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Tin tức dịch vụ tư vấn ISO

Download IATF 16949:2016 – Sanctioned Interpretations #1~15

2018-11-20 03:48:53 | Lượt xem: 6449 | Tin tức dịch vụ tư vấn ISO

Ngày 12/11/2018 - IATF đã đưa ra bản Santion Interpretion bổ xung thêm các thay đổi từ 14 ~ 15

Các thay đổi về tiêu chuẩn IATF 16949:2016 bao gồm các Sanctioned Interpretations (SIs) và thời gian hiệu lực của các SIs như sau:

SI 1-9 issued in October 2017, effective October 2017. 

SI 10-11 issued in April 2018, effective June 2018.

SI 8 revised and reissued in June 2018, effective July 2018.

SI 10 revised and reissued in June 2018, effective July 2018.

SI 12-13 issued in June 2018, effective July 2018.

SI 14-15 issued in November 2018, effective January 2019.

Mời các bạn download IATF 16949:2016 – Sanctioned Interpretations #1~15 qua link:



Các thay đổi bổ xung cụ thể như sau:

Mục thay đổi số 1

3.1 Terms and definitions for the automotive industry

customer requirements

all  requirements  specified  by  the  customer  (e.g.,  technical,  commercial,  product  and manufacturing process-related requirements, general terms and conditions, customer-specific requirements, etc.)

Where  the  audited  organization  is  a  vehicle  manufacturer,  vehicle  manufacturer subsidiary,  or  joint  venture  with  a  vehicle  manufacturer,  the  relevant  customer  is specified by the vehicle manufacturer, their subsidiaries, or joint ventures. 

Rationale for change:

Customer requirements are developed by vehicle manufacturers for application in their supply chain by the nature of the product realization process. Therefore, where the vehicle manufacturers are being certified, the vehicle manufactures define how customer approvals and/or input are managed.

Mục thay đổi số 2 Product safety

The organization shall have documented processes for the management of product-safety related products and manufacturing processes, which shall include but not be limited to the following, where applicable:

a) – m) (…)

NOTE: Special approval of safety related requirements or documents may be required by the customer or the organization’s internal processes.  is an additional approval by the function (typically the customer) that is responsible to approve such documents with safety-related content. 

Rationale for change:

Clarify any confusion related to special approval review for safety related requirements or documents. 

Mục thay đổi số 3 Contingency plans

The organization shall:

a) – b)  (…)

c)  prepare contingency plans for continuity of supply in the event of any of the following: key equipment failures (also see Section; interruption from externally provided products, processes, and services; recurring natural disasters; fire; utility interruptions; cyber-attacks on information technology systems; labour shortages; or infrastructure disruptions;

Rationale for change:

Organizations  need  to  address  the  possibility  of  a  cyber-attack  that  could  disable  the organization's manufacturing and logistics operations, including ransom-ware.  Organizations need to ensure they are prepared in case of a cyber-attack.

Mục thay đổi số 4

7.2.3 Internal auditor competency

The organization shall have a documented process(es) to verify that internal auditors are competent, taking into account any requirements defined by the organization and/or customer-specific requirements. For additional guidance on auditor competencies, refer to ISO 19011. The organization shall maintain a list of qualified internal auditors.

Quality management system auditors, manufacturing process auditors, and product auditors shall all be able to demonstrate the following minimum competencies:

a)  understanding  of the  automotive  process  approach for  auditing,  including  risk -based thinking;

b)  understanding of applicable customer-specific requirements;

c)  understanding  of  applicable  ISO  9001  and  IATF  16949  requirements  related  to  the scope of the audit;

d)  understanding of applicable core tool requirements related to the scope of the audit;

e)  understanding how to plan, conduct, report, and close out audit findings.

Additionally, At a minimum, manufacturing process auditors shall demonstrate technical understanding of the relevant manufacturing process(es) to be audited, including process risk analysis (such as PFMEA) and control plan.

At a minimum, product auditors shall demonstrate competence in understanding product requirements and use of relevant measuring and test equipment to verify product conformity.

Where training is provided If the organization’s personnel provide the training to achieve competency, documented information shall be retained to demonstrate the trainer’s competency with the above requirements.

Rationale for change:

Distinguish competency requirements for quality management system auditors, manufacturing process auditors, and product auditors. Clarified the trainer competency expectations for internally provided training.

Mục thay đổi số 5 Quality management system documentation

The quality manual shall include, at a minimum, the following:

a)  the scope of the quality management system, including details of and justification for any exclusions;

b)  documented processes established for the quality management system, or reference to them;

c)  the organization’s processes and their sequence and interactions (inputs and outputs), including type and extent of control of any outsourced processes;

d)  a document (i.e., matrix for example, a table, a list, or a matrix) indicating where within the organization’s quality management system their customer-specific requirements are addressed.

Rationale for change:

Some CBs and organizations wanted clarification that a matrix was not a mandatory document. A matrix is just one of multiple methods that are acceptable. The format used is up to the organization.

Mục thay đổi số 6 Special characteristics

The organization shall use a multidisciplinary approach to establish, document, and implement its process(es) to identify special characteristics, including those determined by the customer and the risk analysis performed by the organization, and shall include the following:

a)  documentation of all special characteristics in the product and/or manufacturing documents drawings (as required), relevant risk analysis (such as Process FMEA), control plans, and standard work/operator instructions; special characteristics are identified with specific markings and are cascaded through each of these documents; documented in the manufacturing documents which show the creation of, or the controls required, for these special characteristics;

Rationale for change:

Clarifies the documentation of special characteristics in the product and/or manufacturing drawings

Mục thay đổi số 7 Type and extent of control -supplemental

The organization shall have a documented process to identify outsourced processes and to select the types and extent of controls used to verify conformity of externally provided products, processes, and services to internal (organizational) and external customer requirements.

The process shall include the criteria and actions to escalate or reduce the types and extent of controls and development activities based on supplier performance and assessment of product, material, or service risks.

Where  characteristics  or  components  “pass  through”  the  organization’s  quality management system without  validation or controls, the organization shall ensure that the appropriate controls are in place at the point of manufacture.

Rationale for change:

Clarify the organization’s responsibilities for pass through characteristics. 

Mục thay đổi số 8 Supplier quality management system development

The organization shall require their suppliers of automotive products and services to develop, implement, and improve a quality management system (QMS) with the ultimate objective of eligible organizations becoming certified to this Automotive QMS Standard. 

Using a risk-based model, the organization shall define a minimum acceptable level of QMS development and a target QMS development level for each supplier. certified to ISO 9001, unless otherwise Unless otherwise authorized by the customer [e.g., item a) below], a QMS certified to ISO 9001 is the initial minimum acceptable level of development. Based on current performance and the potential risk to the customer, the objective is to move suppliers through the following QMS development progression:  with the ultimate objective of becoming certified to this Automotive QMS Standard. Unless otherwise specified by the customer, the following sequence should be applied to achieve this requirement: 

a)  compliance to ISO 9001 through second-party audits;

b)  certification to ISO 9001 through third-party audits; unless otherwise specified by the customer, suppliers to the organization shall demonstrate conformity to ISO 9001 by maintaining  a  third-party  certification  issued  by  a  certification  body  bearing  the accreditation  mark  of  a  recognized  IAF  MLA  (International  Accreditation  Forum Multilateral Recognition Arrangement) member and where the accreditation body’s main scope includes management system certification to ISO/IEC 17021;

c)  certification to ISO 9001 with compliance to other customer-defined QMS requirements (such as Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers [MAQMSR] or equivalent) through second-party audits; 

d)  certification to ISO 9001 with compliance to IATF 16949 through second-party audits;

e)  certification to IATF 16949 through third-party audits (valid third-party certification of the supplier to IATF 16949 by an IATF-recognized certification body).

NOTE: The minimum acceptable level of QMS development may be compliance to ISO 9001 through second-party audits, if authorized by the customer.

Rationale for change:

Clarified the expected supplier quality management system development progression.  This approach supports the “Risk Based Thinking” concept emphasized throughout Section 8.4 of the standard. Additional clarification added with “as applicable” in the first paragraph to address those organizations that are not eligible for IATF 16949 certification (examples including but not limited to the following: scrap metal suppliers, trucking companies who provide transport and logistics support, etc.).

Mục thay đổi số 9 Customer authorization for concession

The organization shall obtain a customer concession or deviation permit prior to further processing whenever the product or manufacturing process is different from that which is currently approved. 

The organization shall obtain customer authorization prior to further processing for “use as is” and rework for repair (see dispositions of nonconforming product. If subcomponents are reused in the manufacturing process, that sub-component reuse shall be clearly communicated to the customer in the concession or deviation permit. 

Rationale for change:

Clarify requirements and eliminate contradiction in relation to customer approval associated with rework.

Mục thay đổi số 10 External laboratory

External/commercial/independent  laboratory facilities  used for  inspection,  test,  or  calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test, or calibration, and either:

—  the laboratory shall be accredited to ISO/IEC 17025  or  its  national equivalent  (e.g., CNAS-CL01  in  China)  by  an  accreditation  body  (Signatory)  of  the  ILAC  MRA (International Laboratory Accreditation Forum Mutual Recognition Arrangement –  www.ilac.org)  or  national  equivalent  and  include  the  relevant  inspection,  test,  or calibration  service  in  the  scope  of  the  accreditation  (certificate);  the  certificate  of calibration or test report shall include the mark of a national accreditation body; or

—  there shall be evidence that the external laboratory is acceptable to the customer.

Rationale for change:

Some organizations found the lab accreditation requirements for external/commercial/independent laboratory facilities used for inspection, test, or calibration services confusing and needed clarification. Clarified lab accreditation requirements and expectations

Mục thay đổi số 11 Temporary change of process controls

The organization shall identify, document, and maintain a list of the process controls, including inspection, measuring, test, and error-proofing devices., that includes the primary process control and the approved back-up or alternate methods.  The list of process controls shall include the primary process controls and the approved back-up or alternate methods, if back-up or alternate methods exist. 

Rationale for change:

Clarified that not every primary process control has a back-up or alternate method. Clarified that if a back-up or alternate method exists, that those back-up or alternate methods are included on a list maintained by the organization.  It is not a requirement to have an alternative process control for every primary control.

Mục thay đổi số 12 Process effectiveness and efficiency

Top management shall review the product realization processes effectiveness and efficiency of the quality management system and support processes to evaluate and improve their effectiveness and efficiency the organization’s quality management system. The results of the process review activities shall be included as input to the management review (see Section

Rationale for change:

Clarified that not every process requires an efficiency measure. The organization needs to determine which processes require efficiency measures within their quality management system. Additionally, the organization’s problem-solving processes need to have an effectiveness review conducted by the organization’s management. 

Mục thay đổi số 13 Management  review inputs – supplemental

Input to management review shall include:

a)  cost of poor quality (cost of internal and external nonconformance);

b)  measures of process effectiveness; 

c)  measures of process efficiency for product realization processes, as applicable;

d)  product conformance;

e)  assessments of manufacturing feasibility made for changes to existing operations and for new facilities or new product (see Section;

f)  customer satisfaction (see ISO 9001, Section 9.1.2);

g)  review of performance against maintenance objectives;

h)  warranty performance (where applicable);

i)  review of customer scorecards (where applicable); 

j)  identification of potential field failures identified through  risk analysis (such as FMEA); 

k)  actual field failures and their impact on safety or the environment.

Rationale for change:

Clarified that not every process requires an efficiency measure. The organization needs to determine which processes require efficiency measures within their quality management system.

Mục thay đổi số 14

- Quality management system audit

The organization shall audit all quality management system processes over each a three-year audit cycle calendar period, according to an annual programme, using the process approach to verify compliance with this Automotive QMS Standard. Integrated with these audits, the organization shall sample customer-specific quality management system requirements for effective implementation.

The complete audit cycle remains three years in length. The quality management system audit frequency for individual processes, audited within the three-year audit cycle, shall be based upon internal and external performance and risk. Organizations shall maintain justification for the assigned audit frequency of their processes. All processes are required to be sampled throughout the three-year audit cycle and audited to all applicable requirements in the IATF 16949 standard, including ISO 9001 base requirements, and any customer-specific requirements.

Rationale for change: Clarified that the audit cycle remains three years in length. Deleted IATF 16949 FAQ 18 and put former FAQ 18 2 nd paragraph requirements into SI 14. Clarified that all processes are to be audited during the three-year audit cycle.

Mục thay đổi số 15:

3.1. Term and definition for the automotive industry

Embedded software

Embedded software is a specialized programme stored in an automotive component (typically computer chip or other non-volatile memory storage) specified by the customer, or as part of the system design, to control its function(s). To be relevant in the scope of IATF 16949 certification, the part that is controlled by embedded software must be developed for an automotive application (i.e., passenger cars, light commercial vehicles, heavy trucks, buses, and motorcycles; see Rules for achieving and maintaining IATF Recognition, 5th Edition, Section 1.0 Eligibility for Certification to IATF 16949, for what is eligible for “Automotive”).

NOTE: Software to control any aspect of the manufacturing process (e.g., machine to manufacture a component or material) is not included in the definition of embedded software.

Rationale for change:

Minimize confusion regarding embedded software and what is applicable.

Deleted IATF 16949 FAQ 10.

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