Upgrading the existing QMS to ISO 9001:2008 Standard
ISO 9001:2008 QMS Standard has been published on 15 November 2008 by the International Organization for Standardization (ISO). Organizations having the ISO 9001:2000 QMS certifications will upgrade their quality management system as per 2008 version. As per implementation plan jointly announced by International Organization for Standardization (ISO) and International Accreditation Forum (IAF), organizations should upgrade their ISO 9001:2000 QMS to ISO 9001:2008 QMS before 15 November 2010 (within two years from the data of publication of ISO 9001:2008 Standard). However, efforts of many management representatives will be to upgrade their quality management system and obtain certification as per ISO 9001:2008 QMS Standard as early as possible.
It’s good to upgrade the system, but how you can do it in an effective manner. The quality management system of your organization should be able to demonstrate continual improvement as well as changes as per new version. Following steps may be useful.
Step 1 – Get acquainted with ISO 9001:2008 QMS Standard
Nothing can be done without knowing the changes, so please obtain a copy of ISO 9001:2008 Standard. You can obtain the same from the ISO Central Secretariat or from the sales counter of the National Standards Body in your country. ‘Bureau of Indian Standards’ is the national standards body in India, from which you can obtain the equivalent Indian Standard to ISO 9001:2008 QMS. Read ISO 9001:2008 Standard carefully. You should also refer to other reading materials (such as books, articles) on ISO 9001:2008 QMS.
Start ISO 9001:2008 QMS Awareness Programme in your organization. Members of task force, members of steering committee and people, actively involved in ISO 9001 QMS implementation, should be encouraged to attend ISO 9001:2008 Awareness Programme.
Step 2 – Action Plan
Please prepare an action plan for up-gradation to ISO 9001:2008 from the 2000 version. The action plan should indicate the responsibilities of different departments and personnel and set target dates for completion of activities (such as target dates for completion of documentation, training of internal auditors, internal audit, management review etc.).
Step 3 – Revision of QMS Documentation
A few people should be selected for revision of QMS documentation as per ISO 9001:2008 QMS Standard. The Management Representative should be the coordinator of the QMS documentation revision task. Revision in documentation should be done and revised documents should be issued.
Step 4 – Implementation
Implementation should be carried out immediately upon issue of revised documentation as per ISO 9001:2008 QMS Standard.
Step 5 – Training of internal auditors
Internal auditors should be aware of ISO 9001:2008 QMS Standard, so please provide training to your internal auditors, so that they may be able to carry out value added internal audit as per ISO 9001:2008 QMS Standard.
Step 6 – Internal Audit
After implementation as per revised documentation, please carry out internal audit as per ISO 9001:2008 QMS Standard. Take corrective action for the nonconformity or nonconformities observed during the internal audit.
Step 7 – Management Review
After conduct of internal audit, carry out management review of the quality management system of your organization as per ISO 9001:2008 QMS Standard.
Step 8 – Inform Certification Body
After successfully completing all above steps, you should inform your certification body about the up-gradation of your quality management system as per ISO 9001:2008 QMS Standard, so that they may assess your quality management system and upgrade their certificate.
Support from NCQM Ajmer Centre
You can have following support from NCQM Ajmer Centre for up-gradation of your QMS:
Literatures in Hindi and English on ISO 9001:2008 QMS
Training programmes
Guidance for implementation
Friday, January 23, 2009
Monday, January 19, 2009
Understanding ISO 9001:2008 Quality Management System
Understanding ISO 9001:2008 Quality Management System
Chapter 9
DOCUMENTED PROCEDURES AND RECORDS REQUIRED BY ISO 9001:2008
Documented procedures required by ISO 9001:2008 are:
Control of documents (see clause 4.2.3)
Control of records (see clause 4.2.4)
Internal audit (see clause 8.2.2)
Control of nonconforming product (see clause 8.3)
Corrective action (see clause 8.5.2)
Preventive action (see clause 8.5.3)
However, in addition to above the organization may have documented procedures determined by the organization to be necessary to ensure effective planning, operation and control of the processes of the organization.
Records required by ISO 9001:2008 are:
Clause 5.6 (Management review) – Records from management reviews
Clause 6.2.2 (Competence, training and awareness) – Appropriate records of education, training, skills and experience
Clause 7.1 (Planning of product realization) – Records to provide evidence that the realization processes and resulting product meet requirements
Clause 7.2.2 (Review of requirements related to the product) – Records of the result of the review and actions arising from the review
Clause 7.3.2 (Design and development inputs) – Records of inputs relating to product requirements
Clause 7.3.4 (Design and development review) – Records of the results of the reviews and any necessary actions
Clause 7.3.5 (Design and development verification) – Records of the results of the verification and any necessary actions
Clause 7.3.6 (Design and development validation) – Records of the results of validation and any necessary actions
Clause 7.3.7 (Control of design and development changes) – Records of the results of the review of changes and any necessary actions
Clause 7.4.1 (Purchasing process) – Records of the results of supplier evaluations and any necessary actions arising from the evaluation
Clause 7.5.2 (Validation of processes for production and service provision) – Records as per requirements according to established arrangements
Clause 7.5.3 (Identification and traceability) –Where traceability is a requirement, record of unique identification of product
Clause 7.5.4 (Customer property) – Records of reporting to the customer, if any customer property is lost, damaged or otherwise found to be unsuitable for use
Clause 7.6 (Control of monitoring and measuring equipment) – (i) Records of the basis used for calibration or verification, where no international / national measurement standards exist (ii) Records of the results of calibration and verification (iii) Validity of the previous measuring results when equipment is found not to conform requirements
Clause 8.2.2 (Internal audit) – Records of the audits and their results
Clause 8.2.4 (Monitoring and measurement of product) – Records indicating the person(s) authorizing release of product for delivery to the customer
Clause 8.3 (Control of nonconforming product) – Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained
Clause 8.5.2 (Corrective action) – Records of the results of action taken
Clause 8.5.3 (Preventive action) – Records of the results of action taken
However, in addition to above the organization may have records determined by the organization to be necessary to ensure effective planning, operation and control of the processes of the organization.
If we go through the above list and requirements of ISO 9001:2000 QMS Standard, we find that there is no change in the requirements for documented procedures and records needed to keep as per ISO 9001:2008.
Questions
What are the documented procedures and records required as per clause 4 (Quality management system) of ISO 9001:2008?
What are the documented procedures and records required as per clause 5 (Management responsibility) of ISO 9001:2008?
What are the documented procedures and records required as per clause 6 (Resource management) of ISO 9001:2008?
What are the documented procedures and records required as per clause 7 (Product realization) of ISO 9001:2008?
What are the documented procedures and records required as per clause 8 (Measurement, analysis and improvement) of ISO 9001:2008?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
Chapter 9
DOCUMENTED PROCEDURES AND RECORDS REQUIRED BY ISO 9001:2008
Documented procedures required by ISO 9001:2008 are:
Control of documents (see clause 4.2.3)
Control of records (see clause 4.2.4)
Internal audit (see clause 8.2.2)
Control of nonconforming product (see clause 8.3)
Corrective action (see clause 8.5.2)
Preventive action (see clause 8.5.3)
However, in addition to above the organization may have documented procedures determined by the organization to be necessary to ensure effective planning, operation and control of the processes of the organization.
Records required by ISO 9001:2008 are:
Clause 5.6 (Management review) – Records from management reviews
Clause 6.2.2 (Competence, training and awareness) – Appropriate records of education, training, skills and experience
Clause 7.1 (Planning of product realization) – Records to provide evidence that the realization processes and resulting product meet requirements
Clause 7.2.2 (Review of requirements related to the product) – Records of the result of the review and actions arising from the review
Clause 7.3.2 (Design and development inputs) – Records of inputs relating to product requirements
Clause 7.3.4 (Design and development review) – Records of the results of the reviews and any necessary actions
Clause 7.3.5 (Design and development verification) – Records of the results of the verification and any necessary actions
Clause 7.3.6 (Design and development validation) – Records of the results of validation and any necessary actions
Clause 7.3.7 (Control of design and development changes) – Records of the results of the review of changes and any necessary actions
Clause 7.4.1 (Purchasing process) – Records of the results of supplier evaluations and any necessary actions arising from the evaluation
Clause 7.5.2 (Validation of processes for production and service provision) – Records as per requirements according to established arrangements
Clause 7.5.3 (Identification and traceability) –Where traceability is a requirement, record of unique identification of product
Clause 7.5.4 (Customer property) – Records of reporting to the customer, if any customer property is lost, damaged or otherwise found to be unsuitable for use
Clause 7.6 (Control of monitoring and measuring equipment) – (i) Records of the basis used for calibration or verification, where no international / national measurement standards exist (ii) Records of the results of calibration and verification (iii) Validity of the previous measuring results when equipment is found not to conform requirements
Clause 8.2.2 (Internal audit) – Records of the audits and their results
Clause 8.2.4 (Monitoring and measurement of product) – Records indicating the person(s) authorizing release of product for delivery to the customer
Clause 8.3 (Control of nonconforming product) – Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained
Clause 8.5.2 (Corrective action) – Records of the results of action taken
Clause 8.5.3 (Preventive action) – Records of the results of action taken
However, in addition to above the organization may have records determined by the organization to be necessary to ensure effective planning, operation and control of the processes of the organization.
If we go through the above list and requirements of ISO 9001:2000 QMS Standard, we find that there is no change in the requirements for documented procedures and records needed to keep as per ISO 9001:2008.
Questions
What are the documented procedures and records required as per clause 4 (Quality management system) of ISO 9001:2008?
What are the documented procedures and records required as per clause 5 (Management responsibility) of ISO 9001:2008?
What are the documented procedures and records required as per clause 6 (Resource management) of ISO 9001:2008?
What are the documented procedures and records required as per clause 7 (Product realization) of ISO 9001:2008?
What are the documented procedures and records required as per clause 8 (Measurement, analysis and improvement) of ISO 9001:2008?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
Understanding ISO 9001:2008 Quality Management System
Understanding ISO 9001:2008 Quality Management System
Chapter 8
ANNEX, BIBLIOGRAPHY AND OTHER INFORMATION (including implementation plan for ISO 9001:2008 QMS Standard)
Annex A and Annex B have been updated.
Annex A provides informative details of correspondence between ISO 9001:2008 and ISO 14001:2004 For more details, reader should refer to the Standard document ISO 9001:2008.
Annex B provides informative details of changes between ISO 9001:2000 and ISO 9001:2008 in a Table form. For more details, reader should refer to the Standard document ISO 9001:2008.
Bibliography is also updated to reflect new standards and new editions of standards. For more details, reader should refer to the Standard document ISO 9001:2008.
In short, from the study of ISO 9001:2008, we come to a conclusion that ISO 9001:2008 will be an international standard with minor revision to ISO 9001: 2000 and changes are more as clarifications to the requirements.
There will be little impact of the revision. Only a few changes in the requirements may require revision in documentation and implementation. International Organization for Standardization (ISO) and International Accreditation Forum (IAF) have announced schedule for implementation of accredited certification to ISO 9001:2008 QMS Standard. Details are mentioned below.
Implementation Plan for ISO 9001:2008 QMS Standard
International Organization for Standardization (ISO) and International Accreditation Forum (IAF) have announced schedule for implementation of accredited certification to ISO 9001:2008 QMS Standard. Both organizations have agreed on an implementation plan to ensure a smooth transition of accredited certification to ISO 9001:2008 QMS Standard.
The ISO 9001:2008 QMS Standard has been published on 15 November 2008. ISO 9001:2008 QMS Standard replaces the year 2000 version of the Standard. Certification is not a requirement of the standard, however the quality management system (QMS) of about one million organizations have been audited and certified by independent certification bodies to existing ISO 9001:2000 QMS Standard. ISO 9001 certification is frequently used in both private and public sectors to increase confidence in the products and services provided by certified organizations, between partners in business-to-business relations, in the selection of suppliers in supply chains and in the right to tender for procurement contracts.
International Organization for Standardization (ISO) is the developer and publisher of ISO 9001 Standard. ISO does not itself carry out auditing and certification to ISO 9001 Standard. These services are performed independently of ISO by certification bodies. ISO does not control such bodies. But ISO has developed voluntary International Standards to encourage good practice in their activities on a worldwide basis. ISO/IEC 17021:2006, developed and published by ISO, specifies the requirements for certification bodies carrying out auditing and certification of management systems.
Certification bodies that wish to provide further confidence in their services generally apply to be "accredited" as competent by an International Accreditation Forum (IAF) recognized national accreditation body। In India, National Accreditation Board of Certification Bodies (NABCB) is the IAF recognized national accreditation body। ISO/IEC 17011:2004, developed and published by ISO, specifies the requirements for carrying out such accreditation. International Accreditation Forum (IAF) is an international association, having membership of national accreditation bodies of 49 countries/economies. International Organization for Standardization (ISO) has a technical committee, known as ISO/TC 176, Quality management and quality assurance. This committee is responsible for the ISO 9000 family of standards. This committee is preparing a number of support documents explaining the differences between ISO 9001:2008 (forthcoming new version) and ISO 9001:2000 (the year 2000 version), why and what they mean for users. On getting approval, these documents will be posted on the ISO Web site – probably in October 2008.
International Organization for Standardization (ISO) and International Accreditation Forum (IAF) have agreed an implementation plan to ensure a smooth migration of accredited certification to ISO 9001:2008 QMS Standard, after consultation with international groupings representing quality system or auditor certification bodies, and industry users of ISO 9001 certification services. ISO 9001:2008 does not contain any new requirements. As such, ISO and IAF have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 QMS Standard. It also introduces changes intended to improve consistency with ISO14001:2004 EMS Standard. The implementation plan and validity of certification to ISO 9001 QMS, as agreed by ISO and IAF, in relation to accredited certification is as under:(i) Accredited certification to the ISO 9001:2008 QMS Standard shall not be granted until the publication of ISO 9001:2008 QMS Standard as an International Standard. ISO 9001:2008 QMS Standard has since been published as International Standard on 15 November 2008.
(ii) Certification of conformity to ISO 9001:2008 QMS Standard and/or national equivalents (such as, IS/ISO 9001:2008 QMS Standard, in India) shall only be issued after official publication of ISO 9001:2008 (i.e after 15 November 2008) and after a routine surveillance or recertification audit against ISO 9001:2008.
(iii) One year after publication of ISO 9001:2008 QMS Standard all accredited certifications issued (new certifications or re-certifications) shall be to ISO 9001:2008 QMS Standard.
(iv) Twenty four months after publication by ISO of ISO 9001:2008 QMS Standard, any existing certification issued to ISO 9001:2000 shall not be valid.
Questions
1. What is your conclusion with regard to ISO 9001 revision?
2. What is the implementation plan for ISO 9001:2008 QMS Standard announced by International Organization for Standardization (ISO) and International Accreditation Forum (IAF)?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
Chapter 8
ANNEX, BIBLIOGRAPHY AND OTHER INFORMATION (including implementation plan for ISO 9001:2008 QMS Standard)
Annex A and Annex B have been updated.
Annex A provides informative details of correspondence between ISO 9001:2008 and ISO 14001:2004 For more details, reader should refer to the Standard document ISO 9001:2008.
Annex B provides informative details of changes between ISO 9001:2000 and ISO 9001:2008 in a Table form. For more details, reader should refer to the Standard document ISO 9001:2008.
Bibliography is also updated to reflect new standards and new editions of standards. For more details, reader should refer to the Standard document ISO 9001:2008.
In short, from the study of ISO 9001:2008, we come to a conclusion that ISO 9001:2008 will be an international standard with minor revision to ISO 9001: 2000 and changes are more as clarifications to the requirements.
There will be little impact of the revision. Only a few changes in the requirements may require revision in documentation and implementation. International Organization for Standardization (ISO) and International Accreditation Forum (IAF) have announced schedule for implementation of accredited certification to ISO 9001:2008 QMS Standard. Details are mentioned below.
Implementation Plan for ISO 9001:2008 QMS Standard
International Organization for Standardization (ISO) and International Accreditation Forum (IAF) have announced schedule for implementation of accredited certification to ISO 9001:2008 QMS Standard. Both organizations have agreed on an implementation plan to ensure a smooth transition of accredited certification to ISO 9001:2008 QMS Standard.
The ISO 9001:2008 QMS Standard has been published on 15 November 2008. ISO 9001:2008 QMS Standard replaces the year 2000 version of the Standard. Certification is not a requirement of the standard, however the quality management system (QMS) of about one million organizations have been audited and certified by independent certification bodies to existing ISO 9001:2000 QMS Standard. ISO 9001 certification is frequently used in both private and public sectors to increase confidence in the products and services provided by certified organizations, between partners in business-to-business relations, in the selection of suppliers in supply chains and in the right to tender for procurement contracts.
International Organization for Standardization (ISO) is the developer and publisher of ISO 9001 Standard. ISO does not itself carry out auditing and certification to ISO 9001 Standard. These services are performed independently of ISO by certification bodies. ISO does not control such bodies. But ISO has developed voluntary International Standards to encourage good practice in their activities on a worldwide basis. ISO/IEC 17021:2006, developed and published by ISO, specifies the requirements for certification bodies carrying out auditing and certification of management systems.
Certification bodies that wish to provide further confidence in their services generally apply to be "accredited" as competent by an International Accreditation Forum (IAF) recognized national accreditation body। In India, National Accreditation Board of Certification Bodies (NABCB) is the IAF recognized national accreditation body। ISO/IEC 17011:2004, developed and published by ISO, specifies the requirements for carrying out such accreditation. International Accreditation Forum (IAF) is an international association, having membership of national accreditation bodies of 49 countries/economies. International Organization for Standardization (ISO) has a technical committee, known as ISO/TC 176, Quality management and quality assurance. This committee is responsible for the ISO 9000 family of standards. This committee is preparing a number of support documents explaining the differences between ISO 9001:2008 (forthcoming new version) and ISO 9001:2000 (the year 2000 version), why and what they mean for users. On getting approval, these documents will be posted on the ISO Web site – probably in October 2008.
International Organization for Standardization (ISO) and International Accreditation Forum (IAF) have agreed an implementation plan to ensure a smooth migration of accredited certification to ISO 9001:2008 QMS Standard, after consultation with international groupings representing quality system or auditor certification bodies, and industry users of ISO 9001 certification services. ISO 9001:2008 does not contain any new requirements. As such, ISO and IAF have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 QMS Standard. It also introduces changes intended to improve consistency with ISO14001:2004 EMS Standard. The implementation plan and validity of certification to ISO 9001 QMS, as agreed by ISO and IAF, in relation to accredited certification is as under:(i) Accredited certification to the ISO 9001:2008 QMS Standard shall not be granted until the publication of ISO 9001:2008 QMS Standard as an International Standard. ISO 9001:2008 QMS Standard has since been published as International Standard on 15 November 2008.
(ii) Certification of conformity to ISO 9001:2008 QMS Standard and/or national equivalents (such as, IS/ISO 9001:2008 QMS Standard, in India) shall only be issued after official publication of ISO 9001:2008 (i.e after 15 November 2008) and after a routine surveillance or recertification audit against ISO 9001:2008.
(iii) One year after publication of ISO 9001:2008 QMS Standard all accredited certifications issued (new certifications or re-certifications) shall be to ISO 9001:2008 QMS Standard.
(iv) Twenty four months after publication by ISO of ISO 9001:2008 QMS Standard, any existing certification issued to ISO 9001:2000 shall not be valid.
Questions
1. What is your conclusion with regard to ISO 9001 revision?
2. What is the implementation plan for ISO 9001:2008 QMS Standard announced by International Organization for Standardization (ISO) and International Accreditation Forum (IAF)?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
Wednesday, January 14, 2009
Understanding ISO 9001:2008 Quality Management System
Understanding ISO 9001:2008 Quality Management System
Chapter 7
MEASUREMENT, ANALYSIS AND IMPROVEMENT
Author – K. R. Singhal
There are following clauses under this section:
8.1 – General
8.2 – Monitoring and measurement
8.3 – Control of nonconforming product
8.4 – Analysis of data
8.5 – Improvement
General
(Please refer to clause 8.1 of ISO 9001:2008)
The organization must plan and implement the monitoring, measurement, analysis and improvement processes needed for the following:
to demonstrate conformity to product requirements,
to ensure conformity of the quality management system, and
to continually improve the effectiveness of the quality management system.
The organization must determine applicable methods (including statistical techniques) and extent of their use.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in the requirement, however there is editorial change in the wordings. As per ISO 9001:2008, monitoring, measurement, analysis and improvement processes needed ‘to demonstrate conformity to product requirements’, instead of ‘to demonstrate conformity of the product’ (as mentioned in ISO 9001:2000 QMS Standard).
Monitoring and measurement
(Please refer to clause 8.2 of ISO 9001:2008)
There are following clauses under this clause:
8.2.1 – Customer satisfaction
8.2.2 – Internal audit
8.2.3 – Monitoring and measurement of processes
8.2.4 – Monitoring and measurement of product
Customer satisfaction
(Please refer to clause 8.2.1 of ISO 9001:2008)
The organization must monitor information relating to customer perception to know whether the organization has met customer requirements. The organization must determine methods for obtaining and using information relating to customer satisfaction. This monitoring must be done by the organization as one of the measurements of the performance of organization’s quality management system.
Note at the end of this clause clarifies that monitoring customer satisfaction can include obtaining inputs from various sources, such as:
customer satisfaction surveys,
customer data on delivered product quality,
user opinion surveys,
lost business analysis,
compliments,
warranty claims, and
dealer reports.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that in sub-clause 8.2.1 (Customer satisfaction), a note has been added that monitoring customer perception may include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, dealer reports.
Internal audit
(Please refer to clause 8.2.2 of ISO 9001:2008)
The organization must conduct internal audits at planned intervals. Conducting internal audits must be done to determine whether the quality management system of the organization:
conforms to the planned arrangements,
conforms to the requirements of ISO 9001:2008 Standard,
conforms to the quality management system requirements established by the organization, and
is effectively implemented and maintained.
The organization must plan an audit programme by considering the status and importance of the processes, areas to be audited and results of previous audits. The organization must define audit criteria, scope, frequency and methods of internal audit. The organization must ensure objectivity and impartiality of the audit process in selecting internal auditors and conducting internal audits. Auditors must not audit their own work.
The organization must establish a documented procedure to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.
The organization must maintain records of the audits and their results.
The management (of the area or department being audited) must ensure that any necessary corrections and corrective actions are taken promptly (without undue delay) to eliminate detected nonconformities and their causes.
The organization must carry out follow-up activities including verification of the actions taken and the reporting of verification results.
Note at the end of this clause states to refer to ISO 19011 for guidance.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that the requirements of this clause reworded to give more clarity. The requirements in ISO 9001:2008 is very clear that a documented procedure must be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. It also requires that records of the audits and their results must be maintained. In Para 4 of sub-clause 8.2.2 of ISO 9001:2000 QMS Standard, before the word ‘actions’ phrase ‘any necessary corrections and corrective’ has been added in ISO 9001:2008 to give more clarity .A note at the end of sub clause 8.2.2 now refers to ISO 19011 for guidance in ISO 9001:2008, instead of ISO 10011-1, ISO 10011-2 and ISO 10011-3 as mentioned in ISO 9001:2000 QMS Standard.
Monitoring and measurement of processes
(Please refer to clause 8.2.3 of ISO 9001:2008)
The organization must apply:
suitable methods for monitoring of the quality management system processes, and
where applicable, measurement of quality management system processes.
Such suitable methods must demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, the organization must take correction and corrective action, as appropriate.
Note at the end of this clause suggests that organization should consider the type and extent of monitoring or measurement appropriate to each of its processes, when determining suitable methods, in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that in sub-clause 8.2.3 the phrase ‘to ensure conformity of the product’ has been removed as was mentioned in ISO 9001:2000. A note added at the end of sub-clause 8.2.3 now clarifies that when deciding on appropriate methods, the organization should consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and effectiveness of the quality management system.
Monitoring and measurement of product
(Please refer to clause 8.2.4 of ISO 9001:2008)
The organization must monitor and measure the characteristics of the product to verify that product requirements have been met. This must be carried out at appropriate stages of the product realization process in accordance with the planned arrangement. The organization must maintain evidence of conformity with the accepted criteria.
The organization must maintain records indicating the person(s) authorizing release of product for delivery to the customer.
The organization must not proceed to release product and delivery of service to the customer until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority of the organization and, where applicable, by the customer.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there are editorial changes, some additions and deletions. Requirement to maintain evidence of conformity with the accepted criteria is in Para 2 of ISO 9001:2000 QMS Standard, and this requirement has been deleted from this Para and added to Para 1 of this sub-clause in ISO 9001:2008. In Para 2 of this sub-clause in ISO 9001:2000 requires records to indicate the person(s) authorizing release of product, and this has been made more specific now in ISO 9001:2008 and records must indicate the person(s) authorizing release of product for delivery to the customer. The phrase ‘Product release and service delivery’ in Para 3 of this sub-clause (as mentioned in ISO 9001:2000 QMS Standard) has been substituted by the phrase ‘The release of product and delivery of service to the customer’ (in ISO 9001:2008).
Control of nonconforming product
(Please refer to clause 8.3 of ISO 9001:2008)
The organization must ensure that nonconforming product (the product which does not conform to product requirements) is identified and controlled to prevent its unintended use or delivery. The organization must establish a documented procedure to define the controls and related responsibilities and authorities for dealing with nonconforming product.
Where applicable, the organization must deal with nonconforming product by one or more of the following ways:
by taking action to eliminate the detected nonconformity,
by authorizing its use, release or acceptance under concession by relevant authority and, where applicable, by the customer,
by taking action to preclude its original intended use or application,
by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.
When organization carries out correction in nonconforming product, such correction must be subject to re-verification to demonstrate conformity to the requirements.
The organization must main records of the nature of nonconformities and any subsequent actions taken, including concessions obtained.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that Para 1 of this clause has been reframed to provide more clarity. The term ‘where applicable’ is added in the beginning in Para 2 of this clause. The requirements of Para 3 and Para 4 of this clause (in ISO 9001:2000 QMS Standard) have been interchanged as Para 4 and Para 3 in ISO 9001:2008 without any change in wordings. The requirement mentioned in Para 5 of this clause (mentioned in ISO 9001:2000 QMS Standard) has been shifted in Para 3 Bullet d) with appropriate reframing of wordings (in ISO 9001:2008).
Analysis of data
(Please refer to clause 8.4 of ISO 9001:2008)
The organization must determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This must include data generated as a result of monitoring and measurement and from other relevant sources.
The analysis of data must provide information relating to:
customer satisfaction,
conformity to product requirements,
characteristics and trends of processes and products, including opportunities for preventive action, and
suppliers.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in the requirement of this clause, however, reference to clause has been changed or added. In clause 8.4 (b), reference to ‘(see 8.2.4)’ has been mentioned in ISO 9001:2008 instead of ‘(see 7.2.1)’ as mentioned in ISO 9001:2000 QMS Standard. In clause 8.4 (c), after ‘… preventive action’ the words ‘(see 8.2.3 and 8.2.4)’ have been added. In clause 8.4 (d), after suppliers the words ‘(see 7.4)’ added.
Improvement
(Please refer to clause 8.5 of ISO 9001:2008)
There are following clauses under this clause:
8.5.1 – Continual improvement
8.5.2 – Corrective action
8.5.3 – Preventive action
Continual improvement
(Please refer to clause 8.5.1 of ISO 9001:2008)
The organization must continually improve the effectiveness of the organization’s quality management system. This must be done through the use of the following:
quality policy,
quality objectives,
audit results,
analysis of data,
corrective action,
preventive action, and
management review.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in the requirement of sub-clause 8.5.1 (Continual improvement).
Corrective action
(Please refer to clause 8.5.2 of ISO 9001:2008)
The organization must take corrective action, appropriate to the effects of the nonconformities encountered, to eliminate the causes of nonconformities in order to prevent recurrence.
The organization must establish a documented procedure that defines requirements for the following:
reviewing nonconformities,
determining the causes of nonconformities,
evaluating the need for action to ensure that nonconformities do not recur,
determining and implementing action needed,
records of the results of action taken, and
reviewing the effectiveness of the corrective action taken.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in requirements, however in sub-clause 8.5.2 (Corrective action), there are editorial changes in the wordings of the requirements to give more clarity of meaning. The word ‘cause’ (as mentioned in Para 1 of sub-clause 8.5.2 in ISO 9001:2000 QMS Standard) has been substituted by the word ‘causes’ (in ISO 9001:2008). Instead of ‘reviewing the corrective action taken’ (as mentioned in ISO 9001:2000 QMS Standard), now it is mentioned ‘reviewing the effectiveness of the corrective action taken’ (in ISO 9001:2008).
Preventive action
(Please refer to clause 8.5.3 of ISO 9001:2008)
The organization must determine preventive action, appropriate to the effects of the potential problems, to eliminate the causes of potential nonconformities in order to prevent their occurrence.
The organization must establish a documented procedure to define requirements for:
determining potential nonconformities and their causes,
evaluating the need for action to prevent occurrence of nonconformities,
determining and implementing action needed,
records of the results of action taken, and
reviewing the effectiveness of the preventive action taken.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in requirements, however in sub-clause 8.5.3 (Preventive action), there are editorial changes in the wordings of the requirements to give more clarity of meaning. Instead of ‘reviewing the preventive action taken’ (as mentioned in ISO 9001:2000 QMS Standard), now it is mentioned ‘reviewing the effectiveness of the preventive action taken’ (in ISO 9001:2008).
Questions
What are the key changes in clause 8.1 (measurement, analysis and improvement – General) in ISO 9001?
What are the key changes in clause 8.2.1 (Customer satisfaction) in ISO 9001?
What are the key changes in clause 8.2.2 (Internal Audit) in ISO 9001?
What are the key changes in clause 8.2.3 (Monitoring and measurement of processes) in ISO 9001?
What are the key changes in clause 8.2.4 (Monitoring and measurement of product) in ISO 9001?
What are the key changes in clause 8.3 (Control of nonconforming product) in ISO 9001?
What are the key changes in clause 8.4 (Analysis of data) in ISO 9001?
What are the key changes in clause 8.5 (Improvement) in ISO 9001?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
Chapter 7
MEASUREMENT, ANALYSIS AND IMPROVEMENT
Author – K. R. Singhal
There are following clauses under this section:
8.1 – General
8.2 – Monitoring and measurement
8.3 – Control of nonconforming product
8.4 – Analysis of data
8.5 – Improvement
General
(Please refer to clause 8.1 of ISO 9001:2008)
The organization must plan and implement the monitoring, measurement, analysis and improvement processes needed for the following:
to demonstrate conformity to product requirements,
to ensure conformity of the quality management system, and
to continually improve the effectiveness of the quality management system.
The organization must determine applicable methods (including statistical techniques) and extent of their use.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in the requirement, however there is editorial change in the wordings. As per ISO 9001:2008, monitoring, measurement, analysis and improvement processes needed ‘to demonstrate conformity to product requirements’, instead of ‘to demonstrate conformity of the product’ (as mentioned in ISO 9001:2000 QMS Standard).
Monitoring and measurement
(Please refer to clause 8.2 of ISO 9001:2008)
There are following clauses under this clause:
8.2.1 – Customer satisfaction
8.2.2 – Internal audit
8.2.3 – Monitoring and measurement of processes
8.2.4 – Monitoring and measurement of product
Customer satisfaction
(Please refer to clause 8.2.1 of ISO 9001:2008)
The organization must monitor information relating to customer perception to know whether the organization has met customer requirements. The organization must determine methods for obtaining and using information relating to customer satisfaction. This monitoring must be done by the organization as one of the measurements of the performance of organization’s quality management system.
Note at the end of this clause clarifies that monitoring customer satisfaction can include obtaining inputs from various sources, such as:
customer satisfaction surveys,
customer data on delivered product quality,
user opinion surveys,
lost business analysis,
compliments,
warranty claims, and
dealer reports.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that in sub-clause 8.2.1 (Customer satisfaction), a note has been added that monitoring customer perception may include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, dealer reports.
Internal audit
(Please refer to clause 8.2.2 of ISO 9001:2008)
The organization must conduct internal audits at planned intervals. Conducting internal audits must be done to determine whether the quality management system of the organization:
conforms to the planned arrangements,
conforms to the requirements of ISO 9001:2008 Standard,
conforms to the quality management system requirements established by the organization, and
is effectively implemented and maintained.
The organization must plan an audit programme by considering the status and importance of the processes, areas to be audited and results of previous audits. The organization must define audit criteria, scope, frequency and methods of internal audit. The organization must ensure objectivity and impartiality of the audit process in selecting internal auditors and conducting internal audits. Auditors must not audit their own work.
The organization must establish a documented procedure to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.
The organization must maintain records of the audits and their results.
The management (of the area or department being audited) must ensure that any necessary corrections and corrective actions are taken promptly (without undue delay) to eliminate detected nonconformities and their causes.
The organization must carry out follow-up activities including verification of the actions taken and the reporting of verification results.
Note at the end of this clause states to refer to ISO 19011 for guidance.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that the requirements of this clause reworded to give more clarity. The requirements in ISO 9001:2008 is very clear that a documented procedure must be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. It also requires that records of the audits and their results must be maintained. In Para 4 of sub-clause 8.2.2 of ISO 9001:2000 QMS Standard, before the word ‘actions’ phrase ‘any necessary corrections and corrective’ has been added in ISO 9001:2008 to give more clarity .A note at the end of sub clause 8.2.2 now refers to ISO 19011 for guidance in ISO 9001:2008, instead of ISO 10011-1, ISO 10011-2 and ISO 10011-3 as mentioned in ISO 9001:2000 QMS Standard.
Monitoring and measurement of processes
(Please refer to clause 8.2.3 of ISO 9001:2008)
The organization must apply:
suitable methods for monitoring of the quality management system processes, and
where applicable, measurement of quality management system processes.
Such suitable methods must demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, the organization must take correction and corrective action, as appropriate.
Note at the end of this clause suggests that organization should consider the type and extent of monitoring or measurement appropriate to each of its processes, when determining suitable methods, in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that in sub-clause 8.2.3 the phrase ‘to ensure conformity of the product’ has been removed as was mentioned in ISO 9001:2000. A note added at the end of sub-clause 8.2.3 now clarifies that when deciding on appropriate methods, the organization should consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and effectiveness of the quality management system.
Monitoring and measurement of product
(Please refer to clause 8.2.4 of ISO 9001:2008)
The organization must monitor and measure the characteristics of the product to verify that product requirements have been met. This must be carried out at appropriate stages of the product realization process in accordance with the planned arrangement. The organization must maintain evidence of conformity with the accepted criteria.
The organization must maintain records indicating the person(s) authorizing release of product for delivery to the customer.
The organization must not proceed to release product and delivery of service to the customer until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority of the organization and, where applicable, by the customer.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there are editorial changes, some additions and deletions. Requirement to maintain evidence of conformity with the accepted criteria is in Para 2 of ISO 9001:2000 QMS Standard, and this requirement has been deleted from this Para and added to Para 1 of this sub-clause in ISO 9001:2008. In Para 2 of this sub-clause in ISO 9001:2000 requires records to indicate the person(s) authorizing release of product, and this has been made more specific now in ISO 9001:2008 and records must indicate the person(s) authorizing release of product for delivery to the customer. The phrase ‘Product release and service delivery’ in Para 3 of this sub-clause (as mentioned in ISO 9001:2000 QMS Standard) has been substituted by the phrase ‘The release of product and delivery of service to the customer’ (in ISO 9001:2008).
Control of nonconforming product
(Please refer to clause 8.3 of ISO 9001:2008)
The organization must ensure that nonconforming product (the product which does not conform to product requirements) is identified and controlled to prevent its unintended use or delivery. The organization must establish a documented procedure to define the controls and related responsibilities and authorities for dealing with nonconforming product.
Where applicable, the organization must deal with nonconforming product by one or more of the following ways:
by taking action to eliminate the detected nonconformity,
by authorizing its use, release or acceptance under concession by relevant authority and, where applicable, by the customer,
by taking action to preclude its original intended use or application,
by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.
When organization carries out correction in nonconforming product, such correction must be subject to re-verification to demonstrate conformity to the requirements.
The organization must main records of the nature of nonconformities and any subsequent actions taken, including concessions obtained.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that Para 1 of this clause has been reframed to provide more clarity. The term ‘where applicable’ is added in the beginning in Para 2 of this clause. The requirements of Para 3 and Para 4 of this clause (in ISO 9001:2000 QMS Standard) have been interchanged as Para 4 and Para 3 in ISO 9001:2008 without any change in wordings. The requirement mentioned in Para 5 of this clause (mentioned in ISO 9001:2000 QMS Standard) has been shifted in Para 3 Bullet d) with appropriate reframing of wordings (in ISO 9001:2008).
Analysis of data
(Please refer to clause 8.4 of ISO 9001:2008)
The organization must determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This must include data generated as a result of monitoring and measurement and from other relevant sources.
The analysis of data must provide information relating to:
customer satisfaction,
conformity to product requirements,
characteristics and trends of processes and products, including opportunities for preventive action, and
suppliers.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in the requirement of this clause, however, reference to clause has been changed or added. In clause 8.4 (b), reference to ‘(see 8.2.4)’ has been mentioned in ISO 9001:2008 instead of ‘(see 7.2.1)’ as mentioned in ISO 9001:2000 QMS Standard. In clause 8.4 (c), after ‘… preventive action’ the words ‘(see 8.2.3 and 8.2.4)’ have been added. In clause 8.4 (d), after suppliers the words ‘(see 7.4)’ added.
Improvement
(Please refer to clause 8.5 of ISO 9001:2008)
There are following clauses under this clause:
8.5.1 – Continual improvement
8.5.2 – Corrective action
8.5.3 – Preventive action
Continual improvement
(Please refer to clause 8.5.1 of ISO 9001:2008)
The organization must continually improve the effectiveness of the organization’s quality management system. This must be done through the use of the following:
quality policy,
quality objectives,
audit results,
analysis of data,
corrective action,
preventive action, and
management review.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in the requirement of sub-clause 8.5.1 (Continual improvement).
Corrective action
(Please refer to clause 8.5.2 of ISO 9001:2008)
The organization must take corrective action, appropriate to the effects of the nonconformities encountered, to eliminate the causes of nonconformities in order to prevent recurrence.
The organization must establish a documented procedure that defines requirements for the following:
reviewing nonconformities,
determining the causes of nonconformities,
evaluating the need for action to ensure that nonconformities do not recur,
determining and implementing action needed,
records of the results of action taken, and
reviewing the effectiveness of the corrective action taken.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in requirements, however in sub-clause 8.5.2 (Corrective action), there are editorial changes in the wordings of the requirements to give more clarity of meaning. The word ‘cause’ (as mentioned in Para 1 of sub-clause 8.5.2 in ISO 9001:2000 QMS Standard) has been substituted by the word ‘causes’ (in ISO 9001:2008). Instead of ‘reviewing the corrective action taken’ (as mentioned in ISO 9001:2000 QMS Standard), now it is mentioned ‘reviewing the effectiveness of the corrective action taken’ (in ISO 9001:2008).
Preventive action
(Please refer to clause 8.5.3 of ISO 9001:2008)
The organization must determine preventive action, appropriate to the effects of the potential problems, to eliminate the causes of potential nonconformities in order to prevent their occurrence.
The organization must establish a documented procedure to define requirements for:
determining potential nonconformities and their causes,
evaluating the need for action to prevent occurrence of nonconformities,
determining and implementing action needed,
records of the results of action taken, and
reviewing the effectiveness of the preventive action taken.
If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in requirements, however in sub-clause 8.5.3 (Preventive action), there are editorial changes in the wordings of the requirements to give more clarity of meaning. Instead of ‘reviewing the preventive action taken’ (as mentioned in ISO 9001:2000 QMS Standard), now it is mentioned ‘reviewing the effectiveness of the preventive action taken’ (in ISO 9001:2008).
Questions
What are the key changes in clause 8.1 (measurement, analysis and improvement – General) in ISO 9001?
What are the key changes in clause 8.2.1 (Customer satisfaction) in ISO 9001?
What are the key changes in clause 8.2.2 (Internal Audit) in ISO 9001?
What are the key changes in clause 8.2.3 (Monitoring and measurement of processes) in ISO 9001?
What are the key changes in clause 8.2.4 (Monitoring and measurement of product) in ISO 9001?
What are the key changes in clause 8.3 (Control of nonconforming product) in ISO 9001?
What are the key changes in clause 8.4 (Analysis of data) in ISO 9001?
What are the key changes in clause 8.5 (Improvement) in ISO 9001?
Note from the author
The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.
The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.
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