Introduction to ISO 9001:2008

Evolution of quality standards

ISO 9001 1987

ISO 9001 1994

ISO 9001 2000

ISO 9001 2008

Quality System Standard

generic (ISO 9000) industry related (AS 9000, TL 9000)

ISO 9002 and 9003

Prior to ISO 9001:2000, there were ISO 9002 and ISO 9003 too. These were subsets of ISO 9001 with certain exclusions. ISO 9002 & ISO 9003 (1987 and 1994) incorporated in ISO 9001:2000 and withdrawn

Process approach

Process approach to quality management encouraged An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process.

Processes:

Resources
Input

Controls
Output

Activities or set of activities

Processes - understand interactions

Resources Input
Process A

Controls
Process C

Output
Process B Process D

Customer satisfaction
C U S T O M E R S
Continual Improvement of the Quality Management System
R e q u i r e m e n t s

Management responsibility

Resource management
Input Product realisation

Measurement, Analysis and improvement Output Product

C U S T O M E R S

S a t i s f a c t i o n

Relationship with ISO 9001 and ISO 9004

Designed to complement each other Can be used independently Different scope - similar structure ISO 9001 can apply for certification or contractual purposes and focuses on effectiveness ISO 9004 provides wider focus on quality management
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1 Scope (1.1 General) Standard specifies QMS requirements for use to: demonstrate organisations ability to consistently provide product meeting customer & applicable statutory & regulatory (legal) requirements enhance customers satisfaction through effective application of the system including processes for its continual improvement and assurance of conformity to customer and applicable statutory & regulatory requirements
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1.2 Application

Requirements are generic Requirement may be excluded if cannot be applied due to the nature of organisation and its product Exclusions must:
Not affect ability or responsibility to provide conforming product Be limited to Clause 7
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2 Normative reference

ISO 9000 : 2005, Quality management systems Fundamentals and vocabulary.

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3 Terms and definitions

The term product also means service

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4.1 General requirements

Establish, document, implement and maintain a QMS and continually improve its effectiveness in accordance with the standard

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4.1 General Requirements Determine the processes necessary for QMS Determine the sequence and interaction of processes Determine criteria & methods to ensure effective operation & control of the processes Ensure availability of resources and information needed to support the operation & monitoring of the processes Monitor, measure where applicable and analyse processes Implement actions necessary to achieve planned results & continual improvement
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4.1 General Requirements

Manage the processes in accordance with the standard Ensure control of outsourced processes affecting product conformity Define control of outsourced processes within the QMS Control over outsourced processes does not absolve the organization of its responsibilities
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4.2 Documentation requirements

4.2.1 General QMS documentation:

Quality policy, objectives Quality manual Documented procedures and records Documents, including records determined by the organisation
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4.2.1 General

Documented procedure means that it must be established, documented, implemented and maintained Extend of documentation may differ due to
Size & type of organisation Complexity & interaction of processes Competence of personnel

Documentation may be in any type of media

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4.2.2 Quality manual

Quality manual must include as minimum:

The scope of QMS including details of, and justification for, any exclusions Documented procedures or reference thereto Description of the interaction between the processes of the QMS

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4.2.3 Control of documents

Documented procedures to:
approve documents prior to issue review, update as necessary and re-approve documents to identify the changes and the current revision status of documents to ensure documents remain legible, readily identifiable ensure relevant versions of applicable documents are available at points of use ensure that documents of external origin necessary for planning and operation of QMS are identified and distribution controlled obsolete documents are prevented from unintended use and identified if kept for any reason 20

4.2.4 Control of records

Records to provide evidence are controlled Documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of quality records. Records must be legible, readily identifiable and retrievable.
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5 Management responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning
5.4.1 Quality objectives 5.4.2 QMS planning

5.5 Responsibility, authority and communication

5.5.1 Responsibility & authority 5.5.2 Management representative 5.5.3 Internal communication

5.6 Management review

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5.6.1 General 5.6.2 Review input 5.6.3 Review output

5.1 Management commitment

Provide evidence of commitment to the development implementation and continual improvement of QMS by:
communicating the importance of meeting customer and statutory and regulatory requirements establishing quality policy & objectives management reviews provision of resources
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5.2 Customer focus

Determine customer requirements

Meet requirements Customer satisfaction
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5.3 Quality policy

appropriate to the purpose of the organisation commitment to comply with requirements continually improve the effectiveness of the QMS framework for establishing & reviewing quality objectives communicated and understood reviewed for continuing suitability
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5.4.1 Quality objectives

Establish quality objectives Measurable & consistent with the quality policy Include those needed to meet requirements for product

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5.4.2 Quality management system planning

Planning of the QMS is carried out in order to meet requirements given in 4.1, as well as the quality objectives Maintain the integrity of the QMS integrity when changes are planned and implemented

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5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority

define and communicate responsibilities and authorities

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5.5.2 Management Representative Member of the organizations management Ensures that processes needed for the QMS are established, implemented and maintained Reports on performance of QMS including needs for improvement Promotes awareness of customer requirements

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5.5.3 Internal communication

Communication processes are established Communication takes place regarding the effectiveness of QMS

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5.6 Management Review 5.6.1 General Review of the QMS by top management at planned intervals to:
ensure QMS suitability, adequacy & effectiveness assess opportunities for improvement evaluate the need for changes to QMS including policy & objectives

Records maintained.

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5.6.2 Review input

audit results customer feedback process performance product conformity status of PAs and CAs follow up actions from earlier reviews changes that could affect the QMS recommendations for improvement
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Management Review

5.6.3 Review output

Management Review

improved effectiveness of the QMS improvement of product resource needs

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6 Resource Management

6.1 Provision of resources 6.2 Human resources

6.2.1 General 6.2.2 Competence, training and awareness

6.3 Infrastructure 6.4 Work environment

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6.1 Provision of resources

Determine & provide the resources needed to:

implement, maintain the QMS and continually improve its effectiveness enhance customer satisfaction

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6.2 Human Resources

6.2.1 General Personnel performing work affecting conformity to product requirements must be competent on the basis of :
appropriate education training skills experience.
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6.2.2 Competence, training and awareness

Determine the necessary competence Provide training or take other action to satisfy those needs Evaluate the effectiveness of actions taken Ensure staff aware of relevance and importance of their activities and contribution to achieving objectives Maintain appropriate records of education, training, skills and experience
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6.3 Infrastructure

Determine, provide & maintain the infrastructure needed to achieve product conformity. Infrastructure includes, as applicable:
buildings, workspace equipment supporting services
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6.4 Work environment

Determine and manage the work environment needed to achieve product conformity.

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7 Product realization

7.1 7.2 7.3 7.4 7.5 7.6

Planning of product realization Customer related processes Design & development Purchasing Production & service provision Control of measuring & monitoring equipment
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7.1 Planning of product realization

Planning must determine as appropriate:

quality objectives and requirements for the product the need for processes, documentation, resources specific to the product verification and validation activities & acceptance criteria Records to provide evidence
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7.2 Customer related processes

7.2.1 Determination of requirements related to product 7.2.2 Review of requirements related to product 7.2.3 Customer communication

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7.2.1 Determination of requirements related to product

Organisation must determine:

requirements specified by the customer requirements not specified but necessary statutory and regulatory requirements applicable to product, any additional requirements

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7.2.2 Review requirements related to the product

Review requirements before commitment to supply product & ensure that:
product requirements are defined difference between contract requirements from those previously expressed resolved organisation has ability to meet the requirements

Record the results of review and actions Confirm requirements, when customer does not provide documented requirements When requirements are changed ensure that documents are amended and relevant persons are made aware of the changes.
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7.2.3 Customer communication

Effective arrangements for communication with customers relating to :

product information enquiry, contract & order handling including amendments customer feedback including complaints

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7.3 Design & development (not applicable in L&M) 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 Design & development planning Design & development inputs Design & development outputs Design & development review Design & development verification Design & development validation Control of design & development changes
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7.3.1 Design & development (D&D) planning

Plan & control D&D of the product. Planning to include:

D&D stages required review, verification and validation activities responsibilities & authorities for D&D

Interfaces between groups must be managed Planning to be updated as the D&D progresses
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7.3.2 Design & development inputs Determine & record product requirements including:
functional & performance requirements applicable statutory and regulatory requirements information from previous similar designs any other essential requirements

Review input for adequacy Requirements must be complete, unambiguous and not in conflict with each other
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7.3.3 Design & development outputs D&D output in a form suitable for verification D&D output must
meet the input requirements provide information for purchasing, production and service provision contain or reference acceptance criteria define characteristics essential for proper & safe use

Approve output prior to release

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7.3.4 Design & development review

At suitable stages systematic reviews of D&D to:

evaluate the ability to meet requirements identify problems and propose follow up

Involve all functions concerned Record the results and any necessary actions

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7.3.5 Design & development verification

Verify D&D to ensure that output meets the input requirements Record the results of verification and necessary actions

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7.3.6 Design & development validation

Perform D&D validation to confirm that product is capable of meeting the requirements for the specified or intended use Whenever applicable to be completed prior to delivery Results of validation and necessary actions must be recorded
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7.3.7 Control of design and development changes

Design & development changes must be identified and records maintained Changes must be reviewed, verified and validated as appropriate and approved before implementation Record results of review of changes and any necessary actions
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7.4 Purchasing

7.4.1 7.4.2 7.4.3

Purchasing process Purchasing information Verification of purchased product

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7.4.1 Purchasing process Ensure that purchased product meets requirements Type & extend of control depends on effect purchased product may have on the final product Evaluate and selects suppliers based on their ability to supply conforming product Establish criteria for selection, evaluation and re-evaluation of suppliers Results of evaluation and any necessary actions must be recorded
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7.4.2 Purchasing information

Purchasing information must include where appropriate:

requirements for approval of product, procedures, processes and equipment requirements for qualification of personnel quality management system requirements

Ensure adequacy of specified purchase requirements prior to their communication to supplier

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7.4.3 Verification of purchased product

Establish & implement inspection or other activities needed to ensure purchased product conformity Where organisation or its customer propose verification at suppliers premises, organisation must specify in purchasing information:
verification arrangements method of product release
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7.5

Production and service provision

7.5.1 7.5.2

7.5.3 7.5.4 7.5.5

Control of production and service provision Validation of processes for production and service provision Identification & traceability Customer property Preservation of product
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7.5.1 Control of production and service provision Plan and carry out production & service provision under controlled conditions. Controlled conditions include as applicable:
a) availability of information describing product characteristics b) availability of work instructions, as necessary c) the use of suitable equipment d) availability & use of monitoring and measuring equipment e) implementation of monitoring and measurement f) the implementation of product release, delivery and post delivery activities
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7.5.2 Validation of processes

Validate processes where outcome is not verified and as a consequence, deficiencies may become apparent after delivery Validation shall demonstrate the ability of processes to achieve results For these processes establish: criteria for review and approval of the process approval of equipment and qualification of personnel use of defined methods & procedures requirements for records revalidation
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7.5.3 Identification and traceability

Where appropriate identify product by suitable means throughout product realization Identify status with respect to measurement & monitoring requirements throughout product realization Where traceability is required control the unique identification of product Maintain records
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7.5.4 Customer property Care for customers property while it is under organisations control or being used by organisation Identification, verification, protection & safeguarding customer property provided for use or incorporation Any customer property that is lost, damaged or found unsuitable must recorded & reported to customer
Customer property includes intellectual property & personal data
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7.5.5

Preservation of product

Preserve the product during internal processing and final delivery to intended destination Include identification, handling, packaging, storage and protection This applies to constituent parts of a product

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7.6 Control of monitoring & measuring equipment Determine monitoring and measurements to be made & measurement & monitoring equipment needed to provide evidence of conformity of product Ensure measuring and monitoring is carried out consistently with monitoring and measurement requirements Suitability of measuring/monitoring software must be confirmed prior to use and re-confirm as necessary
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7.6 Control of monitoring & measuring equipment

Calibrate or verify or both at specified intervals or prior to use against international or national standards. Where no such standard exist record the basis Adjust or re-adjust as necessary Have identification to determine calibration status Safeguard from adjustments invalidating calibration Protect from damage or deterioration during handling, maintenance& storage record results of calibration assess and record validity of previous results when device found to be out of calibration

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8 Measurement, analysis and improvement

8.1 General 8.2 Monitoring/measurement
8.2.1 Customer satisfaction 8.2.2 Internal Audit 8.2.3 Monitoring & measurement of processes 8.2.4 Monitoring & measurement of product

8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement

8.5.1 Continual improvement 8.5.2 Corrective action 8.5.3 Preventive action

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8.1 General

Plan & implement measurement, monitoring analysis and improvement processes needed to:
demonstrate conformity to product requirements ensure conformity of the QMS continually improve the effectiveness of the QMS

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8.2.1 Customer satisfaction

Organisation shall monitor information related to customer perception as to whether the organisation has met customer requirements. The methods for obtaining and using this information must be determined

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8.2.2 Internal audit Conduct internal audits at planned intervals to determine if :

QMS conforms to the planned arrangements, requirements of the standard and organisations requirements QMS is effectively implemented & maintained

Plan the audit programme considering:

status and importance of the processes and the areas results of previous audits

Define audit criteria, scope, frequency & methodologies

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8.2.2 Internal audit Select auditors to ensure objectivity and impartiality. Auditor must not audit own work. The documented procedure must cover:
responsibilities & requirements for planning and conducting audits reporting results and maintaining records

Corrective actions without undue delay Follow up to verify actions taken & report verification results
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8.2.3 Monitoring and measurement of processes

Apply suitable methods for monitoring and, where applicable, measurement of QMS processes
These methods shall demonstrate the ability of the processes to achieve planned results Where planned results are not achieved corrections and corrective actions must be taken

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8.2.4 Monitoring and measurement of product

Monitor & measure product characteristics to verify conformity at appropriate stages Evidence of conformity with the acceptance criteria must be maintained. Records must indicate the person(s) authorising release of the product for delivery to the customer Release or delivery must not proceed until all the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by the customer

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8.3 Control of nonconforming product

Nonconforming product must be identified and controlled to prevent unintended use or delivery Documented procedure to define controls, responsibility and authority When the nonconforming product is corrected it must be re-verified to demonstrate conformity
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8.3 Control of nonconforming product Organisation must deal with nonconforming product by one or more of the following ways: action to eliminate detected nonconformity concession preclude original intended use or application Taking actions appropriate to the effects, when nonconformity is detected after delivery Records of the nature of nonconformity and any subsequent action including concessions must be maintained
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8.4 Analysis of data

Determine, collect & analyse appropriate data to demonstrate the suitability and effectiveness of QMS and to evaluate where continual improvement of the QMS can be made Data from measurement & monitoring & other relevant sources Analyze data to provide information on:

customer satisfaction conformity to product requirements process, product characteristics and their trends including opportunities for preventive action suppliers
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8.5 Improvement
8.5.1 Continual improvement Organisation shall continually improve the effectiveness of the QMS through use of:
quality policy quality objectives audit results analysis of data corrective actions preventive actions management review 76

8.5.2 Corrective action

Take actions to eliminate the causes of nonconformities to prevent recurrence. Corrective actions appropriate to the impact of the problem Documented procedure shall define requirements for:
reviewing nonconformities (including customer complaints) determining the causes of nonconformities Evaluating the need for corrective action determining & implementing action needed recording results of action taken reviewing the effectiveness of the corrective action taken 77

8.5.3 Preventive action Determine action to eliminate the causes of potential nonconformances to prevent occurrence. Actions appropriate to the impact of the potential problem Documented procedure must define the requirements for
determining potential nonconformances & their causes evaluating the need for preventive action determining and implementing action needed recording the results of action taken reviewing the effectiveness of the preventive action taken
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