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1
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2
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- “ISO” stands for the International Organization for
Standardization.
- It is a worldwide federation of national standards bodies (ISO member
bodies).
- The work of preparing international standards is normally carried out
through ISO technical committees.
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3
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- ISO 9001:2000 is an international
standard for quality management systems.
- ISO 9001:2000 aims to give quality assurance of product and to enhan=
ce
customer satisfaction.
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4
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- ISO 9000:2000
- Fundamentals and Vocabulary
- ISO 9001:2000
- ISO 9004:2000
- Guidelines for Performance
Improvements
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5
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- Customer focus
- Leadership
- Involvement of people
- Process approach
- System approach to management
- Continual improvement
- Factual approach to decision making
- Mutually beneficial supplier relationship
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6
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- ISO 9001 promotes the adoption of a process approach.
- For an organization to function effectively and efficiently, it has =
to
identify and manage numerous linked activities.
- The application of a system of processes within an organization,
together with the identification and interactions and managing of th=
ese
processes can be referred to as the “process approach”.<=
/li>
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7
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8
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- 1. Scope
- 1.1 General
- 1.2 Application
- 2. Normative reference
- 3. Terms and definiti=
ons
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9
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- Organizations may exclude some of the requirements in Section 7 (pro=
duct
realization) for requirements that:
- Don’t apply to the organization
- Customers’ needs make reasonable to exclude
- Are superseded by regulatory requirements
- Do not compromise an organization’s ability or willingness to
meet the demands set by its customers and other parties
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10
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- 4.1 General requiremen=
ts
- Document, implement and maintain a quality management system and
continually improve its effectiveness.
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- 4.2 Documentation
requirements
- Documented quality policy and objectives
- A Quality manual
- Documented procedures
- Control of Documents
- Control of Records
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12
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13
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- 5.1 Management commitm=
ent
- 5.2 Customer Focus
- 5.3 Quality Policy
- 5.4 Quality Planning
- 5.5 Responsibility,
authority and communication
- 5.6 Management review
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14
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- 6.1 Provision of resou=
rces
- 6.2 Human resources
- 6.3 Infrastructure
- 6.4 Work Environment
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15
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7 Product Realization
- 7.1 Planning of product
realization
- Quality objectives and requirements for the product,
- Relevant processes, documents and resources specific to the product=
,
- Verification, validation, monitoring, inspection and test activitie=
s,
- Records needed to provide evidence that the realization process and
resulting product meet requirements.
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7 Product Realization
- 7.2 Customer-related
processes
- Determination of requirements related to the product
- Review of requirements related to the product
- Customer communication
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7 Product Realization
- 7.3 Design and develop=
ment
- Planning
- Inputs
- Outputs
- Review
- Verification
- Validation
- Control of changes
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7 Product Realization
- 7.4 Purchasing
- Purchasing process
- Purchasing information
- Verification of purchased product
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19
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7 Product Realization
- 7.5 Production and ser=
vice
provision
- Controls
- Validation
- Identification and traceability
- Customer property
- Preservation of product
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7 Product Realization
- 7.6 Control of monitor=
ing
and measuring de=
vices
- Calibrated where nece=
ssary
- Adjusted or readjuste=
d as
necessary
- Identified to enable
calibration status to be determined
- Safeguarded from
adjustments that would invalidate the measurement result
- Be protected from dam=
age or
deterioration
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- 8.1 General
- Plan and implement monitoring, measurement, analysis and improvement
process needed to:
- Demonstrate product conformity
- Ensure conformity of the quality management system
- Continually improve the QMS
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- 8.2 Monitoring and
measurement
- Customer satisfaction
- Internal audit
- Processes
- Product
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- 8.3 Control of nonconf=
orming
product
- Taking action to eliminate the detected nonconformity
- Authorizing use, release or acceptance under concession
- Taking action to preclude original intended use or application
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- 8.4 Analysis of data
- Customer satisfaction
- Conformity to product requirements
- Characteristics and trends of processes and products including
opportunities for preventative action
- Suppliers
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25
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- 8.5 Improvement
- Continual improvement
- Corrective action
- Preventive action
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26
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- MAS Solutions LLC
- PO Box 941113
- Houston TX 77094
- Tel: 281-494-4874
- Fax: 413-294-4874
- Email: information@masquality.com
- Visit our website: www.masquality.com
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