Amendments in ISO 9001 : 2008 Version

ISO 9001 is a global standard. World changes faster then standards and hence standards need to be revised to keep them continuing suitable to user needs. This may be due to emergence of new industry sectors, World Wide Web, outsourcing, off-shoring, globalization etc.

Changes in General

There are many changes in the standard, mostly typographical corrections or amendments that, normally, do not alter the basic interpretation of the standard. The Introduction section of the standard explains that design and implementation of quality management system can be influenced by organizations business environment, changes in business environment and risks associated with that environment apart from organizations varying needs, objectives, products, processes, size and structure.

When to upgrade to new standard

The ISO 9001: 2008 is available from 13-Nov-2008 but officially published on 15-November-2008.

As per the agreement between ISO and IAF, existing ISO 9001: 2000 certified organizations shall upgrade to ISO 9001: 2008 within 24 months from the date of release of ISO 9001: 2008. Certification bodies can issue certificates to ISO 9001:2000 up to 12 months from date of release of ISO 9001: 2008.

That means existing ISO 9001:2000 certified companies can continue ISO 9001:2000 based surveillance audit until 14-November-2009.

Certification bodies will issue new certificate of ISO 9001:2000 till 12-November-2008 which will be valid till 14-November-2010 and not three years.
From 15-November-2009, all audits, New Certifications or surveillance will be based on ISO 9001:2008 only.

You have sufficient time, read on, make changes to your system and get ready before your surveillance audit.

Wording of many clauses has been changed, but requirement remains same as year 2000 edition. There are some logical corrections such as ISO 9000:2000 is replaced by ISO 9000: 2005 as the standard was revised in 2005, similarly reference to ISO 10011 part 1, 2, 3 is replaced by ISO 19011: 2002 as later has replaced the former in 2002.

Specific Changes and their effect on exiting certified organizations

Following changes that are of some importance in implementation to organizations, other changes are explained within various clauses of the standard within the guide:

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  Clause No.: 0.1
  Change: Statement on statutory requirement 
  Explanation: Statutory requirements have same importance as customer requirements and regulatory requirements
  What does it mean to you: Nothing; It is always like that.


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  Clause No.: 0.4
  Change: 2008 version is more compatible with ISO 14001:2004
  Explanation: This is an ongoing process as two management system standards are kept aligned.
  What does it mean to you: Companies seeking certification to ISO 9001 and ISO 14001 both are at ease.


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  Clause No.: 1.1 Scope: General
  Change: "regulatory requirements" is replaced by "statutory and regulatory requirement"
  Explanation: Clauses 5.1, 7.2.1, 7.3.2 already require meeting applicable statutory and regulatory requirements.
  This is should be seen as a correction only. Please note again that statutory requirements are restricted to those applicable for the product.
  What does it mean to you: Nothing


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  Clause No.: 2 Normative Reference
  Change: ISO 9000: 2005 instead of ISO 9000: 2000
  Explanation: Same is already in force
  What does it mean to you: Nothing


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  Clause No.: 3 Terms and definitions
  Change: Explanation on customer, organization and supplier is deleted.
  Explanation: The standard has introduced new definitions in year 2000 and no longer required to be reminded.
  What does it mean to you: Nothing


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  Clause No.: 4.1 Quality Management System: General Requirements
  Change: Two notes are added to define outsourcing and type and nature of control.
  Explanation: Due to globalization of business, outsourcing is one of the basic requirements to remain competitive. To have proper clarity on outsourcing two notes are added.
  What does it mean to you: Nothing; Notes gives clarity but does not change interpretation; Refer clause 4.1 for details. 


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  Clause No.: 4.2.1 Documentation Requirements: General
  Change: Clause reframed having same interpretation
  Explanation: Note expanded to explain that you may have a single document for multiple procedures or multiple documents for various requirements for a documented procedure. Many organizations already have one procedure for corrective actions and preventive actions instead of two separate procedures.
  What does it mean to you: This note gives clarity, which otherwise called for some discussion. Nothing for existing QMS.
  Those designing a new QMS may consider defining procedures in line with responsibility and authority.
  In large organizations, it is difficult to define all the requirements of a documented procedure within one document due to restricted authority.


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  Clause No.: 4.2.3 Control of Documents
  Change: Point (f) on control of external origin documents revised to "ensure that documents of external origin determined by organization to be necessary for planning and operation of quality management system"  Earlier in absence of the clarity or detailing many organizations have taken only those external origin documents under control which affected product quality or product requirement.
  Explanation: Now organizations will need to control many other external origin documents as term "necessary for planning and operation of quality management system" is very wide. Review your external origin document control system.
  Most probably you have taken only standards and customer drawings in control.
  What does it mean to you: Government Laws affecting product delivery (such as VAT, Excise procedures, etc), which is a product requirement or customer requirement, as covered in 7.2.1, and hence needs to taken in document control.


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  Clause No.: 5.5.2 Management Representative
  Change: replacing "member of organizations management" for "member of management"
  Explanation: Earlier some auditors (read certification bodies) have made wrong interpretation (in year 2000) and allowed consultants (external persons) as management representative.
  What does it mean to you: Nothing if you have not outsourced the job of management representative.


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  Clause No.: 6.2.1 and 6.2.2 (a) Human Resources: General and Competence, Training and awareness
  Change: "product quality" term is replaced by "conformity to product requirements"
  Explanation: A note is added after 6.2.1 explaining that conformity to product requirements may be affected directly or indirectly by the personnel performing any task within the quality management system. "product quality" and "conformity to product requirements" have vastly different meanings.
  product quality is limited to the quality of product whereas "product requirements" means all the requirements defined within the purview of clause 7.2.1 which includes delivery requirements.
  This change along with note after 6.2.1 has expanded the scope for defining competence requirement for personnel to almost all processes and levels of organization.
  Earlier interpretation was to define competence requirement for personnel whose work directly affected product quality. To meet the requirement of 2000 edition defining and ensuring competence requirements for quality assurance and production personnel is considered sufficient.
  What does it mean to you: To meet the requirement of 2008 edition you are now required to define and ensure competence requirement of dispatch personnel, maintenance personnel and all other processes which are covered in quality management system because directly or indirectly all processes of QMS affects conformity to product requirements as covered in 7.2.1.


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  Clause No.:  6.3 (c) Infrastructure
  Change: In point C, supporting services, information system is added as example
  Explanation: Enterprise Resource Planning Software fall under category of information system The standard, in 2000 edition, referred supporting services such as transport and communication. But a liberal interpretation included information systems as well.
  Large corporate are already having Enterprise Resource Planning (ERP) Software. Medium, small and even tiny industries are implemented ERP. Records are maintained on electronic media instead of paper.
  What does it mean to you: This should not impact you if your ERP is under document control and covered in audit schedules (internal and external).
  If you have an ERP and your auditor has not included it within scope of audit then be prepared to face questions on it during next audit. Auditor may like to see its features, its operation, training to its user etc., during next audit.


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  Clause No.: 6.4 Work Environment
  Change: Note added after the clause to explain work environment, that it relates to conditions under which work is performed including physical, environmental and other factors such as noise, temperature, humidity, humidity, lighting or weather.
  Explanation: Note simply explains the work environment conditions and does not add any requirement
  What does it mean to you: Nothing; Only if you thought that noise other factors does not constitute work environment, be prepared to work on them.


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  Clause No.: 7.2.1 Determination of requirements related to product
  Change: A note added at the end of clause explains that post delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling and final disposal.
  Explanation: The note expands post delivery activities to a new level and includes even recycling or final disposal, which was not the case in 2000 edition.
  What does it mean to you: For some this was obvious interpretation but for some this will be a big new addition. The extent of impact on your organization will depend upon:
  1. scope of your quality management system
  2. statutory and regulatory requirements applicable to the product in your country.
  3. your agreements with your customer.


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  Clause No.: 7.3.1 Design and development planning
  Change: A note after the clause explains that design and development review, verification and validation have distinct purposes. They may be conducted and recorded separately or in any combination suitable for the product or the organization
  Explanation: This is merely a clarification as in many cases review; verification and validation are performed at the same time, for example engineering drawing preparation.
  What does it mean to you: Majority of ISO 9001:2000 certified companies have excluded design and development and hence this should not impact them.
  For others, the requirement might already been  taken care of.


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  Clause No.: 7.3.3 Design and development outputs
  Change: A note after the clause specifies that information for production and service provision may include details for preservation of product
  Explanation: This is merely a clarification as preservation of product was appropriately considered, as applicable, in design and development outputs.
  What does it mean to you: Majority of ISO 9001:2000 certified companies have excluded design and development and hence this should not impact them.
  For others, the requirement might already been taken care of.


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  Clause No.: 7.5.1 (d) Control of production and services
  Change: Term "device" is replaced by "equipment"
  Explanation: A small appropriate change to make the term suitable for a wider range of industry segment.
  What does it mean to you: Nothing


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  Clause No.: 7.5.4 Customer Property
  Change: Note at the end of clause is expanded to include "personal data" as customer property
  Explanation: A small appropriate change to make incorporate a term normally associated with IT and ITES industry segment.
  What does it mean to you: Nothing; This was obvious interpretation.


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  Clause No.: 7.5.5 Preservation of product
  Change: "in order to maintain conformity to requirements" added as objective of preservation and term "as applicable" added for preservation activities which are defined as identification, handling, packaging, storage and protection.
  Explanation: This should be seen as appropriate amendment for clarity, and A small appropriate change to make the requirement suitable for a wider range of industry segment.
  What does it mean to you: Nothing


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  Clause No.: 7.6 Control of monitoring and measuring equipment
  Change: Term "device" is replaced by "equipment" .
  A note at the end of clause is added stating that 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.
  Clause reworded
  Explanation: A small appropriate change to make the term suitable for a wider range of industry segment. Computer software is now being extensively used for quality assurance purposes in all types of industry and hence clarity was needed.
  What does it mean to you: Nothing if your self calibrated, automated, or computer based measurement systems are calibrated and you have evidence; Else be prepared to increase your calibration activity.


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  Clause No.: 8.2.1 Customer satisfaction
  Change: A note at the end of clause states 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.
  Explanation: This clarification will help organizations:
  •         Who do not get any formal feedback from the customers.
  •         can  not afford the expenditure
  •         are operating in a industry segment, where customer satisfaction surveys are not practical
  •         who are ancillaries to other organizations and have only one customer.
  •         many others
  What does it mean to you: Revise your customer satisfaction measurement methodology, which asks for taking feedback from customer (which never comes). Define a procedure where you measure customer satisfaction level by consolidating results from one or more types of data such as customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, dealer reports instead of only customer satisfaction surveys.


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  Clause No.: 8.2.2 Internal Audit
  Change: Note at the end of clause now refers to ISO 19011 for guidance instead of ISO 10011 parts 1, 2 and 3.
  Explanation: Small change as ISO 10011 parts 1, 2 and 3 are replaced by ISO 19011.
  What does it mean to you: Nothing; Take a look at new ISO 19011 and try to incorporate guidance given in the standard in your internal audit practices.


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  Clause No.: 8.2.3 Monitoring and measurement of processes
  Change: 2000 edition asked for action, when planned results are not achieved, as appropriate, to ensure product conformity.
  In 2008 "to ensure product conformity" is deleted.  By deleting  "to ensure product conformity" the scope of requirement to take action is expanded.
  Explanation: Now standard wants you to take action, as appropriate, on all cases where planned results are not achieved.  In cases like delay in delivery, which does not affect product conformity, many organizations were simply monitoring delays and sufficient and appropriate actions were not initiated by them.
  Another case is when production is not carried out as planned.
  Such cases can no longer be ignored just because they do not affect product quality.
  What does it mean to you: A lot; This will affect your corrective-preventive action system. You are now required to take appropriate action on every failure.


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  Clause No.: 8.2.3 Monitoring and measurement of processes
  Change: A note at the end of clause added as:
  When determining suitable methods, the organization should consider the type and extent of monitoring and 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. Note is added as guidance only.
  Explanation: In Process monitoring and measurement, normally, consideration is given to its impact of effectiveness of system, product quality etc.
  What does it mean to you: As such nothing.


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  Clause No.: 8.3 Control of nonconforming products
  Change: "Where applicable" term added.
  Explanation: This eliminates the need to control all nonconforming products, if the same is not applicable.
  In some industry segments, like consultancy, it is not possible to eliminate the detected nonconformity. though actions can be taken to minimize or nullify the effects of nonconforming service.
  What does it mean to you: You can change your procedure, appropriately and define cases with appropriate actions.


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  Clause No.: 8.5.2 Corrective Action
  Change: f) updated to read “reviewing the effectiveness of the corrective action taken.”
  Explanation: Should be seen as appropriate amendment for clarity.
  What does it mean to you: Nothing


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  Clause No.: 8.5.3 Preventive Action
  Change: e) updated to read “reviewing the effectiveness of the corrective action taken.”
  Explanation: Should be seen as appropriate amendment for clarity.
  What does it mean to you: Nothing




 


Apart from the changes listed above, there are some changes, for example clause 4.2.1, 4.2.4, where paragraph is rewritten but meaning and requirement is same as 2000 edition. In some cases clause name is changed.