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8/14/2019 QMS Update From 2000 to 2008 Rev 0 11.25.09
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By Sid Calayag QMS Lead Auditor
Presented on November 25, 2009Ver. 0 11.25.09
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Introduction
The need for an update of TPI QMS manual andprocedure is brought about by the new guidelinesissued 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 againstISO 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, existingISO 9001:2000 certifications will not be valid.
2
NOTE: The new standard has a release date of November 14, 2008
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3
Main modifications
Outsourcing process defined.
Training to achieve competence.
Work environment includes physical andenvironmental factors.
Process measurement focused to
effectiveness.
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The Changes
The update in ISO 9001:2008 brought about anumber of changes in TPI QMS manual andprocedures.
48 lines in the manual
93 lines in procedures
There are also some changes based on actualpractice
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The obvious . . .
5
. . . the NOT so obvious. . . and for further review
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HOME PAGE
The obvious
The NOT so obvious
For further review
Changes to TPI Procedures
Changes to the ISO Standard
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Information to the reader
The differences in ISO 9001:2008 vs. ISO 9001:2000 aredescribed 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 thenew text, even if this paper is printed without color.
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Section 6.2: Human Resources
9
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 productrequirements.
6.2.2 Competence, Training and Awareness and Training
Reference ISO 9001:2008 Section 6
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However:
Clause 6.2.2: Human Resources
There is no other revision in this clause of TPI QMSsince the new requirements are already stated in thepresent manual. To quote Clause 6.2.2:
Qualifications are reviewed upon hire, when an employee changes positions orthe requirements for a position change. Personnel Division maintains records ofemployee qualifications. If any differences between the employees qualificationsand the requirements for the job are found, training or other action is taken toprovide the employee with the necessary competence for the job. The results arethen evaluated to determine if they were effective. Training and evaluation areconducted according to the Competence, Training and Awareness Procedure.(TPI-02-622)
All employees are trained on the relevance and importance of their activities andhow they contribute to the achievement of the quality objectives.
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6.3: Resource Management
CLAUSE CHANGES
6.3
Second
Sentence.
. . ..The infrastructure has been provided, and includes
buildings, workspace, utilities, process equipment and
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).
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7.1 Planning of Product Realization
CLAUSE CHANGES
7.1
Bullet (2)
Bullet (3)
Bullet (4)
Bullet (5)
Quality planning is required before new products or
processes are implemented . . .
The need to establish processes, and documents, and toprovide resources specific to the product. Processes, documentation and resources required Required verification, validation, monitoring,
measurement, inspection, and test activities, specific tothe product and the criteria for product acceptance.
Records needed to provide evidence that the realizationprocesses and resulting product meet requirements.
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Reference ISO 9001:2008 Section 4 and Section 7
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Section 7: Product Realization
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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 otherwisefound to be unsuitable for use, this is reported to thecustomer and records maintained. TPI shall report to thecustomer and maintains its records
7.5.5 TPI preserves the conformity of product during internal
processing and installation in order to maintain conformityto requirements. This As applicable, preservation includesidentification, handling, packaging, storage andprotection. Preservation also applies to the constituentparts of a product.
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Reference ISO 9001:2008 Section 7
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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 devicesequipment needed to provide evidence of conformity ofproduct to determined requirements
7.6 Bullet (1) Calibrated or verified, or both, at specified intervals, orprior to use, against measurement standards traceable tointernational or national measurement standards
7.6 Bullet (3) Identified to enable the calibration status to be determinedin order to determine its calibration status
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Reference ISO 9001:2008 Section 7
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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 necessarycorrection and corrective action are taken without unduedelay to eliminate detected
8.2.3 When planned results are not achieved, correction andcorrective action is taken, as appropriate, to ensure
conformity of the product.
Evidence of conformity with the acceptance criteria ismaintained. Records indicate the person authorizingrelease of product for delivery to the customer.
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Reference ISO 9001:2008 Section 8
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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 withnonconforming product by one or more of the followingways:
8.3 Bullet (1) By containment of correction of the detectednonconformity and corrective action appropriate to the
effects or potential effect to eliminate its cause to preventits recurrence.
8.3 Bullet (2) By authorizing its use, release or acceptance with theapproval of the relevant authority
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Reference ISO 9001:2008 Section 8
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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 anysubsequent actions taken, including concessions obtainedshall be maintained.
8.5.2 Par (1) TPI takes action to eliminate the cause causes ofnonconformities 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
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Reference ISO 9001:2008 Section 8
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8.2.2 Internal audit
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Requirements for the audit evidence andresults had been added. It is made clearernow that the management is responsible to
ensure preventive and corrective action willbe taken.
The reference to the ISO 10011 had beenupdated to ISO 19011.
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8.2.3 Monitoring and Measurement ofProcesses
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Minor change of words i.e. "to ensureconformity of the product" had been removed.
A note had been added to clarify that theorganization should determine the type of themonitoring and measuring according to theprocesses and, how will this affect the quality
management system.
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Explanation
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Paragraph 8.2.4
Change of words: "maintain
evidence of conformity withacceptance criteria" had beenremoved but it is still aperceived requirement.
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8.3 Control of Non-conformingProduct
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An addition sub-clause (d) that specifies howto deal with a nonconforming product that wasdiscovered after delivery.
(Nothing new as it had always been addressedunder Warranty or After-sales protocol.)
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19.Non conforming product(8.3)
Dealing with non conforming product nowincludes the analysis of potential effects of nonconformity after the use has started.
FMEA for every non conformity not corrected/correctable could be a requirement.
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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 thataffects product conformity to the requirement.
4.1 Bullet (6) Established systems to monitor, measure where applicable
and analyze these processes, and
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Reference ISO 9001:2008 Section 4 Clause 4.1
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Explanation
Clause 4.1 Bullet 1:
2000 version standard says IDENTIFY theprocesses meaning recognize or establish
something as being a particular thing.
to determineis to apply reason and reach a
decision.
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Implies more analysis and judgment than merely listingthem
List them
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Explanation
Clause 4.1 Bullet 2: On outsourcing
All outsourced processes must be defined in thequality management system
Normally, outsourcing is a process owned byPurchasing Department.
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But since selection,negotiation and control is left to the end-user(department), it can also be part of thedepartment(s) involved.
PURCHASING is buying a product
OUTSOURCING is buying capability
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TC 176 Interpretation: No exclusion on outsourced process
RFI: ISO 9001:2000 Clause(s): 1.2
Question:
Does the standard requires an organization thatpurchases a complete design , then manufactures aproduct to the design and sells it under its own brandname to include design as one of the processesneeded for the Quality Management System?
Interpretation:
Yes
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Example:
If TPI purchases or employs a subcontractorto design a system, then the design of theproduct is identified and established as one of
the outsourced processes needed to becontrolled and included in the qualityManagement System.
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Explanation
Clause 4.1 Bullet 2: Contn
Control the outsourcing process by considering:
What is the potential impact of the processes on theproduct requirements?
What are the controls and are they shared?
Is there Existing control through Purchasing?
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NOTE 2 on Clause 4.1 of ISO 9001:2008An "outsourced process" is a process that the organizationneeds for its quality management system and which theorganization chooses to have performed by an externalparty.
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Explanation
Clause 4.1 Bullet 6:
In the new version, ISO clarifies the intention byreplacing the management with measurement,
analysis and improvement in the NOTE(S).
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Section 4.1: General Requirement
NOTE on ISO 9001:2000
Processes needed for the QMS referred to aboveinclude processes for management activities,
provision of resources, product realization andmanagement
NOTE1 on ISO 9001:2008
Processes needed for the QMS referred to aboveinclude processes for management activities,provision of resources, product realization,measurement, analysis and improvement.
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Section 4.2: DocumentationRequirements
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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
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Explanation
Clause 4.2.1 Bullet 3 and 6:
This is to emphasize that documentation can alsoinclude records and that mandatory procedures may
be in the form of combined documents, or thatrequirements may be covered by more than onedocument.
Clarified that external documentation are the
ones needed for the quality managementsystem.
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Section 4.2.3: Control of Documents
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CLAUSE CHANGES
4.2.3 Bullet (6) Ensuring that documents of external origin determined by
the management to be necessary for the planning andoperation of the quality management system are identified
and their distribution controlled, and . .
Reference ISO 9001:2008 Section 4 Clause 4.2.3.
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Explanation
Clause 4.2.3 Bullet 6:
Clarified that external documentation are the onesneeded for the quality management system.
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Section 4.2.4: Control of Records
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CLAUSE CHANGES
4.2.4 Quality records are maintained established to provide evidence
of conformity to requirements and of the effective operation ofthe 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.
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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 themin good condition.
Controlling the records means to regulate theiruse.
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Section 5.5.2: ManagementRepresentative
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5.5.2 The Vice President has been appointed by top
management as Management Representative.
Reference ISO 9001:2008 Section 5 Clause 5.5.2.
There is no change in the QMS Manual
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Explanation
Clause 5.5.2: Management Representative
An addition for a demand that the managementrepresentative would have to be a member of the
organization's management.
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Explanation
Clause 5.5.2: Management Representative
An addition for a demand that the managementrepresentative would have to be a member of the
organization's management.
Outsourcing of the Management
Representative (MR) is NOT conforming.
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3. FOR FURTHER REVIEW
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Section 7: Product Realization
CLAUSE CHANGES
7.2.1
Bullet (4)
Bullet (5)
Customer requirements include those:
Statutory and regulatory requirements relatedapplicable to the product
Additional requirements determined considerednecessary by TPI
7.3.1 A note had been added to clarify that designreview, verification and validation are separatedprocesses 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 formatthat enables verification against the design anddevelopment inputs, and are approved prior to release.
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Reference ISO 9001:2008 Section 7
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Section 7: Product Realization
CLAUSE CHANGES
7.5.1
Bullet (4)
Bullet (6)
. . . Controlled conditions include, as applicable:
The availability and use of monitoring and measuring
devices equipment
The implementation of product release, delivery and
post-delivery activities
7.5.2 TPI validates any processes for production and serviceprovision where the resulting output cannot be verified bysubsequent monitoring or measurement. This includesany processes where and as a consequence, deficiencies
become apparent only after the product is in use or theservice has been delivered. Validation demonstrates theability of these processes to achieve planned results.
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Reference ISO 9001:2008 Section 7
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Explanation
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Clause 7.2.1 Customer Related ProcessBullet (4) the word 'applicable' replaced 'related meanslaws or regulation that affect the quality of the product willbe considered as customer requirement.
Clause 7.3.1: Design and Development Planning
Revision in this clause is subject for deliberation dueto validation requirement.
Clause 7.3.3: Design and Development OutputThe revisions are just rewording and do not requireadditional action or change in the manual
.
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Explanation
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Clause 7.5.1 Control of Production and ServiceProvision
Bullet (4) the word equipment' replaced devicescorresponds to the change in the title of Clause 7.6: Control
of Monitoring and Measuring Devices EquipmentBullet (6) the insertion of the word product clarifies thesubject being discussed
Clause 7.5.2: Validation of Processes for Production andService Provision
- Subject for deliberation
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8.2.1 Customer Satisfaction
NOTE was added as follows:
Monitoring customer perception caninclude obtaining input from sources suchas customer satisfaction surveys, customerdata o delivered product quality, useropinion surveys, lost business analysis,
compliments, warranty claims and dealerreports.
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Explanation
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A note had been added to throw light on someof the means for conducting customersatisfaction evaluation.
The standard balances perception with dataand relies on warranty failures, dealerfeedback, product quality data, user surveys,lost business analysis etc.
Formula for
Delighting
Customers
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Revisions in the procedures brought about by
changes in the QMS manual
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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 listedin the Quality Records Index (DCC 102). The indexcontains the following information
02-424 Access to TPI controlled records is limited to employeesand authorized visitors
02-424 Controlled records are readily retrievable by referring tothe Quality Records Index for location
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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 retentionperiod has been reached, the records are archived ordisposed 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, qualityobjectives and product requirements and documents aredetermined as appropriate and provide resources specificto the product.
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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 qualityplan
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 andresulting product meet requirements.
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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 eachapplicable section of the Project Quality Plan (ENG 104).
02 - 710 When the project is completed, management reviews thequality planning table project output against the qualityplan to make sure that all requirements have been met.and signs to indicate approval
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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 bidQuotation in accordance with the requirements
02 - 720 Assists in the coordination of Coordinate status of on-going projects between Client and ConstructionDepartment
02 - 720 Prepare sales forecast on a monthly, quarterly or andannual basis based on the requirement of the topmanagement
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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 arequest for quotation, client the representative he
identifies and documents customers requirement.
02 - 720 Queries from Engineering Department (Technical) andSales and Marketing (Commercial) base based on theTender Documents are submitted and discussed to clientsduring Pre Bid Conference.
02 - 720 Sales Department and Marketing and EngineeringDepartment prepare the proposal in accordance withTender Requirements incorporating if any all the changesin the Tender Documents
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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 Customers Authorized
Representatives02 - 720 Proposal shall have a unique identification using the
quotations job number order which will be provided by theManagement Data Control.
02 - 720 For closed sales, Sales and Marketing reviews andevaluates Contract versus Tender Documents. . . .Discusses deviations to Engineering Department andother departments concerned. Contract Document withcomments of Department concerned are sent to Legal forfinal comment. These comments deviations are discussedand negotiated to the customer. . . .
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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 requirement02 - 730 Estimates: Owner provides the design drawing,
specification and TPI to do an estimation work estimatesonly
02 - 730 The Design Manager designates a Design Team Leaderfor the project
02 - 730 Design outputs are documented and filed in the designfile. Design outputs are documented in a manner thatenables them are suitable to be verified against thedesign inputs
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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 monitoringhow a project complies with the HSE program
02-750 Use the same unique identification of project provided bythe Management Data Control in the approved proposal
02-750 TPI preserves the product during internal processing andinstallation in order to maintain conformity torequirements. TPI also exercises care with customerproperty while it is under the organization's control or
being used. Preservation includes identification,verification, protection and safeguarding of customerproperty provided for use. If any customer property islost, damaged or otherwise found to be unsuitable for use,TPI shall report to the customer and maintains its records.
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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 ManagerPresident
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 ofequipment.
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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 asPreliminary Testing Equipment only prior to final testing.by a calibrated equipment and device. Official CalibrationCertificate is no longer required for this preliminarytesting.
02-822 The management staff person responsible for the area
being audited shall take timely corrective action onnonconformities found during the audit. The managementof the area being audited is responsible for ensuring thatany necessary corrections and corrective actions aretaken without undue delay to eliminate detected nonconformities and their causes.
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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 thecustomer by the Project Manager.
02-824 The final inspection and commissioning shall bemonitored by the GM - Engineering Project Engineer
02-830 The Area Project / Site Manager or Section Head maydetermine to scrap the item. The scrap is logged on theirscrap report.
02-830 All reworked/repaired products/materials shall be re-inspected with the approval of the authorizing body andwhere applicable by the customer.
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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 NCRform and identifies the disposition of the product ormaterial as:a) Scrapb) Rework to correctc) Use as is
02-830 Quality control or Project/Sites Manager determines if acorrective action will be initiated.
02-830 Quality control or Project/Sites Manager determines if acorrective action will be initiated.
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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 contactthe customer and take appropriate correction and initiatea corrective
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Here are the revisions in the INTERNATIONALSTANDARD Quality Management System
Requirements
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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.
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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.
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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.
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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 organizations 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.
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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.
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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.
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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.
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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.
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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.
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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 theeffectiveness 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.
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Summary
No new requirements were introduced in ISO9001:2008 edition but, in order to benefit fromthe clarifications of ISO 9001:2008, we will
need to take into consideration whether theclarifications introduced have an impact on ourcurrent interpretation of ISO 9001:2000, aschanges may be necessary to the Quality
Management System.
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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/QCManager
Ms. Wilma Corpuz - Sr. Personnel Officer
Mr. Norman Joseph Sr. Info. Officer
Ms. Rose Llanera - Central Docs. and Data Controller
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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
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Thank You