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By Sid Calayag – QMS Lead Auditor
Presented on November 26, 2009
Ver. 0 11.25.09
Introduction
This is a summary of the update of *TPI‟s QMS manual
and procedure brought about by the new guidelines
issued by International Organization for Standardization
in agreement with IAF. According to them:
1. Certification to ISO 9001:2008 will only be issued after a
   routine surveillance audit or re-certification audit against
   ISO 9001:2008.
2. All certifications issued (new certifications and re-
   certifications) must be to ISO 9001:2008.
3. Two years after publication of ISO 9001:2008, existing
   ISO 9001:2000 certifications will not be valid.

*TPI – Taikisha Philippines, Inc.

  NOTE: The new standard has a release date of November 14, 2008

                                                                   2
Main modifications

• Outsourcing process defined.
• Training to achieve competence.
• Work environment includes physical and
  environmental factors.
• Process measurement focused to
  effectiveness.




                                           3
The Changes

• The update in ISO 9001:2008 brought about a
  number of changes in QMS manual and
  procedures.
  – 48 lines in the manual
  – 93 lines in procedures

• There are also some changes based on actual
  practice



                                                4
The obvious . . .

  . . . the NOT so obvious
                . . . and for further review


                                               5
HOME PAGE


• The obvious

• The NOT so obvious

• For further review

• Changes to current Procedures

• Changes to the ISO Standard
Information to the reader

The differences in ISO 9001:2008 vs. ISO 9001:2000 are
described as follows.
• Deleted ISO 9001:2000 text is indicated by
  strikethroughs.
• New ISO 9001:2008 text is highlighted and underlined.
  The underlining will allow readers to distinguish the
  new text, even if this paper is printed without color.




                                                           7
HOME




       8
Section 6.2: Human Resources

CLAUSE         CHANGES

6.2.1            To ensure competence of our personnel, job descriptions have
                 been prepared identifying the qualifications required for each
                 position that affects product quality conformity to product
                 requirements.



6.2.2            Competence, Training and Awareness and Training




        Reference ISO 9001:2008 Section 6
                                                                                  9
However:

Clause 6.2.2: Human Resources
 There is no other revision in this clause of QMS since
 the new requirements are already stated in the present
 manual. To quote Clause 6.2.2:
 “Qualifications are reviewed upon hire, when an employee changes positions or
 the requirements for a position change. Personnel Division maintains records of
 employee qualifications. If any differences between the employee‟s qualifications
 and the requirements for the job are found, training or other action is taken to
 provide the employee with the necessary competence for the job. The results are
 then evaluated to determine if they were effective. Training and evaluation are
 conducted according to the Competence, Training and Awareness Procedure.
 (TPI-02-622)”

 “All employees are trained on the relevance and importance of their activities and
 how they contribute to the achievement of the quality objectives.”



                                                                                10
6.3: Resource Management

CLAUSE      CHANGES

6.3          . . ..The infrastructure has been provided, and includes
Second       buildings, workspace, utilities, process equipment and
Sentence.    supporting services (such as transport, communication or
             information systems).
6.4          No revision in the manual but Note was added in the ISO
             standard requirement to clarify definition of work
             environment.

             NOTE :The term "work environment" relates to those
             conditions under which work is performed including
             physical, environmental and other factors (such as noise,
             temperature, humidity, lighting or weather).


                                                                        11
7.1 Planning of Product Realization

CLAUSE        CHANGES

7.1             Quality planning is required before new products or
                processes are implemented . . .
Bullet (2)      • The need to establish processes, and documents, and to
                  provide resources specific to the product.
Bullet (3)      • Processes, documentation and resources required
Bullet (4)      • Required verification, validation, monitoring,
                  measurement, inspection, and test activities, specific to
                  the product and the criteria for product acceptance.
Bullet (5)      • Records needed to provide evidence that the realization
                  processes and resulting product meet requirements.




       Reference ISO 9001:2008 Section 4 and Section 7
                                                                          12
Section 7: Product Realization
CLAUSE         CHANGES
7.5.3 Par. 2    TPI controls and records the unique identification of the
                product and maintains record wherever traceability is a
                specified requirement.

7.5.4 Par. 1    If any customer property is lost, damaged or otherwise
                found to be unsuitable for use, this is reported to the
                customer and records maintained. TPI shall report to the
                customer and maintains its records

7.5.5           TPI preserves the conformity of product during internal
                processing and installation in order to maintain conformity
                to requirements. This As applicable, preservation includes
                identification, handling, packaging, storage and
                protection. Preservation also applies to the constituent
                parts of a product.

        Reference ISO 9001:2008 Section 7
                                                                              13
Section 7: Product Realization

CLAUSE           CHANGES
7.6 Title         Control of Monitoring and Measuring Devices Equipment

7.6 Par 1         TPI has determined the monitoring and measurement to
                  be undertaken and the monitoring and measuring devices
                  equipment needed to provide evidence of conformity of
                  product to determined requirements

7.6 Bullet (1)    Calibrated or verified, or both, at specified intervals, or
                  prior to use, against measurement standards traceable to
                  international or national measurement standards

7.6 Bullet (3)    Identified to enable the calibration status to be determined
                  in order to determine its calibration status


        Reference ISO 9001:2008 Section 7
                                                                                 14
Section 8: Measurement . . .

CLAUSE         CHANGES
8.1             To demonstrate conformity of the product to product
                requirements
8.2.2           The management responsible for the area being audited
                is responsible for ensuring that actions any necessary
                correction and corrective action are taken without undue
                delay to eliminate detected

8.2.3           When planned results are not achieved, correction and
                corrective action is taken, as appropriate, to ensure
                conformity of the product.
                Evidence of conformity with the acceptance criteria is
                maintained. Records indicate the person authorizing
                release of product for delivery to the customer.

        Reference ISO 9001:2008 Section 8
                                                                           15
Section 8: Measurement . . .

CLAUSE           CHANGES
8.2.4 Par (3)     Product release and service delivery to the customer does
                  not proceed until all the planned arrangements have been
                  satisfactorily completed, . . .
8.3 Par (2)       Where applicable, the organization shall deal with
                  nonconforming product by one or more of the following
                  ways:
8.3 Bullet (1)    By containment of correction of the detected
                  nonconformity and corrective action appropriate to the
                  effects or potential effect to eliminate its cause to prevent
                  its recurrence.
8.3 Bullet (2)    By authorizing its use, release or acceptance with the
                  approval of the relevant authority

       Reference ISO 9001:2008 Section 8
                                                                                  16
Section 8: Measurement . . .

CLAUSE             CHANGES
8.3 Par (3)         TPI shall re-evaluate the result of the corrective action by
                    testing and inspection to demonstrate conformity to the
                    requirements.
8.3 Par (4)         Records of the noted nonconformities and any
                    subsequent actions taken, including concessions obtained
                    shall be maintained.
8.5.2 Par (1)       TPI takes action to eliminate the cause causes of
                    nonconformities in order to prevent recurrence.
8.5.2 Bullet (6)    Reviewing the effectiveness of the corrective action taken

8.5.3 Bullet (5)    Reviewing the effectiveness of the preventive action taken


       Reference ISO 9001:2008 Section 8
                                                                                   17
8.2.2 Internal audit

Requirements for the audit evidence and
results had been added. It is made clearer
now that the management is responsible to
ensure preventive and corrective action will
be taken.

The reference to the ISO 10011 had been
updated to ISO 19011.




                                               18
8.2.3 Monitoring and Measurement of
      Processes


Minor change of words i.e. "to ensure
conformity of the product" had been removed.
A note had been added to clarify that the
organization should determine the type of the
monitoring and measuring according to the
processes and, how will this affect the quality
management system.




                                                  19
Explanation

Paragraph 8.2.4

Change of words: "maintain
evidence of conformity with
acceptance criteria" had been
removed but it is still a
perceived requirement.




                                20
8.3 Control of Non-conforming
    Product

An addition sub-clause (d) that specifies how
to deal with a nonconforming product that was
discovered after delivery.
(Nothing new as it had always been addressed
under Warranty or After-sales protocol.)




                                                21
19.Non conforming product
(8.3)
• Dealing with non conforming product now
  includes the analysis of potential effects of non
  conformity after the use has started.


   – FMEA for every non conformity not corrected
     /correctable could be a requirement.




                                                   22
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       23
Section 4: General Requirement

CLAUSE           CHANGES


4.1 Bullet (1)   Identified Determined the processes needed for the QMS . . .

4.1 Bullet (2)   TPI shall ensure control of all outsourced processes that
                 affects product conformity to the requirement.

4.1 Bullet (6)   Established systems to monitor, measure where applicable
                 and analyze these processes, and …




       Reference ISO 9001:2008 Section 4 Clause 4.1

                                                                             24
Explanation

Clause 4.1 Bullet 1:
  • 2000 version standard says IDENTIFY the
    processes meaning recognize or establish
    something as being a particular thing.
   – List them

  • to determine is to apply reason and reach a
    decision.
    – Implies more analysis and judgment than merely listing
      them



                                                               25
Explanation

Clause 4.1 Bullet 2: On outsourcing
  •   All outsourced processes must be defined in the
      quality management system
      Normally, “outsourcing” is a process owned by
      Purchasing Department. But since selection,
      negotiation and control is left to the end-user
      (department), it can also be part of the
      department(s) involved.

      •   PURCHASING is buying a product
      •   OUTSOURCING is buying capability

                                                    26
TC 176 Interpretation:
 – No exclusion on outsourced process

RFI: ISO 9001:2000 Clause(s): 1.2
Question:
  Does the standard requires an organization that
  purchases a complete design , then manufactures a
  product to the design and sells it under its own brand
  name to include “design” as one of the processes
  needed for the Quality Management System?

Interpretation:
   Yes
Example:

If TPI purchases or employs a subcontractor
to design a system, then the design of the
product is identified and established as one of
the outsourced processes needed to be
controlled and included in the quality
Management System.




                                                  28
Explanation

Clause 4.1 Bullet 2: Cont‟n
  • Control the “outsourcing” process by considering:
    – What is the potential impact of the processes on the
      product requirements?
    – What are the controls and are they shared?
    – Is there Existing control through Purchasing?


   NOTE 2 on Clause 4.1 of ISO 9001:2008
   An "outsourced process" is a process that the organization
   needs for its quality management system and which the
   organization chooses to have performed by an external
   party.

                                                                29
Explanation

Clause 4.1 Bullet 6:
• In the new version, ISO clarifies the intention by
  replacing the “management” with “measurement,
  analysis and improvement” in the NOTE(S).




                                                       30
Section 4.1: General Requirement

• NOTE on ISO 9001:2000
  Processes needed for the QMS referred to above
    include processes for management activities,
    provision of resources, product realization and
    management

• NOTE1 on ISO 9001:2008
  Processes needed for the QMS referred to above
  include processes for management activities,
  provision of resources, product realization,
  measurement, analysis and improvement.

                                                      31
Section 4.2: Documentation
             Requirements

CLAUSE             CHANGES

4.2.1 Bullet (3)    • documented procedures and records.


4.2.1 Bullet (4)    • documents identified as needed determined to be necessary
                      for the effective planning, . . .
4.2.1 Bullet (5)    • quality records




       Reference ISO 9001:2008 Section 4 Clause 4.2
                                                                              32
Explanation

Clause 4.2.1 Bullet 3 and 6:
  This is to emphasize that “documentation” can     also
  include “records” and that mandatory procedures   may
  be in the form of combined documents, or          that
  requirements may be covered by more than          one
  document.
  Clarified that external documentation are the
  ones needed for the quality management
  system.


                                                      33
Section 4.2.3: Control of Documents


CLAUSE             CHANGES

4.2.3 Bullet (6)    • Ensuring that documents of external origin determined by
                      the management to be necessary for the planning and
                      operation of the quality management system are identified
                      and their distribution controlled, and . .




       Reference ISO 9001:2008 Section 4 Clause 4.2.3.
                                                                                  34
Explanation

Clause 4.2.3 Bullet 6:
  Clarified that external documentation are the ones
  needed for the quality management system.




                                                       35
Section 4.2.4: Control of Records


CLAUSE         CHANGES

4.2.4             Quality records are maintained established to provide evidence
                  of conformity to requirements and of the effective operation of
                  the QMS shall be controlled. The records are maintained
                  according to the Control of Quality Records Procedure (TPI-02-
                  424). This procedure requires that quality records shall remain
                  legible, readily identifiable and retrievable. The procedure
                  defines the controls needed for identification, storage,
                  protection, retrieval, retention time and disposition of quality
                  records.



        Reference ISO 9001:2008 Section 4 Clause 4.2.1/4.2.4.
                                                                                 36
Explanation

Clause 4.2.4: Control of Records
  • The opening sentence for clause 4.2.4 has
    expanded from records being "maintained"
    to having them "controlled".
    – Maintaining records would simply keep them
      in good condition.
    – Controlling the records means to regulate their
      use.



                                                        37
Section 5.5.2: Management
               Representative

CLAUSE         CHANGES

5.5.2             The Vice President has been appointed by top
                  management as Management Representative.




            There is no change in the QMS Manual




        Reference ISO 9001:2008 Section 5 Clause 5.5.2.
                                                                 38
Explanation

Clause 5.5.2: Management Representative
  An addition for a demand that the management
  representative would have to be a member of the
  organization's management.




                                                    39
Explanation

Clause 5.5.2: Management Representative
An addition for a demand that the management
representative would have to be a member of the
organization's management.


           Outsourcing of the Management
       Representative (MR) is NOT conforming.




                                                  40
HOME




3. FOR FURTHER REVIEW




                           41
Section 7: Product Realization
CLAUSE         CHANGES
7.2.1           Customer requirements include those:
Bullet (4)      • Statutory and regulatory requirements related
                  applicable to the product
Bullet (5)      • Additional requirements determined considered
                  necessary by TPI

7.3.1           • A note had been added to clarify that design
                  review, verification and validation are separated
                  processes but they can be conducted together.
                   • No revision in the manual yet – for deliberation

7.3.3           • . . .They are documented in a form suitable for format
                  that enables verification against the design and
                  development inputs, and are approved prior to release.


        Reference ISO 9001:2008 Section 7
                                                                           42
Section 7: Product Realization
CLAUSE         CHANGES
7.5.1           . . . Controlled conditions include, as applicable:
Bullet (4)      • The availability and use of monitoring and measuring
                     devices equipment
Bullet (6)      • The implementation of product release, delivery and
                     post-delivery activities

7.5.2           TPI validates any processes for production and service
                provision where the resulting output cannot be verified by
                subsequent monitoring or measurement. This includes
                any processes where and as a consequence, deficiencies
                become apparent only after the product is in use or the
                service has been delivered. Validation demonstrates the
                ability of these processes to achieve planned results.



        Reference ISO 9001:2008 Section 7
                                                                             43
Explanation

Clause 7.2.1 Customer Related Process
 Bullet (4) – the word 'applicable' replaced 'related„ means
 laws or regulation that affect the quality of the product will
 be considered as customer requirement.

Clause 7.3.1: Design and Development Planning
 Revision in this clause is subject for deliberation due
 to “validation” requirement.

Clause 7.3.3: Design and Development Output
      The revisions are just rewording and do not require
      additional action or change in the manual

  .
                                                                  44
Explanation
Clause 7.5.1 Control of Production and Service
              Provision
  Bullet (4) – the word equipment' replaced devices„
  corresponds to the change in the title of Clause 7.6: Control
  of Monitoring and Measuring Devices Equipment
  Bullet (6) – the insertion of the word “product” clarifies the
  subject being discussed

Clause 7.5.2: Validation of Processes for Production and
               Service Provision
  - Subject for deliberation



                                                                   45
8.2.1 Customer Satisfaction

    NOTE was added as follows:
    Monitoring customer perception can
    include obtaining input from sources such
    as customer satisfaction surveys, customer
    data o delivered product quality, user
    opinion surveys, lost business analysis,
    compliments, warranty claims and dealer
    reports.



                                             46
Explanation


 A note had been added to throw light on some
 of the means for conducting customer
 satisfaction evaluation.

 The standard balances perception with data
 and relies on warranty failures, dealer
 feedback, product quality data, user surveys,
 lost business analysis etc.



                                     Formula for
                                      Delighting
                                     Customers     47
HOME




Revisions in the procedures brought about by
        changes in the QMS manual




                                               48
Section 7: Product Realization

PROCEDURE CHANGES
02-423    The author is responsible for writing the document,
          creating related forms, getting a number and submitting
          the documents to all concerned department/division
          heads for review

02-424    Quality Records are maintained as established and listed
          in the Quality Records Index (DCC 102). The index
          contains the following information

02-424    Access to TPI controlled records is limited to employees
          and authorized visitors

02-424    Controlled records are readily retrievable by referring to
          the Quality Records Index for location



                                                                       49
Section 7: Product Realization
PROCEDURE CHANGES
02-424     . . .. At the end of the project, all project records
           concerning the project shall be transferred to the Central
           Document/Data Controller (CDDC) for storage.
02-424     After records are no longer needed and the retention
           period has been reached, the records are archived or
           disposed of in coordination with CDDC.
02-424     DCC101 - Controlled Document Master List.
02 - 710   HSE – Health Safety and Environment
02 - 710   As new processes or projects are introduced, quality
           objectives and product requirements and documents are
           determined as appropriate and provide resources specific
           to the product.



                                                                        50
Section 7: Product Realization
PROCEDURE CHANGES
02 - 710   Engineering – Senior Manager assigns responsibility to
           initiate a project quality plan or design project. The Design
           and Estimate Manager initiates the project quality plan
           and a project manager completes it before the project is
           started.
02 - 710   The Project Manager initiate implements project quality
           plan
02 - 710   Conduct the required verification, validation, monitoring,
           measurement, inspection, and test activities, specific to
           the product and the criteria for product acceptance.
02 - 710   Provide records as evidence that the processes and
           resulting product meet requirements.



                                                                           51
Section 7: Product Realization
PROCEDURE CHANGES
02 - 710   Project Quality Plan includes but not limited to:
02 - 710   Quality objectives and project requirements for the project

02 - 710   Verification, validation, monitoring, inspection and test
           activities
02 - 710   HSE Program

02 - 710   The Project Manager investigates and completes each
           applicable section of the Project Quality Plan (ENG 104).

02 - 710   When the project is completed, management reviews the
           quality planning table project output against the quality
           plan to make sure that all requirements have been met.
           and signs to indicate approval



                                                                         52
Section 7: Product Realization
PROCEDURE CHANGES
02 - 710   Testing Report Forms
02 - 710   HSE 105 - Job Safety Analysis

02 - 720   Assists in review of Tender Documents

02 - 720   Assist Engineering Department in the preparation of bid
           Quotation in accordance with the requirements
02 - 720   Assists in the coordination of Coordinate status of on-
           going projects between Client and Construction
           Department
02 - 720   Prepare sales forecast on a monthly, quarterly or and
           annual basis based on the requirement of the top
           management



                                                                     53
Section 7: Product Realization
PROCEDURE CHANGES
02 - 720   Inquiry of document Request is received by e-mail,
           phone, and fax or post mail or during pre-bid conference.
02 - 720   When Sales and Marketing representative receives a
           request for quotation, client the representative he
           identifies and documents customer‟s requirement.
02 - 720   Queries from Engineering Department (Technical) and
           Sales and Marketing (Commercial) base based on the
           Tender Documents are submitted and discussed to clients
           during Pre Bid Conference.
02 - 720   Sales Department and Marketing and Engineering
           Department prepare the proposal in accordance with
           Tender Requirements incorporating if any all the changes
           in the Tender Documents



                                                                       54
Section 7: Product Realization
PROCEDURE CHANGES
02 - 720   Whenever required by the Client, Sales and Marketing
           together with or the Engineering Department
           representative will discuss the Technical and Commercial
           details of the Tender to Customer‟s Authorized
           Representatives
02 - 720   Proposal shall have a unique identification using the
           quotations job number order which will be provided by the
           Management Data Control.
02 - 720   For closed sales, Sales and Marketing reviews and
           evaluates Contract versus Tender Documents. . . .
           Discusses deviations to Engineering Department and
           other departments concerned. Contract Document with
           comments of Department concerned are sent to Legal for
           final comment. These comments deviations are discussed
           and negotiated to the customer. . . .

                                                                       55
Section 7: Product Realization
PROCEDURE CHANGES
02 - 730   The Design Team shall be responsible for the preparation
           of tender documents with the assistance of Sales
           Department
02 - 730   Design Team Leader: Senior Engineer or Engineer III as
           minimum required requirement
02 - 730   Estimates: Owner provides the design drawing,
           specification and TPI to do an estimation work estimates
           only
02 - 730   The Design Manager designates a Design Team Leader
           for the project
02 - 730   Design outputs are documented and filed in the design
           file. Design outputs are documented in a manner that
           enables them are suitable to be verified against the
           design inputs


                                                                      56
Section 7: Product Realization
PROCEDURE CHANGES
02-750    Site Safety Officer shall be responsible in the execution of
          Project HSE indicators.
02-750    HSE Indicator: field of measurements and monitoring
          how a project complies with the HSE program
02-750    Use the same unique identification of project provided by
          the Management Data Control in the approved proposal
02-750    TPI preserves the product during internal processing and
          installation in order to maintain conformity to
          requirements. TPI also exercises care with customer
          property while it is under the organization's control or
          being used. Preservation includes identification,
          verification, protection and safeguarding of customer
          property provided for use. If any customer property is
          lost, damaged or otherwise found to be unsuitable for use,
          TPI shall report to the customer and maintains its records.

                                                                         57
Section 7: Product Realization
PROCEDURE CHANGES
02-750    The VP - Engineering - Senior Manager President or his
          designee shall conduct a monthly project progress
          meeting to discuss the progress of the project. The
          following shall attend the meeting:
          Chairman : Engineering - Vice President Senior Manager
          President
          Members : President or his designate
                     Project Managers / Project Engineers
                    Any other personnel deemed necessary
02-760    Calibrate and maintain equipment as assigned.

02-760    Designate an Equipment Controller.

02-760    Assign responsibility for calibration and maintenance of
          equipment.


                                                                     58
Section 7: Product Realization
PROCEDURE CHANGES
02-750    All listed equipment that is out of calibration period can
          only be used after being validated verified by a current
          calibrated unit of the same type.
02-760    All Testing Equipment and Devices which are not
          calibrated for more than a year can be used as
          Preliminary Testing Equipment only prior to final testing.
          by a calibrated equipment and device. Official Calibration
          Certificate is no longer required for this preliminary
          testing.
02-822    The management staff person responsible for the area
          being audited shall take timely corrective action on
          nonconformities found during the audit. The management
          of the area being audited is responsible for ensuring that
          any necessary corrections and corrective actions are
          taken without undue delay to eliminate detected non
          conformities and their causes.
                                                                       59
Section 8: Measurement . . .
PROCEDURE CHANGES
02-824    In process checks on completed part of the work shall be
          carried out together with the customer's representatives,
          in case required.
02-824    The final inspection and commissioning shall be
          authorized, monitored and approved for hand-over to the
          customer by the Project Manager.
02-824    The final inspection and commissioning shall be
          monitored by the GM - Engineering Project Engineer
02-830    The Area Project / Site Manager or Section Head may
          determine to scrap the item. The scrap is logged on their
          scrap report.
02-830    All reworked/repaired products/materials shall be re-
          inspected with the approval of the authorizing body and
          where applicable by the customer.


                                                                      60
Section 8: Measurement . . .
PROCEDURE CHANGES
02-830    The works must be identified as non-conforming and a
          Non Conformance form is initiated. The work is identified:
          a)   The nonconformity is described
          b)   The location of the work is identified.
02-830    Quality control or Project/Site Manager reviews the NCR
          form and identifies the disposition of the product or
          material as:
          a) Scrap
          b) Rework to correct
          c) Use as is

02-830    Quality control or Project/Sites Manager determines if a
          corrective action will be initiated.
02-830    Quality control or Project/Sites Manager determines if a
          corrective action will be initiated.

                                                                       61
Section 8: Measurement . . .
PROCEDURE CHANGES
02-830    If product will be “Used as is”, quality control or
          management is responsible for determining and obtaining
          any necessary customer concession. If there are certain
          uses that are not appropriate it will be noted on the NCR
          form.
02-830    If nonconforming product is detected after delivery or use,
          sales representative or the project manager will contact
          the customer and take appropriate correction and initiate
          a corrective




                                                                        62
HOME




Here are the revisions in the INTERNATIONAL
  STANDARD Quality Management System
                Requirements




                                              63
The Changes to the Standard
CLAUSE        CHANGES

0.1 Para. 3   Text added to include statutory requirements as well as customer
              and regulatory and clarifies that these requirements are
              applicable to the product.


0.2 Para. 3   Text added to focus on importance of processes producing the
              desired outcome.


0.3 Para. 2   Text added to include statutory and regulatory requirements.




                                                                                 64
The Changes to the Standard

CLAUSE   CHANGES

1.1      Text added to include statutory requirements.
         Note 1 expanded to include purchased product and output from
         product realization processes.
         Note 2 added indicating that statutory and regulatory
         requirements may be expressed as legal requirements.

1.2      Text added to include statutory requirements.


2        Reference to ISO 9000 now indicates 2005 version.


3        Definition of supplier, organization and customer has been
         deleted.


                                                                        65
The Changes to the Standard

CLAUSE   CHANGES

4.1      a. – The word ‘determine’ has replaced ‘identify.’
         e. - The phrase ‘where applicable’ was added after ‘measure.’
         Note. 1 - The wording ‘analysis and improvement’ was added.
         Note 2 - Added to define outsourced process.
         Note 3 - Added to define type and nature of control applied to
         outsourced processes.

4.2.1    Revised to clarify that QMS documentation includes records.
         Note 1 expanded to clarify that one document may include the
         requirements of one or more procedures and the requirements of
         one procedure may be covered by more than one document.




                                                                          66
The Changes to the Standard

CLAUSE   CHANGES

4.2.3    Text added to clarify that external documents are those needed for
         use in the QMS.

5.5.2    Clarifies that management representative must be a member of
         the organization’s own management.

6.2.1    Note added to clarify that conformity to product requirements may
         be affected directly or indirectly by personnel performing any task
         within the QMS.




                                                                          67
The Changes to the Standard

CLAUSE   CHANGES

6.2.2    Change in title from ‘Competence, awareness and training’ to
         ‘Competence, training and awareness.’
         a. – Wording change from ‘affecting product quality’ to
         ‘conformity to product requirements.’
         b. - The phrase ‘where applicable’ was added.
         c. - Revised to require assurance that the necessary competence
         has been achieved, rather than evaluating the effectiveness of
         training.

6.3      c. - Revised to include information systems.


6.4      Note added to clarify definition of work environment.



                                                                           68
The Changes to the Standard

CLAUSE   CHANGES
7.1      c. – The word ‘measurement’ was added.
7.2.1    a. – Slightly reworded
         c. - The word ‘related’ was replaced with ‘applicable.’
         d. – The word ‘determined’ was replaced with ‘considered
         necessary.’
         Note added to clarify that post-delivery activities include actions
         under warranty provisions, contractual obligations such as
         maintenance services, and supplementary services such as
         recycling or final disposal.
7.3.1    Note added to clarify that design and development review,
         verification and validation have distinct purposes and may be
         performed separately or in any combination as suitable for the
         product and the organization.

                                                                               69
The Changes to the Standard

CLAUSE   CHANGES
7.3.2    In last paragraph, ‘these’ changed to ‘the.’

7.3.3    First paragraph – The word ‘provided’ was omitted and the phrase
         ‘that enables’ was replaced by ‘suitable for.’
         Note added to clarify that production and service provision may
         include details for the preservation of product.

7.5.3    Second paragraph – The phrase ‘throughout product realization’
         was added.
         Last paragraph – The phrase ‘and maintain records’ was added.

7.5.4    Note – The phrase ‘and personal data’ was added as part of
         customer property.



                                                                            70
The Changes to the Standard

CLAUSE   CHANGES
7.5.5    Phrase ‘conformity of’ was changed to ‘in order to maintain
         conformity to requirements’ and ‘where appropriate’ was changed
         to ‘as applicable.’

7.6      Title of clause changed from ‘devices’ to ‘equipment.’
         The reference to 7.2.1 was removed.
         a. – The phrase ‘or both’ was added.
         c. – The phrase ‘be identified to enable’ was replaced with ‘have
            identification.’
         Note referencing ISO 10012-1 and ISO 10012-2 was deleted and
         replaced with a note related to the confirmation of computer
         software used as monitoring and measuring equipment.


                                                                             71
The Changes to the Standard

CLAUSE   CHANGES
8.1      a. – The word ‘requirements’ was added.
8.2.1    Note added to provide examples of how customer satisfaction data
         can be measured.
8.2.2    Editorial changes to clause to clarify requirements.
             Reworded requirement for documented procedure
            Clarified record requirements by adding ‘records of the audits
            and their results’
            Clarified that management responsible for the area being
            audited shall ensure that ‘any necessary corrections and
            corrective actions are taken.’
            Note – Reference to ISO 10011-1, 10011-2 and 10011-3
            changed to ISO 19011.
                                                                             72
The Changes to the Standard

CLAUSE   CHANGES

8.2.3    The phrase ‘to ensure conformity of the product’ was deleted.
         Note added to clarify that the organization should consider the
         type of monitoring and measuring of processes and the extent to
         which they effect conformity to product requirements and the
         effectiveness of the QMS.

8.2.4    The phrase ‘for delivery to the customer’ was added to clarify that
         the release of the product relates to the delivery to the customer.

8.3      Reworded requirement for documented procedure.
         Second paragraph – The phrase ‘where practicable’ was added.




                                                                           73
Summary

No new requirements were introduced in ISO
9001:2008 edition but, in order to benefit from
the clarifications of ISO 9001:2008, we will
need to take into consideration whether the
clarifications introduced have an impact on our
current interpretation of ISO 9001:2000, as
changes may be necessary to the Quality
Management System.




                                                  74
Prepared and Presented by:
  Sid Calayag - QMS Lead Auditor
Date: November 25, 2009
Venue:
  TPI Conference Room No. 2
Attendees:
  Mr. Enrico Concepcion – Vice President
  Mr. Nelson Tan      – Purchasing Manager and QA/QC
                      Manager
  Ms. Wilma Corpuz - Sr. Personnel Officer
  Mr. Norman Joseph – Sr. Info. Officer
  Ms. Rose Llanera       - Central Docs. and Data Controller

                                                               75
References

ISO 9000: 2005 Fundamentals and vocabulary
ISO 9001: 2008 Requirements
ISO/TC 176 Publications
International Register of Certified Auditors Publications
International Accreditation Forum Publications
Auditing Practices Group Publications
TPI QMS 9001:2000 Manual and Procedures



                                                            76
Thank You…




             77

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Upgrade iso 9001 2000 to 2008 version

  • 1. By Sid Calayag – QMS Lead Auditor Presented on November 26, 2009 Ver. 0 11.25.09
  • 2. Introduction This is a summary of the update of *TPI‟s QMS manual and procedure brought about by the new guidelines issued by International Organization for Standardization in agreement with IAF. According to them: 1. Certification to ISO 9001:2008 will only be issued after a routine surveillance audit or re-certification audit against ISO 9001:2008. 2. All certifications issued (new certifications and re- certifications) must be to ISO 9001:2008. 3. Two years after publication of ISO 9001:2008, existing ISO 9001:2000 certifications will not be valid. *TPI – Taikisha Philippines, Inc. NOTE: The new standard has a release date of November 14, 2008 2
  • 3. Main modifications • Outsourcing process defined. • Training to achieve competence. • Work environment includes physical and environmental factors. • Process measurement focused to effectiveness. 3
  • 4. The Changes • The update in ISO 9001:2008 brought about a number of changes in QMS manual and procedures. – 48 lines in the manual – 93 lines in procedures • There are also some changes based on actual practice 4
  • 5. The obvious . . . . . . the NOT so obvious . . . and for further review 5
  • 6. HOME PAGE • The obvious • The NOT so obvious • For further review • Changes to current Procedures • Changes to the ISO Standard
  • 7. Information to the reader The differences in ISO 9001:2008 vs. ISO 9001:2000 are described as follows. • Deleted ISO 9001:2000 text is indicated by strikethroughs. • New ISO 9001:2008 text is highlighted and underlined. The underlining will allow readers to distinguish the new text, even if this paper is printed without color. 7
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  • 9. Section 6.2: Human Resources CLAUSE CHANGES 6.2.1 To ensure competence of our personnel, job descriptions have been prepared identifying the qualifications required for each position that affects product quality conformity to product requirements. 6.2.2 Competence, Training and Awareness and Training Reference ISO 9001:2008 Section 6 9
  • 10. However: Clause 6.2.2: Human Resources There is no other revision in this clause of QMS since the new requirements are already stated in the present manual. To quote Clause 6.2.2: “Qualifications are reviewed upon hire, when an employee changes positions or the requirements for a position change. Personnel Division maintains records of employee qualifications. If any differences between the employee‟s qualifications and the requirements for the job are found, training or other action is taken to provide the employee with the necessary competence for the job. The results are then evaluated to determine if they were effective. Training and evaluation are conducted according to the Competence, Training and Awareness Procedure. (TPI-02-622)” “All employees are trained on the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.” 10
  • 11. 6.3: Resource Management CLAUSE CHANGES 6.3 . . ..The infrastructure has been provided, and includes Second buildings, workspace, utilities, process equipment and Sentence. supporting services (such as transport, communication or information systems). 6.4 No revision in the manual but Note was added in the ISO standard requirement to clarify definition of work environment. NOTE :The term "work environment" relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting or weather). 11
  • 12. 7.1 Planning of Product Realization CLAUSE CHANGES 7.1 Quality planning is required before new products or processes are implemented . . . Bullet (2) • The need to establish processes, and documents, and to provide resources specific to the product. Bullet (3) • Processes, documentation and resources required Bullet (4) • Required verification, validation, monitoring, measurement, inspection, and test activities, specific to the product and the criteria for product acceptance. Bullet (5) • Records needed to provide evidence that the realization processes and resulting product meet requirements. Reference ISO 9001:2008 Section 4 and Section 7 12
  • 13. Section 7: Product Realization CLAUSE CHANGES 7.5.3 Par. 2 TPI controls and records the unique identification of the product and maintains record wherever traceability is a specified requirement. 7.5.4 Par. 1 If any customer property is lost, damaged or otherwise found to be unsuitable for use, this is reported to the customer and records maintained. TPI shall report to the customer and maintains its records 7.5.5 TPI preserves the conformity of product during internal processing and installation in order to maintain conformity to requirements. This As applicable, preservation includes identification, handling, packaging, storage and protection. Preservation also applies to the constituent parts of a product. Reference ISO 9001:2008 Section 7 13
  • 14. Section 7: Product Realization CLAUSE CHANGES 7.6 Title Control of Monitoring and Measuring Devices Equipment 7.6 Par 1 TPI has determined the monitoring and measurement to be undertaken and the monitoring and measuring devices equipment needed to provide evidence of conformity of product to determined requirements 7.6 Bullet (1) Calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards 7.6 Bullet (3) Identified to enable the calibration status to be determined in order to determine its calibration status Reference ISO 9001:2008 Section 7 14
  • 15. Section 8: Measurement . . . CLAUSE CHANGES 8.1 To demonstrate conformity of the product to product requirements 8.2.2 The management responsible for the area being audited is responsible for ensuring that actions any necessary correction and corrective action are taken without undue delay to eliminate detected 8.2.3 When planned results are not achieved, correction and corrective action is taken, as appropriate, to ensure conformity of the product. Evidence of conformity with the acceptance criteria is maintained. Records indicate the person authorizing release of product for delivery to the customer. Reference ISO 9001:2008 Section 8 15
  • 16. Section 8: Measurement . . . CLAUSE CHANGES 8.2.4 Par (3) Product release and service delivery to the customer does not proceed until all the planned arrangements have been satisfactorily completed, . . . 8.3 Par (2) Where applicable, the organization shall deal with nonconforming product by one or more of the following ways: 8.3 Bullet (1) By containment of correction of the detected nonconformity and corrective action appropriate to the effects or potential effect to eliminate its cause to prevent its recurrence. 8.3 Bullet (2) By authorizing its use, release or acceptance with the approval of the relevant authority Reference ISO 9001:2008 Section 8 16
  • 17. Section 8: Measurement . . . CLAUSE CHANGES 8.3 Par (3) TPI shall re-evaluate the result of the corrective action by testing and inspection to demonstrate conformity to the requirements. 8.3 Par (4) Records of the noted nonconformities and any subsequent actions taken, including concessions obtained shall be maintained. 8.5.2 Par (1) TPI takes action to eliminate the cause causes of nonconformities in order to prevent recurrence. 8.5.2 Bullet (6) Reviewing the effectiveness of the corrective action taken 8.5.3 Bullet (5) Reviewing the effectiveness of the preventive action taken Reference ISO 9001:2008 Section 8 17
  • 18. 8.2.2 Internal audit Requirements for the audit evidence and results had been added. It is made clearer now that the management is responsible to ensure preventive and corrective action will be taken. The reference to the ISO 10011 had been updated to ISO 19011. 18
  • 19. 8.2.3 Monitoring and Measurement of Processes Minor change of words i.e. "to ensure conformity of the product" had been removed. A note had been added to clarify that the organization should determine the type of the monitoring and measuring according to the processes and, how will this affect the quality management system. 19
  • 20. Explanation Paragraph 8.2.4 Change of words: "maintain evidence of conformity with acceptance criteria" had been removed but it is still a perceived requirement. 20
  • 21. 8.3 Control of Non-conforming Product An addition sub-clause (d) that specifies how to deal with a nonconforming product that was discovered after delivery. (Nothing new as it had always been addressed under Warranty or After-sales protocol.) 21
  • 22. 19.Non conforming product (8.3) • Dealing with non conforming product now includes the analysis of potential effects of non conformity after the use has started. – FMEA for every non conformity not corrected /correctable could be a requirement. 22
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  • 24. Section 4: General Requirement CLAUSE CHANGES 4.1 Bullet (1) Identified Determined the processes needed for the QMS . . . 4.1 Bullet (2) TPI shall ensure control of all outsourced processes that affects product conformity to the requirement. 4.1 Bullet (6) Established systems to monitor, measure where applicable and analyze these processes, and … Reference ISO 9001:2008 Section 4 Clause 4.1 24
  • 25. Explanation Clause 4.1 Bullet 1: • 2000 version standard says IDENTIFY the processes meaning recognize or establish something as being a particular thing. – List them • to determine is to apply reason and reach a decision. – Implies more analysis and judgment than merely listing them 25
  • 26. Explanation Clause 4.1 Bullet 2: On outsourcing • All outsourced processes must be defined in the quality management system Normally, “outsourcing” is a process owned by Purchasing Department. But since selection, negotiation and control is left to the end-user (department), it can also be part of the department(s) involved. • PURCHASING is buying a product • OUTSOURCING is buying capability 26
  • 27. TC 176 Interpretation: – No exclusion on outsourced process RFI: ISO 9001:2000 Clause(s): 1.2 Question: Does the standard requires an organization that purchases a complete design , then manufactures a product to the design and sells it under its own brand name to include “design” as one of the processes needed for the Quality Management System? Interpretation: Yes
  • 28. Example: If TPI purchases or employs a subcontractor to design a system, then the design of the product is identified and established as one of the outsourced processes needed to be controlled and included in the quality Management System. 28
  • 29. Explanation Clause 4.1 Bullet 2: Cont‟n • Control the “outsourcing” process by considering: – What is the potential impact of the processes on the product requirements? – What are the controls and are they shared? – Is there Existing control through Purchasing? NOTE 2 on Clause 4.1 of ISO 9001:2008 An "outsourced process" is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party. 29
  • 30. Explanation Clause 4.1 Bullet 6: • In the new version, ISO clarifies the intention by replacing the “management” with “measurement, analysis and improvement” in the NOTE(S). 30
  • 31. Section 4.1: General Requirement • NOTE on ISO 9001:2000 Processes needed for the QMS referred to above include processes for management activities, provision of resources, product realization and management • NOTE1 on ISO 9001:2008 Processes needed for the QMS referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvement. 31
  • 32. Section 4.2: Documentation Requirements CLAUSE CHANGES 4.2.1 Bullet (3) • documented procedures and records. 4.2.1 Bullet (4) • documents identified as needed determined to be necessary for the effective planning, . . . 4.2.1 Bullet (5) • quality records Reference ISO 9001:2008 Section 4 Clause 4.2 32
  • 33. Explanation Clause 4.2.1 Bullet 3 and 6: This is to emphasize that “documentation” can also include “records” and that mandatory procedures may be in the form of combined documents, or that requirements may be covered by more than one document. Clarified that external documentation are the ones needed for the quality management system. 33
  • 34. Section 4.2.3: Control of Documents CLAUSE CHANGES 4.2.3 Bullet (6) • Ensuring that documents of external origin determined by the management to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and . . Reference ISO 9001:2008 Section 4 Clause 4.2.3. 34
  • 35. Explanation Clause 4.2.3 Bullet 6: Clarified that external documentation are the ones needed for the quality management system. 35
  • 36. Section 4.2.4: Control of Records CLAUSE CHANGES 4.2.4 Quality records are maintained established to provide evidence of conformity to requirements and of the effective operation of the QMS shall be controlled. The records are maintained according to the Control of Quality Records Procedure (TPI-02- 424). This procedure requires that quality records shall remain legible, readily identifiable and retrievable. The procedure defines the controls needed for identification, storage, protection, retrieval, retention time and disposition of quality records. Reference ISO 9001:2008 Section 4 Clause 4.2.1/4.2.4. 36
  • 37. Explanation Clause 4.2.4: Control of Records • The opening sentence for clause 4.2.4 has expanded from records being "maintained" to having them "controlled". – Maintaining records would simply keep them in good condition. – Controlling the records means to regulate their use. 37
  • 38. Section 5.5.2: Management Representative CLAUSE CHANGES 5.5.2 The Vice President has been appointed by top management as Management Representative. There is no change in the QMS Manual Reference ISO 9001:2008 Section 5 Clause 5.5.2. 38
  • 39. Explanation Clause 5.5.2: Management Representative An addition for a demand that the management representative would have to be a member of the organization's management. 39
  • 40. Explanation Clause 5.5.2: Management Representative An addition for a demand that the management representative would have to be a member of the organization's management. Outsourcing of the Management Representative (MR) is NOT conforming. 40
  • 41. HOME 3. FOR FURTHER REVIEW 41
  • 42. Section 7: Product Realization CLAUSE CHANGES 7.2.1 Customer requirements include those: Bullet (4) • Statutory and regulatory requirements related applicable to the product Bullet (5) • Additional requirements determined considered necessary by TPI 7.3.1 • A note had been added to clarify that design review, verification and validation are separated processes but they can be conducted together. • No revision in the manual yet – for deliberation 7.3.3 • . . .They are documented in a form suitable for format that enables verification against the design and development inputs, and are approved prior to release. Reference ISO 9001:2008 Section 7 42
  • 43. Section 7: Product Realization CLAUSE CHANGES 7.5.1 . . . Controlled conditions include, as applicable: Bullet (4) • The availability and use of monitoring and measuring devices equipment Bullet (6) • The implementation of product release, delivery and post-delivery activities 7.5.2 TPI validates any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where and as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered. Validation demonstrates the ability of these processes to achieve planned results. Reference ISO 9001:2008 Section 7 43
  • 44. Explanation Clause 7.2.1 Customer Related Process Bullet (4) – the word 'applicable' replaced 'related„ means laws or regulation that affect the quality of the product will be considered as customer requirement. Clause 7.3.1: Design and Development Planning Revision in this clause is subject for deliberation due to “validation” requirement. Clause 7.3.3: Design and Development Output The revisions are just rewording and do not require additional action or change in the manual . 44
  • 45. Explanation Clause 7.5.1 Control of Production and Service Provision Bullet (4) – the word equipment' replaced devices„ corresponds to the change in the title of Clause 7.6: Control of Monitoring and Measuring Devices Equipment Bullet (6) – the insertion of the word “product” clarifies the subject being discussed Clause 7.5.2: Validation of Processes for Production and Service Provision - Subject for deliberation 45
  • 46. 8.2.1 Customer Satisfaction NOTE was added as follows: Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data o delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims and dealer reports. 46
  • 47. Explanation A note had been added to throw light on some of the means for conducting customer satisfaction evaluation. The standard balances perception with data and relies on warranty failures, dealer feedback, product quality data, user surveys, lost business analysis etc. Formula for Delighting Customers 47
  • 48. HOME Revisions in the procedures brought about by changes in the QMS manual 48
  • 49. Section 7: Product Realization PROCEDURE CHANGES 02-423 The author is responsible for writing the document, creating related forms, getting a number and submitting the documents to all concerned department/division heads for review 02-424 Quality Records are maintained as established and listed in the Quality Records Index (DCC 102). The index contains the following information 02-424 Access to TPI controlled records is limited to employees and authorized visitors 02-424 Controlled records are readily retrievable by referring to the Quality Records Index for location 49
  • 50. Section 7: Product Realization PROCEDURE CHANGES 02-424 . . .. At the end of the project, all project records concerning the project shall be transferred to the Central Document/Data Controller (CDDC) for storage. 02-424 After records are no longer needed and the retention period has been reached, the records are archived or disposed of in coordination with CDDC. 02-424 DCC101 - Controlled Document Master List. 02 - 710 HSE – Health Safety and Environment 02 - 710 As new processes or projects are introduced, quality objectives and product requirements and documents are determined as appropriate and provide resources specific to the product. 50
  • 51. Section 7: Product Realization PROCEDURE CHANGES 02 - 710 Engineering – Senior Manager assigns responsibility to initiate a project quality plan or design project. The Design and Estimate Manager initiates the project quality plan and a project manager completes it before the project is started. 02 - 710 The Project Manager initiate implements project quality plan 02 - 710 Conduct the required verification, validation, monitoring, measurement, inspection, and test activities, specific to the product and the criteria for product acceptance. 02 - 710 Provide records as evidence that the processes and resulting product meet requirements. 51
  • 52. Section 7: Product Realization PROCEDURE CHANGES 02 - 710 Project Quality Plan includes but not limited to: 02 - 710 Quality objectives and project requirements for the project 02 - 710 Verification, validation, monitoring, inspection and test activities 02 - 710 HSE Program 02 - 710 The Project Manager investigates and completes each applicable section of the Project Quality Plan (ENG 104). 02 - 710 When the project is completed, management reviews the quality planning table project output against the quality plan to make sure that all requirements have been met. and signs to indicate approval 52
  • 53. Section 7: Product Realization PROCEDURE CHANGES 02 - 710 Testing Report Forms 02 - 710 HSE 105 - Job Safety Analysis 02 - 720 Assists in review of Tender Documents 02 - 720 Assist Engineering Department in the preparation of bid Quotation in accordance with the requirements 02 - 720 Assists in the coordination of Coordinate status of on- going projects between Client and Construction Department 02 - 720 Prepare sales forecast on a monthly, quarterly or and annual basis based on the requirement of the top management 53
  • 54. Section 7: Product Realization PROCEDURE CHANGES 02 - 720 Inquiry of document Request is received by e-mail, phone, and fax or post mail or during pre-bid conference. 02 - 720 When Sales and Marketing representative receives a request for quotation, client the representative he identifies and documents customer‟s requirement. 02 - 720 Queries from Engineering Department (Technical) and Sales and Marketing (Commercial) base based on the Tender Documents are submitted and discussed to clients during Pre Bid Conference. 02 - 720 Sales Department and Marketing and Engineering Department prepare the proposal in accordance with Tender Requirements incorporating if any all the changes in the Tender Documents 54
  • 55. Section 7: Product Realization PROCEDURE CHANGES 02 - 720 Whenever required by the Client, Sales and Marketing together with or the Engineering Department representative will discuss the Technical and Commercial details of the Tender to Customer‟s Authorized Representatives 02 - 720 Proposal shall have a unique identification using the quotations job number order which will be provided by the Management Data Control. 02 - 720 For closed sales, Sales and Marketing reviews and evaluates Contract versus Tender Documents. . . . Discusses deviations to Engineering Department and other departments concerned. Contract Document with comments of Department concerned are sent to Legal for final comment. These comments deviations are discussed and negotiated to the customer. . . . 55
  • 56. Section 7: Product Realization PROCEDURE CHANGES 02 - 730 The Design Team shall be responsible for the preparation of tender documents with the assistance of Sales Department 02 - 730 Design Team Leader: Senior Engineer or Engineer III as minimum required requirement 02 - 730 Estimates: Owner provides the design drawing, specification and TPI to do an estimation work estimates only 02 - 730 The Design Manager designates a Design Team Leader for the project 02 - 730 Design outputs are documented and filed in the design file. Design outputs are documented in a manner that enables them are suitable to be verified against the design inputs 56
  • 57. Section 7: Product Realization PROCEDURE CHANGES 02-750 Site Safety Officer shall be responsible in the execution of Project HSE indicators. 02-750 HSE Indicator: field of measurements and monitoring how a project complies with the HSE program 02-750 Use the same unique identification of project provided by the Management Data Control in the approved proposal 02-750 TPI preserves the product during internal processing and installation in order to maintain conformity to requirements. TPI also exercises care with customer property while it is under the organization's control or being used. Preservation includes identification, verification, protection and safeguarding of customer property provided for use. If any customer property is lost, damaged or otherwise found to be unsuitable for use, TPI shall report to the customer and maintains its records. 57
  • 58. Section 7: Product Realization PROCEDURE CHANGES 02-750 The VP - Engineering - Senior Manager President or his designee shall conduct a monthly project progress meeting to discuss the progress of the project. The following shall attend the meeting: Chairman : Engineering - Vice President Senior Manager President Members : President or his designate Project Managers / Project Engineers Any other personnel deemed necessary 02-760 Calibrate and maintain equipment as assigned. 02-760 Designate an Equipment Controller. 02-760 Assign responsibility for calibration and maintenance of equipment. 58
  • 59. Section 7: Product Realization PROCEDURE CHANGES 02-750 All listed equipment that is out of calibration period can only be used after being validated verified by a current calibrated unit of the same type. 02-760 All Testing Equipment and Devices which are not calibrated for more than a year can be used as Preliminary Testing Equipment only prior to final testing. by a calibrated equipment and device. Official Calibration Certificate is no longer required for this preliminary testing. 02-822 The management staff person responsible for the area being audited shall take timely corrective action on nonconformities found during the audit. The management of the area being audited is responsible for ensuring that any necessary corrections and corrective actions are taken without undue delay to eliminate detected non conformities and their causes. 59
  • 60. Section 8: Measurement . . . PROCEDURE CHANGES 02-824 In process checks on completed part of the work shall be carried out together with the customer's representatives, in case required. 02-824 The final inspection and commissioning shall be authorized, monitored and approved for hand-over to the customer by the Project Manager. 02-824 The final inspection and commissioning shall be monitored by the GM - Engineering Project Engineer 02-830 The Area Project / Site Manager or Section Head may determine to scrap the item. The scrap is logged on their scrap report. 02-830 All reworked/repaired products/materials shall be re- inspected with the approval of the authorizing body and where applicable by the customer. 60
  • 61. Section 8: Measurement . . . PROCEDURE CHANGES 02-830 The works must be identified as non-conforming and a Non Conformance form is initiated. The work is identified: a) The nonconformity is described b) The location of the work is identified. 02-830 Quality control or Project/Site Manager reviews the NCR form and identifies the disposition of the product or material as: a) Scrap b) Rework to correct c) Use as is 02-830 Quality control or Project/Sites Manager determines if a corrective action will be initiated. 02-830 Quality control or Project/Sites Manager determines if a corrective action will be initiated. 61
  • 62. Section 8: Measurement . . . PROCEDURE CHANGES 02-830 If product will be “Used as is”, quality control or management is responsible for determining and obtaining any necessary customer concession. If there are certain uses that are not appropriate it will be noted on the NCR form. 02-830 If nonconforming product is detected after delivery or use, sales representative or the project manager will contact the customer and take appropriate correction and initiate a corrective 62
  • 63. HOME Here are the revisions in the INTERNATIONAL STANDARD Quality Management System Requirements 63
  • 64. The Changes to the Standard CLAUSE CHANGES 0.1 Para. 3 Text added to include statutory requirements as well as customer and regulatory and clarifies that these requirements are applicable to the product. 0.2 Para. 3 Text added to focus on importance of processes producing the desired outcome. 0.3 Para. 2 Text added to include statutory and regulatory requirements. 64
  • 65. The Changes to the Standard CLAUSE CHANGES 1.1 Text added to include statutory requirements. Note 1 expanded to include purchased product and output from product realization processes. Note 2 added indicating that statutory and regulatory requirements may be expressed as legal requirements. 1.2 Text added to include statutory requirements. 2 Reference to ISO 9000 now indicates 2005 version. 3 Definition of supplier, organization and customer has been deleted. 65
  • 66. The Changes to the Standard CLAUSE CHANGES 4.1 a. – The word ‘determine’ has replaced ‘identify.’ e. - The phrase ‘where applicable’ was added after ‘measure.’ Note. 1 - The wording ‘analysis and improvement’ was added. Note 2 - Added to define outsourced process. Note 3 - Added to define type and nature of control applied to outsourced processes. 4.2.1 Revised to clarify that QMS documentation includes records. Note 1 expanded to clarify that one document may include the requirements of one or more procedures and the requirements of one procedure may be covered by more than one document. 66
  • 67. The Changes to the Standard CLAUSE CHANGES 4.2.3 Text added to clarify that external documents are those needed for use in the QMS. 5.5.2 Clarifies that management representative must be a member of the organization’s own management. 6.2.1 Note added to clarify that conformity to product requirements may be affected directly or indirectly by personnel performing any task within the QMS. 67
  • 68. The Changes to the Standard CLAUSE CHANGES 6.2.2 Change in title from ‘Competence, awareness and training’ to ‘Competence, training and awareness.’ a. – Wording change from ‘affecting product quality’ to ‘conformity to product requirements.’ b. - The phrase ‘where applicable’ was added. c. - Revised to require assurance that the necessary competence has been achieved, rather than evaluating the effectiveness of training. 6.3 c. - Revised to include information systems. 6.4 Note added to clarify definition of work environment. 68
  • 69. The Changes to the Standard CLAUSE CHANGES 7.1 c. – The word ‘measurement’ was added. 7.2.1 a. – Slightly reworded c. - The word ‘related’ was replaced with ‘applicable.’ d. – The word ‘determined’ was replaced with ‘considered necessary.’ Note added to clarify that post-delivery activities include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal. 7.3.1 Note added to clarify that design and development review, verification and validation have distinct purposes and may be performed separately or in any combination as suitable for the product and the organization. 69
  • 70. The Changes to the Standard CLAUSE CHANGES 7.3.2 In last paragraph, ‘these’ changed to ‘the.’ 7.3.3 First paragraph – The word ‘provided’ was omitted and the phrase ‘that enables’ was replaced by ‘suitable for.’ Note added to clarify that production and service provision may include details for the preservation of product. 7.5.3 Second paragraph – The phrase ‘throughout product realization’ was added. Last paragraph – The phrase ‘and maintain records’ was added. 7.5.4 Note – The phrase ‘and personal data’ was added as part of customer property. 70
  • 71. The Changes to the Standard CLAUSE CHANGES 7.5.5 Phrase ‘conformity of’ was changed to ‘in order to maintain conformity to requirements’ and ‘where appropriate’ was changed to ‘as applicable.’ 7.6 Title of clause changed from ‘devices’ to ‘equipment.’ The reference to 7.2.1 was removed. a. – The phrase ‘or both’ was added. c. – The phrase ‘be identified to enable’ was replaced with ‘have identification.’ Note referencing ISO 10012-1 and ISO 10012-2 was deleted and replaced with a note related to the confirmation of computer software used as monitoring and measuring equipment. 71
  • 72. The Changes to the Standard CLAUSE CHANGES 8.1 a. – The word ‘requirements’ was added. 8.2.1 Note added to provide examples of how customer satisfaction data can be measured. 8.2.2 Editorial changes to clause to clarify requirements. Reworded requirement for documented procedure Clarified record requirements by adding ‘records of the audits and their results’ Clarified that management responsible for the area being audited shall ensure that ‘any necessary corrections and corrective actions are taken.’ Note – Reference to ISO 10011-1, 10011-2 and 10011-3 changed to ISO 19011. 72
  • 73. The Changes to the Standard CLAUSE CHANGES 8.2.3 The phrase ‘to ensure conformity of the product’ was deleted. Note added to clarify that the organization should consider the type of monitoring and measuring of processes and the extent to which they effect conformity to product requirements and the effectiveness of the QMS. 8.2.4 The phrase ‘for delivery to the customer’ was added to clarify that the release of the product relates to the delivery to the customer. 8.3 Reworded requirement for documented procedure. Second paragraph – The phrase ‘where practicable’ was added. 73
  • 74. Summary No new requirements were introduced in ISO 9001:2008 edition but, in order to benefit from the clarifications of ISO 9001:2008, we will need to take into consideration whether the clarifications introduced have an impact on our current interpretation of ISO 9001:2000, as changes may be necessary to the Quality Management System. 74
  • 75. Prepared and Presented by: Sid Calayag - QMS Lead Auditor Date: November 25, 2009 Venue: TPI Conference Room No. 2 Attendees: Mr. Enrico Concepcion – Vice President Mr. Nelson Tan – Purchasing Manager and QA/QC Manager Ms. Wilma Corpuz - Sr. Personnel Officer Mr. Norman Joseph – Sr. Info. Officer Ms. Rose Llanera - Central Docs. and Data Controller 75
  • 76. References ISO 9000: 2005 Fundamentals and vocabulary ISO 9001: 2008 Requirements ISO/TC 176 Publications International Register of Certified Auditors Publications International Accreditation Forum Publications Auditing Practices Group Publications TPI QMS 9001:2000 Manual and Procedures 76

Editor's Notes

  1. About IAF 1. What is the IAF?  The International Accreditation Forum, Inc. (IAF) is the world association of Conformity Assessment Accreditation Bodies and other bodies interested in conformity assessment in the fields of management systems, products, services, personnel and other similar programmes of conformity assessment. Its primary function is to develop a single worldwide program of conformity assessment which reduces risk for business and its customers by assuring them that accredited certificates may be relied upon. Accreditation assures users of the competence and impartiality of the body accredited. IAF members accredit certification or registration bodies that issue certificates attesting that an organization's management, products or personnel comply with a specified standard (called conformity assessment). IAF has prepared an informative brochure which provides general information about IAF, its activities, membership and programs.  To access the  Brochure please click on the following link:  IAF Brochure 2. Role of IAF  The primary purpose of IAF is two-fold. Firstly, to ensure that its accreditation body members only accredit bodies that are competent to do the work they undertake and are not subject to conflicts of interest. The second purpose of the IAF is to establish mutual recognition arrangements, known as Multilateral Recognition Arrangements (MLA), between its accreditation body members which reduces risk to business and its customers by ensuring that an accredited certificate may be relied upon anywhere in the world. The MLA contributes to the freedom of world trade by eliminating technical barriers to trade. IAF works to find the most effective way of achieving a single system that will allow companies with an accredited conformity assessment certificate in one part of the world, to have that certificate recognized else where in the world. The objective of the MLA is that it will cover all accreditation bodies in all countries in the world, thus eliminating the need for suppliers of products or services to be certified in each country where they sell their products or services. Certified once - accepted everywhere.
  2. The presentation is organized in such a way that we can move from one part (module) of the presentation to another. Also included are two ice breakers during or after the scheduled coffee break. Application form each module is also included although in such a way that it can be part of each or both module, although the advance application will require module 2 to better understand its application.
  3. The change in 6.2.1 from “product quality” to “productrequirements” has been made to this sub-clause: a) determine the necessary competence for personnel performing work affecting conformity to product quality requirements, Use below of the phrase "where applicable" recognizes thattraining or other actions may not be necessary, since individuals may already have the necessary competence. And,since "these needs" could be taken out of context, the requirement has been revised to specifically mentioncompetence. b) where applicable, provide training or take other actions to satisfy these needs achieve the necessarycompetence,
  4. NOTE The term "work environment" relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting or weather).
  5. Although similar, identify and determine have slightly different meaning. To identify is to recognize or establish something as being a particular thing.To determine is to apply reason and reach a decision.To determine the process implies more analysis and judgment than merely listing them.4.1 General RequirementsSub-clause (a), the word "Identify" has been replaced with "Determine".a) IdentifyDetermine the processes needed for the quality management system and their application throughout the organization (see 1.2),Although similar, the words "Identify" and "Determine" used above have slightly different meanings. We recognize or establish something as being a particular thing when we identify but we apply reason and reach a decision when we determine - to determine the process implies more analysis and judgment.e) monitor, measure (where applicable), and analyze these processes, and ...Processes are monitored but may not need to be measured; therefore, the requirement change above indicates processes are only measured where applicable.Regarding outsourcing:Where an organization chooses to outsource any process that affects product conformity withto requirements, the organization shall ensure control over such processes. Control of suchThe type and extent of control to be applied to these outsourced processes shall be identifieddefined within the quality management system.This addition clarifies that specific controls are to be defined and applied, not just identified.The current Note under clause 4.1 has been expanded and two new Notes have been added:NOTE 1: Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization, and measurement, analysis, and improvement.The text above expands from "measurement" to "measurement, analysis, and improvement" to match the title for clause 8 to clearly state that these processes are included rather than should be included.The new Note below provides an explanation of what is considered an outsourced process.NOTE 2: An outsourced process is identified as one being needed for the organization's quality management system, but chosen to be performed by a party external to the organization.The new Note below identifies the factors influencing the control of an outsourced process.NOTE 3: Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all Customer, statutory, and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such asa) the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements,b) the degree to which the control for the process is shared;c) the capability of achieving the necessary control through the application of clause 7.4.Outsourcing a process to another organization typically involves the purchase of those services; as a result, the requirements of clause 7.4, including the controls mentioned in 7.4.1, apply equally to the supplier selected to perform the outsourced process.
  6. 2.2    Intent of Clause 4.1 The intent of Clause 4.1 of ISO 9001:2008 is to emphasize that when an organization chooses to outsource (either permanently or temporarily) a process that affects product conformity with requirements (see ISO 9001:2008 clause 7.2.1), it can not simply ignore this process, nor exclude it from the quality management system.The organization has to demonstrate that it exercises sufficient control to ensure that this process is performed according to the relevant requirements of ISO 9001:2008, and any other requirements of the organization’s quality management system. The nature of this control will depend on the importance of the outsourced process, the risk involved, and the competence of the supplier to meet the process requirements. Based on the nature of the control, it should consider the processes referred to quality management system for management activities, provision of resources, product realization and measurement, analysis and improvement. The outsourced organization does not necessarily have to have a certified Quality Management System, but it has to demonstrate the capability of the previously mentioned processes.Outsourced processes will interact with other processes from the organization's quality management system (these other processes may be carried out by the organization itself, or may themselves be outsourced processes). These interactions also need to be managed (see ISO 9001:2008 clause 4.1 (a) and (b)). 2.3    Control of outsourced processes 2.3.1    The acquisition of outsourced processes will normally be subject to the capability of achieving the necessary control through the application of requirements of both ISO 9001:2008 clause 7.4 (Purchasing) and clause 4.1 (General Requirements) As mentioned in the Note, in some situations, the organization might not “purchase” the outsourced process in the traditional sense; it might, for example, receive the service from a corporate head office or from another division within a group of organizations, without any monetary transaction taking place (see 2.1 above). Under these circumstances, however, ISO 9001:2008 Clauses 7.4 and 4.1 are still applicable.2.3.2    There are two situations that frequently need to be considered when deciding the appropriate level of control of an outsourced process:When an organization has the competence and ability to carry out a process, but chooses to outsource that process (for commercial or other reasons).In this situation the process control criteria should already have been defined, and can be transposed into requirements for the supplier of the outsourced process, if necessary. When the organization does not have the competence to carry out the process itself, and chooses to outsource it.In this situation the organization has to ensure that the controls proposed by the supplier of the outsourced process are adequate. In some cases it may be necessary to involve external specialists in making this evaluation.2.3.3    It may be convenient, or even necessary, to define some or all of the methods to be used for control of the outsourced processes in a contract between the organization and the supplier. The potential impact of the outsourced process is based on the outsourcing’s capability to provide product that conforms to requirements. Care should be taken, however, not to inhibit the supplier from proposing innovations to the outsourced process. The organization’s control of the outsourced process has to be based on the need for product conformity to requirements. Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. 2.3.4    In some situations it might not be possible to verify the output from the outsourced process by subsequent monitoring or measurement. In these cases, the organization needs to ensure that the control over the outsourced process includes process validation in accordance with ISO 9001:2008 clause 7.5.2.
  7. 4.1 General RequirementsIn 4.1, General Requirements, sub-clause (a), the word "Identify" has been replaced with "Determine". a) Identify Determine the processes needed for the quality management system and their application throughout the organization (see 1.2), Although similar, the words "Identify" and "Determine" have slightly different meanings. To identify is to recognize or establish something as being a particular thing. To determine is to apply reason and reach a decision. To determine the processes implies more analysis and judgment than merely identifying them. e) monitor, measure (where applicable), and analyze these processes, and ... Processes are monitored, but may not need to be measured. Therefore, the requirement change above indicates processes are only measured where applicable. Later in clause 4.1, regarding outsourcing: Where an organization chooses to outsource any process that affects product conformity with to requirements, the organization shall ensure control over such processes. Control of such The type and extent of control to be applied to these outsourced processes shall be identified defined within the quality management system. This addition clarifies that specific controls are to be defined and applied, not just identified. See the new Note 3 below for an explanation of the type and extent of controls for an outsourced process. The current Note under clause 4.1 has been expanded and two new Notes have been added: NOTE 1: Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization, and measurement, analysis, and improvement. The text above expands from "measurement" to "measurement, analysis, and improvement" to match the title for clause 8. And, by deleting "should", it clearly states that these processes are included. The new Note below provides an explanation of what is considered an outsourced process. NOTE 2: An outsourced process is identified as one being needed for the organization's quality management system, but chosen to be performed by a party external to the organization. The new Note below identifies the factors influencing the control of an outsourced process. NOTE 3: Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory, and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as a) the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements, b) the degree to which the control for the process is shared; c) the capability of achieving the necessary control through the application of clause 7.4. Outsourcing a process to another organization typically involves the purchase of those services. As a result, the requirements of clause 7.4, including the controls mentioned in 7.4.1, apply equally to the supplier selected to perform the outsourced process.
  8. 4.2 Documentation Requirements 4.2.1 GeneralThe changes in this section are basically just a restructuring of the sub-clauses c), d), and e). c) documentedprocedures and records required by this International Standard, and d) documents, including records, needed determined by the organization to be necessary to ensure the effective planning, operation and control of its processes,and e) records required by this International Standard (see 4.2.4). You can see that adding "records" to sub-clause (c)allowed sub-clause (e) to be dropped. Sub-clause (d) has been expanded to include the necessary records. The firstNote for clause 4.2.1 has added two more sentences: A single document may include the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document. Anexample for the first sentence would be satisfying the requirements for documented procedures in 8.5.2, CorrectiveAction, and 8.5.3, Preventive Action, through one combined Corrective and Preventive Action procedure. An examplefor the second sentence would be splitting the required procedure for the Control of Documents into two separatedocumented procedures.
  9. 4.2.4 Control of RecordsThe opening sentence for clause 4.2.4 has expanded from records being "maintained" to having them "controlled". Maintaining records would simply keep them in good condition. Controlling the records means to regulate their use. Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. Records shall remain legible, readily identifiable andretrievable. The organization shall establish a documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time, and disposition of records. Records shallremain legible, readily identifiable, and retrievable. The requirement for a documented Record Control procedure hasbeen rewritten, but the content is basically the same. It is now a separate paragraph for emphasis and moved up in thesection. Note that "retention time" has been reduced to "retention". And, you can see that records must still remain legible, readily identifiable, and retrievable. This requirement is now a separate paragraph and moved to the end ofclause 4.2.4.
  10. One example may be outsourcing where it is now concluded that it cannot be part of any exclusion to the requirement.