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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.
2
NOTE: The new standard has a release date of November 14, 2008
3
Main modifications
• Outsourcing process defined.
• Training to achieve competence.
• Work environment includes physical and
environmental factors.
• Process measurement focused to
effectiveness.
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 . . .
5
. . . the NOT so obvious
. . . and for further review
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
8
HOME
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 product
requirements.
6.2.2 Competence, Training and Awareness and Training
Reference ISO 9001:2008 Section 6
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
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).
11
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 to
provide resources specific to the product.
• Processes, documentation and resources required
• Required verification, validation, monitoring,
measurement, inspection, and test activities, specific to
the product and the criteria for product acceptance.
• Records needed to provide evidence that the realization
processes and resulting product meet requirements.
12
Reference ISO 9001:2008 Section 4 and Section 7
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.
13
Reference ISO 9001:2008 Section 7
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
14
Reference ISO 9001:2008 Section 7
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.
15
Reference ISO 9001:2008 Section 8
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
16
Reference ISO 9001:2008 Section 8
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
17
Reference ISO 9001:2008 Section 8
8.2.2 Internal audit
18
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.
8.2.3 Monitoring and Measurement of
Processes
19
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.
Explanation
20
Paragraph 8.2.4
Change of words: "maintain
evidence of conformity with
acceptance criteria" had been
removed but it is still a
perceived requirement.
8.3 Control of Non-conforming
Product
21
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.)
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
23
HOME
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 …
24
Reference ISO 9001:2008 Section 4 Clause 4.1
Explanation
Clause 4.1 Bullet 1:
• 2000 version standard says IDENTIFY the
processes meaning recognize or establish
something as being a particular thing.
• to determine is to apply reason and reach a
decision.
25
– Implies more analysis and judgment than merely listing
them
– List them
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.
26
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
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?
29
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.
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
32
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
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.
Section 4.2.3: Control of Documents
34
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.
35
Explanation
Clause 4.2.3 Bullet 6:
Clarified that external documentation are the ones
needed for the quality management system.
Section 4.2.4: Control of Records
36
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.
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.
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Section 5.5.2: Management
Representative
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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
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.
3. FOR FURTHER REVIEW
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HOME
Section 7: Product Realization
CLAUSE CHANGES
7.2.1
Bullet (4)
Bullet (5)
Customer requirements include those:
• Statutory and regulatory requirements related
applicable to the product
• 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.
42
Reference ISO 9001:2008 Section 7
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 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.
43
Reference ISO 9001:2008 Section 7
Explanation
44
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
.
Explanation
45
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
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
47
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
Revisions in the procedures brought about by
changes in the QMS manual
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HOME
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
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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 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.
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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 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
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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 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. . . .
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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 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
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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 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.
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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 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.
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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 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.
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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 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.
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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 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.
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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 contact
the customer and take appropriate correction and initiate
a corrective
62
Here are the revisions in the INTERNATIONAL
STANDARD Quality Management System
Requirements
63
HOME
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
65
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.
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. 2 NOTE: The new standard has a release date of November 14, 2008
  • 3. 3 Main modifications • Outsourcing process defined. • Training to achieve competence. • Work environment includes physical and environmental factors. • Process measurement focused to effectiveness.
  • 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 . . . 5 . . . the NOT so obvious . . . and for further review
  • 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
  • 9. 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 product requirements. 6.2.2 Competence, Training and Awareness and Training Reference ISO 9001:2008 Section 6
  • 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 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). 11
  • 12. 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 to provide resources specific to the product. • Processes, documentation and resources required • Required verification, validation, monitoring, measurement, inspection, and test activities, specific to the product and the criteria for product acceptance. • Records needed to provide evidence that the realization processes and resulting product meet requirements. 12 Reference ISO 9001:2008 Section 4 and Section 7
  • 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. 13 Reference ISO 9001:2008 Section 7
  • 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 14 Reference ISO 9001:2008 Section 7
  • 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. 15 Reference ISO 9001:2008 Section 8
  • 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 16 Reference ISO 9001:2008 Section 8
  • 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 17 Reference ISO 9001:2008 Section 8
  • 18. 8.2.2 Internal audit 18 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.
  • 19. 8.2.3 Monitoring and Measurement of Processes 19 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.
  • 20. Explanation 20 Paragraph 8.2.4 Change of words: "maintain evidence of conformity with acceptance criteria" had been removed but it is still a perceived requirement.
  • 21. 8.3 Control of Non-conforming Product 21 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.)
  • 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
  • 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 … 24 Reference ISO 9001:2008 Section 4 Clause 4.1
  • 25. Explanation Clause 4.1 Bullet 1: • 2000 version standard says IDENTIFY the processes meaning recognize or establish something as being a particular thing. • to determine is to apply reason and reach a decision. 25 – Implies more analysis and judgment than merely listing them – List them
  • 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. 26 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
  • 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? 29 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.
  • 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 32 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
  • 33. 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.
  • 34. Section 4.2.3: Control of Documents 34 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.
  • 35. 35 Explanation Clause 4.2.3 Bullet 6: Clarified that external documentation are the ones needed for the quality management system.
  • 36. Section 4.2.4: Control of Records 36 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.
  • 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 38 CLAUSE CHANGES 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
  • 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. 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.
  • 41. 3. FOR FURTHER REVIEW 41 HOME
  • 42. Section 7: Product Realization CLAUSE CHANGES 7.2.1 Bullet (4) Bullet (5) Customer requirements include those: • Statutory and regulatory requirements related applicable to the product • 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. 42 Reference ISO 9001:2008 Section 7
  • 43. 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 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. 43 Reference ISO 9001:2008 Section 7
  • 44. Explanation 44 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 .
  • 45. Explanation 45 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
  • 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 47 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
  • 48. Revisions in the procedures brought about by changes in the QMS manual 48 HOME
  • 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. Here are the revisions in the INTERNATIONAL STANDARD Quality Management System Requirements 63 HOME
  • 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 65 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.
  • 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