Iso 9001 2008-ammendments

What’s new in ISO 9001:2008 Draft International Standards? While ISO 9001 and ISO 9004 QMS standards are undergoing revision. ISO 9001:2008 Beta version (Draft International Standards (DIS)) has been issued and after voting by ISO members, it is likely to be published as International Standard in October 2008. (Say 29th Oct, 08) Changes are mostly editorial giving more clarity to the right interpretation of requirements. Users (such as, organizations implementing ISO 9001 QMS, QMS auditors, etc.) will find the forthcoming international standard useful for right interpretation of the standard’s requirements. Para 0.1 (General) of the ISO 9001:2000 states: “…..The design and implementation of an organization’s quality management system is influenced by varying needs, particular objectives the products provided, the processes employed and the size and structure of the organization… …..” ISO 9001:2008 (DIS) clarifies that design and implementation of an organization’s is influenced by organization’s business environment, changes in business environment and risks associated environment in addition to the organization’s particular objectives, the products provided, the processes employed and the size and structure of the organization. Statement of where and who can use the standard now includes statutory requirements as well as regulatory and clarifies that these requirements are restricted to those applicable to the product. The text of Para 0.2 (process approach) is modified and it is emphasized in ISO 9001:2008 (DIS) the importance of process being capable of achieving desired output. Para 0.3 (Relationship with ISO 9004) – No change Para 0.4 (Compatibility with other management systems) – A comment has been added that the development of ISO 9001:2008 made due consideration to ISO 14001:2004 EMS. Clause 1 (Scope) – Sub clause 1.1 (General) and Sub Clause 1.2(Application) – It is mentioned in ISO 9001:2008 (DIS) that product also includes intermediate product. The words ‘regulatory requirements’ have been replaced by ’statutory and regulatory requirements’, thus making the requirement of this clause more clearly in meaning. Clause 2 (Normative reference) – It now refers to ISO 9000:2005 version. Clause 3 (Terms and definitions) – The explanation of who the ‘customer’, ‘organization’ and ’supplier’ are, has been removed. Sub clause 4.1 (Quality Management system – General requirements) – The word ‘identity’ has been replaced with the word ‘determine’. Two additional notes have been given in ISO 9001:2008 (DIS). These additional notes provide more explanation about outsourcing and nature of control to be applied to the outsourced process. This clause also clarifies that outsourced organization and must be included in the quality management system of the organization.

Sub clause 4.2.1 (Documentation requirements – General) – This clause wordings are reframed, however, having same meaning as stated in ISO 9001:2000, such as – (I) Quality management System documentation includes records. (ii) The documents required may be combined. (iii) The requirements of the standard (ISO 9001) may be covered by more than one document. (iv) The organization may have a single document for multiple procedures or multiple documents for various requirements of the document procedures (Note 1 of the sub clause is expanded in ISO 9001:2008 DS) Sub clause 4.2.2 (Quality manual) – No Change Sub clause 4.2.3 (Control of documents) – In this sub clause, the requirements on control of external origin documents have been mentioned to give more clarity. External documents referred to are those needed for use in the QMS. Now the organization needs to ensure identification and distribution control of documents of external origins determined by the organization for planning and operation of the quality management system Sub clause 4.2.4 (Control of records) – Editorial change and requirements of this clause significantly reduced in length but requirements remain unchanged. Clause 5.1 (Management Commitment) – The word ’statutory’ has been added in 5.1(a). Clause 5.2 (Customer focus) – No change Clause 5.3 (Quality Policy) – No change Clause 5.4 (Planning) – No Change. Clause 5.5 (Responsibility, authority and communication) – Sub clause 5.5.2 of ISO 9001:2008 DIS is modified with a clarity that member of the organization’s own management must be appointed as a management representative. Clause 5.6 (Management review) – No change Clause 6.1 (Provision of resources) – No change Clause 6.2 (Human resources) – In sub clause 6.2.1 and 6.2.2, the words ‘product quality’ have been replaced by ‘conformity to product requirements.’ Accordingly, the personnel performing work affecting conformity to product requirements must be competent and the organization needs to determine the necessary competence for personnel performing work affecting conformity to product requirements. According to 6.2.2 (b) now states that ‘where applicable’ training needs to be provided to achieve the ‘necessary competence’. 6.2.2 (c) now requires that

the achievement of competence has been ensured rather than checking the effectiveness of the training. A note is added after sub clause 6.2.1 mentioning that product requirement may be affected directly or indirectly by personnel performing any task within the quality management system. Clause 6.3 (Infrastructure) – In sub clause 6.3 (c), information systems has been included. Clause 6.4 (Work environment) – A note has been added to make clearer the conditions under which the work is performed. Physical, environmental and other factors such as noise, temperature, humidity, lighting, weather have been mentioned. Clause 7.1 (Planning of product realization) – In clause 7.1 (c), the word ‘measurement’ has been added. Clause 7.2 (Customer related processes) – Requirement has been slightly re-worded. The word ‘related’ has been changed to ‘applicable’. A note has been added at the end of sub clause 7.2.1 clarifying the first delivery activities to include actions under warranty provisions, contractual obligations (such as maintenance services) and supplementary services (such as recycling and final disposal). Clause 7.3 (Design and Development) – Notes added in sub clause 7.3.1 (Design & development planning) and sub clause 7.3.3 (Design and development out put). A note in the sub clause 7.3.1 clarifies that design review, verification and validation are separate activities and these may be conducted and recorded separately or in combination as suitable for the product and the organization. A note in the sub clause 7.3.3 clarifies that information for production and service provision may detail for preservation of the product. The word ‘provided’ has been removed and the phrase ’suitable for’ replaces ‘that enables’. The word ‘for’ (service provision) has been removed. Clause 7.4 (Purchasing) – No change Clause 7.5 (Production and service provision) – In sub clause 7.5.1 (d), the term ‘monitoring & measuring devices’ has been replaced by ‘Monitoring and measuring equipments’ A note at the end of sub clause 7.5.4 (customer property) has been made clearer to include personal data as customer property. In sub clause 7.5.5 the term ‘conformity to requirements’ and ‘as applicable’ have been added to provide more clarity. Clause 7.6 (Control of monitoring and measuring equipments) – The term ‘device’ has been replaced by ‘equipment’

The requirement of this clause has been rewarded to bring in more clarity. Explanatory notes have been added at the end of this clause regarding the use of computer ’software to satisfy the intended application typically includes its verification and configuration management to maintain its suitability for use. Clause 8.1 (Measurement, analysis and improvement – General) – No change Clause 8.2 (monitoring and measurement) – A note has been added in the sub clause 8.2.1 (Customer satisfaction) that monitoring customer perception may include input from services such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, last business analysis, compliments, warranty claims, dealer reports. A note at the end of sub clause 8.2.2 (Internal audit) now refers ISO 19011 for guidance. A requirement for records of audits and their results has been added. In sub-clause 8.2.3 the phrase ‘to ensure conformity of the product ‘ has been removed. A note at the end of sub clause 8.2.3 (Monitoring and measurement of processes) now clarifies that when deciding on appropriate methods, the organization should consider the impact on the conformity to product requirements and effectiveness of QMS. Clause 8.3 (Control of nonconforming product) – In the requirement of this clause, the term; where practicable’ is added. Clause 8.4 (Analysis of data) – No change Clause 8.5 (Improvement) – No change In short, 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. It is expected that a transition period of 12 months from the date of publication of the International Standard will be available to organizations for upgrading their QMS as per ISO 9001:2008.