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CONTENTS
1   Introduction
2   What’s New in ISO 9001:2008
3   ISO 9000 Project Management
4   Eight Quality Management Principles
5   Requirements
1
ISO 9000:87
                                                  ISO 9000:94
                                                  ISO 9001:2000
                                         BS5750   ISO 9001:2008
                                          1979
                 AQAP1
                 (NATO)
                  1970’s
MIL-STD-9858
   (1940’s)

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                   at TCG {0336-2350594}
   International Organization for Standardization
   Develops standards do not certify companies
   Around 140 countries members
   Around 13000 standards produced
   Technical Committees are formed to produce
    standards
   TC 176 for ISO 9000
   International Organization for Standardization
    Email: central@iso.ch
    Web: http://www.iso.ch
          http://www.bsi.org.uk/iso-tc176-sc2.




                     Prepare by: Adnan Masood Manager QHSE
                              at TCG {0336-2350594}
2   WHAT’S NEW IN ISO
    9001:2008
    Compared to ISO 9001:1994
   Cancels and replaces second edition of 1994
   revised title which no more uses the term QA,
    instead just QMS (QA + Customer Satisfaction)
   Released on 15 Dec 2000
   up-graded in contents, effectiveness, and logical
    implementation
   9000- and 9004- series guidelines eliminated and
    9004 to serve as a general purpose guidelines
   Many guidelines available in the form of TR
    (Technical Reports)
   compatible with ISO 14001


                  Prepare by: Adnan Masood Manager QHSE
                           at TCG {0336-2350594}
• Scope (modified):
   • to demonstrate its ability to provide consistently, product
   that meets customer and applicable regulatory
   requirements, and

   • to address customer satisfaction through the effective
   application of the system, including processes for
   continual improvement and the prevention of
     nonconformity



                     Prepare by: Adnan Masood Manager QHSE
                              at TCG {0336-2350594}
• ISO 9001, 9002, & 9003 merged into a single 9001:2008

• ISO 8402 and ISO 9000-1 merged into a new ISO
  9001:2008

• ISO 10011 will be merged with ISO 14010 into a new ISO
  19001 Quality & Environmental Auditing

• 3 years for co-existence



                   Prepare by: Adnan Masood Manager QHSE
                            at TCG {0336-2350594}
1.   The Standard
2.   The Structure
3.   The Definitions
4.   The Emphasis
5.   The Requirements
6.   The Flexibility
7.   The Approach


                 Prepare by: Adnan Masood Manager QHSE
                          at TCG {0336-2350594}
1. New Standard
  ISO 9002 and 9003 dropped

  ISO 9001 modified




2. New Structure
• 20 clauses abandoned
• Now 5 sections


                Prepare by: Adnan Masood Manager QHSE
                         at TCG {0336-2350594}
3. New Definitions
• Supplier: Vendors, subcontractors, etc.
• Organization: The company implementing QMS
• Product Realization: The interconnected processes
  that are used to bring products into being. When you start
  with an idea and end up with a product, you’ve gone through
  the process of product realization

4. New Emphasis
  Customer Focused

  Continual Improvement

  Integration of Processes with the QMS
                Prepare by: Adnan Masood Manager QHSE
                         at TCG {0336-2350594}
5. New Requirements
1.    Communication with customers
2.    Identify customer needs and expectations
3.    Meet customer needs and expectations
4.    Measure and monitor customer needs and expectations
5.    Meet legal and regulatory requirements
6.    Internal Communication
7.    Provide competent human resources
8.    Provide necessary facilities and work environment
9.    Evaluate the effectiveness of training
10.   Measure and monitor realization processes
11.   Evaluate the effectiveness and suitability of quality system
12.   Identify QMS improvements
13    Improve QMS regularly               Prepare by: Adnan Masood Manager QHSE
                                                       at TCG {0336-2350594}
6. New Flexibility
1. Permissible Exclusions from Section 7 if
   a. it doesn’t apply
   b. customer’s requirements make it reasonable to exclude
   c. regulatory requirements make it reasonable to exclude

However, no part can be excluded, if doing so will undermine the
  organization’s abilities or performance




                       Prepare by: Adnan Masood Manager QHSE
                                at TCG {0336-2350594}
7. New Approach
PROCESS APPROACH TO QMS
QMS can now be considered as a single large process with many sub-
   processes. Each of these sub-processes uses inputs and outputs.
   These are:
1. Resource Management                            10. Internal Communication
2. Regulatory Research                            11. Document Control
3. Market Research                                12. Record Keeping
4. Product Design                                 13. Planning
5. Purchasing                                     14. Training
6. Service                                        15. Internal Audit
7. Product Protection                              16. Management Review
8. Customer Needs Assessment                      17. Measurement Processes
9. Customer Communication                         18. Nonconformance Mgt
            Prepare by: Adnan Masood Manager QHSE
                                                   19. Continual Improvement.
                  at TCG {0336-2350594}
   Generic QMS Model
   Non prescriptive
   Documentation culture
   Implementation without training not
    possible
   Control of vendors
   HRD
   SPC
   Not free of cost


     Prepare by: Adnan Masood Manager QHSE
              at TCG {0336-2350594}
   Main objective - image enhancing or market
    compulsion - not quality improvement
   Delegated to lower level of management - lack of
    top management’s (CEO’s and dept’l heads
    involvement
   Insufficient training/understanding
   Ineffective project management
   Eagerness to achieve certification (rather than
    Quality) as quickly as possible
   dominated by the influence of non-believers
   Insufficient writing strengths in management
   Role of Consultants and Certification Agency




                       Prepare by: Adnan Masood Manager QHSE
                                at TCG {0336-2350594}
   ISO does not certify itself
   Hundreds of agencies available world wide
   every company is free to choose
   Selection criteria
       Reputation
       Accreditation (ISO Guide 62, scope of accreditation, IAF)
       Quality of auditors with process know-how and experience
       Cost
       Availability and easy communication
   Scope of Certification
   Re-certification after every three years/surveillance
    after 6-12 months



             Prepare by: Adnan Masood Manager QHSE
                      at TCG {0336-2350594}
3
   About one year project
   project team is formed (dept’l heads) and a Proj. Coord.
   project team is trained
   dept’l procedures are mapped/documented
   ISO 9001 requirements are interpreted into each dept.
   Solutions (quality processes) to fulfill the requirements are
    identified
   Solutions are run on trials
   Solutions are added into prevalent dept’l procedures
   Solutions are implemented
   Internal Quality Auditing is started
   Corrective Action Program is initiated
   Selection of suitable certification agency
   pre-audit/audit is carried out
                      Prepare by: Adnan Masood Manager QHSE
                               at TCG {0336-2350594}
   Project Coordinator - Quality Management
    Representative (QMR)
   Project members from each dept. (usually dept’l
    heads)
   Main Responsibilities
       process mapping/documenting
       project realization
       project monitoring
       system designing
       validation of procedures
       project control
       owning the QMS at a company-wide level

                     Prepare by: Adnan Masood Manager QHSE
                              at TCG {0336-2350594}
   Quality of the Quality Management System is
    dependent on the Quality of Project Team
   Training (ISO 9001, IQA, SQC, Process
    Mapping, etc.)
   Visits to good models of certified firms
   Self study, interest, and initiatives
   membership to professional organizations, e.g..
    ASQ, IQA, etc.
   Browsing internet
   participating in discussions with professionals

                 Prepare by: Adnan Masood Manager QHSE
                          at TCG {0336-2350594}
Excellent                                                   C

Good

Satisfactory

Acceptable                                                      B

                                                                A

   3                 6      9      12                  18
                     Time (months)

               Prepare by: Adnan Masood Manager QHSE
                        at TCG {0336-2350594}
4
   Organizations depend on their customers
    and therefore should understand current and
    future customer needs, meet customer
    requirements and strive to exceed customer
    expectations




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             at TCG {0336-2350594}
   Leaders establish unity of purpose and
    direction of the organization. They
    should create and maintain the internal
    environment in which people can
    become fully involved in achieving the
    organization’s objectives

                                        Corporate
                                         Goals

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                        at TCG {0336-2350594}
     People at all levels are the essence of an
      organization and their full
      involvement enables their abilities to
      be used for the organization’s benefit




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         at TCG {0336-2350594}
   A desired result is achieved more
    efficiently when related resources and
    activities are managed as a process




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                        at TCG {0336-2350594}
   Identifying, understanding and managing
    a system of interrelated processes for a
    given objective improves the
    organization’s effectiveness and
    efficiency




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         at TCG {0336-2350594}
   Continual improvement should be a
    permanent objective of the organization




               Prepare by: Adnan Masood Manager QHSE
                        at TCG {0336-2350594}
   Effective decisions are based on the
    analysis of data and information




                Prepare by: Adnan Masood Manager QHSE
                         at TCG {0336-2350594}
    An organization and its suppliers are
     interdependent, and a mutually beneficial
     relationship enhances the ability of both to
     create value




    Prepare by: Adnan Masood Manager QHSE
             at TCG {0336-2350594}
5
CONTINUAL IMPROVEMENT OF THE
                  QUALITY MANAGEMENT SYSTEM


C   R
    e                      Management                                           C   S
                                                                                    a
U   q
                           responsibility                                       U
                                                                                    t
                                                                                    i
    u
S   i
                                                                                S   s
    r                                        Measurement,                           f
T   e            Resource
                                             analysis and                       T   a
                                                                                    c
O   m           management                   improvement
    e                                                                           O   t
                                                                                    i
M   n
    t                                                                           M   o
        Input                                                                       n
E   s                    Product                                       Output
                                                                                E
R                       realization                          Product
                                                                                R


                     Prepare by: Adnan Masood Manager QHSE
                              at TCG {0336-2350594}
1 Scope                         1.1 General
                                1.2 Application

2 Normative Reference

3 Terms and Definitions




                   Prepare by: Adnan Masood Manager QHSE
                            at TCG {0336-2350594}
4      Quality Management
       System                               4.1 General Requirements
                                            4.2 Documentation Requirements

5    Management                             5.1 Management Commitment
     Responsibility                         5.2 Customer focus
                                            5.3 Quality Policy
                                            5.4 Planning
                                            5.5 Responsibility, authority and communication
                                            5.6 Management Review

6     Resource Management                   6.1 Provision of resources
                                            6.2 Human resources
                                            6.3 Infrastructure
                                            6.4 Work environment

7    Product Realization                    7.1 Planning of product realization
                                            7.2 Customer-related processes
                                            7.3 Design and development
                                            7.4 Purchasing
                                            7.5 Production and service provision
    Prepare by: Adnan Masood Manager QHSE   7.6 Control of monitoring and measuring devices
             at TCG {0336-2350594}
8 Measurement, Analysis
  and Improvement             8.1 General
                              8.2 Monitoring and measurement
                              8.3 Control of nonconforming product
                              8.4 Analysis of data
                              8.5 Improvement




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                          at TCG {0336-2350594}
1.1 General

   Product consistently meets customer and
    applicable regulatory requirements

   to enhance customer satisfaction, including
    continual improvement of the system and
    assurance of conformity to customer and
    applicable regulatory requirements




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                           at TCG {0336-2350594}
1.2 Application

      Generic requirements; applicable to all
       organizations, regardless of type, size and
       product provided

      exclusion can be considered if certain
       requirements not applicable

      Exclusion allowed only from Clause 7


                  Prepare by: Adnan Masood Manager QHSE
                           at TCG {0336-2350594}
   ISO 9001:2008 Fundamentals and
    vocabulary
                                                          Quality
   (ISO 8402 is now obsolete)




                  Prepare by: Adnan Masood Manager QHSE
                           at TCG {0336-2350594}
   As given in ISO 9001
   Product also means services

                  Supply Chain

     Supplier          Organization                       Customer




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                           at TCG {0336-2350594}
INTEGRATION?




           Prepare by: Adnan Masood Manager QHSE
                    at TCG {0336-2350594}
4.1 Quality Management System




                                                 Examples
                         Quality                 • C/A with dept’l
   ISO
9001:2000                                          procedures
              Quality                            • Documentation with
             Processes                             company administration
                    Management
                                                 • Training with HRD
    System                                       • Quality Objectives
                                                   with Corporate Review


                         Prepare by: Adnan Masood Manager QHSE
                                  at TCG {0336-2350594}
4.2.1 General
    Documented statements of a quality policy and
     quality objectives
    a quality manual
    documented procedures required by ISO
     9001:2008
    documents needed by the organization to ensure
     the effective planning, operation and control of its
     processes, and
    quality records required by this standard

                   Prepare by: Adnan Masood Manager QHSE
                            at TCG {0336-2350594}
Documentation Requirements

• Documented Procedure means
   – Established
   – Documented
   – Implemented
   – Maintained
  Appropriate documentation as per Nature
   and size of the organization
  Documentation can be in any form or
   medium
                   Prepare by: Adnan Masood Manager QHSE
                            at TCG {0336-2350594}
4.2.2 Quality Manual

         Scope and justification for exclusion
         procedures of the QMS or its reference
         integration between QMS and Processes




 Prepare by: Adnan Masood Manager QHSE
          at TCG {0336-2350594}
How
                  What
                                           Applicable         Dept A     Relevant
                                            Clauses         Procedures   Records
            QUALITY
                                           Applicable         Dept B
            MANUAL                          Clauses         Procedures
                                                                         Relevant
               (SUMMARY)                                                 Records
                                           Applicable         Dept C
                                                                         Relevant
                                            Clauses         Procedures
                                                                         Records
                                           Applicable         Dept D     Relevant
                                            Clauses         Procedures   Records

                                           Applicable         Dept E     Relevant
                                            Clauses         Procedures   Records


                                             Supporting Documents
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                                        e.g. standards, Manuals, GMP’s
4.2.3 Control of documents

    QMS documents shall be controlled                     Examples
    appropriate review and approval
     prior to issue                                        • Quality Manual
                                                           • QMS Procedures
    changes in revision are identified
                                                           • Dept’l Procedures
    available at locations of use                         • Work Instructions
    legible and identifiable                              • Drawings/standards
                                                           • Machine Manuals
    external documents are included in
                                                           • Reference Manuals
     control                                                 etc.
    identification of obsolete
     documents


                   Prepare by: Adnan Masood Manager QHSE
                            at TCG {0336-2350594}
4.2.4 Control of Quality Records
                                                     Examples
   Legible, readily identifiable
                                                     • Quality Reports
    and retrievable                                  • Audit Reports
                                                     • Output of Mgt
                                                       Reviews
   clear procedure to define                        • Test Reports
    the control, including                           • C/P Actions
    retention and disposition                        • Customer Surveys
                                                     • Design Reviews,
                                                       validations etc.
                                                     • Customer
                                                       complaints, etc.

                   Prepare by: Adnan Masood Manager QHSE
                            at TCG {0336-2350594}
Documented Procedures required
 for:
   Control of documents
   Control of Quality records
   Product non-conformance
   Internal audits
   Corrective actions
   Preventive actions



    Prepare by: Adnan Masood Manager QHSE
             at TCG {0336-2350594}
5.1 Management Commitment
                                                             Examples
   Evidence of top management
    commitment for development,                              Visible involvement of
    Implementation and continual                               CEO and dept’l heads
    improvement of QMS by:                                     in:
                                                             • forming quality policy
   communication with the rest of the                         and objectives
    organization on the importance of
    meeting customer and regulatory                          • measuring and reviewing
    requirements                                               objectives and quality
                                                             • addressing resource
   establishing the quality policy                            requirements
   establishing quality objectives                          • addressing quality with
   holding management reviews                                 reporting team members
   ensuring availability of resources                         regularly

                     Prepare by: Adnan Masood Manager QHSE
                              at TCG {0336-2350594}
5.2 Customer Focus
    Top management shall ensure                            Examples
     that customer requirements are
     determined and fulfilled with                          • Customer needs
                                                              identification
     the aim of enhancing customer                            procedure?
     satisfaction (7.2.1 and 8.2.1)                           (e.g. surveys, focus
                                                              groups, contracts)
                                                            • Top management
                                                              verification (through
                                                              1st, 2nd, 3rd party
                                                              assessment etc., that
                                                              such requirements are
                                                              fulfilled

                         Prepare by: Adnan Masood Manager QHSE
                                  at TCG {0336-2350594}
5.3 Quality Policy
Top management shall ensure that the                   What broad Quality aspects
   quality policy:                                      should be Covered in the
                                                        Quality Policy?
• is appropriate to the purpose of the
   organization
                                                       1. Fulfillment of Customer needs
• includes a commitment to comply with
                                                       2. Fulfillment of applicable
   the requirements and continually
                                                         national laws and regulations
   improve the effectiveness of the QMS
                                                       3. Minimization of waste,errors
• provides a framework for establishing                  and nonconformance
   and reviewing quality objectives                    4. Continual improvement
• communicated and understood in the                   5. Employees quality and
   organization                                          organizational culture
• is reviewed for continuing suitability

                       Prepare by: Adnan Masood Manager QHSE
                                at TCG {0336-2350594}
5.4 Planning

• Quality Objectives:                                     • What does Quality
    – are established at relevant functions                 objectives for each
      and levels, and are measurable and                    function means?
      consistent with the quality policy
                                                          • What does Quality
• QMS Planning:                                             objectives for each
    – Each applicable process/dept. is                      level means?
      addressed under the PDCA model;
    – planning at changes is carried out




                       Prepare by: Adnan Masood Manager QHSE
                                at TCG {0336-2350594}
5.5 Responsibility, Authority and Communication

• Responsibility and Authority:                         Examples
   – defined and communicated within                    • Job Descriptions
     the organization                                   • QMR’s clear role
• Management Representative:
   appoint a QMS Coordination role to a
     management member
   – ensure QMS is established,
     implemented and maintained
   – report the performance and the
     need for improvement
   – promote awareness
   – liaison with external parties
                     Prepare by: Adnan Masood Manager QHSE
                              at TCG {0336-2350594}
• Internal Communication:                                 Examples
   ensure effective communication                         • Team briefing and
   regarding the effectiveness of the                       meetings
   QMS                                                    • notice boards
                                                          • newsletter
                                                          • intranet
                                                          • employees surveys
                                                          • Project presentations




                       Prepare by: Adnan Masood Manager QHSE
                                at TCG {0336-2350594}
5.6 Management Review

       INPUTS
                             QUALITY
                             PROCESS                                OUTPUTS

  QUALITY REPORT                                                Improvements in QMS
covering                     Management                          Improvements in
•Audit results
                              Reviews
•Customer feedback                                              Products/Processes
•process performance
•product conformity                                               Resource Needs
•C/P Action
•follow-ups
•changes / follow-ups
•recommendations
for improvements        Prepare by: Adnan Masood Manager QHSE
                                 at TCG {0336-2350594}
5.6B Management Review


 • Management reviews at planned
   Intervals to ensure:
   – Continuing suitability
   – Adequacy
   – Effectiveness
   – Identifying opportunities for
     improvement
   – Assessment of needs for changes to
     QMS




                     Prepare by: Adnan Masood Manager QHSE
                              at TCG {0336-2350594}
   Break the group into smaller teams
   Name your company and its business
   Draft a quality policy and quality objectives for
    approval by the Board of directors
   Identify the major processes
   Present in the plenary session




                   Prepare by: Adnan Masood Manager QHSE
                            at TCG {0336-2350594}
   The organization shall
    determine and provide the
    resources needed to:
       Implement and maintain
        QMS and continually
        improve its effectiveness
       Enhance customer
        satisfaction by meeting
        requirement


                      Prepare by: Adnan Masood Manager QHSE
                               at TCG {0336-2350594}
6.2.1 General


 Right person for the right job

 qualified managers?
                                                         Qualified /
 qualified supervisors?                                  Appropriate means
 appropriate workers?                                    1.   Education
                                                         2.   Training
                                                         3.    Skills
                                                         4.    Experience

                 Prepare by: Adnan Masood Manager QHSE
                          at TCG {0336-2350594}
6.2.2 Competence, Awareness and Training

• Determine necessary                               Examples
  competence of people                              • Performance
                                                        Evaluation
• provide training and other means
                                                    • Training Programs to
  to satisfy these needs                                fulfil the gaps
• evaluate the training/other                       • Training evaluation
  means to check effectiveness                      • Maintaining
• Provide awareness of the                              Resumes
  relevance and importance of
  their activities and its linkage to
  Quality Objectives
• record of education, training,
  skills, and experience         Prepare by: Adnan Masood Manager QHSE
                                          at TCG {0336-2350594}
• Determine and maintain                    Examples
  necessary infrastructure for the          • suitable machines,
  QMS program, e.g.                           workspaces,
                                              software, hardware,
                                              information
   – building, workspace, utilities         • Support services for
   – process equipment (hardware/             logistics
     software)
   – supporting services, e.g. transport,
     communication,




                                             Prepare by: Adnan Masood Manager QHSE
                                                      at TCG {0336-2350594}
• The organization shall determine                    Examples
  and manage the work
  environment needed to achieve                       • work space
  conformity to product                               • heat, humidity, light
                                                        airflow,
  requirements
                                                      • hygiene, cleanliness,
                                                        noise, vibration and
                                                        pollution, etc.




                   Prepare by: Adnan Masood Manager QHSE
                            at TCG {0336-2350594}
For the new organization you have just formed:
 Draw an Organization Chart

 Determine the infrastructure required

 Determine the requirements for the work
  environment
 Present in the plenary session




               Prepare by: Adnan Masood Manager QHSE
                        at TCG {0336-2350594}
7.1
             Planning        7.2
    7.6
Monitoring &              Customer
 Measuring                 Related
  Devices                 Processes
              PRODUCT
             REALIZATION
    7.5                      7.3
Production &               Design &
  Service                Development
 Provision       7.4
             Purchasing
                           Prepare by: Adnan Masood Manager QHSE
                                    at TCG {0336-2350594}
• Quality objectives and                • Product Quality
  requirements for the product            Plans?
• establish processes, documents,       • Guidance ISO 10005
  and provide resources specific to     • Process flowcharts
  the product                           • Applicable industry
                                          standards
• required verification, validation,
                                        • Relevant Regulatory
  monitoring, inspection and test         Requests
  activities specific to the product
  and the criteria for product
  acceptance
• identification of relevant records
  to provide objective evidence the
  realization process and resulting
  product fulfill requirements         Prepare by: Adnan Masood Manager QHSE
                                                at TCG {0336-2350594}
7.2 Customer-related Processes

7.2.1 Determination of requirements related to the Product
 • Determine:                                             Examples
    – customer’s requirements (including                  • contracts
      delivery & past delivery)                           • customer surveys,
    – unstated but necessary requirements                   focus groups
    – statutory and regulatory product req’t              • applicable national
    – any additional requirement                            regulations
      determined by the organization




                       Prepare by: Adnan Masood Manager QHSE
                                at TCG {0336-2350594}
7.2 Customer-related Processes

7.2.2 Review of requirements related to the Product
                                                        Examples
 •   review contract before acceptance                  • Contract review
                                                        • review of results of
 •   ensure product reqts are defined                     surveys and focus
 •   resolve issues before acceptance                     groups, etc.
 •   confirm organization capability                    • Amendment

 •   maintain records
 •   ensure amendments understood,
     recorded, and communicated to
     relevant persons

                     Prepare by: Adnan Masood Manager QHSE
                              at TCG {0336-2350594}
7.2 Customer-related Processes

7.2.3 Customer Communication
 • Make effective arrangements for                         Examples
   communicating with customers in                         • printing of product
   relation to:                                              information on
                                                             packaging
    – product information
                                                           • internet
    – inquiries, contracts or order handling,
      including amendments, and                            • catalogs and service
                                                             manuals, etc.
    – customer feedback, including
      customer complaints




                        Prepare by: Adnan Masood Manager QHSE
                                 at TCG {0336-2350594}
Design Review

 Customer
Regulatory
Professional   Inputs   Review    Designing     Output
   Reqts.



                                 Verification


                                  Validation

This section includes Design as well as Development
7.3 Design and Development

7.3.1 D&D Planning
 • Determine D&D stages                                 • Development Review
                                                          Committee?
 • plan the review, verification and
                                                        • Design &
   validation for each stage                              Documentation
 • responsibilities and authorities                       stages
 • define interfaces
 • planning documents (output) shall
   be updated regularly




                     Prepare by: Adnan Masood Manager QHSE
                              at TCG {0336-2350594}
7.3 Design and Development

7.3.2 D&D Inputs
 • Determine functional and                             • What are some
   performance requirements                               examples of design
                                                          inputs?
 • applicable statutory and
   regulatory requirements
 • information from previous similar
   designs
 • clarity must be established in the
   information



                     Prepare by: Adnan Masood Manager QHSE
                              at TCG {0336-2350594}
7.3 Design and Development

7.3.3 D&D Outputs
 • D&D output shall:                                     •    Examples
     ° meet the input requirements                       •    actual prototypes
     ° provide appropriate information for               •    specifications
       purchasing, production and service                •    drawings
       provision                                         •    tooling
     ° Contain or reference product                      •    jigs/fixtures
       acceptance criteria
     ° Supply the Characteristic of the
       product for its safe & proper use.
 • Systematic reviews at suitable
   stages
 • participation by relevant depts
 • records of reviews        Prepare by: Adnan Masood Manager QHSE
                                            at TCG {0336-2350594}
7.3 Design and Development

7.3.4 D&D Review
 • At suitable stages             Examples
 • by appropriate persons         • Review of outcomes
                                    of experiments, trials,
 • identify problems and their      research, etc.
   remedies




                                 Prepare by: Adnan Masood Manager QHSE
                                          at TCG {0336-2350594}
7.3 Design and Development

7.3.5 D&D Verification
 • To ensure that design output   Examples
   meets the design inputs        • Output of design
                                    reviews
 • records
                                  • tests
                                  • 3rd party tests
                                  • Comparative studies




                                   Prepare by: Adnan Masood Manager QHSE
                                            at TCG {0336-2350594}
7.3 Design and Development

7.3.6 D&D Validation
 • Ensure resulting product              Examples
   capability for intended use or        • Simulations
   application                           • Field Trials
 • evidences/records                     • Environmental tests
                                         • 3rd party tests
                                         • Trial markets
                                           evidences




                                    Prepare by: Adnan Masood Manager QHSE
                                             at TCG {0336-2350594}
7.3 Design and Development

7.3.7 D&D Changes
 • Changes shall be revised,           Examples
   verified, validated and approved    • changes in all
   before implementation                 drawings
                                         /specifications,
 • Ensure communication and              including vendors’
   records of changes




                                      Prepare by: Adnan Masood Manager QHSE
                                               at TCG {0336-2350594}
7.4 Purchasing




                 PURCHASING


               Verification of
             Purchased Product

             Prepare by: Adnan Masood Manager QHSE
                      at TCG {0336-2350594}
7.4 Purchasing

7.4.1 Purchasing Process
 • Ensure that purchased product                        • Procurement of
   conforms to specified                                  Material
   requirements                                         • hiring of services, e.g.
                                                          Maintenance,
 • type of control over suppliers                         calibration, consultants,
   purchased product depend upon                          certification agencies,
   their necessity                                        etc.
                                                        • Vendor Evaluation
 • suppliers evaluation and selection
                                                          Form
 • criteria for selection, and                          • Criteria for approval
   evaluation
 • records of evaluation

                     Prepare by: Adnan Masood Manager QHSE
                              at TCG {0336-2350594}
7.4 Purchasing

7.4.2 Purchasing Information
 • Product approval requirements       Examples
 • requirements for qualification of   Purchase Orders to
                                       completely define:
   personnel
                                       • product specification
 • QMS requirements                    • AQL
                                       • Types of tests (where
                                       applicable)
                                       • Q.A. requirements, if
                                       any




                                       Prepare by: Adnan Masood Manager QHSE
                                                at TCG {0336-2350594}
7.4 Purchasing

7.4.3 Verification of Purchased Product
 • Inspection and other activities to                    • Verification System
   ensure quality purchases                                for the products
                                                         • verification system
 • inspection at suppliers end should                      for services
   be specified in purchasing
   information




                      Prepare by: Adnan Masood Manager QHSE
                               at TCG {0336-2350594}
7.5 Production and Service
    Provision

          7.5.1
       Control of                                               7.5.4
      Production &                                            Customer
        Service                                               Property
       Provision               7.5.3
                           Identification
                                and
                            Traceability                     7.5.5
          7.5.2                                          Preservation
      Validation of                                       of Product
       Processes


                      Prepare by: Adnan Masood Manager QHSE
                               at TCG {0336-2350594}
7.5 Production and Service
    Provision

7.5.1 Control of Production and Service Provision
 • Production to be carried out under                      Give examples of Service
   controlled conditions                                   Provision Depts in the
    – product specs                                        following Service
    – correct methods to produce                           Organizations?
    – suitable equipment
                                                           • Hotel?
    – provision of monitoring and
      measurement devices                                  • University?
    – monitoring and measurement                           • Hospitals?
      programs
    – effective release, delivery and post-                • After sales service is also
      delivery systems                                     included, e.g. warrantees


                        Prepare by: Adnan Masood Manager QHSE
                                 at TCG {0336-2350594}
7.5 Production and Service
    Provision

7.5.2 Validation of Processes for Production and Service Provision
 • In the absence of any                                    Examples
   measurement program, that                                • Validation/qualification
   process needs to be validated.                             of doctors and nurses
   This should include:                                       in hospitals, welders in
                                                              metal industry, cooks
     – review and approval criteria
                                                              in hotels, etc.
     – approval of eqpt and qualification of
                                                            • Validation of special
       personnel
                                                              processes, e.g. types
     – use of specific methods and                            of electrodes,
       procedures                                             machines, and
     – records                                                environment in a
     – revalidation                                           welding process.


                         Prepare by: Adnan Masood Manager QHSE
                                  at TCG {0336-2350594}
7.5 Production and Service Provision

7.5.3 Identification and traceability

 • Identify the product by suitable                   All incoming and final
   means throughout product                           products should be assured
                                                      both identification and
   realization                                        traceability, e.g.. Hardware
 • identify product monitoring and                    (product marking, lot
   measurement status                                 numbers); software
                                                      (computer programs/files);
 • if traceability is required, then                  services (transport, test
   control and record unique                          reports), etc.
   identification system



                      Prepare by: Adnan Masood Manager QHSE
                               at TCG {0336-2350594}
7.5 Production and Service
    Provision

7.5.4 Customer Property
 • Take care of customer property                      Examples
 • identify, verify, protect, and                      • Blood products,
                                                         tissues, babies,
   safeguard customer property                           medications, personal
 • if it is lost, damaged or found                       valuables, mobility
   unsuitable, then it should be                         aids (walkers, chairs,
                                                         crutches) in hospital
   reported to customer and records
                                                       • Customer cars in
   maintained
                                                         hotels and companies
                                                       • Authors manuscripts in
                                                         publishing, etc.



                    Prepare by: Adnan Masood Manager QHSE
                             at TCG {0336-2350594}
   Preserve conformity of
    product during processing
    and delivery to the
    intended destination
   Preservation includes
    identification, handling,
    packaging, storage and
    protection.
   Applies to the constitute
    parts of product

                 Prepare by: Adnan Masood Manager QHSE
                          at TCG {0336-2350594}
7.6 Control of Monitoring and
    Measuring Devices
• Identification of correct need to monitor
  and measure product
• correct use of monitor and measuring                         • Correct
  devices                                                      • correct point of
                                                                 measure
• calibration, at defined intervals, with                      • correct selection of
  authentic/traceable sources                                    measuring equipment
• correct use of adjustments                                   • correct accuracy and
                                                                 precision of measure
• safeguarding adjustments
• proper handling, maintenance & storage
• C/A when devices found out of
  calibration
• confirmation of software
                       Prepare by: Adnan Masood Manager QHSE
                                at TCG {0336-2350594}
     Draw a process of product/service
        realization of your new company
       Present in the plenary session




Prepare by: Adnan Masood Manager QHSE
         at TCG {0336-2350594}
8.1
General

                     8.3
                 Control of
               non-conforming
                  product




          Prepare by: Adnan Masood Manager QHSE
                   at TCG {0336-2350594}
8 Measurement, Analysis and
  Improvement

8.1 General
 • Plan and implement the process               • This section is about
   for monitoring, measurement,                   Quality Control (QC)
   analysis and input to:                       • Conformity to customer
                                                  needs, contracts, and
       – Ensure conformity of the product         national regulation must
       – ensure conformity of the QMS             be ensured before
       – ensure effectiveness and continually     product is dispatched
         improving the QMS                      • Validation of measuring
                                                  procedures
                                                • Regularly up-grade
                                                  accuracy and
                                                  effectiveness of QMS


  Prepare by: Adnan Masood Manager QHSE
           at TCG {0336-2350594}
8 Measurement, Analysis and
  Improvement

8.2 Monitoring and Measurement              Examples of CS:
                                            • Direct interfaces
 8.2.1 Customer Satisfaction
                                            • focus groups
    – device a method to measure and
      monitor customer satisfaction from    • surveys
      customer perception point of view     • sector and industry
    – Method for obtaining and using the      studies
      information shall be determined.      Examples of IA:
                                            • Main objective is to
                                              check the correctness
                                              and performance of
                                              functions and
                                              processes; not
                                              documentation of
                                              processes

                                           Prepare by: Adnan Masood Manager QHSE
                                                    at TCG {0336-2350594}
8.2 Monitoring and
   Measurement


8.2.2 Internal Audit
      Regularly carryout internal
       audit to check conformity and
       effectiveness of the QMS
      design an effective audit
       program and plan, criteria
      competent auditors
      audit results and records
      follow-ups and timely C/A

                     Prepare by: Adnan Masood Manager QHSE
                              at TCG {0336-2350594}
8 Measurement, Analysis and
  Improvement

8.2 Monitoring and Measurement
                                                           Examples
 8.2.3 Processes                                           • use of SPC,
    – apply suitable monitoring of                           especially control
      processes where required                               charts
    – C/A when deviation occurs                            • monitoring and
                                                             supervision of
                                                             process parameters
 8.2.4 Products                                            • daily morning reviews
    – measure product characteristics to                     of quality by workers
      confirm fulfillment of quality                         and their supervisors
    – at appropriate stages in accordance                  • Appropriate product
      with the quality plans                                 quality plan
    – define acceptance criteria
    – authorize release and records
                       Prepare by: Adnan Masood Manager QHSE
                                at TCG {0336-2350594}
8 Measurement, Analysis and
  Improvement

8.3 Control of nonconforming product
 • Ensure nonconforming product is                      Identification and taking
   identified and controlled                               corrective actions on:
                                                        • wrong purchases
 • define responsibilities and
                                                        • wrong deliveries
   authorities in this procedure
                                                        • defective products
 • clear action: C/A, concession, re-                      produced
   grade with customers’ consent                        • wrong packing
   and evidence                                         • wrong storage
 • re-verification                                      • wrong dispatches
 • if detected in use, then take                        • wrong invoices
   appropriate action of recall or                      • etc.
   compensation
                     Prepare by: Adnan Masood Manager QHSE
                              at TCG {0336-2350594}
8 Measurement, Analysis and
  Improvement

8.4 Analysis of Data
 • Determine, collect and analyze                            • Analysis is not
   appropriate data from                                       compiling of data
   measurement sources to check                              • Analysis is after
                                                               compiling of quality
   conformance and analysis for                                data
   improvement in:                                           • Analysis is part of
     –   customer satisfaction                                 Quality Report
     –   product conformance                                 • Sources of data?
     –   process
     –   suppliers




                          Prepare by: Adnan Masood Manager QHSE
                                   at TCG {0336-2350594}
8 Measurement, Analysis and
  Improvement

8.5 Improvement
 8.5.1 Continual Improvement                               • Clear evidence of
    – identify opportunities of improvement                  improvement
      from quality policy, objectives, audit                 processes
      results, analysis of data, C/P actions,              • Clear evidence of
      and management reviews                                 improvements
    – mobilize improvement programs




                        Prepare by: Adnan Masood Manager QHSE
                                 at TCG {0336-2350594}
8 Measurement, Analysis and
  Improvement

8.5 Improvement
 8.5.2 Corrective Action                                   • What is the
    – take timely action to eliminate the                    difference between
      cause of nonconformities.                              Correction,
                                                             Corrective Action
    – Review nonconformities                                 and Preventive
    – determine causes                                       Action?
    – evaluate                                             • Corrective Action
    – determine and implement action                         Form
    – records of results                                   • Control of Corrective
    – review and confirm results                             Actions




                        Prepare by: Adnan Masood Manager QHSE
                                 at TCG {0336-2350594}
8 Measurement, Analysis and
  Improvement

8.5 Improvement
 8.5.3 Preventive Action                                  • Outputs of
    – determine potential nonconformities                   management
      current mistakes and future planning                  reviews or corrective
                                                            actions
    – determine their causes
    – device actions
    – implement actions
    – record results
    – review action taken




                       Prepare by: Adnan Masood Manager QHSE
                                at TCG {0336-2350594}
– What would be some of the
  performance indicators of the
  processes/products of your
  new company?
– How would you measure and
  analyze them and at what
  frequency?
– Present in the plenary session.




                Prepare by: Adnan Masood Manager QHSE
                         at TCG {0336-2350594}
Systems are not what documents say what they are;
they are the habits of people which they practice .

Most failures are not because of documents or systems;
but because of people who do not change their
prevalent habits (systems).

Therefore, Systems usually do not fail, people do.




                    Prepare by: Adnan Masood Manager QHSE
                             at TCG {0336-2350594}
Adnan Masood
       Manager QHSE
The Chishtian Goods Transport
           Company

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Workshop on ISO 9001 2008

  • 1.
  • 2. CONTENTS 1 Introduction 2 What’s New in ISO 9001:2008 3 ISO 9000 Project Management 4 Eight Quality Management Principles 5 Requirements
  • 3. 1
  • 4. ISO 9000:87 ISO 9000:94 ISO 9001:2000 BS5750 ISO 9001:2008 1979 AQAP1 (NATO) 1970’s MIL-STD-9858 (1940’s) Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 5. International Organization for Standardization  Develops standards do not certify companies  Around 140 countries members  Around 13000 standards produced  Technical Committees are formed to produce standards  TC 176 for ISO 9000  International Organization for Standardization Email: central@iso.ch Web: http://www.iso.ch http://www.bsi.org.uk/iso-tc176-sc2. Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 6. 2 WHAT’S NEW IN ISO 9001:2008 Compared to ISO 9001:1994
  • 7. Cancels and replaces second edition of 1994  revised title which no more uses the term QA, instead just QMS (QA + Customer Satisfaction)  Released on 15 Dec 2000  up-graded in contents, effectiveness, and logical implementation  9000- and 9004- series guidelines eliminated and 9004 to serve as a general purpose guidelines  Many guidelines available in the form of TR (Technical Reports)  compatible with ISO 14001 Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 8. • Scope (modified): • to demonstrate its ability to provide consistently, product that meets customer and applicable regulatory requirements, and • to address customer satisfaction through the effective application of the system, including processes for continual improvement and the prevention of nonconformity Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 9. • ISO 9001, 9002, & 9003 merged into a single 9001:2008 • ISO 8402 and ISO 9000-1 merged into a new ISO 9001:2008 • ISO 10011 will be merged with ISO 14010 into a new ISO 19001 Quality & Environmental Auditing • 3 years for co-existence Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 10. 1. The Standard 2. The Structure 3. The Definitions 4. The Emphasis 5. The Requirements 6. The Flexibility 7. The Approach Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 11. 1. New Standard  ISO 9002 and 9003 dropped  ISO 9001 modified 2. New Structure • 20 clauses abandoned • Now 5 sections Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 12. 3. New Definitions • Supplier: Vendors, subcontractors, etc. • Organization: The company implementing QMS • Product Realization: The interconnected processes that are used to bring products into being. When you start with an idea and end up with a product, you’ve gone through the process of product realization 4. New Emphasis  Customer Focused  Continual Improvement  Integration of Processes with the QMS Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 13. 5. New Requirements 1. Communication with customers 2. Identify customer needs and expectations 3. Meet customer needs and expectations 4. Measure and monitor customer needs and expectations 5. Meet legal and regulatory requirements 6. Internal Communication 7. Provide competent human resources 8. Provide necessary facilities and work environment 9. Evaluate the effectiveness of training 10. Measure and monitor realization processes 11. Evaluate the effectiveness and suitability of quality system 12. Identify QMS improvements 13 Improve QMS regularly Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 14. 6. New Flexibility 1. Permissible Exclusions from Section 7 if a. it doesn’t apply b. customer’s requirements make it reasonable to exclude c. regulatory requirements make it reasonable to exclude However, no part can be excluded, if doing so will undermine the organization’s abilities or performance Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 15. 7. New Approach PROCESS APPROACH TO QMS QMS can now be considered as a single large process with many sub- processes. Each of these sub-processes uses inputs and outputs. These are: 1. Resource Management 10. Internal Communication 2. Regulatory Research 11. Document Control 3. Market Research 12. Record Keeping 4. Product Design 13. Planning 5. Purchasing 14. Training 6. Service 15. Internal Audit 7. Product Protection 16. Management Review 8. Customer Needs Assessment 17. Measurement Processes 9. Customer Communication 18. Nonconformance Mgt Prepare by: Adnan Masood Manager QHSE 19. Continual Improvement. at TCG {0336-2350594}
  • 16. Generic QMS Model  Non prescriptive  Documentation culture  Implementation without training not possible  Control of vendors  HRD  SPC  Not free of cost Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 17. Main objective - image enhancing or market compulsion - not quality improvement  Delegated to lower level of management - lack of top management’s (CEO’s and dept’l heads involvement  Insufficient training/understanding  Ineffective project management  Eagerness to achieve certification (rather than Quality) as quickly as possible  dominated by the influence of non-believers  Insufficient writing strengths in management  Role of Consultants and Certification Agency Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 18. ISO does not certify itself  Hundreds of agencies available world wide  every company is free to choose  Selection criteria  Reputation  Accreditation (ISO Guide 62, scope of accreditation, IAF)  Quality of auditors with process know-how and experience  Cost  Availability and easy communication  Scope of Certification  Re-certification after every three years/surveillance after 6-12 months Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 19. 3
  • 20. About one year project  project team is formed (dept’l heads) and a Proj. Coord.  project team is trained  dept’l procedures are mapped/documented  ISO 9001 requirements are interpreted into each dept.  Solutions (quality processes) to fulfill the requirements are identified  Solutions are run on trials  Solutions are added into prevalent dept’l procedures  Solutions are implemented  Internal Quality Auditing is started  Corrective Action Program is initiated  Selection of suitable certification agency  pre-audit/audit is carried out Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 21. Project Coordinator - Quality Management Representative (QMR)  Project members from each dept. (usually dept’l heads)  Main Responsibilities  process mapping/documenting  project realization  project monitoring  system designing  validation of procedures  project control  owning the QMS at a company-wide level Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 22. Quality of the Quality Management System is dependent on the Quality of Project Team  Training (ISO 9001, IQA, SQC, Process Mapping, etc.)  Visits to good models of certified firms  Self study, interest, and initiatives  membership to professional organizations, e.g.. ASQ, IQA, etc.  Browsing internet  participating in discussions with professionals Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 23. Excellent C Good Satisfactory Acceptable B A 3 6 9 12 18 Time (months) Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 24. 4
  • 25. Organizations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 26. Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives Corporate Goals Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 27. People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 28. A desired result is achieved more efficiently when related resources and activities are managed as a process Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 29. Identifying, understanding and managing a system of interrelated processes for a given objective improves the organization’s effectiveness and efficiency Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 30. Continual improvement should be a permanent objective of the organization Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 31. Effective decisions are based on the analysis of data and information Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 32. An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 33. 5
  • 34. CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM C R e Management C S a U q responsibility U t i u S i S s r Measurement, f T e Resource analysis and T a c O m management improvement e O t i M n t M o Input n E s Product Output E R realization Product R Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 35. 1 Scope 1.1 General 1.2 Application 2 Normative Reference 3 Terms and Definitions Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 36. 4 Quality Management System 4.1 General Requirements 4.2 Documentation Requirements 5 Management 5.1 Management Commitment Responsibility 5.2 Customer focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, authority and communication 5.6 Management Review 6 Resource Management 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment 7 Product Realization 7.1 Planning of product realization 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing 7.5 Production and service provision Prepare by: Adnan Masood Manager QHSE 7.6 Control of monitoring and measuring devices at TCG {0336-2350594}
  • 37. 8 Measurement, Analysis and Improvement 8.1 General 8.2 Monitoring and measurement 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 38. 1.1 General  Product consistently meets customer and applicable regulatory requirements  to enhance customer satisfaction, including continual improvement of the system and assurance of conformity to customer and applicable regulatory requirements Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 39. 1.2 Application  Generic requirements; applicable to all organizations, regardless of type, size and product provided  exclusion can be considered if certain requirements not applicable  Exclusion allowed only from Clause 7 Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 40. ISO 9001:2008 Fundamentals and vocabulary Quality  (ISO 8402 is now obsolete) Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 41. As given in ISO 9001  Product also means services Supply Chain Supplier Organization Customer Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 42. INTEGRATION? Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 43. 4.1 Quality Management System Examples Quality • C/A with dept’l ISO 9001:2000 procedures Quality • Documentation with Processes company administration Management • Training with HRD System • Quality Objectives with Corporate Review Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 44. 4.2.1 General  Documented statements of a quality policy and quality objectives  a quality manual  documented procedures required by ISO 9001:2008  documents needed by the organization to ensure the effective planning, operation and control of its processes, and  quality records required by this standard Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 45. Documentation Requirements • Documented Procedure means – Established – Documented – Implemented – Maintained Appropriate documentation as per Nature and size of the organization Documentation can be in any form or medium Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 46. 4.2.2 Quality Manual  Scope and justification for exclusion  procedures of the QMS or its reference  integration between QMS and Processes Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 47. How What Applicable Dept A Relevant Clauses Procedures Records QUALITY Applicable Dept B MANUAL Clauses Procedures Relevant (SUMMARY) Records Applicable Dept C Relevant Clauses Procedures Records Applicable Dept D Relevant Clauses Procedures Records Applicable Dept E Relevant Clauses Procedures Records Supporting Documents Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594} e.g. standards, Manuals, GMP’s
  • 48. 4.2.3 Control of documents  QMS documents shall be controlled Examples  appropriate review and approval prior to issue • Quality Manual • QMS Procedures  changes in revision are identified • Dept’l Procedures  available at locations of use • Work Instructions  legible and identifiable • Drawings/standards • Machine Manuals  external documents are included in • Reference Manuals control etc.  identification of obsolete documents Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 49. 4.2.4 Control of Quality Records Examples  Legible, readily identifiable • Quality Reports and retrievable • Audit Reports • Output of Mgt Reviews  clear procedure to define • Test Reports the control, including • C/P Actions retention and disposition • Customer Surveys • Design Reviews, validations etc. • Customer complaints, etc. Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 50. Documented Procedures required for:  Control of documents  Control of Quality records  Product non-conformance  Internal audits  Corrective actions  Preventive actions Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 51. 5.1 Management Commitment Examples  Evidence of top management commitment for development, Visible involvement of Implementation and continual CEO and dept’l heads improvement of QMS by: in: • forming quality policy  communication with the rest of the and objectives organization on the importance of meeting customer and regulatory • measuring and reviewing requirements objectives and quality • addressing resource  establishing the quality policy requirements  establishing quality objectives • addressing quality with  holding management reviews reporting team members  ensuring availability of resources regularly Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 52. 5.2 Customer Focus  Top management shall ensure Examples that customer requirements are determined and fulfilled with • Customer needs identification the aim of enhancing customer procedure? satisfaction (7.2.1 and 8.2.1) (e.g. surveys, focus groups, contracts) • Top management verification (through 1st, 2nd, 3rd party assessment etc., that such requirements are fulfilled Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 53. 5.3 Quality Policy Top management shall ensure that the What broad Quality aspects quality policy: should be Covered in the Quality Policy? • is appropriate to the purpose of the organization 1. Fulfillment of Customer needs • includes a commitment to comply with 2. Fulfillment of applicable the requirements and continually national laws and regulations improve the effectiveness of the QMS 3. Minimization of waste,errors • provides a framework for establishing and nonconformance and reviewing quality objectives 4. Continual improvement • communicated and understood in the 5. Employees quality and organization organizational culture • is reviewed for continuing suitability Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 54. 5.4 Planning • Quality Objectives: • What does Quality – are established at relevant functions objectives for each and levels, and are measurable and function means? consistent with the quality policy • What does Quality • QMS Planning: objectives for each – Each applicable process/dept. is level means? addressed under the PDCA model; – planning at changes is carried out Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 55. 5.5 Responsibility, Authority and Communication • Responsibility and Authority: Examples – defined and communicated within • Job Descriptions the organization • QMR’s clear role • Management Representative: appoint a QMS Coordination role to a management member – ensure QMS is established, implemented and maintained – report the performance and the need for improvement – promote awareness – liaison with external parties Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 56. • Internal Communication: Examples ensure effective communication • Team briefing and regarding the effectiveness of the meetings QMS • notice boards • newsletter • intranet • employees surveys • Project presentations Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 57. 5.6 Management Review INPUTS QUALITY PROCESS OUTPUTS QUALITY REPORT Improvements in QMS covering Management Improvements in •Audit results Reviews •Customer feedback Products/Processes •process performance •product conformity Resource Needs •C/P Action •follow-ups •changes / follow-ups •recommendations for improvements Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 58. 5.6B Management Review • Management reviews at planned Intervals to ensure: – Continuing suitability – Adequacy – Effectiveness – Identifying opportunities for improvement – Assessment of needs for changes to QMS Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 59. Break the group into smaller teams  Name your company and its business  Draft a quality policy and quality objectives for approval by the Board of directors  Identify the major processes  Present in the plenary session Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 60. The organization shall determine and provide the resources needed to:  Implement and maintain QMS and continually improve its effectiveness  Enhance customer satisfaction by meeting requirement Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 61. 6.2.1 General Right person for the right job qualified managers? Qualified / qualified supervisors? Appropriate means appropriate workers? 1. Education 2. Training 3. Skills 4. Experience Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 62. 6.2.2 Competence, Awareness and Training • Determine necessary Examples competence of people • Performance Evaluation • provide training and other means • Training Programs to to satisfy these needs fulfil the gaps • evaluate the training/other • Training evaluation means to check effectiveness • Maintaining • Provide awareness of the Resumes relevance and importance of their activities and its linkage to Quality Objectives • record of education, training, skills, and experience Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 63. • Determine and maintain Examples necessary infrastructure for the • suitable machines, QMS program, e.g. workspaces, software, hardware, information – building, workspace, utilities • Support services for – process equipment (hardware/ logistics software) – supporting services, e.g. transport, communication, Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 64. • The organization shall determine Examples and manage the work environment needed to achieve • work space conformity to product • heat, humidity, light airflow, requirements • hygiene, cleanliness, noise, vibration and pollution, etc. Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 65. For the new organization you have just formed:  Draw an Organization Chart  Determine the infrastructure required  Determine the requirements for the work environment  Present in the plenary session Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 66. 7.1 Planning 7.2 7.6 Monitoring & Customer Measuring Related Devices Processes PRODUCT REALIZATION 7.5 7.3 Production & Design & Service Development Provision 7.4 Purchasing Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 67. • Quality objectives and • Product Quality requirements for the product Plans? • establish processes, documents, • Guidance ISO 10005 and provide resources specific to • Process flowcharts the product • Applicable industry standards • required verification, validation, • Relevant Regulatory monitoring, inspection and test Requests activities specific to the product and the criteria for product acceptance • identification of relevant records to provide objective evidence the realization process and resulting product fulfill requirements Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 68. 7.2 Customer-related Processes 7.2.1 Determination of requirements related to the Product • Determine: Examples – customer’s requirements (including • contracts delivery & past delivery) • customer surveys, – unstated but necessary requirements focus groups – statutory and regulatory product req’t • applicable national – any additional requirement regulations determined by the organization Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 69. 7.2 Customer-related Processes 7.2.2 Review of requirements related to the Product Examples • review contract before acceptance • Contract review • review of results of • ensure product reqts are defined surveys and focus • resolve issues before acceptance groups, etc. • confirm organization capability • Amendment • maintain records • ensure amendments understood, recorded, and communicated to relevant persons Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 70. 7.2 Customer-related Processes 7.2.3 Customer Communication • Make effective arrangements for Examples communicating with customers in • printing of product relation to: information on packaging – product information • internet – inquiries, contracts or order handling, including amendments, and • catalogs and service manuals, etc. – customer feedback, including customer complaints Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 71. Design Review Customer Regulatory Professional Inputs Review Designing Output Reqts. Verification Validation This section includes Design as well as Development
  • 72. 7.3 Design and Development 7.3.1 D&D Planning • Determine D&D stages • Development Review Committee? • plan the review, verification and • Design & validation for each stage Documentation • responsibilities and authorities stages • define interfaces • planning documents (output) shall be updated regularly Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 73. 7.3 Design and Development 7.3.2 D&D Inputs • Determine functional and • What are some performance requirements examples of design inputs? • applicable statutory and regulatory requirements • information from previous similar designs • clarity must be established in the information Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 74. 7.3 Design and Development 7.3.3 D&D Outputs • D&D output shall: • Examples ° meet the input requirements • actual prototypes ° provide appropriate information for • specifications purchasing, production and service • drawings provision • tooling ° Contain or reference product • jigs/fixtures acceptance criteria ° Supply the Characteristic of the product for its safe & proper use. • Systematic reviews at suitable stages • participation by relevant depts • records of reviews Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 75. 7.3 Design and Development 7.3.4 D&D Review • At suitable stages Examples • by appropriate persons • Review of outcomes of experiments, trials, • identify problems and their research, etc. remedies Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 76. 7.3 Design and Development 7.3.5 D&D Verification • To ensure that design output Examples meets the design inputs • Output of design reviews • records • tests • 3rd party tests • Comparative studies Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 77. 7.3 Design and Development 7.3.6 D&D Validation • Ensure resulting product Examples capability for intended use or • Simulations application • Field Trials • evidences/records • Environmental tests • 3rd party tests • Trial markets evidences Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 78. 7.3 Design and Development 7.3.7 D&D Changes • Changes shall be revised, Examples verified, validated and approved • changes in all before implementation drawings /specifications, • Ensure communication and including vendors’ records of changes Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 79. 7.4 Purchasing PURCHASING Verification of Purchased Product Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 80. 7.4 Purchasing 7.4.1 Purchasing Process • Ensure that purchased product • Procurement of conforms to specified Material requirements • hiring of services, e.g. Maintenance, • type of control over suppliers calibration, consultants, purchased product depend upon certification agencies, their necessity etc. • Vendor Evaluation • suppliers evaluation and selection Form • criteria for selection, and • Criteria for approval evaluation • records of evaluation Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 81. 7.4 Purchasing 7.4.2 Purchasing Information • Product approval requirements Examples • requirements for qualification of Purchase Orders to completely define: personnel • product specification • QMS requirements • AQL • Types of tests (where applicable) • Q.A. requirements, if any Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 82. 7.4 Purchasing 7.4.3 Verification of Purchased Product • Inspection and other activities to • Verification System ensure quality purchases for the products • verification system • inspection at suppliers end should for services be specified in purchasing information Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 83. 7.5 Production and Service Provision 7.5.1 Control of 7.5.4 Production & Customer Service Property Provision 7.5.3 Identification and Traceability 7.5.5 7.5.2 Preservation Validation of of Product Processes Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 84. 7.5 Production and Service Provision 7.5.1 Control of Production and Service Provision • Production to be carried out under Give examples of Service controlled conditions Provision Depts in the – product specs following Service – correct methods to produce Organizations? – suitable equipment • Hotel? – provision of monitoring and measurement devices • University? – monitoring and measurement • Hospitals? programs – effective release, delivery and post- • After sales service is also delivery systems included, e.g. warrantees Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 85. 7.5 Production and Service Provision 7.5.2 Validation of Processes for Production and Service Provision • In the absence of any Examples measurement program, that • Validation/qualification process needs to be validated. of doctors and nurses This should include: in hospitals, welders in metal industry, cooks – review and approval criteria in hotels, etc. – approval of eqpt and qualification of • Validation of special personnel processes, e.g. types – use of specific methods and of electrodes, procedures machines, and – records environment in a – revalidation welding process. Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 86. 7.5 Production and Service Provision 7.5.3 Identification and traceability • Identify the product by suitable All incoming and final means throughout product products should be assured both identification and realization traceability, e.g.. Hardware • identify product monitoring and (product marking, lot measurement status numbers); software (computer programs/files); • if traceability is required, then services (transport, test control and record unique reports), etc. identification system Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 87. 7.5 Production and Service Provision 7.5.4 Customer Property • Take care of customer property Examples • identify, verify, protect, and • Blood products, tissues, babies, safeguard customer property medications, personal • if it is lost, damaged or found valuables, mobility unsuitable, then it should be aids (walkers, chairs, crutches) in hospital reported to customer and records • Customer cars in maintained hotels and companies • Authors manuscripts in publishing, etc. Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 88. Preserve conformity of product during processing and delivery to the intended destination  Preservation includes identification, handling, packaging, storage and protection.  Applies to the constitute parts of product Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 89. 7.6 Control of Monitoring and Measuring Devices • Identification of correct need to monitor and measure product • correct use of monitor and measuring • Correct devices • correct point of measure • calibration, at defined intervals, with • correct selection of authentic/traceable sources measuring equipment • correct use of adjustments • correct accuracy and precision of measure • safeguarding adjustments • proper handling, maintenance & storage • C/A when devices found out of calibration • confirmation of software Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 90. Draw a process of product/service realization of your new company  Present in the plenary session Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 91. 8.1 General 8.3 Control of non-conforming product Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 92. 8 Measurement, Analysis and Improvement 8.1 General • Plan and implement the process • This section is about for monitoring, measurement, Quality Control (QC) analysis and input to: • Conformity to customer needs, contracts, and – Ensure conformity of the product national regulation must – ensure conformity of the QMS be ensured before – ensure effectiveness and continually product is dispatched improving the QMS • Validation of measuring procedures • Regularly up-grade accuracy and effectiveness of QMS Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 93. 8 Measurement, Analysis and Improvement 8.2 Monitoring and Measurement Examples of CS: • Direct interfaces 8.2.1 Customer Satisfaction • focus groups – device a method to measure and monitor customer satisfaction from • surveys customer perception point of view • sector and industry – Method for obtaining and using the studies information shall be determined. Examples of IA: • Main objective is to check the correctness and performance of functions and processes; not documentation of processes Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 94. 8.2 Monitoring and Measurement 8.2.2 Internal Audit  Regularly carryout internal audit to check conformity and effectiveness of the QMS  design an effective audit program and plan, criteria  competent auditors  audit results and records  follow-ups and timely C/A Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 95. 8 Measurement, Analysis and Improvement 8.2 Monitoring and Measurement Examples 8.2.3 Processes • use of SPC, – apply suitable monitoring of especially control processes where required charts – C/A when deviation occurs • monitoring and supervision of process parameters 8.2.4 Products • daily morning reviews – measure product characteristics to of quality by workers confirm fulfillment of quality and their supervisors – at appropriate stages in accordance • Appropriate product with the quality plans quality plan – define acceptance criteria – authorize release and records Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 96. 8 Measurement, Analysis and Improvement 8.3 Control of nonconforming product • Ensure nonconforming product is Identification and taking identified and controlled corrective actions on: • wrong purchases • define responsibilities and • wrong deliveries authorities in this procedure • defective products • clear action: C/A, concession, re- produced grade with customers’ consent • wrong packing and evidence • wrong storage • re-verification • wrong dispatches • if detected in use, then take • wrong invoices appropriate action of recall or • etc. compensation Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 97. 8 Measurement, Analysis and Improvement 8.4 Analysis of Data • Determine, collect and analyze • Analysis is not appropriate data from compiling of data measurement sources to check • Analysis is after compiling of quality conformance and analysis for data improvement in: • Analysis is part of – customer satisfaction Quality Report – product conformance • Sources of data? – process – suppliers Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 98. 8 Measurement, Analysis and Improvement 8.5 Improvement 8.5.1 Continual Improvement • Clear evidence of – identify opportunities of improvement improvement from quality policy, objectives, audit processes results, analysis of data, C/P actions, • Clear evidence of and management reviews improvements – mobilize improvement programs Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 99. 8 Measurement, Analysis and Improvement 8.5 Improvement 8.5.2 Corrective Action • What is the – take timely action to eliminate the difference between cause of nonconformities. Correction, Corrective Action – Review nonconformities and Preventive – determine causes Action? – evaluate • Corrective Action – determine and implement action Form – records of results • Control of Corrective – review and confirm results Actions Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 100. 8 Measurement, Analysis and Improvement 8.5 Improvement 8.5.3 Preventive Action • Outputs of – determine potential nonconformities management current mistakes and future planning reviews or corrective actions – determine their causes – device actions – implement actions – record results – review action taken Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 101. – What would be some of the performance indicators of the processes/products of your new company? – How would you measure and analyze them and at what frequency? – Present in the plenary session. Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 102. Systems are not what documents say what they are; they are the habits of people which they practice . Most failures are not because of documents or systems; but because of people who do not change their prevalent habits (systems). Therefore, Systems usually do not fail, people do. Prepare by: Adnan Masood Manager QHSE at TCG {0336-2350594}
  • 103. Adnan Masood Manager QHSE The Chishtian Goods Transport Company