Learning Session 01

February 14, 2009 NTC Boardroom, 1:00-3:30 pm

Internal Quality Auditors

Auditing Customer Communication

Learning Session 02

Importance of Customer Communication

Requirements
ISO 9001:2000 clause 7.2.3 : Customer communication
The organization shall determine and implement effective arrangements for communicating with customers in relation to a) product information, b) enquiries, contracts or order handling, including amendments, and c) customer feedback, including customer complaints.

Other ISO 9001:2008 requirements regarding Customer Communication

Clause 5.2 Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction Clause 7.2.2 The organizations review of the requirements related to the product conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders); Clause 7.2.2 Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance; the organization needs to have a system in place to obtain those requirements. Clause 8.3b Authorizing the use of non conforming product by release or acceptance under concession by a relevant authority and, where applicable, by the customer.

Guidance from ISO 9004:2000 (clause 7.2)

Processes related to interested parties Management should ensure that the organization has defined mutually acceptable processes for communicating effectively and efficiently with its customers and other interested parties. The organization should implement and maintain such processes to ensure adequate understanding of the needs and expectations of its interested parties, and for translation into requirements for the organization

Verifying the effectiveness of customer communications

Verifying the effectiveness of customer communication is therefore a critical component for achieving customer satisfaction. Although there is no specific requirement in ISO 9001:2000 for a documented procedure, depending on the size, complexity and culture of the organization it may be necessary to have one in order to ensure effective implementation of the customer communication process. ISO 9000 defines the term customer as the recipient of the product. It further gives examples of customers including the end user. Many organizations sell their products / services through dealers and retailers and may not be receiving orders directly from the end users. It is important for the auditor to verify how the organization communicates about the quality of its product / service to the end users and also the mechanism for obtaining a feedback (besides complaints) from the end users. It should be recognized that the needs of the dealers / retailers may at times be different from those of the end users.

The auditors approach - 1

Customer communication falls in three general categories: An organizations general communication to existing or potential customers such as advertisements or marketing information, Specific information relating to a customer enquiry, requirement or order, and

Communication in response on customer feedback and complaints

The auditors approach - 2

Some or all of the following means of an organizations general customer communication may be observed by the auditor: Product information, which includes
advertising material web sites product catalogues

Where the organization receives orders from dealers and not the end users, the auditor should establish that the product information available to the end users (pamphlets, brochures, web sites etc) describes the product / service adequately and accurately. The auditor should also try to establish how the customer needs have been identified and product specifications arrived at.

The auditors approach - 3

Verify the product information to confirm that it is readily available to customers or potential customers and provides information that is up-to-date and accurate.

Query/take a look into, for example, how often advertising material, web sites and product catalogues are reviewed to reflect the organizations current product offerings and services and what measures are taken if a particular product is modified, discontinued or no longer available.

The auditors approach - 4

Some or all of the following means of an organizations specific customer communication may be observed by the auditor: Enquiries, contracts or order handling, including amendments
quotations order forms confirmation of order amendment to order delivery documentation invoices credit notes e-mail & general correspondence visit reports or notes to/from customer

Customer feedback and complaints management process

Letters in response to complaints Acknowledgments

The auditors approach - 5

There are also further instances where the auditor will experience the organizations communication with the customer:
During the ordering process where the customer provides no documented statement of requirement, the organization needs to have a system in place to obtain or confirm these customer requirements before the organization accepts the order. During the design/development process there may be considerable communication between the organization and the customer. During the process of authorizing the use of non conforming product by release or acceptance under concession by a relevant authority and, where applicable, by the customer

The auditors approach - 6

The auditor would use normal trace methods to verify compliance with the customer communications requirements of ISO 9001 and whether the organization communicated effectively with the customer in the execution of the enquiry, contract or order.

Audit Finding Evaluation

Scenario 1 :
Customer property (intellectual property) controlled by a bank

Situation:
A bank provides a variety of services to its customers (i.e. personal and company bank accounts), but chooses to implement a QMS only for its Internet banking services. For this service the bank has claimed conformity to ISO 9001:2008. The bank clearly states in its Quality Manual which services are covered by the QMS. The bank applies all the requirements of ISO 9001:2008 for the realization of its Internet banking services, with the exception of sub-clause 7.5.4 Customer property. The bank does not feel that it has possession of any customer property as part of its Internet banking services and has stated this in the justification for the exclusion of sub-clause 7.5.4 Customer property from its QMS.

Issue(s):
Can the bank exclude sub-clause 7.5.4 Customer property from its QMS and claim conformity to ISO 9001:2008?

Scenario 2 :
Exclusion of design and development by a contract manufacturer
Situation:
XYZ Electronics is building a new factory to perform manufacturing of mobile phones, as a subcontractor. It has only one customer and this customer maintains responsibility and authority for product design. XYZ Electronics is responsible for purchasing of all components and for performing the manufacturing activities. The customer provides XYZ with the manufacturing and parts specifications, and is also responsible for notifying XYZ of any design changes and providing the appropriate change information.
XYZ Electronics, in the development of its QMS, has excluded the requirements of ISO 9001:2008 sub-clause 7.3 Design and development. XYZ Electronics considers the customer specifications as a customer supplied product and therefore controls this according to ISO 9001:2008 sub-clause 7.5.4 Customer property.

Issue(s):
Can the XYZ Electronics exclude sub-clause 7.3 Design and development from its QMS and claim conformity to ISO 9001:2008?

Scenario 3 :
Regulators permit the exclusion of design development
Situation:
KML designs and fabricates pressure vessels for electricity generating stations, in accordance with various mandatory pressure vessel regulations. The regulatory authority has not yet revised its requirements to take ISO 9001:2008 into account, but has confirmed that it will continue not to require manufacturers QMSs to include design. On this basis KML decides to exclude sub-clause 7.3 Design and development from its QMS and to claim conformity to ISO 9001:2008.

Issue(s):
Can KML exclude sub-clause 7.3 Design and development from its QMS and claim conformity to ISO 9001:2008?

Scenario 4 : Outsourced design and development activities

Situation:

CDH Construction Ltd. provides engineering and construction services for various developers, but does not have in-house design capabilities. The company employs a project manager who is responsible for the management of design activities. These activities are outsourced to TPL Engineering Ltd, an engineering consulting company.
The activities of TPL Engineering Ltd. are managed through the application of the requirements of sub-clause 7.4 Purchasing. The project manager of CDH Construction Ltd. oversees the design activities and is involved in design review meetings and design verification and validation activities. In addition, the project manager is responsible for ensuring that the design activities are carried out in accordance with the requirements of ISO 9001:2008 sub-clause 7.3 Design and development. However, CDH Construction Ltd. has excluded subclause 7.3 Design and development from its QMS, since the design activities have been outsourced.
Issue(s):
Can CDH Construction Ltd. exclude sub-clause 7.3 Design and development from its QMS and claim conformity to ISO 9001:2008?

Scenario 5 : Traceability
Situation:
AKP Corp. is a company that manufactures electric motors for sale by licensed distributors. Traceability of the component parts of the product is not an internal or external requirement of this company. The organization has excluded the traceability requirement of subclause 7.5.3 Identification and traceability from its QMS, while claiming conformity to ISO 9001:2008.

Issue(s):
Can AKP Corp. exclude the traceability requirement of sub-clause 7.5.3 Identification and traceability from its QMS and claim conformity to ISO 9001:2008?

Scenario 6 : Design of services

Situation:
JWB is a consulting firm that performs internal audits for small organizations that have implemented quality management systems that conform to ISO 9001:2008. JWB developed its methodology and tools for performing customers internal audits based on the guidance of ISO 19011:2002. It delivers a customized service that has as its output a written internal audit report and all the supporting data from the audit. The organization wishes to exclude clause 7.3 Design and development with the justification that, as a service provider, it cannot have any design and development activities.

Issue(s):
Can JWB exclude sub-clause 7.3 Design and development from its QMS and claim conformity to ISO 9001:2008?

Scenario 7 : Post delivery activities

Situation:
The ABC consultancy organization provides financial auditing services to large manufacturing organizations. The product delivered to its customers is an internal financial audit report. Contracts for internal financial audit services state that a contract is completed when ABC has issued, clarified and reviewed its report with the customer, and that the customer has finally signed-off the report as being fully agreed; any activity beyond that the sign-off would be subject to a supplementary contract. The consulting firm claims its QMS conforms to ISO 9001:2008 with the exclusion of post-delivery requirement (f) of sub-clause 7.5.1.Control of production and service provision.

Issue(s):
Can the ABC consultancy organization exclude the post-delivery requirement in bullet (f) of sub-clause 7.5.1.Control of production and service provision from its QMS and claim conformity to ISO 9001:2008?

Scenario 8 : Validation of processes

Situation:
A small garment manufacturer carries out cutting work on textiles that are delivered to an internal sewing department for the next phase of the process. The quality of the output of the cutting work can be checked after finalization of the work. It has implemented a QMS and claims conformity to ISO 9001:2008 , with the exclusion of sub-clause 7.5.2 Validation of processes for production and

service provision.

Issue(s):
Can the small garment manufacturer exclude sub-clause 7.5.2 Validation processes for production and service provision from its QMS and claim conformity to ISO 9001:2008?

Scenario 9 : Monitoring and measuring devices

Situation:

A small training organization provides training to people who are not currently working and would like to upgrade their skills. The organization carries out practical skills training. In this process the participants practice the use of simple measuring equipment such as rulers, spirit levels and plumb lines. The organizations product is the skills development, and not the crafted items produced by the participants. The training organization has implemented ISO 9001: 2000 QMS and claims conformity to the standard with the exclusion of sub-clause 7.6 Control of monitoring and measuring

devices.
Issue(s):

Can the small training organization exclude sub-clause 7.6 Control of monitoring and measuring devices from its QMS and claim conformity to ISO 9001:2008.

Scenario 10 : Complex Organization (Global TV)

10.1 Introduction

This example illustrates some of the key issues a multinational organization with multiple work centres faces when implementing ISO 9001:2008 throughout the entire organization.
Global TV (GTV) is an organization that designs, manufactures, sells, distributes and services televisions (TVs) worldwide. GTV sells its product to retail outlets, which in-turn sell the TVs to end-user customers. Headquarters provides global support for quality management, all purchasing functions and sales and distribution contracts for its operations worldwide. GTV consists of a design centre, a sub-assembly plant, a manufacturing centre and a distribution centre, all of which are wholly owned by GTV. GTV management has decided to implement ISO 9001:2008 in all its facilities worldwide, and expects all facilities of GTV to have their own quality management system (QMS). However, not all facilities are required to obtain certification. In addition, all facilities have to comply with the contents of the corporate quality policy, which is To provide customers of GTV with products and services that meet their needs and expectations, and to continually improve the QMS.

Scenario 10 : Complex Organization (Global TV)

NOTE:

For the purpose of simplifying the example for a complex organization, the number of centres and plants has been reduced to one of each (design centre, sub-assembly plant, manufacturing centre and distribution centre).
ISO 9001:2008 allows for the exclusion of any requirement(s) within clause 7, where such exclusions do not affect the organizations ability or responsibility to consistently provide product that meets customer and applicable statutory and regulatory requirements. When applying clause 1.2 Application to a complex organization (Global TV) we have to take into consideration the organizations customer. Global TVs ultimate customer is the end user who purchases the product from a retail distributor. The customer of the individual centres and plants is the centre or plant that receives its product (i.e., the design centres customers are the subassembly plant and the manufacturing centre).

Scenario 10 : Complex Organization (Global TV)

Scenario 10.2: Manufacturing Centre (MC)

Situation:
MC receives orders from headquarters and delivers products to the distribution centre. It has established its QMS guided by, and in conformity with, the quality policy of GTV. All aspects of quality management required by ISO 9001:2008 are performed within the MC, with the sole exception of product design and development. The MC decided to exclude Sub-Clause 7.3 Design and development from the scope of its QMS since it performs no design activities. The MC does include a statement and justification in its quality manual that it is excluding the product design and development process and further indicates that a) its customer is Global TV headquarters who provide orders to the manufacturing plant, and b) Global TV headquarters is responsible for ensuring the Design Centre conforms to ISO 9001:2008.

Issue(s):
Can the MC exclude Sub-Clause 7.3 Design and development from its QMS and claim conformity with ISO 9001:2008?

Scenario 10.3 : Global TV

Situation:
Global TV Headquarters distributes its products through retail outlets to the end user customer. The organization has implemented ISO 9001:2008 at it headquarters and has requested that all its facilities implement a quality management system conforming to ISO 9001:2008. To date the only facility that has not implemented a quality management system is the Design Centre. In its quality management system manual Global TV headquarters states that all of its facilities conform to ISO 9001:2008 and the organization has not taken any exceptions.

Issue(s):
Can Global TV claim conformity with ISO 9001:2008?

10.4 Summary
Any complex organization (such as Global TV) has to be careful of its claim that its quality management system conforms to ISO 9001:2008. The organization has responsibility for all ISO 9001:2008 requirements that can affect the organizations ability to provide products that meet its customer and statutory and regulatory requirements. Therefore, in order to claim conformity to ISO 9001:2008 at the corporate level, it has to ensure that all its relevant facilities are conforming to ISO 9001:2008. The organizations individual facilities may exclude requirements within Clause 7 based on a justification making it clear that their customer is another division of the corporation, and not the end-user. The certificates of conformity referencing internal customers are of no direct value to the external customers of the organization.

Mandatory records required by ISO 9001:2008 standard

4.2.1 Records determined by the organization to be necessary to ensure effective planning, operation and control of processes 5.6.1 Records of management review 6.2.2 Records of education, training, skills, and experience 7.1 Records of evidence that realization processes and product meet requirements 7.2.2 Records of review of customer requirements and follow-up actions 7.3.2 Records of design and development input 7.3.4 Records of design and development review 7.3.5 Records of design verification actions 7.3.6 Records of design validation actions 7.3.7 Records of design changes and results 7.4.1 Records of the evaluation of suppliers 7.5.2 Records of special process validations 7.5.3 Records of the unique identification of product (traceability)
7.5.4 Records of lost, damaged or unsuitable customer property 7.6 Records of the basis of calibration used when no traceable standards exist 7.6 Records of the results of calibration 7.6 Records of assessment of product when calibration is out of tolerance 8.2.2 Records of internal audits 8.2.4 Records of person(s) authorizing release of product to the customer 8.3 Records of the nature of nonconformities and subsequent actions 8.5.2 Records of the results of corrective action taken 8.5.3 Records of the results of preventive action taken

PLUS

records the organization may choose to keep

e.g. delivery notes and copies of purchase orders are not mentioned in that list but most organizations would want to keep them.