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QMS Update from 2000 to 2008 rev 0 11.25.09

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QMS Update  from 2000 to 2008 rev 0 11.25.09 Powered By Docstoc
					By Sid Calayag – QMS Lead Auditor Presented on November 26, 2009 Ver. 0 11.25.09

Introduction
The need for an update of TPI QMS manual and procedure is 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 recertifications) must be to ISO 9001:2008. 3. Two years after publication of ISO 9001:2008, existing ISO 9001:2000 certifications will not be valid.
NOTE: The new standard has a release date of November 14, 2008
2

Main modifications
• Outsourcing process defined.

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

3

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

– 93 lines in procedures

• There are also some changes based on actual practice

4

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

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HOME PAGE
• The obvious • The NOT so obvious • For further review • Changes to TPI 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.

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HOME

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Section 6.2: Human Resources
CLAUSE 6.2.1 CHANGES To ensure competence of our personnel, job descriptions have been prepared identifying the qualifications required for each position that affects product quality conformity to product requirements.

6.2.2

Competence, Training and Awareness and Training

Reference ISO 9001:2008 Section 6
9

However:
Clause 6.2.2: Human Resources
There is no other revision in this clause of TPI 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 6.3 Second Sentence. 6.4 CHANGES . . ..The infrastructure has been provided, and includes buildings, workspace, utilities, process equipment and supporting services (such as transport, communication or information systems). 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 7.1 Bullet (2) Bullet (3) Bullet (4) Bullet (5) CHANGES 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.

Reference ISO 9001:2008 Section 4 and Section 7
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Section 7: Product Realization
CLAUSE 7.5.3 Par. 2 CHANGES TPI controls and records the unique identification of the product and maintains record wherever traceability is a specified requirement. 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 TPI preserves the conformity of product during internal processing and installation in order to maintain conformity to requirements. This As applicable, preservation includes identification, handling, packaging, storage and protection. Preservation also applies to the constituent parts of a product. Reference ISO 9001:2008 Section 7
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7.5.4 Par. 1

7.5.5

Section 7: Product Realization
CLAUSE CHANGES

7.6 Title
7.6 Par 1

Control of Monitoring and Measuring Devices Equipment
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 Calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards Identified to enable the calibration status to be determined in order to determine its calibration status

7.6 Bullet (1)

7.6 Bullet (3)

Reference ISO 9001:2008 Section 7
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Section 8: Measurement . . .
CLAUSE CHANGES

8.1
8.2.2

To demonstrate conformity of the product to product requirements
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 When planned results are not achieved, correction and corrective action is taken, as appropriate, to ensure conformity of the product. Evidence of conformity with the acceptance criteria is maintained. Records indicate the person authorizing release of product for delivery to the customer. Reference ISO 9001:2008 Section 8
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8.2.3

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, . . .
Where applicable, the organization shall deal with nonconforming product by one or more of the following ways: 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. By authorizing its use, release or acceptance with the approval of the relevant authority

8.3 Par (2)

8.3 Bullet (1)

8.3 Bullet (2)

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.
Records of the noted nonconformities and any subsequent actions taken, including concessions obtained shall be maintained. TPI takes action to eliminate the cause causes of nonconformities in order to prevent recurrence. Reviewing the effectiveness of the corrective action taken Reviewing the effectiveness of the preventive action taken

8.3 Par (4)

8.5.2 Par (1) 8.5.2 Bullet (6) 8.5.3 Bullet (5)

Reference ISO 9001:2008 Section 8
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8.2.2 Internal audit
Requirements for the audit evidence and results had been added. It is made clearer now that the management is responsible to ensure preventive and corrective action will be taken. The reference to the ISO 10011 had been updated to ISO 19011.

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

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Explanation
Paragraph 8.2.4
Change of words: "maintain evidence of conformity with acceptance criteria" had been removed but it is still a perceived requirement.

20

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

21

19.Non conforming product (8.3)
• Dealing with non conforming product now includes the analysis of potential effects of non conformity after the use has started.
– FMEA for every non conformity not corrected /correctable could be a requirement.

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HOME

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Section 4: General Requirement
CLAUSE CHANGES

4.1 Bullet (1)
4.1 Bullet (2)

Identified Determined the processes needed for the QMS . . .
TPI shall ensure control of all outsourced processes that affects product conformity to the requirement. Established systems to monitor, measure where applicable and analyze these processes, and …

4.1 Bullet (6)

Reference ISO 9001:2008 Section 4 Clause 4.1
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Explanation
Clause 4.1 Bullet 1:
• 2000 version standard says IDENTIFY the processes meaning recognize or establish something as being a particular thing.
– List them

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

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

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Explanation
Clause 4.1 Bullet 2: Cont‟n
• Control the “outsourcing” process by considering:
– What is the potential impact of the processes on the product requirements? – What are the controls and are they shared? – Is there Existing control through Purchasing?
NOTE 2 on Clause 4.1 of ISO 9001:2008 An "outsourced process" is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party.
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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).

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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.
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Section 4.2: Documentation Requirements
CLAUSE 4.2.1 Bullet (3) CHANGES • 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 include “records” and that mandatory procedures be in the form of combined documents, or requirements may be covered by more than document. also may that one

Clarified that external documentation are the ones needed for the quality management system.

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Section 4.2.3: Control of Documents

CLAUSE
4.2.3 Bullet (6)

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

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Section 4.2.4: Control of Records

CLAUSE
4.2.4

CHANGES
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-02424). 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 them in good condition. – Controlling the records means to regulate their use.

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Section 5.5.2: Management Representative
CLAUSE
5.5.2

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

There is no change in the QMS Manual

Reference ISO 9001:2008 Section 5 Clause 5.5.2.
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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.

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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.

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HOME

3. FOR FURTHER REVIEW

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Section 7: Product Realization
CLAUSE 7.2.1 Bullet (4) Bullet (5) 7.3.1 CHANGES Customer requirements include those: • Statutory and regulatory requirements related applicable to the product • Additional requirements determined considered necessary by TPI • 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 • . . .They are documented in a form suitable for format that enables verification against the design and development inputs, and are approved prior to release.

7.3.3

Reference ISO 9001:2008 Section 7
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Section 7: Product Realization
CLAUSE 7.5.1 Bullet (4) Bullet (6) CHANGES . . . 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.

Reference ISO 9001:2008 Section 7
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Explanation
Clause 7.2.1 Customer Related Process
Bullet (4) – the word 'applicable' replaced 'related„ means laws or regulation that affect the quality of the product will be considered as customer requirement.

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

Clause 7.3.3: Design and Development Output
The revisions are just rewording and do not require additional action or change in the manual
.
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Explanation
Clause 7.5.1 Control of Production and Service Provision
Bullet (4) – the word equipment' replaced devices„ corresponds to the change in the title of Clause 7.6: Control of Monitoring and Measuring Devices Equipment Bullet (6) – the insertion of the word “product” clarifies the subject being discussed

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

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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.

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Explanation
A note had been added to throw light on some of the means for conducting customer satisfaction evaluation. The standard balances perception with data and relies on warranty failures, dealer feedback, product quality data, user surveys, lost business analysis etc.

Formula for Delighting Customers

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HOME

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
Quality Records are maintained as established and listed in the Quality Records Index (DCC 102). The index contains the following information Access to TPI controlled records is limited to employees and authorized visitors Controlled records are readily retrievable by referring to the Quality Records Index for location

02-424

02-424 02-424

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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. After records are no longer needed and the retention period has been reached, the records are archived or disposed of in coordination with CDDC. DCC101 - Controlled Document Master List.

02-424

02-424

02 - 710
02 - 710

HSE – Health Safety and Environment
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.
The Project Manager initiate implements project quality plan Conduct the required verification, validation, monitoring, measurement, inspection, and test activities, specific to the product and the criteria for product acceptance. Provide records as evidence that the processes and resulting product meet requirements.

02 - 710 02 - 710

02 - 710

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Section 7: Product Realization
PROCEDURE CHANGES

02 - 710
02 - 710 02 - 710 02 - 710 02 - 710 02 - 710

Project Quality Plan includes but not limited to:
Quality objectives and project requirements for the project Verification, validation, monitoring, inspection and test activities HSE Program The Project Manager investigates and completes each applicable section of the Project Quality Plan (ENG 104). 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

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Section 7: Product Realization
PROCEDURE CHANGES

02 - 710
02 - 710 02 - 720 02 - 720 02 - 720

Testing Report Forms
HSE 105 - Job Safety Analysis Assists in review of Tender Documents Assist Engineering Department in the preparation of bid Quotation in accordance with the requirements Assists in the coordination of Coordinate status of ongoing projects between Client and Construction Department Prepare sales forecast on a monthly, quarterly or and annual basis based on the requirement of the top management

02 - 720

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Section 7: Product Realization
PROCEDURE CHANGES

02 - 720
02 - 720

Inquiry of document Request is received by e-mail, phone, and fax or post mail or during pre-bid conference.
When Sales and Marketing representative receives a request for quotation, client the representative he identifies and documents customer‟s requirement. 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. 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

02 - 720

02 - 720

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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 Customer‟s Authorized Representatives Proposal shall have a unique identification using the quotations job number order which will be provided by the Management Data Control.
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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02 - 720

02 - 720

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
Design Team Leader: Senior Engineer or Engineer III as minimum required requirement

02 - 730

02 - 730

Estimates: Owner provides the design drawing, specification and TPI to do an estimation work estimates only
The Design Manager designates a Design Team Leader for the project

02 - 730

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
02-750 02-750 02-750

Site Safety Officer shall be responsible in the execution of Project HSE indicators.
HSE Indicator: field of measurements and monitoring how a project complies with the HSE program Use the same unique identification of project provided by the Management Data Control in the approved proposal 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
Calibrate and maintain equipment as assigned. Designate an Equipment Controller. Assign responsibility for calibration and maintenance of equipment.
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02-760 02-760 02-760

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.
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. 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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02-760

02-822

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.
The final inspection and commissioning shall be authorized, monitored and approved for hand-over to the customer by the Project Manager. The final inspection and commissioning shall be monitored by the GM - Engineering Project Engineer The Area Project / Site Manager or Section Head may determine to scrap the item. The scrap is logged on their scrap report. All reworked/repaired products/materials shall be reinspected with the approval of the authorizing body and where applicable by the customer.

02-824

02-824 02-830

02-830

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

02-830 02-830

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. 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

02-830

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HOME

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

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The Changes to the Standard
CLAUSE 0.1 Para. 3 CHANGES Text added to include statutory requirements as well as customer and regulatory and clarifies that these requirements are applicable to the product. Text added to focus on importance of processes producing the desired outcome. Text added to include statutory and regulatory requirements.

0.2 Para. 3

0.3 Para. 2

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The Changes to the Standard
CLAUSE 1.1 CHANGES 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. Text added to include statutory requirements. Reference to ISO 9000 now indicates 2005 version. Definition of supplier, organization and customer has been deleted.
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1.2 2 3

The Changes to the Standard
CLAUSE 4.1 CHANGES 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. 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.

4.2.1

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The Changes to the Standard
CLAUSE 4.2.3 CHANGES Text added to clarify that external documents are those needed for use in the QMS. Clarifies that management representative must be a member of the organization’s own management. Note added to clarify that conformity to product requirements may be affected directly or indirectly by personnel performing any task within the QMS.

5.5.2

6.2.1

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The Changes to the Standard
CLAUSE 6.2.2 CHANGES 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. c. - Revised to include information systems.

6.3

6.4

Note added to clarify definition of work environment.

68

The Changes to the Standard
CLAUSE CHANGES

7.1
7.2.1

c. – The word ‘measurement’ was added.
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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The Changes to the Standard
CLAUSE 7.3.2 7.3.3 CHANGES In last paragraph, ‘these’ changed to ‘the.’ 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. Second paragraph – The phrase ‘throughout product realization’ was added. Last paragraph – The phrase ‘and maintain records’ was added. Note – The phrase ‘and personal data’ was added as part of customer property.

7.5.3

7.5.4

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The Changes to the Standard
CLAUSE
7.5.5

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

7.6

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
8.2.1 8.2.2

a. – The word ‘requirements’ was added.
Note added to provide examples of how customer satisfaction data can be measured. 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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



The Changes to the Standard
CLAUSE 8.2.3 CHANGES 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. The phrase ‘for delivery to the customer’ was added to clarify that the release of the product relates to the delivery to the customer. Reworded requirement for documented procedure. Second paragraph – The phrase ‘where practicable’ was added.

8.2.4

8.3

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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

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Thank You…

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Description: This is a recommendation to update the current quality manual of an organization based on the new standard requirement of ISO 9001:2008