The New BS EN ISO 9001:2008 Standard

What do the changes mean for you, if you are already registered to BS EN ISO 9001:2000?

The fourth and latest edition of the Quality Management Systems - Requirements Standard (BS EN ISO 9001:2008) was published on November 14th 2008. This revision contains minor amendments only. The aim of this revision is to clarify existing requirements and to improve consistency of approach with other management standards, such as ISO 14001:2004. In reality there will be little impact, there are very few changes of any consequence and most organisations will have little problem adapting their system to satisfy these changes. Following is information to help you to make the required changes. BS EN ISO 9001:2008 will replace BS EN ISO 9001:2000 but each organisation will be given approximately one year after its publication to make any updates (check with your Certifying Organisation). There should not be any major disruption to your organisation or your registration. Your auditor should be able to guide you through the process. Most changes relate to the reading of the standard and a few (highlighted) relate to changes in your documentation mainly your Quality Manual. In some cases the changes in the standard will have no effect on your activities or documentation.

Section
0.1

Ref

Changes

Para. 1 The influences on the design and implementation of an organisations quality management system are redefined and listed including environmental considerations and risk. Para. 4 Statement of where and who can use the standard now includes statutory requirements as well as customer and regulatory and clarifies that these requirements are restricted to those applicable to the product.

0.2 0.3

Paras. Minor clarifications and process definitions. 2&3 Changed description of the relationship between ISO 9001 and ISO 9004. Continue to complement each other. Notes New note stating ISO 9004:2000 under revision.

0.4

Para. 1 A comment has been added that the development of ISO 9001:2008 made due consideration to ISO 14001:2004, and reference to Annex A for correspondence between the standards. Bullets Again, statutory requirements have been added (as in 0.1). a) & b) Notes Note 1 has been amended to include comments regarding purchased product as well as product from realisation processes. Note 2 has been added explaining that statutory and regulatory requirements may be expressed as legal requirements.

1.1

1.2

Para. 3 Again, statutory requirements have been added (as in 0.1).

Para. 1 Amended to emphasise use of referenced documents. Para. 2 The reference to ISO 9000 now states the fact that is at version 2005.

3 4.1

Paras. The explanation of who the customer, organisation and supplier are, has 2 & 3 been removed Bullets a) The word identify has been replaced with determine e) Where applicable has been added to measure. Para. 4 The statement regarding outsourced processes has been slightly re-worded and emphasises that the outsourced controls shall be defined in the quality management system. This is a new shall. Notes Note 1 analysis and improvement added to list of process inclusions; Note 2 has been added giving a definition of an outsourced process; Note 3 expands on the type of control that may be applied to outsourced processes in order to ensure control over them including a link to clause 7.4 Purchasing.

4.2.1

c) & d) The wording has been slightly re-modelled but the intent stays the same. The requirements for records previously in bullet e) have been incorporated in to bullets c) and d). Notes Note 1 has been added to clarify that 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.

4.2.3 4.2.4 5.5.2

f)

Clarification that the external documents referred to are those needed for use in the Quality Management System. Restructured to three paragraphs but contain the same requirements. The shall requirement for control emphasised.

Para. 1 The requirement that the management representative needs to be a member of the organisations management has been added. This has always been the case. Notes Word change from liaison to liaising.

6.2.1

Para. 1 Change in wording to replace product quality with conformity to product requirements. Notes New note added concerning the effects of direct or indirect personnel on conformity.

6.2.2

Title a) b)

Change in title to Competence, training and awareness but keeps same words (change in their order). Where the current version mentions affecting product quality, it now states affecting conformity to product requirements. b) Now states that where applicable training needs to be provided to achieve the necessary competence. Now includes information systems.

6.3 6.4

c)

Notes New note added to clarify what work environment includes and gives some examples such as noise, temperature, humidity. If relevant to you, this may be worth discussion. b) Slightly re-worded.

7.1

c) 7.2.1 c) d)

The word measurement has been added to list. The word related has changed to applicable. The word determined has changed to considered necessary.

Notes New note added to explain what the phrase post delivery activities may include, i.e. warranty provisions, etc. If relevant, you should check this against your documents. 7.3.1 Notes New note added to explain that design review, verification and validation are separate activities though they may be performed separately or in any combination, e.g. verification and validation may be performed together. Para. 2 These inputs becomes the inputs (last paragraph). Para. 1 The words provided in a form that enables have been replaced by in a form suitable for. b) The word for (service provision) has been removed.

7.3.2 7.3.3

Notes New note added regarding the inclusion of preservation of product. 7.5.1 d) f) 7.5.2 7.5.3 Measuring devices has been replaced by measuring equipment. Release has been replaced by product release.

Para. 1 Sentences combined with the removal of This includes any processes where and the inclusion of and, as a consequence of. Para. 2 An added requirement to clarify that inspection and test status must be identified throughout product realisation. This could require a wording change in some cases. Para. 3 Slight re-wording of record requirement under traceability.

7.5.4

Para. 1 Re-wording of the requirement to inform the customer if there is a problem and keep records. Notes The phrase and personal data has been added to the intellectual property note.

7.5.5

Para. 1 Re-wording and changed placement of conformity of to in order to maintain conformity to requirements. This has changed to As applicable (sentence 2). Title Title change from measuring devices to measuring equipment

7.6

Para. 1 Change from measuring devices to measuring equipment and the reference to 7.2.1 has been removed a) c) Addition of or both after verified. Complete reword but no change.

Paras. Last sentence of paragraph 4 made in to separate paragraph without change. 4&5 Notes Original note removed and replaced by note to explain about the verification and configuration management of computer software (where it is used to monitor and measure). If relevant to you this wording should be checked. 'Of the product' replaced with 'to product requirements'.

8.1 8.2.1

a)

Notes A Note has been added to provide some ideas as to how customer satisfaction

can be measured. OK, but make sure that you can use whatever information is available. 8.2.2 Para. 2 This added for the selection of auditors. Para. 3 The requirement for a documented procedure has been re-worded but remains unchanged Para. 4 New paragraph. Taken the records requirements for paragraph 3 and given separate emphasis. Para. 5 A requirement for management responsible for the area audited to ensure that necessary corrections and corrective actions has been added. This may not be possible in some companies. The Management Representative should still take overall responsibility. Notes Note that makes reference to ISO 19011. 8.2.3 Para. 1 The phrase to ensure conformity of the product has been removed. Notes A Note has been added to explain that the organisation should consider the type of monitoring and measuring of processes and the extent to which they affect quality and the Quality Management System. 8.2.4 Para. 1 The requirement to maintain evidence of conformity with acceptance criteria has moved but is still a requirement. Paras. Evidence of conformity moved to paragraph 1. 2 & 3 Clarification of the fact that product release/service delivery is to the customer has been added. 8.3 Para. 1 The requirement for a documented procedure has been re-worded but remains unchanged. Para. 2 The phrase where applicable has been added to the methods for dealing with nonconforming product. d) New bullet, was paragraph 4 concerning action to be taken after delivery has been made.

Paras. Content unchanged but swapped. 3&4 8.4 b) c) d) 8.5.2 Change of reference to 8.2.4. Addition of reference to 8.2.3 & 8.2.4. Addition of reference to 7.4.

Para. 1 Cause becomes causes. f) Insertion of the effectiveness of the to Corrective Action. Insertion of the effectiveness of the to Preventive Action. Updated to show BS EN ISO 9001:2008 and BS EN ISO 14001:2004

8.5.3 Annexes

e) All

Summary of the basics: Update all of the ISO 9001:2000 references in your Quality Manual, Policies, Procedures, Work Instructions and documentation to ISO 9001:2008 (or BS EN ISO 9001:2008). In older systems

you may need to update the reference to ISO 9000 to ISO 9000:2005. Leave the reference to ISO 9004:2000 as it is as this will not be reissued until late in 2009. Change the following headings to read: 6.2.2 Competence, training and awareness and 7.6 Control of measuring and monitoring equipment. These are minor word changes only. However, if 7.6 Control of measuring and monitoring devices is listed as a Permissible Exclusion you should change the word devices to equipment where you have recorded this as an exclusion. This could be at the beginning and in the text of your Quality Manual. If there is a reference or diagram in your Quality Manual related to the supplier chain showing Customer > Organisation > Supplier this can be removed completely. Where you have references to Statutory or Legal and Statutory requirements this wording should be changed to Statutory and Regulatory requirements. You should consider compliance with statutory requirements when appointing and dealing with suppliers and subcontractors. When planning staff training you should ensure that it is suitable in advance and evaluate effectiveness on completion. Product identification should be carried out through the realisation process as well as the post production activities.

Understanding the Requirements of BS EN ISO 9001:2008

Following is general guidance where we have attempted to translate the basics of BS EN ISO 9001:2008 into Plain English. NOTE: Where the term Product is used this should be read as a reference to either Product or Service. The term Supplier means a supplier of Products or Services.

The starting point is Section 4 Quality Management System. The pages before this comprise a Contents page, Foreword Introduction and other general information as follows:

1 - Scope
1.1 General 1.2 Application

2 - Normative References 3 - Terms and Definitions 4 - Quality Management System

4.1 General Requirements Establish and document your Quality Management System Implement your Quality Management System Maintain and improve your Quality Management System 4.2 Documentation Requirements Develop Quality Management System documents including your Quality Policy and measurable Quality Objectives Prepare your Quality Manual, Procedures and Work Instructions to reflect what you do and how you do it Control your Quality management System documents Maintain Quality Management System records

5 - Management Responsibility
5.1 Management Commitment Demonstrate your commitment to quality

Promote the importance of quality within your organisation Support the development of your Quality Management System Support the implementation of your Quality Management System Support the continual improvement of your Quality Management System

5.2 Customer Focus Enhance customer satisfaction by ensuring that you identify customer requirements Enhance customer satisfaction by ensuring that customer requirements are being met 5.3 Quality Policy Ensure that your organisation's Quality Policy serves its overall purpose. Ensure that your Quality Policy makes it clear that requirements must be met. Ensure that your Quality Policy makes a commitment to continually improve the effectiveness of your Quality Management System. Ensure that your Quality Policy supports your organisation's Quality Objectives. Ensure that your Quality Policy is communicated and discussed throughout your organisation. Ensure that your Quality Policy is periodically reviewed to make sure that it is still relevant to your organisation. 5.4 Planning 5.4.1 Establish and periodically review measurable Quality Objectives 5.4.2 Plan the establishment, documentation and implementation of your Quality Management System. Plan to ensure that you maintain and continually improve your Quality Management System 5.5 Responsibility, Authority and Communication 5.5.1 Define and communicate your organisations responsibilities and authorities 5.5.2 Appoint a Management Representative from the organisations management 5.5.3 Ensure that appropriate internal communications are established throughout your organisation 5.6 Management Review 5.6.1 Review the organisations Quality Management System at planned intervals 5.6.2 Examine management review inputs including records and data 5.6.3 Generate management review outputs including decisions, actions and improvements.

6 - Resource Management

6.1 Provision of Resources Identify and provide resources required to implement, maintain and continually improve your Quality Management System Identify and provide resources required to enhance customer satisfaction by meeting customer requirements. 6.2 Human Resources 6.2.1 Employ and use competent personnel. 6.2.2 Regularly review employee competence. Provide and evaluate training and keep records of education, training, skills and experience. Promote employee awareness of quality within the organisation. 6.3 Infrastructure Identify, provide and maintain infrastructure needs such as buildings, work areas, equipment and transport. Infrastructure includes hardware, software, information systems and communications equipment. 6.4 Work Environment Identify and manage the work environment required to carry out your activities satisfactorily. Examples of conditions under which work is performed could include safety, hygiene, noise, vibration, temperature, humidity, light, air quality, weather, etc.

7 - Product Realisation
7.1 Planning of Product Realisation Plan, develop and record product realisation processes 7.2 Customer-related Processes 7.2.1 Identify customers' product requirements including delivery and post-delivery activities. Verify product statutory and regulatory requirements and any other additional requirements. Requirements could include warranties, maintenance, recycling, final disposal, etc. 7.2.2 Review your customers' product requirements, maintain records of product requirement reviews and control changes in customers product requirements. 7.2.3 Communicate with your customers. 7.3 Design and Development 7.3.1. Plan the design and development of your products. Control the design and development of your products. Update your planning outputs whenever product design and development progress makes this necessary. 7.3.2 Identify product design and development inputs. Maintain a record of design and development inputs. Review your product design and development inputs. 7.3.3 Produce product design and development outputs. Approve product design and development outputs before they are formally released. Verify that product design and development outputs meet design and development input requirements.

7.3.4 Perform systematic design and development reviews throughout the design and development process. Maintain a record of design and development reviews. 7.3.5 Carry out design and development verifications. Maintain a record of design and development verifications. 7.3.6 Perform design and development validations. Maintain a record of design and development validations. 7.3.7 Control design and development changes:
a) b) c) d) e) f)

Identify changes in design and development. Record changes in design and development. Review changes in design and development. Verify changes in design and development. Validate changes in design and development. Approve changes in design and development before you implement these changes.

7.4 Purchasing 7.4.1 Establish criteria that you can use to control suppliers. Evaluate your suppliers' ability to supply products that meet your organisation's requirements. Select suppliers that are capable of supplying products that meet your organisation's specified requirements. Make sure that purchased products meet specified purchase requirements. 7.4.2 Describe your purchasing requirements. Ensure that purchasing requirements are adequately specified before you discuss them with suppliers. 7.4.3 Establish product verification or inspection methods in order to ensure that purchased products meet purchase requirements. Implement product verification or inspection methods in order to ensure that purchased products meet purchase requirements. 7.5 Production and Service Provision 7.5.1 Carry out production and/or service provision under controlled conditions. 7.5.2 Validate production and service provision processes whenever process outputs cannot be measured, monitored, or verified until after the product is in use or the service has been delivered (such a process is often referred to as a special process). Establish arrangements to control special processes. 7.5.3 Establish the unique identity of your organisation's products (if appropriate). Identify the monitoring and measurement status of your organisation's products. 7.5.4 Identify property supplied to you by customers. Verify property supplied to you by customers. Protect property supplied to you by customers. Safeguard property supplied to you by customers. This includes work carried out on sites on behalf of customers. 7.5.5 Make sure that your products and components continue to conform to requirements while they are being processed internally. Make sure that your products and components continue to conform to requirements while they are being delivered to the intended destination. 7.6 Control of Monitoring and Measuring Equipment Identify your organisation's monitoring and measuring needs and requirements. Select equipment that can meet your organisation's monitoring and measuring needs and requirements. Establish monitoring and measuring processes. Calibrate your monitoring and measuring equipment whenever necessary to ensure that results are valid. Protect your monitoring and measuring equipment. Confirm that monitoring and measuring software is capable of doing the job you want it to do. Evaluate the validity of previous

measurements whenever you discover that your measuring or monitoring equipment is out-of-calibration. Maintain calibration records.

8 - Measurement, Analysis and Improvement

8.1 General Identify the monitoring, measurement, and analytical processes that your organisation needs to have in order to be able to demonstrate conformity and make improvements. Plan how monitoring, measurement, and analytical processes will be used to demonstrate conformity and make improvements. Implement your organisation's monitoring, measurement, and analytical processes. 8.2 Monitoring and Measurement 8.2.1 Establish methods that you can use to monitor and measure customer satisfaction (perceptions). Monitor and measure customer satisfaction. 8.2.2 Establish an internal audit procedure. Carry out internal audits of your Quality Management System. Take action to address audit results. 8.2.3 Select suitable methods to monitor and measure the processes that make up your organisation's Quality Management System. Take appropriate action whenever your Quality Management System processes fail to achieve planned results. 8.2.4 Monitor your organisation's product characteristics. Measure your organisation's product characteristics. 8.3 Control of Nonconforming Product Establish and document a procedure to identify and control nonconforming products. Identify and control your nonconforming products. Re-verify nonconforming products that were corrected. Control nonconforming products after delivery or use. Maintain records of nonconforming products. 8.4 Analysis of Data Define quality management information needs. Collect Quality Management System performance data. Provide information to management by analysing data. Utilise findings to develop measurable Quality Objectives. 8.5 Improvement 8.5.1 Continually improve the effectiveness of your Quality Management System. Use information and data to improve the effectiveness of your Quality Management System. 8.5.2 Establish a corrective action procedure. Document your corrective action procedure. Implement your corrective action procedure. Maintain your corrective action procedure. 8.5.3 Establish a preventive action procedure. Document your preventive action procedure. Implement your preventive action procedure. Maintain your preventive action procedure.

The Quality Standards Family

BS EN ISO 9001:2008 - Requirements. BS EN ISO 9000:2005 - Fundamentals and Vocabulary. BS EN ISO 9004:2000 - Guidelines for Performance Improvements (due to be reissued in 2009).