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Awareness Programand

Overview of the Revisions

in ISO 9001:2008

Presented by: V. MANIVANNAN

Introduce the concept of new ISO 9001:2008 Standard

Highlight important areas and changes of the Standard

Briefly introduce the system requirements of the Standard

Important issues in implementations

Transition Plan with Your Certification Body

3rd revision of Quality Management System Requirement Standard from International Organization for Standards

Replacement for previous standard of ISO 9001:2000

Introduced considerable conceptual changes

From product centric to customer / business centric approach

QMSResource

management

Measurement, analysis &

improvements

Product Realization

Management

Responsibility

Continual Improvement cycle

QMSResource

management

Measurement, analysis &

improvements

Product Realization

Management

Responsibility

CUSTOMER

CUSTOMERInput

Continual Improvement of the QMS

Information

Info

Product Realization

Measurement, Analysis &

Improvements

ManagementResponsibility

Requirements

Satisfaction

Product

ResourceManagement

Based and developed on eight quality management

principles

Leadership

Process approach

Involvement of people

System approach to Managemen

t

Continual improvement

Factual approach to

decision making

Mutual beneficial supplier

relationship

Customer focus

Customer focus•Organization depends customers •Understand current & future customer needs.•Meet / exceed customer expectations

Leadership•Leaders establish purpose & direction of the organization•Should create & maintain environment to achieve organization’s objectives

Involvement of People•People of all levels are essence of an organization•Their full involvement for organization’s benefit

Process approachDesired results are achieved more efficiently when activities and resources

are managed as process

System approach to ManagementIdentifying, understanding and managing interrelated process as a system

contributes to the organization’s effectiveness & efficiency

Continual improvementsContinual improvement of the organization’s overall performance should be a

permanent objective of the organization

Factual approach to decision makingEffective decisions are based on the analysis of data and information

Mutually beneficial supplier relationships•An organization & its suppliers are interdependent•Mutually beneficial relationship enhances the ability of both to create value

Avoid the application of systems that are separate from the organization’s business process

Enable the development of a quality system that is fully integrated into the business operations of the organization

Enable continual improvements of the system for enhanced customer satisfaction

Enable compliance to statutory & regulatory requirements

+ Why it is to be done

Continual improvements should be achieved

+ Statutory & regulatory requirements

Value adding processes

Customer satisfaction

9001:2008 Previous versions

Supporting services e.g. transport, communication & information system

Post delivery activities e.g. warranty issues, contractual obligations, maintenance services

Customer property – organization shall report to the customer – include personal data of customer

Include customer perception

Process definition Set of interrelated and interacting activities which transforms

inputs into outputs

Ensure continual

improvements

Identify the

processes

Identify the Inputs & outputs

Identify the

Interactions to other processes

Do it for all value adding processes

Establish measuring

criteria

Performance Measurement

•Final testing

•Conformance rate

•Achieving of KPIs

OutputFinished product

Inputs• Raw material• Manufacturing

formulations / Specs• Equipments

Manufacture /Testing• Labour

Process control•Process parameters•Inspection & testing•Calibration and maintenance of equipments

Interactions toInspection & testingWarehousingSupply / PurchasingSalesTraining

Manufacturing Process

E.g.: ManufacturingE.g.: Manufacturing

Linked and interacting with other processes

Out put of one process will be an input to another process

Product development process

Management review process

Sales Process

Manufacturing Process

PurchasingProcess

Maintenance process

QA process

Training & Development process

Warehousing process

PDCA CycleProcesses in terms

Of Added ValueDO

Continual improvements of Processes based on objective measurements

ACTION

Measure results of processPerformance and effectiveness

- Objective MeasurementsCHECK

Understandings & meeting requirements

PLAN

QMSResource

Management(PLAN)

Measure, analysis improvements

(CHECK)

Product Realization

(DO)

ManagementResponsibility

(ACTION)

Continual Improvement cycle

General requirements

General requirements

4 Quality Management System

5

Management Responsibility

6

Resource Management

7

Product Realization

8 Measurement, Analysis & improvement

General requirements

Documentation Requirements

Management Commitment

Customer focus

Quality policy

Planning

Responsibility, authority & communication

Management Reviews

Planning

Customer related processes

Design & development

Purchasing

Production & service provision

Provision of resources

Human resources

Infrastructures

Work environment

General

Monitoring & measurement

Control of NCP

Analysis of data

Improvements

System RequirementsSystem Requirements

CHANGES (highlighted in BOLD RED italics type) show the revised wording of the requirement. Remember that NOTES in the Standard DO

NOT constitute requirements, but are meant to clarify them.

COMMENTS (highlighted in BOLD BLUE type) are intended to further help you determine if changes to your system are warranted by the INTENT of the new/revised requirement or Note in the Standard.

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4.1 General RequirementsNOTE 2: An outsourced process is identified as one being needed for the organization's quality management system but chosen to be performed by a party external to the organization.Comment: This new Note provides an explanation of what is considered an outsourced process. NOTE 3: The type and nature of control to be applied to the outsourced process may be influenced by factors such as:

a) the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements;

b) the extent to which the control for the process is shared;c) the capability of achieving the necessary control through the

application of clause 7.4.Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory, and regulatory requirements.Comment: This new Note identifies the factors influencing the control of an outsourced process. Outsourcing a process to another organization typically involves the purchase of those services. As a result, the requirements of clause 7.4, including the controls mentioned in 7.4.1, apply to the supplier selected to perform the outsourced process.

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4.2 Documentation Requirements

4.2.1 Generalc) documented procedures and records required by this

International Standard, and

d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.Comment: No real change to the requirement; you can see that adding "records" to sub-clauses c) and d) allowed sub-clause e) to be dropped. NOTE 1: A single document may include the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.Comment: An example for the first sentence would be satisfying the requirements for documented procedures in 8.5.2, Corrective Action, and 8.5.3, Preventive Action, by one combined Corrective and Preventive Action procedure. An example for the second sentence would be splitting the required procedure for the Control of Documents into two separate documented procedures, one for internal document control and one for external document control.

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4.2 Documentation Requirements

4.2.3 Control of Documentsf) to ensure that documents of external origin determined by

the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, andComment: This change simply clarifies that not all external documents have to be identified and controlled; only those necessary for the planning and operation of the quality management system.

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4.2 Documentation Requirements

4.2.4 Control of RecordsRecords established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.

The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention, and disposition of records.

Records shall remain legible, readily identifiable, and retrievable. Comment: The opening sentence was rewritten to emphasize that records should be "controlled“ (versus just “maintained”). Maintaining the records would be to simply keep them in good condition; controlling the records means to regulate their use.

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5.5 Responsibility, Authority and Communication

5.5.2 Management RepresentativeTop management shall appoint a member of the organization's management who, irrespective of other responsibilities, shall have responsibility and authority that includes:Comment: Most organizations already appoint a Management Representative that is a member of their own management team; this change simply clarifies that requirement. It also appears to prohibit outsourcing of the Management Representative role (since the intent is to establish/maintain internal oversight and responsibility for establishing, maintaining and improving an organization’s quality management system).

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6.2 Human Resources

6.2.1 GeneralPersonnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience.NOTE: Conformity to product requirements may be affected directly or indirectly by personnel performing any task within the quality management system.

Comment: Wording was changed from work affecting "product quality" to work affecting "conformity to product requirements". Quality is the degree to which a set of inherent characteristics fulfils requirements; conformity is the fulfillment of a requirement. The change to the requirement (and addition of the new Note) will not likely result in new interpretations of the requirement since anyone performing, verifying, or managing work within the scope of the quality management system, including supporting services, can affect conformity to product requirements.

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6.2 Human Resources

6.2.2 Competence, Training and Awarenessa) determine the necessary competence for personnel performing work affecting conformity to product requirements,b) where applicable, provide training or take other actions to achieve the necessary competence, c) ensure that the necessary competence has been achieved,Comment: Use of the phrase "where applicable" seems to recognize that training or other actions may not always be necessary, since individuals may already have the necessary competence. Likewise, since “satisfy these needs" was sometimes taken out of context to infer action was always required, the requirement was revised to focus on determining “competence”. Finally, since people have struggled with how to evaluate the “effectiveness of the actions taken”, the clause was modified to focus more on determining competence. For example, a student’s evaluation of the effectiveness of training they attend, is not as useful as an (independent) evaluation of their knowledge, skills and abilities (regardless of how/when this ‘competency’ was acquired).

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6.3 Infrastructurec) supporting services (such as transport, communication or information systems).

Comment: The only change was to add “information systems" as an example of a supporting service included within the definition of infrastructure).

6.4 Work EnvironmentNOTE: The term “work environment’” relates to conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting, or weather).Comment: The only change was to add a NOTE to explain the term Work Environment by providing examples of work environment conditions for achieving product conformity .

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7.2 Customer-related Processes

7.2.1 Determination of Requirements Related to the Producta) requirements specified by the customer, including the requirements for delivery, and for post-delivery activities, c) statutory and regulatory requirements applicable to the product, and d) any additional requirements considered necessary by the organization. NOTE: Post delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

Comment: The slight change to "for delivery, and for post-delivery activities" adds emphasis to post-delivery activities; for similar reasons a Note was added with examples. The change from "related" to "applicable" shifts the meaning from determining legal requirements that are merely associated with the product to those that are relevant and can be applied to the product. The final revision to this clause clarifies that the additional requirements aren't just determined, they are determined to be needed by the organization.

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7.3 Design and Development

7.3.3 Design and Development OutputsThe outputs of design and development shall be in a form suitable for verification against the design and development input and shall be approved prior to release. Comment: The change switches from "a form that enables verification" to "a form suitable for verification". To enable something is to make it possible; however, to be suitable means it is meant for use, or in this case, for verification. NOTE: Information for production and service provision may include details for the preservation of product.

Comment: The new Note was added to remind the reader that clause 7, Production and Service Provision, includes sub-clause 7.5.5, Preservation of product, probably to indicate that the design output should consider product preservation, especially product packaging.

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7.5 Production and Service Provision

7.5.2 Validation of Process for Production and Service Provision

The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.

Comment: The revised text clarifies that any process output that can't be verified may result in deficiencies becoming known only after the product is in use or the service has been delivered. Accordingly, validation requirements could apply to processes such as welding, sterilization, training, heat treatment, call center service, or emergency response.

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7.5 Production and Service Provision

7.5.3 Identification and TraceabilityThe organization shall identify product status with respect to monitoring and measurement requirements throughout product realization.

Comment: The revised text clarifies that identifying product status applies throughout product realization, from received product, through in-process product, to final product. Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records (see 4.2.4).Comment: By moving the "records" reference to the end of the sentence, the meaning has changed from recording the product identification, to keeping any type of record associated with product traceability.

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7.5 Production and Service Provision

7.5.3 Identification and TraceabilityThe organization shall identify product status with respect to monitoring and measurement requirements throughout product realization.

Comment: The revised text clarifies that identifying product status applies throughout product realization, from received product, through in-process product, to final product. Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records (see 4.2.4).Comment: By moving the "records" reference to the end of the sentence, the meaning has changed from recording the product identification, to keeping any type of record associated with product traceability.

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7.5 Product and Service Provision 7.5.4 Customer Property

If any customer property is lost, damaged or otherwise found to be unsuitable for use the organization shall report this to the customer and maintain records (see 4.2.4).

NOTE: Customer property can include intellectual property and personal data.

Comment: The requirement was revised to read better and the NOTE was revised to The existing Note was modified to include "personal data" as an example of customer property, broadening the applicability of clause 7.5.4 to more organizations, especially service organizations.

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7.5 Product and Service Provision 7.5.5 Preservation of Product

The organization shall preserve the conformity of product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. Comment: The term “conformity to requirements" should be easier to understand than “conformity of product”.

As applicable, preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product. Comment: The addition of “as applicable” allows product preservation to be applied (i.e. include or not include product identification, handling, packaging, storage, and protection) as appropriate.

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7.6 Control of Monitoring and Measuring EquipmentThe organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.Where necessary to ensure valid results, measuring equipment shallc) have identification in order to determine its calibration status.NOTE: Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use. Comment: The term "devices" was changed to "equipment“ because 1) the term equipment was already used in several places in clause 7.6, 2) the term devices has a broader scope and could include non-equipment types of tools, and 3) the term equipment is the better choice for this (calibration) clause. Also, wording of the clause was changed because stating that measuring equipment must "be identified" sounded like the organization was to add identification while most measuring equipment comes with identification already in place . Finally, since many software development organizations were unsure how to confirm that software used for monitoring and measurement has the ability to satisfy the intended application (per clause 7.6), a new Note was added to explain that it should include verification and configuration management for the software.

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8.2 Monitoring and Measurement

8.2.1 Customer SatisfactionNOTE: Monitoring customer perception may include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, dealer reports.

Comment: A new Note was added to provide examples of sources for monitoring customer perception.

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8.2 Monitoring and Measurement

8.2.2 Internal AuditA documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.

Records of the audits and their results shall be maintained (see 4.2.4). The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.NOTE: See ISO 19011 for guidance. Comment: The requirement for a documented procedure was emphasized by placing it first in the sentence. Also, "establishing records" was moved ahead of "reporting results" in the list of topics to be defined in the procedure because records are being captured throughout the audit and should be listed before the reporting of results. The new text highlights the need to maintain records of the audit and its results. Further, the change expands management "actions" to include "any necessary corrections and corrective actions" to emphasize that immediate correction might be needed before determining the cause of the nonconformity and taking corrective action to prevent its recurrence. Finally, the reference to the withdrawn ISO 10011 was replaced with a reference to ISO 19011, Guidelines for Quality and/or Environmental Management Systems Auditing.

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8.2 Monitoring and Measurement

8.2.3 Monitoring and Measurement of ProcessesWhen planned results are not achieved, correction and corrective action shall be taken, as appropriate. Comment: Clause 8.2.3 requires applying suitable methods for monitoring and measuring processes to demonstrate their ability to achieve planned results. For some supporting processes, these results are only indirectly related to product conformity. Therefore, the reference to product conformity (above) was moved to the new Note below. NOTE: When determining suitable methods, the organization should consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system. Comment: The new Note above was added to provide guidance in determining “suitable” methods: it says to consider the type and extent of monitoring or measurement based on the impact of the process on product conformity and system effectiveness.

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8.2 Monitoring and Measurement

8.2.4 Monitoring and Measurement of ProductThe organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria shall be maintained. Comment: The requirement to maintain evidence of conformity with acceptance criteria has been moved from the paragraph below to the paragraph above. Records shall indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4). The release of product and delivery of service to the customer shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer. Comment: Wording was changed to emphasize and clarify that the release of product and delivery of service is to the customer. 38

8.3 Control of Nonconforming ProductA documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming product. Comment: For clarity and added emphasis, the sentence above was revised to begin with (instead of end with) the requirement for a documented procedure. Where practicable, the organization shall deal with nonconforming product by one or more of the following ways:

d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started. Comment: For clarity, the above requirement was added to the list of ways for dealing with nonconforming product (from wording previously located below the list).

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CHANGES in ISO 9001:2008 are primarily clarifications

… intended to ensure improved understanding of the existing (ISO 9001:2000) requirements

… SO …

changes should be MINIMAL IF you implemented ISO 9001:2000 “as

intended”. 40

AS 9100 / 9110 / 9120 - Major changes expected on the additional aerospace requirements

TS 16949 – No changes expected

TL 9000 – Unclear at this time

ISO 14001 – TC 176 and TC 207 are working even closer, but (against some rumors) no integrated “Q&E” ISO Standard is in the works

OHSAS 18001, revised and released in July 2007, is closer to ISO 14001:2004.

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QUESTION AND

ANSWER SESSION

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