manual packs

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has an absolute requirement to maintain the following records:
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
* All of these records are provided in our manual packs

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of the
main driving criteria for any organization.
In order to evaluate if a product meets
customer needs and expectations, it is
necessary to monitor and measure
customer satisfaction. Improvements
can be made by taking action to address any identified issues and concerns. Your customers will gain confidence that your products will meet their needs and increase their satisfaction.

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identification and management of the processes within an organization and the interactions between the processes is known as a process approach to management.
The process approach is a key element of the ISO 9000 standards.

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logical, method that can be used to improve a process. This requires:

(P) planning (what to do and how to do it),
(D) executing the plan (do what was planned),
(C) checking the results (did things happened according to plan) and
(A) act to improve the process (how to improve next time).
The PDCA cycle can be applied within an individual process, or across a group of processes.

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When initially starting to use ISO 9001, you should familiarize yourself with the Quality Management System standards, especially ISO 9000, ISO 9001 and ISO 9004, and consider their requirements.

If you wish to proceed to certification, you
should follow our guides and checklists and
implement the procedures and records in our
manual pack then use Gap Analysis Checklist
to determine if your system meets the requirements of ISO 9001. Developing and implement additional procedures or processes to address any shortfalls.

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are able to understand the organization's activities and processes and appropriately audit against the requirements of the ISO 9001 in relation to the organization's objectives.

Auditors should be able to demonstrate
competency in:
Quality Management Systems.
The requirements of the ISO 9001:2008.
A general understanding of ISO 9000:2005 and ISO 9004.
Auditing techniques.

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and Streamlines operations:

Your quality management system focuses on your objectives and operating processes. This encourages you to improve the efficiency of your business, the quality of your products, the service you provide and helps to reduce your waste and customer complaints levels.

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customer satisfaction:

The structure of ISO 9001 ensures that the needs of the customer are being considered and met and your company focus is on constantly increasing customer satisfaction.
"Customer satisfaction" is one of the main driving criteria for any organization. In order to evaluate if a product meets customer needs and expectations, it is necessary to monitor and measure customer satisfaction. Improvements can be made by taking action to address any identified issues and concerns. Your customers will gain confidence that your products will meet their needs and increase their satisfaction.

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process of Implementing an ISO9001:2008 compliant manual at www.9001manual.com

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