ISO 9001:2008

0.1 - General

• The standard is including the ability to meet any statutory requirements along with regulatory requirements.

• It's also clarified that these requirements are restricted to those which are applicable to the product.

0.2 – Process approach

• Text added to identify a process as “an activity or set of activities”

0.3 - Relationship with ISO 9004

• Revised to emphasize continual improvement.

• Removed reference to “applicable statutory and regulatory requirements.”

• Specifies that ISO 9004 can be used “to move beyond the requirements of ISO 9001.”

0.4 - Compatibility with other management systems

• Added reference to Annex A, which compares ISO 9001:2008 and ISO 14001:2004.

1.1 and 1.2 - Scope

• First note adds that the term product can be any intended output from the product realization process.

• Second note explains that a statutory requirement can be a legal requirement.

2 - Normative references

• Clarification for current reference - the ISO 9000:2000 is now replaced by ISO 9000:2005.

3 - Terms and definitions

• Explanation of customer, organization and supplier terms have been removed.

4.1 - General requirements

• Clause a - The word “determine” replaces the word “identify” for processes.

• Notes cover definition of outsourced process and types of control that may be applied to outsourced processes.

• Relationship to clause 7.4 has been added.

4.2.1 – Documentation requirements, general

• Clarification that QMS documentation also includes records.

• Note 1 was changed - a single document may include the requirements for one or more procedures, and a requirement for a documented procedure may be covered by more than one document.

4.2.3 (f) - Control of documents

• Clarification that only external documentation relevant to the quality management system needs to be controlled.

4.2.4 - Control of records

• Editorial changes to better align with ISO 14001.

5.5.2 - Management representative

• Additional clarification that the management representative be a member of the organization’s management.

6.2.2 - Competence, training and awareness

• Clause b – “provide training or take other actions to satisfy these needs” changed to “where applicable, provide training or take other action to achieve the necessary competence”

6.3 - Infrastructure

• Clause c – “information systems” is now included as part of the infrastructure.

6.4 - Work environment

• Clarification of “work environment” to include conditions under which work is performed.

• New conditions include noise, temperature, humidity, lighting, and weather as part of the working environment.

7.1 (c) - Planning of product realization

• The term “measurement” had been added to the activities.

7.2.1 - Determination of requirements related to the product

• Note includes clarification of the meaning of “post delivery activities.”

7.3.1 - Design and development planning

• A note has been added clarifying that design review, verification, and validation are separate activities, but they might be conducted combined as suitable to the product and the organization.

7.3.3 - Design and development outputs

• Note added to clarify that information needed for production and service provision may include details for preservation of the product.

7.5.3 - Identification and traceability

• Added/clarified that the organization shall identify product status with respect to monitoring and measuring requirements throughout product realization.

7.5.4 - Customer property

• Slight wording change in the requirement to inform the customer of any problem regarding his property.

• The note has been amended to include personal data as customer property.

7.5.5 - Preservation of product

• Slight wording changes:– Added "in order to maintain conformity to requirements.”– Addition of the term “As applicable…” to identification,

handling, packaging, storage, and protection.

7.6 - Control of monitoring and measuring equipment

• 7.6 has changed from monitoring and measuring “devices” to “equipment”

• The reference to paragraph 7.2.1 has been removed

• Clause a – Changed “and/or” to “or,” so it now reads “be calibrated or verified, or both.”

• Clause c – from “be identified to enable the”to “have identification in order to”

• Note 1 – the references to ISO 10012-1 and ISO 10012-2 have been removed

7.6 - Control of monitoring and measuring equipment

• Note added – 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.

8.2.1 - Customer satisfaction

• Note added to explain that monitoring of customer perception can include input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, and dealer reports.

8.2.2 - Internal audit

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

• Records of audits now include audit results.• The references to ISO 10011-1, ISO 10011-2, and

ISO 10011-3 are now changed to ISO 19011.

8.2.3 - Monitoring and measurement of processes

• A change of words: “to ensure conformity of the product” had been removed.

• Note added: When determining suitable methods, it is advisable that 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 on the effectiveness of the quality management system.

8.3 - Control of nonconforming product

• Where applicable, the organization shall deal with nonconforming product by one or more of the following ways:– Section d is added and now states “by taking action

appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.”

8.4 - Analysis of data

• References to other clauses updated in items b),c), and d).

8.5.2 - Corrective action

• Item f) updated to read “reviewing the effectiveness of the corrective action taken.”

8.5.3 - Preventive action

• Item e) updated to read “reviewing the effectiveness of the preventative action taken.”

ISO 9001:2008

• Changes should not affect present or future implementation.

• Notes of explanation to clarify the standard.

• ISO/TS 16949 and AS9100 will change as they are derivatives of ISO 9001.

Questions & Answers

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