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Introduction to ISO9001:2008

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Title: Introduction to ISO9001:2008


1
Introduction to ISO90012008
  • www.9001manual.com

2
What are the ISO 9000 standards?
  • 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

3
What are the main ISO 9000 standards?
  • ISO 90002005 Quality management systems
    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 90012008 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 90042000 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.

4
What are the ISO 9001 requirements for a Quality
Management System?
  • 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.

5
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 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

6
What are the ISO 90012008 Quality Management
System requirements?
  • The ISO90012008 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

7
ISO 90012008 Quality Management System
requirements Section 4 Quality Management
System from our Manual
Quality Management System Section 4 ISO90012008 Quality Management System Section 4 ISO90012008
Section 4.1 Introduction to the Quality Management System
Section 4.1 Document Hierarchy
Section 4.2 Documentation Requirements
Section 4.2 Customer, Statutory and Regulatory Requirements
Section 4.2 Document Control Procedure
Section 4.2 Record Control Procedure
ISO 90012008 Clause
Our Procedure
8
ISO 90012008 Quality Management System
requirements Section 5 Management
Responsibility from our Manual
Management Responsibility Section 5 ISO90012008 Management Responsibility Section 5 ISO90012008
Section 5.1 Senior Management Commitment
Section 5.2 Customer Focus
Section 5.3 Quality Policy
Section 5.4 Quality Management System Planning
Section 5.4 Quality Objectives
Section 5.5 Responsibility, Authority and Communication
Section 5.5 Responsibility Authority
Section 5.5 Management Representative
Section 5.5 Internal Communication
Section 5.6 Management Review
ISO 90012008 Clause
Our Procedure
9
ISO 90012008 Quality Management System
requirements Section 6 Resource Management
from our Manual
Resource Management Section 6 ISO90012008 Resource Management Section 6 ISO90012008
Section 6.1 Provision of Resources
Section 6.2 Human Resources
Section 6.3 Infrastructure
Section 6.4 Work Environment
ISO 90012008 Clause Our
Procedure
10
ISO 90012008 Quality Management System
requirements Section 7 Product Realisation
from our Manual
Product Realisation Section 7 ISO90012008 Product Realisation Section 7 ISO90012008
Section 7.1 Planning of Product Realisation
Section 7.2 Customer Related Processes
Section 7.2 Contract Review
Section 7.2 Production Planning
Section 7.2 Communication
Section 7.2 Customer Communication
Section 7.2 Authority Communication
Section 7.3 Design and Development
Section 7.4 Purchasing
Section 7.4 Purchasing Documents
Section 7.4 Supplier Assurance and Approval
Section 7.4 Verification of Purchased Materials
Section 7.4 Supplier Performance Review
Section 7.4 Suppliers and Contractor Communication
ISO 90012008 Clause
Our Procedure
11
ISO 90012008 Quality Management System
requirements Section 7 Product Realisation
from our Manual
Product Realisation Section 7 ISO90012008 Product Realisation Section 7 ISO90012008
Section 7.5 Control of Production and Service Provision
Section 7.5 Identification and Traceability
Section 7.5 Customer Property
Section 7.5 Systems of Preservation of Product
Section 7.5 Housekeeping Policy
Section 7.5 Cleaning Policy
Section 7.5 Pest Control Policy
Section 7.5 Control of Visitors and Contractors
Section 7.5 Despatch and Distribution
Section 7.5 Maintenance
Section 7.5 Waste Management
Section 7.5 Crisis Management
Section 7.6 Control of Monitoring and Measurement Equipment
ISO 90012008 Clause
Our Procedure
12
ISO 90012008 Quality Management System
requirements Section 8 Measurement, Analysis
and Improvement from our Manual
Measurement, Analysis and Improvement Section 8 ISO90012008 Measurement, Analysis and Improvement Section 8 ISO90012008
Section 8.1 Measurement, Analysis and Improvement of the Quality Management System
Section 8.2 Monitoring and Measurement
Section 8.2 Customer Satisfaction
Section 8.2 Internal Audits
Section 8.2 Monitoring and Measurement of Processes
Section 8.2 Monitoring and Measurement of Product
Section 8.3 Control of Non-Conforming Product
Section 8.3 Product Recall
Section 8.4 Analysis of Data
Section 8.5 Corrective Action
Section 8.5 Preventative Action
Section 8.5 Improvement
ISO 90012008 Clause
Our Procedure
13
What are the ISO 90012008 Quality Management
System document requirements?
  • ISO 90012008 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 90012008 with 9 procedures/documents our
    ISO90012008 is much more detailed and has 30
    documents. Both include 14 records.

14
What are the ISO 90012008 Quality Management
System requirements?
  • The standard specifies 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 90012008 requires a
    Quality Policy and Quality Manual

15
What are the ISO 90012008 Quality Management
System requirements?
  • The standard specifies six compulsory documents
  • Control of Documents (4.2.3)
  • The ISO90012008 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.

16
What are the ISO 90012008 Quality Management
System requirements?
  • The standard specifies six compulsory documents
  • Corrective Action (8.5.2)
  • The ISO90012008 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 ISO90012008 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.

17
What are the ISO 90012008 Quality Management
System requirements?
  • ISO 90012008 requires 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.

18
What are the ISO 90012008 Quality management
systems requirements?
  • The ISO90012008 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 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

19
What are the ISO 90012008 Quality Management
System requirements?
  • The ISO90012008 standard 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

20
What are the 8 Quality Management Principles?
21
Why is customer satisfaction included in ISO 9001?
  • "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.

22
ISO 90012008 Process Approach to Management
  • What is a process approach?
  • The systematic 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.

23
ISO 90012008 Process Approach to Management

24
What is the PDCA cycle?
  • The PDCA cycle is an established, 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.

25
PDCA Cycle
26
What do you need to do to comply with ISO
90012008?
  • 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.

27
What are the requirements for auditors?
  • The standards require that auditors 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 90012008.
  • A general understanding of ISO 90002005 and ISO
    9004.
  • Auditing techniques.

28
How will the implementation of the ISO90012008
standard help us?
  • Improves Efficiency 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.

29
How will the implementation of the ISO90012008
standard help us?
  • It increases 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.

30
What is the next stage for us?
  • View our Guide to the process of Implementing an
    ISO90012008 compliant manual at
    www.9001manual.com
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