18681007 Introduction to ISO 90012008 Presentation

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Introduction to ISO9001:2008

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What is ISO?

The International Organization for Standardization(ISO) was established in 1947 and is an associationof 157 members, which each represent their own

country. ISO employs a system of TechnicalCommittees and Working Groups to developInternational Standards.

British Standards Institute is the National Standards

Body that represents the United Kingdom at ISO www.bsigroup.com

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What are the ISO 9000 standards?

The ISO 9000 standards are a collection of formalInternational Standards, Technical Specifications,Technical Reports, Handbooks and web based

documents on Quality Management. There are 25 documents in the collection altogether

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What are the main ISO 9000 standards?

ISO 9000:2005 Quality management systems – Fundamentals and vocabulary.Covers the basics of what quality management systems are and also contains thecore language of the ISO 9000 series of standards. A guidance document used forreference to understand terms and vocabulary related to quality managementsystems.

ISO 9001:2008 Quality management systems – Requirements

This is the only ISO9000 standard for which certification can be gained.Intended for use in any organization regardless of size, type or productincluding service. It provides a number of Quality Management Systemrequirements which an organization needs to fulfil to achieve customersatisfaction. It includes a requirement for the continual improvement.

ISO 9004:2000 Quality management systems - Guidelines forperformance improvements. Covers continual improvement. This gives youadvice on what you could do to enhance a mature system. This standard very specifically states that it is not intended as a guide to implementation.

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What is the ISO 9001 History?

• ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products. Had the same structure as the UK Standard BS 5750 unfortunately theemphasis tended to be placed on conformance with procedures rather than the overallprocess of management.

•

ISO 9001:2000Combination of the three standards 9001, 9002, and 9003 into one, called 9001. Designand development procedures are required only if a company does engage in the creationof new products. Introduced the concept of process management. Required theinvolvement of Senior Management in order to integrate quality into the business systemand avoid delegation of quality functions to junior staff. Required measurement of theeffectiveness of tasks and activities. Expectations of continual process improvement andtracking customer satisfaction were defined.

• ISO 9001:2008Introduces clarifications to the existing requirements of ISO 9001:2000 and somechanges intended to improve consistency with Environmental Management StandardISO 14001:2004. The standard is now practical and business improvement focused. It iscompletely different to the original standard which was discredited in some areas as apaper exercise.

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What are the ISO 9001 requirements for aQuality Management System?

The organisation needs to demonstrate its ability toconsistently provide product that meets customer

and regulatory requirements The organisation must aim to enhance customer

satisfaction through the effective application of thequality management system. This includes processes

for continual improvement of the system.

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What are the requirements of ISO 9001?

The requirements in ISO 9001 include:

a set of procedures that cover all key processes in a business

monitoring processes to ensure they are effective keeping adequate records

checking output for defects, with appropriate andcorrective action where necessary

regularly reviewing individual processes and thequality system itself for effectiveness

Focus on continual improvement

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What are the ISO 9001:2008 Quality management systems requirements?

The ISO9001:2008 Standard consists of the followingsections:

Section 1: Scope

Section 2: Normative Reference

Section 3: Terms and definitions

Section 4: Quality Management System

Section 5: Management Responsibility

Section 6: Resource Management Section 7: Product Realization

Section 8: Measurement, analysis and improvement

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ISO 9001:2008 Quality management system requirements: Section 4: Quality Management System from our Manual

Quality Management System Section 4 ISO9001:2008

4.1 Introduction QM001 Quality Management System

4.2 DocumentationQM002 QMS Manual Summary

4.2.3 Internal Document ControlQM003 Document Control

4.2.3 External Document Control

QM004

Customer, Statutory and

Regulatory Conformance

4.2.4 Quality System RecordsQM005 Record Control

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ISO 9001:2008 Clause Our Document Number Our Procedure



ISO 9001:2008 Quality management system requirements: Section 5: Management Responsibility from our Manual

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Management Responsibility Section 5 ISO9001:2008

5.1 Management Commitment QM006 Management Commitment

5.2 Customer FocusQM007 Quality Policy

5.3 Quality Policy

5.4 Planning QM001 Quality Management System

5.5 Responsibility & Authority

QM008 Responsibility and Authority

5.5 Communication

5.6 Management Review QM009 Management Review




ISO 9001:2008 Quality management system requirements: Section 6: Resource Management from our Manual

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Resource Management Section 6 ISO9001:2008

6.1 Resources

QM010 Resources and Training6.2 Human Resources & Training

6.3 Infrastructure

QM011Infrastructure and Work

Environment6.4 Work Environment




ISO 9001:2008 Quality management system requirements: Section 7: Product Realisation from our Manual

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Product Realisation Section 7 ISO9001:2008

7.1 Product RealisationQM012 Contract Review and Planning

7.2 Customer Related Processes

7.3 Design and Development QM013 Design and Development

7.4 Purchasing, Orders andVerification of Purchased

Materials

QM014Purchasing, Orders andVerification of Purchased

Materials

7.5 Operational Control

7.5.1 ProductionQM015 Production

7.5.2 Validation of Processes

7.5.3 Identification and Traceability QM016 Identification and Traceability

7.5.4 Customer Property QM017 Customer Property

7.5.5 Preservation of Product

QM018 Preservation of Product

QM019 Despatch and Distribution

QM020 Maintenance

7.6 Control of Monitoring andMeasuring Equipment

QM020 Calibration




ISO 9001:2008 Quality system requirements: Section 8: Measurement, Analysis and Improvement from our Manual

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Measurement, Analysis and Improvement Section 8 ISO9001:2008

8.1 General

QM023 Measurement and Monitoring8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction QM024 Customer Satisfaction

8.2.2 Internal Audit QM025 Internal Audit

8.2.3 Monitoring and Measuring

ProcessesQM023 Measurement and Monitoring

8.3 Control of Non-Conforming

Product

QM027Control of Non-Conforming

Product8.4 Analysis of Data

QM026Monitoring and Measuring QMS

Processes, Analysis of Data

8.5 Improvement

8.5.1 Corrective Action

8.5.2 Preventative Action

QM028

QM029

QM030

Corrective Action, Preventive

Action and Improvement

Crisis Management

Product Recall




What are the ISO 9001:2008 Quality management systems document requirements?

ISO 9001:2008 refers specifically to only 6 documented

procedures (See next Slide).

Other documentation may be required by an organizationin order to manage the processes that are necessary for the

effective operation of the quality management system.

This will vary depending on the size of the organization, thekind of activities in which it is involved and theircomplexity. Our Small Business ISO 9001 Manual covers all

the basic clauses of ISO 9001:2008 with 9procedures/documents our ISO9001:2008 Quality Management System is much more detailed and has 30documents. Both include 14 records.

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The standard specifies six compulsory documents:

Control of Documents (4.2.3)

Control of Records (4.2.4)

Internal Audits (8.2.2) Control of Nonconforming Product / Service (8.3)

Corrective Action (8.5.2)

Preventive Action (8.5.3) In addition to these ISO 9001:2008 requires a

Quality Policy and Quality Manual

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Control of Documents (4.2.3)

The ISO9001:2008 standard requires that an

organization needs a documented procedure tocontrol quality documents. All employees must haveaccess to up-to-date documents and be aware of how to use them.

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Control of Records (4.2.4)

The ISO9001:2008 standard requires that Records

are controlled in a similar way to documents. They should be retained to demonstrate conformity, show how products were processed and to allow productsand problems to be traced to the source.

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Internal Audits (8.2.2)

The ISO9001:2008 standard requires a

documented procedure for internal audits. It is arequirement to regularly review performancethrough internal audits to determine whether thequality system is working and what improvements

can be made. It is a requirement to keep records of these activities and the resulting decisions.

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Control of Nonconforming Product / Service (8.3)

You need documented procedures for dealing with actualand potential non-conformances (problems involvingsuppliers or customers, or internal problems). Theprocedure should define how to isolate and quarantineproduct that does not meet requirements, how you decide what to do with this product and how you take action to

deal with the root cause of the problem. You must also keeprecords of Non-Conforming Product to use as a tool to

improve the system.

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Corrective Action (8.5.2)

The ISO9001:2008 standard requires that you takeCorrective Action to rectify non-conformances. It is arequirement to keep records of these activities and monitortheir effectiveness.

Preventive Action (8.5.3)

The ISO9001:2008 standard requires that you need to takePreventative Action to eliminate potential causes of problems. It is a requirement to keep records of theseactivities and monitor their effectiveness.

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ISO 9001:2008 requires a Quality Policy and Quality Manual

• The quality policy is a formal statement from

management, closely linked to the business andmarketing plan and to customer needs. The quality policy is understood and followed at all levels and by all employees. Each employee needs measurable

objectives to work towards.• Your procedures will be maintained in your Quality

Manual.

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The ISO9001:2008 standard requires that decisionsabout the quality system are made based on recordeddata and the system is regularly audited andevaluated for conformance and effectiveness.

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The ISO9001:2008 standard requires that tomaintain the quality system and produce conforming

product, you need to provide suitable infrastructure,resources, information, equipment, measuring andmonitoring devices, and work environment.

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The ISO9001:2008 standard requires that anorganisation needs to map out all key processes in your company, control them by monitoring,

measurement and analysis, and ensure that productquality objectives are met.

If you can’t monitor a process by measurement, thenmake sure the process is well enough defined that you can make adjustments if the product does notmeet user needs.

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The ISO9001:2008 standard has an absolute requirementto maintain the following records:

Management Review Minutes

Training Record

Product Release Record

Design and Development Records

- Results of the review of customer requirements

- Design and development inputs relating to product requirements

- Results of design and development reviews and actions

- Results of design and development verification and actions

- Results of design and development validation and actions- Results of the review of design and development changes

Supplier Assessment Record

All of these records are provided in our manual packs

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The ISO9001:2008 standard has an absolute requirement

to maintain the following records: Validation Record

Identification and Traceability Record

Register of Customer Property Calibration Record

- Basis used for calibration or verification of measuring equipment where nointernational or national measurement standards exist

- Validity of the previous measuring results when the measuring equipment is found notto conform to requirements

- Results of calibration and verification of measuring equipment Internal Audit Record

Records of Non-conforming Product

Corrective Action Request Form

Preventative Action Request Form

All of these records are provided in our manual packs www.9001manual.com




The ISO9001:2008 standard requires that youestablish quality objectives, plan processes, anddocument and measure results to use as a tool for

improvement. For each process it is important to determine what

kind of procedural documentation is required

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• The ISO9001:2008 standard requires that you need todetermine key points where each process requiresmonitoring and measurement, and ensure that allmonitoring and measuring devices are properly maintainedand calibrated.

• The ISO9001:2008 standard requires that you need to haveclear requirements for purchased product.

• The ISO9001:2008 standard requires that you need todetermine customer requirements and create systems forcommunicating with customers about product information,inquiries, contracts, orders, feedback and complaints.

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The ISO9001:2008 standard requires that you when aredeveloping new products, you need to plan the stages of development, with appropriate testing at each stage. Youneed to test and document whether the product meets

design requirements, regulatory requirements and userneeds.

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What are the 8 Quality Management Principles?

Customer focus

Leadership

Involvement of people

Process approach System approach to management

Continual improvement

Factual approach to decision making Mutually beneficial supplier relationships

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Why is customer satisfaction included in ISO 9001?

"Customer satisfaction" is one of the main drivingcriteria for any organization. In order to evaluate if aproduct meets customer needs and expectations, it is

necessary to monitor and measure customersatisfaction. Improvements can be made by takingaction to address any identified issues and concerns. Your customers will gain confidence that your

products will meet their needs and increase theirsatisfaction.

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What is Continual Improvement?

Continual improvement is the process focused oncontinually increasing the effectiveness and/orefficiency of the organization to fulfil its policies and

objectives.

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ISO 9001:2008 Process Approach to Management

The ISO9001:2008 standard requires that anorganisation needs to map out all key processes in your company, control them by monitoring,

measurement and analysis, and ensure that productquality objectives are met.

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What is a process?

An activity which receives inputs and converts them

to outputs is a process.

Almost all activities and operations involved ingenerating a product or providing a service are

processes.

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What is a “process approach”?

The systematic identification and management of the

processes within an organization and theinteractions between the processes is known as aprocess approach to management.

The process approach is a key element of the ISO

9000 standards.

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What are the benefits “process approach”?

The integration and alignment of its processes to enable the achievement of its planned results.

An ability to focus effort on process effectiveness and efficiency. Transparency of operations within the organization. Lower costs and shorter cycle times through effective and efficient use of

resources. The encouragement and involvement of people, and the clarification of

their responsibilities. The elimination of barriers between different functional units and the

unification of their focus to the objectives of the organization. Improved management of process interfaces.

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How do you measure a process?Typical factors that are useful to consider when identifyingmeasures of process control and process performanceinclude:

• Product Conformity with requirements• Customer satisfaction• Supplier performance• On time delivery • Lead times•

Incident numbers and Failure rates• Percentage Waste• Process costs• Order completion

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What is the difference between a process and aprocedure?

A process may be explained as a set of interacting or

interrelated activities, which are employed to add value. A procedure is a method of describing the way or in which all or part of that process activitiesshould be performed.

ISO 9000:2005 defines a procedure as a "specified way to carry out an activity or a process", which doesnot necessarily have to be documented.

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What is the PDCA cycle?

The PDCA cycle is an established, logical, method thatcan be used to improve a process.

This requires: (P) planning (what to do and how to do it),

(D) executing the plan (do what was planned), (C) checking the results (did things happened according

to plan) and (A) act to improve the process (how to improve next

time).

The PDCA cycle can be applied within an individualprocess, or across a group of processes.

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PDCA Cycle

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What do you need to do to comply with ISO 9001:2008?

When initially starting to use ISO 9001, you shouldfamiliarize yourself with the Quality ManagementSystem standards, especially ISO 9000, ISO 9001and ISO 9004, and consider their requirements.

If you wish to proceed to certification, you shouldfollow our guides and checklists and implement theprocedures and records in our manual pack then use

Gap Analysis Checklist to determine if your systemmeets the requirements of ISO 9001. Developing andimplement additional procedures or processes toaddress any shortfalls.

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What are the requirements for auditors?

The standards require that auditors are able to understand theorganization's activities and processes and appropriately auditagainst the requirements of the ISO 9001 in relation to theorganization's objectives.

Auditors should be able to demonstrate competency in:

The requirements of the ISO 9001:2008.

Quality Management Systems.

A general understanding of ISO 9000:2005 and ISO 9004. Auditing techniques.

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What is certification to ISO9001:2008?

Organizations have their quality management system certified toISO 9001:2008.

When an organization seeks to certify (sometimes referred to asregister) it’s quality management system to ISO 9001:2008, it isrequired to agree a "scope of certification" with its certification body (sometimes called registrar).

This will define the products to which the organization's quality management system is applicable, and against which it will beassessed. An organization is not obliged to include within its "scopeof certification" all the products that it provides but may be selectiveabout those that are included. All applicable requirements of ISO

9001:2008 will need to be addressed by the organization's quality management system that covers those products that are included inthe "scope of certification".

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What is ISO 9001 certification?

A company or organization that has beenindependently audited and certified to be inconformance with ISO 9001 may publicly state thatit is "ISO 9001 certified" or "ISO 9001 registered".

Certification to an ISO 9001 standard does notguarantee any quality of end products, it certifiesthat approved business processes are being applied.

Although the standards originated in manufacturing,

they are now employed across several types of organizations. A "product" in ISO vocabulary canmean a physical object or services

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Wh t th i b fit t b d i d f i l ti



What are the main benefits to be derived from implementing an

ISO 9000 quality management system?

The ISO 9000 standards give organizations thediscipline to focus their activities and to continually improve their performance.

The standards require implementation of a quality management system which manages the processes within an organisation.

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How will the implementation of the



o e p e e a o o eISO9001:2008 standard help us?

ISO 9001:2008 aims at guaranteeing theeffectiveness of the organization

Further progress can be made by using ISO 9004 in

addition to ISO 9001:2008. The ISO 9004 guidingquality management principles are intended to assistan organization in continual improvement

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pISO9001:2008 standard help us?

It gives you a Competitive advantage

ISO 9001 is senior management led so ensuring astrategic approach to your management systems.

The certification process ensures that your businesspolicies and objectives drive your processes and working practices to ensure you maximise the returnfrom your resources.

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Improves performance

ISO 9001 helps your employees to raise theorganization’s performance above and beyond

competitors who aren’t using structuredmanagement systems. Certification also makes iteasier to measure performance and improve the way you manage your business.

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Enhances Company reputation

Certification to ISO 9001 will boost your company’sreputation and can be a useful promotional andmarketing tool. It sends a clear message to allinterested parties that this is a company committedto high standards and continual improvement.

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Saves you money

Evidence shows that the financial benefits forcompanies that have invested in and certified theirquality management systems to ISO 9001 includeoperational efficiencies, increased sales, higherreturn on assets and greater profitability.

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Improves Efficiency and Streamlinesoperations

Your quality management system focuses on yourobjectives and operating processes. This encourages you to improve the efficiency of your business, thequality of your products, the service you provide andhelps to reduce your waste and customer complaints

levels.

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Increases customer satisfaction

The structure of ISO 9001 ensures that the needs of thecustomer are being considered and met and your company focus is on constantly increasing customer satisfaction.

"Customer satisfaction" is one of the main driving criteriafor any organization. In order to evaluate if a product meetscustomer needs and expectations, it is necessary to monitorand measure customer satisfaction. Improvements can be

made by taking action to address any identified issues andconcerns. Your customers will gain confidence that yourproducts will meet their needs and increase theirsatisfaction.

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Encourages internal communication, raisesmorale and employee ownership

ISO 9001 ensures that employees feel more involvedthrough improved communication and training they will understand and take ownership of the company policies and objectives.

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What is the next stage for us?

Use our ISO 9001 Quality Manual Templatesupplied with:

A Guide to the Process of Implementing anISO 9001:2008 compliant manual

“with you all the way” Implementationguide to help you integrate our manual

templates into your quality managementsystem

ISO 9001:2008 Gap Analysis Checklist



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