ISO 9001 2008 Summary Changes

Review of differences between Colour code: RED- Changes in wording

ISO 9001:2000 and ISO 9001:2008 BLUE- Text deleted

VIOLET- New text No colour code used where there is only change in word order

ISO 9001:2000 Clause ISO 9001:2008 Clause Summary of change Impact of change

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4.1 General requirements 4.1 General requirements

a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),

a) determine the processes needed for the quality management system and their application throughout the organization (see 1.2),

a) The word ‘identify’ has been replaced with ‘determine’

No impact with most customers

Determine implies that processes should be defined and managed effectively rather than just identifying that a process is needed.

e) monitor, measure and analyse these processes, and

e) monitor, measure where applicable, and analyse these processes, and

e) ‘Where applicable’ has been added to measure

The change allows the freedom not to measure some processes. Where measurement is not carried out the client will need to explain why it is not necessary to measure a process.

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Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.

Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.

‘With requirements’ changed to ‘to requirements’

‘Identified’ changed to ‘defined’.

The need to ‘define’ rather than ‘identify’ means control of outsourcing now needs to be adequately described.

This should only effect customers with minimal detail in their QMS

NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.

NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvement.

Note 1 ‘analysis and improvement ‘ added to list of process inclusions

This adds two processes that will need to be included. Some customers will already have these but it will now need to be clearer.

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NOTE 2 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.

Note 2 has been added defining an outsourced process

Clarification text only.

NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as

Note 3 Reinforces the Clients responsibility for control over outsourced processes and expands on the type of control that may be applied.

In theory no change to what should have been checked before.Control should still be demonstrated within the organisation.

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

Appropriate records will need to be maintained.

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b) the degree to which the control for the process is shared;

Need to check monitoring and measurement processes cover outsourcing

c) the capability of achieving the necessary control through the application of 7.4.

Need to check purchasing processes cover outsourcing

4.2.1 General 4.2.1 Generalc) documented procedures required by this International Standard,

c) documented procedures and records required by this International Standard, and

c) & d)

The clauses have been restructured but the intent stays the same.

No impact

d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and

d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.

This puts more onus on the organisation to show what documents and records it has and why. And also why it might not have some records.

e) records required by this International Standard (see 4.2.4).

The requirements for records previously in bullet e) have been incorporated in to bullets c) and d).

No impact

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NOTE 1 Where the term “documented procedure“ appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.

NOTE 1 Where the term “documented procedure“ appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.

Note 1 Additional text has been added to clarify a requirement or requirements may be covered in a single document or many documents

This gives more freedom for how requirements are documented.

In theory one procedure can cover many clauses or one requirement can be spread over many documents. Where the organisation has spread coverage over several documents or combined into one the organisation will need to be able to show how it has done this.

4.2.3 Control of documents 4.2.3 Control of documentsf) to ensure that documents of external origin are identified and their distribution controlled, and

f) 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, and

Clarification that the external documents needing control are those needed for use in the QMS

Gives the freedom to exclude some external documents where they do not have any impact.

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4.2.4 Control of records 4.2.4 Control of recordsRecords shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.

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

Wording and has been modified to give a change of emphasis but the requirements are the same.

No impact

A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.

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

No impact

5.5.2 Management representative

5.5.2 Management representative

Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes

Top management shall appoint a member of the organization’s management who, irrespective of other responsibilities, shall have responsibility and authority that includes.

Clarification that the management representative needs to be a member of the organisation’s own management.

Management representative needs to be within the organisation.

6.2 Human resources 6.2 Human resources6.2.1 General 6.2.1 General

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Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.

Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience.

‘product quality’ changed to ‘conformity to product requirements’.

No impact

NOTE Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system.

New note added about impact on product conformity by personnel with direct or indirect involvement

This broadens the requirement to analyse competence and activities throughout the company

6.2.2 Competence, awareness and training

6.2.2 Competence, training and awareness

Word order changed No impact

The organization shall The organization shalla) determine the necessary competence for personnel performing work affecting product quality,

a) determine the necessary competence for personnel performing work affecting conformity to product requirements,

Wording ‘affecting product quality’ changed to ‘affecting conformity to product requirements’.

No impact

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b) provide training or take other actions to satisfy these needs,

b) where applicable, provide training or take other actions to achieve the necessary competence,

‘Where applicable’ added and training should now ‘achieve the necessary competence’ as opposed to satisfy these needs.

Confirms the allowance for alternative methods than training to establish competence.

6.3 Infrastructure 6.3 Infrastructurec) supporting services (such as transport or communication).

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

Now includes information systems

IT should have previously been audited in infrastructure. This just confirms it.

6.4 Work environment 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).

New note added to clarify what is meant by the term ‘work environment’

No impact, just clarification.

7 Product realization 7 Product realization

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7.1 Planning of product

realization

7.1 Planning of product realization

b) the need to establish processes, documents, and provide resources specific to the product;

b) the need to establish processes and documents, and to provide resources specific to the product;

Slightly re-worded No impact

c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;

c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance;

The word ‘measurement’ has been added.

This clarifies that the Processes in the QMS should include measurement requirements. Measurement should already have been included. It may mean a slight change in records only.

7.2 Customer-related processes 7.2 Customer-related processes7.2.1 Determination of requirements related to the product

7.2.1 Determination of requirements related to the product

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c) statutory and regulatory requirements related to the product, and

c) statutory and regulatory requirements applicable to the product, and

The word ‘related’ has been changed to ‘applicable’

Confirms only applicable regulations relating to a product need to be determined.

d) any additional requirements determined by the organization.

d) any additional requirements considered necessary by the organization.

The word ‘determined’ has been changed to ‘considered necessary’

No impact.

. 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.

New note added to explain what ‘post delivery activities’ might mean. Such as warranty provisions.

Post delivery was already included in clause a), this just clarifies what is meant. This may impact on some companies where not all post delivery activities were considered.

7.3 Design and development 7.3 Design and development7.3.1 Design and development planning

7.3.1 Design and development planning

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NOTE Design and development review, verification and validation have distinct purposes. They may be conducted and recorded separately or in any combination as suitable for the product and the organization.

New note added to clarify that design review, verification and validation have distinct purposes but that they may be carried out in any suitable manner or combination.

This just gives more freedom to recording design information.

7.3.2 Design and development inputs

7.3.2 Design and development inputs

These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.

The inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.

‘These’ inputs changed to ‘the’ inputs

No impact

7.3.3 Design and development outputs

7.3.3 Design and development outputs

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The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.

The 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.

‘Provided in a form that enables’ has been changed to ‘in a form suitable for’.

No impact

NOTE Information for production and service provision can include details for the preservation of product.

New note added concerning the inclusion of preservation of product

Preservation should be checked as design element for manuals.

7.5 Production and service provision

7.5 Production and service provision

7.5.1 Control of production and service provision

7.5.1 Control of production and service provision

d) the availability and use of monitoring and measuring devices,

d) the availability and use of monitoring and measuring equipment,

‘Measuring devices’ has been changed to ‘measuring equipment’ to expand the scope of coverage as a device is a type of equipment.

No impact

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f) the implementation of release, delivery and post-delivery activities.

f) the implementation of product release, delivery and post-delivery activities.

‘Release’ has been changed to ‘product release’

No impact

7.5.2 Validation of processes for production and service provision

7.5.2 Validation of processes 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. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.

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.

Sentences have been combined. ‘This includes any processes where’ modified to ‘and as a consequence’

No impact

7.5.3 Identification and traceability

7.5.3 Identification and traceability

The organization shall identify the product status with respect to monitoring and measurement requirements.

The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization.

Clarification that inspection and test status must be identified ‘throughout product realization’

Should have no impact but will need confirming

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Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).

Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records (see 4.2.4).

Rewording of records requirement under traceability.

No impact

7.5.4 Customer property 7.5.4 Customer propertyNOTE Customer property can include intellectual property.

NOTE Customer property can include intellectual property and personal data.

The words ‘and personal data’ has been added to the note about intellectual property

Personal data will need checking as part of Customer Property.

7.5.5 Preservation of product 7.5.5 Preservation of product

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The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.

The organization shall preserve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.

Rewording to clarify the reasons for preservation.‘This’ has changed to ‘As applicable’

The ‘As Applicable’ may mean some records are required to say why any methods of preservation have been excluded or how methods are ‘applicable’.

7.6 Control of monitoring and measuring devices

7.6 Control of monitoring and measuring equipment

‘Measuring devices’ changed to ‘measuring equipment’

No impact

The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1).

The 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.

‘Measuring devices’ changed to ‘measuring equipment’ and the reference to 7.2.1 has been removed

No impact

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a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;

a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded (see 4.2.4);

Addition of ‘or both’ after verified.

Reference (See 4.2.4) added.

No impact

c) be identified to enable the calibration status to be determined;

c) have identification in order to determine its calibration status;

Reworded but no change in meaning.Identification can include reference to calibration status on equipment or separately.

No impact

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NOTE See ISO 10012-1 and ISO 10012-2 for guidance.

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.

The original note has been removed and replaced by a new note to explain about the use of computer software (when it is used for monitoring and measurement)

Where software is used for calibration this should have some evidence that it can perform the function it is being used for. This should already be the case.

8.1 General 8.1 Generala) to demonstrate conformity of the product,

a) to demonstrate conformity to product requirements,

‘Of the product' has been changed to 'to product requirements'

No impact

8.2 Monitoring and measurement

8.2 Monitoring and measurement

8.2.1 Customer satisfaction 8.2.1 Customer satisfaction

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NOTE Monitoring customer perception can 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 and dealer reports.

A new Note has been added to give some ideas on how customer satisfaction can be measured

No impact.

8.2.2 Internal audit 8.2.2 Internal audit

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An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.

An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.

No impact.

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

Paragraph order has been changed.Paragraph has also been reworded but requirement effectively the same.

No impact.

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The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.

Records of the audits and their results shall be maintained (see 4.2.4).

The records requirements has been given a separate paragraph.

No impact.

The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes.

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.

‘Actions’ changed to make it clear that both Correction and Corrective Action are required.

Records for solving problems found at audit will now need to show both Correction and Corrective Action

NOTE See ISO 19011 for guidance.

New note No impact guidance only.

8.2.3 Monitoring and measurement of processes

8.2.3 Monitoring and measurement of processes

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The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product.

The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate.

‘To ensure conformity of the product.’ has been removed.

Changed to make sure all processes are considered not just processes for product.

NOTE When determining suitable methods, it is advisable that the organization 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.

New Note added to explain that consideration of the type of monitoring and measuring of processes should relate to the extent to which they affect quality and the QMS

No impact note only.

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8.2.4 Monitoring and measurement of product

8.2.4 Monitoring and measurement of product

Records shall indicate the person(s) authorizing release of product (see 4.2.4).

Records shall indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4).

Clarification of product release records.

No impact

Product release and service delivery 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.

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.

‘Product release and service delivery’ changed to ‘The release of product and delivery of service to the customer’. This clarifies final release.

No impact

8.3 Control of nonconforming product

8.3 Control of nonconforming product

The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.

A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming product.

The requirement for a documented procedure has been reworded but the meaning remains unchanged

No impact

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The organization shall deal with nonconforming product by one or more of the following ways:

Where applicable, the organization shall deal with nonconforming product by one or more of the following ways:

The phrase ‘where applicable’ has been added.

Where one of the prescribed methods has not been followed reasons why it was ‘Not Applicable’ will need to be recorded. Other actions will still need to have been taken.

When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.

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.

Paragraph 4 has been change to d) but effectively no change.

No impact

8.4 Analysis of data 8.4 Analysis of data

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The analysis of data shall provide information relating tob) conformity to product requirements (see 7.2.1),c) characteristics and trends of processes and products including opportunities for preventive action, andd) suppliers.

The analysis of data shall provide information relating tob) conformity to product requirements (see 8.2.4),c) characteristics and trends of processes and products, including opportunities for preventive action (see 8.2.3 and 8.2.4), andd) suppliers (see 7.4).

b) conformity to product requirements is now pointed to the Clause 8.2.4 monitoring and measurement of product rather than 7.2.1.c) A reference to the monitoring and measuring clauses has been added.d) A reference to the Purchasing clause has been added.

No impact.

8.5.2 Corrective action 8.5.2 Corrective actionThe organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.

The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence.

‘cause’ becomes ‘causes’

Implies that corrective actions should look for causes not just one cause. If proper analysis is done this will not have any impact.

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f) reviewing corrective action taken.

f) reviewing the effectiveness of the corrective action taken.

The words ‘the effectiveness’ have been added to emphasise the purpose of the review.

Review of actions should look at their effectiveness

8.5.3 Preventive action 8.5.3 Preventive actione) reviewing preventive action taken.

e) reviewing the effectiveness of the preventive action taken

The words ‘the effectiveness’ have been added to emphasise the purpose of the review.

Review of actions should look at their effectiveness

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ISO 9001 2008 Summary Changes

Documents

Transcript of ISO 9001 2008 Summary Changes