Quality Manual-Quality & Certification Division · 1.1 This Quality Manual was prepared according to ISO 17021 requirements. 1.2 The Quality Manual refers to the Quality and Certification

Procedure No.: AC.01.00 Quality and Certification Division Procedures

Procedure : Quality Manual Chapter: Organisation

Page : 1 of 26 Edition 8

Valid from : 06/11

Change follow up Changes Date Revision

Para 5.1.2 - food added, para 5.4.1 – food safety systems added, 6.5.3 deleted (approval of contractors)

06/11 8

Division Director’s Signature: Eli Cohen - Kagan

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Valid from : 06/11

Quality Manual Content

1. GENERAL: ..................................................................................................................... 3

2. SCOPE: .......................................................................................................................... 3

3. OBLIGATORY GUIDELINES AND REQUIRED RULES GOVERNING THE DIVISION:3

4. QUALITY AND CERTIFICATION DIVISION: ................................................................. 4

4.2 DIVISIONS VISION: ....................................................................................................... 6

4.3 QUALITY AND CERTIFICATION DIVISIONS VALUES: ............................................... 6

4.4 DIVISIONS QUALITY POLICY: ..................................................................................... 7

4.5 DIVISIONS GOALS: ....................................................................................................... 8

5. DIVISIONS PRODUCTS: ............................................................................................... 8

6. ORGANISATIONAL STRUCTURE OF THE DIVISION - DIAGRAM: .......................... 13

7. JOB DESCRIPTION OF THE DIVISION - DIAGRAM: ................................................. 14

8. DIVISIONS CORE PROCESSES , FOCUSING ON THE CUSTOMER - DIAGRAM: .. 15

9. FLOW DIAGRAM OF WORK PROCESS – QUALITY SYSTEM APPROVAL: ........... 16

10. FLOW DIAGRAM OF WORK PROCESS – STANDARDS MARK APPROVAL: ........ 17

11. MAPPING CORE PROCESSES: ................................................................................. 18

12. OMMISSIONS: ............................................................................................................. 20

13. DETAILED DIVISIONS RESPONSE TO THE REQUIREMENTS OF THE ISO 9001:2008 STANDARD.: ............................................................................................. 20

14. CORRESPONDING TABULATION OF THE DIVISIONS PROCEDURES TO THE STANDARDS REQUIREMENTS: ................................................................................ 24







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1. General

1.1 This Quality Manual was prepared according to ISO 17021 requirements. 1.2 The Quality Manual refers to the Quality and Certification Division which is one of the divisions of

the Standards Institution of Israel. 1.3 The manual refers to all the divisions activities, in the field of :

1.3.1 Quality systems certification 1.3.2 Standards mark systems' operation for processes and products. 1.3.3 Training center of the Standards Institution – Professional guidance only. 1.3.4 Providing services to the various bodies connected to the core operations of the division

such as: Recognized contractor management, Supervision of quality systems of supervising and service providers for vehicle product manufacturing, Safety Training management for the education department.

1.3.5 Providing Assessment services such as IQ NET 9004 2. Scope

2.1.1 Approval provision to meet the requirements of the Israeli Standard for management systems. 2.1.2 Operating Standards mark system 2.1.3 Certification and system approval according to various specifications and international

standards. 2.1.4 Professional direction for the training centers' activities. 2.1.5 Providing accompanying services to the core processes of the division.

3. Obligatory guidelines and required rules governing the division: 3.1 Standards rule – 1953 ( combined version ) 3.2 Standards mark regulations – Standards regulations (Standards mark and supervision symbol) 1982 3.3 Standards directive (Standards outline determination) 1992 3.4 ISO IEC 17021 : 2006 – Conformity assessment – Requirements for bodies providing audit and certification of management standards. 3.5 ISO IEC GUIDE 65 3.6 ISO IEC GUIDE 67 3.7 I.S. ISO 9001:2008 3.8 Ethical Code – W.I 0.1 3.9 Form 101.06 - Milestones and meeting minutes for the Committee for safeguarding impartiality

4. Background on the Standards Institution of Israel

4.1 The Standards Institution of Israel is a non profit organization, operating with authorized powers according to the" Standards Rule" determined in 1953. The rules define the goals of the Institution, Primarily standards preparation and product quality assurance, by standards preparation, conducting audits, implementation of tests and research, granting approval to label with the Standards mark etc.







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4.2 The Standards Institution operates as an objective body and is a nonprofit organisation. The rules and regulations of the institution determine the institutes managing it – the general board and operating committee – and its composition. These institutes consist of representatives from organizations which have influence on the daily activities of country such as – Manufacturers Associations, Consumer organisations, Government offices, Engineers Society, Contractors, Trade Associations, Local Councils , Science and Research Institutes and more.

Organisational Structure of the Institute

4.3 In order to complete the designated assignments the standards institution is organized according to divisions and operational units as follows: 4.3.1 Standardizations division – Responsible for the coordination and preparation of the Israeli Standards and various specifications. 4.3.2 Industrial division – Responsible for the operation of the Institutes labs such as: Electricity and electronics lab, Mechanics Hydraulics and Energy lab, Chemistry Food and Textiles lab , Calibrations lab and teleprocessing lab. The labs perform the tests in the manufacturer's plants, Importers

Managing Director

Spokesman

Quality and Certification Division.

Standardization Division.

Industrial Division.

Construction Division.

Finance Division.

Computer Division.

Human Resources And Maintenance

Comptroller







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warehouse and customs. 4.3.3 Construction division – Responsible for the operation of centralized labs for soil, roads and construction material. The labs perform tests at the various construction sites. The division has various branches and centers in the large cities in order to supervise public and private construction countrywide. 4.3.4 Quality and Certification division – Coordinates the following subjects: Permit granting to manufacturers for the production of products, Process certification, Management system approval, Certification of Food safety management, Information assurance etc. The operation of the division is conducted through auditors who perform the checks in order to provide permits in organizations and companies. The division operates the training center as well. 4.3.5 Service divisions – Finance division, Human resource division and central computer division who provide service to all the institutes units. 4.4 The institute actively initiates, operates and participates in quality processes in the country such as: National Quality week, National prize for quality in industry, Prize for quality in service and more. 4.5 The Standards Institution of Israel (SII) represents Israel in International standardization organizations such as: ISO and IEC and is a member in institutes that manage these organizations. The Institute maintains diverse contacts with parallel institutes overseas and is connected with parallel bodies under bilateral recognition agreements. With these agreements the Institute obtains international recognition allowing complete response to customer's requirements worldwide and provides Israeli companies the opportunity to market their products overseas. 5 Quality and Certification division 5.1 Background/Objective 5.1.1 The Quality and Certification division provides certification services to quality management, environmental and safety systems and product certification in order to promote the quality of management, service and human resource and to improve the competitive ability and quality of life in the country. In addition the division provides operational management services to the Standards Mark System which certifies products and processes by permit committees. Certificate holders of the Institute benefit from their management systems and marketing advantages. 5.1.2 The division employs more than 60 academically qualified auditors with experience in engineering, finance, environmental affairs, programming and IT, safety, chemistry, food, agriculture, public management, microbiology, and more. The expertise in these fields provides a broad data source needed for certification and accreditation processes. 5.1.3 The division has accreditation from RvA, an international accreditation body located in Holland. The division, as a representative of the institute, is a member of IQNET which is a chain of 39 certification bodies that includes 150 branches in different countries. The members are connected through mutual agreements, so that the certificates provided by the division are recognized in the countries in which the organizations members operate. This fact assists the manufacturers in international trade and reduces the cost of auditing required of them in the countries of destination.







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5.1.4 The institute cooperates with various certification bodies worldwide, and is used as the operational section to conduct audits in the organizations in the country. The meaning of this, is that audits are conducted by qualified auditors of the division and the certificate is given by the relevant certification body. In this way the certification spectrum given to manufacturers in the country has increased. Organisations with whom a cooperation exists are : NQA ( England ) in the field of automotive industry, aerospace and communication, MDC (Germany )- medical products, LNE/GMED (France ) – medical products , ECAS ( Holland ) – agriculture, ISA ( Holland ) – food and agriculture and more 5.2 Vision of the division "The Quality and Certification division will be a leader in the market and with its products, in all its businesses, by innovation and advancement, professional authority as well as reputation, providing value to its customers. The division will operate as a profit and loss center expanding its activities over the course of time.

5.3 Values of the Quality and Certification division

• Client focus Clear understanding and meeting the customer's needs and expectations.

• Professional service Providing service solely on a professional merit.

• Cooperation and mutual responsibility Team work, Openness, Transparency, Listening, Respect of feelings, Mutual bi lateral understanding of needs: employee to employee and employee to manager, loyalty to work place, responsibility for results.

• Continuous Improvement and Innovation Personal motivations to enrich knowledge, penetration of new products, improve internal processes and improve performance (efficiency, effectiveness)

• Information confidentiality Safe guarding the intellectual property of the division/client and preventing leaks to concerns to whom the division/client did not express his agreement (defined manner) of revealing to them.

• Impartiality and Objectivity The moral integrity of the employee rests on the actual application of the issues he demands from the client.

5.4 The Quality policy of the division 5.4.1 Operating Standards Mark System for processes and products and certifying quality management systems, certification of environmental management systems and safety and health in the workplace of organizations in various frameworks, food safety systems and professional guidance of the training centers activities dealing with the public, providing various services to governmental offices and other clients, in issues which are the core of the divisions activities, with emphasis on: - Providing service to all those demanding without bias - High degree of accuracy and reliability - Courtesy and pleasant manner







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- Short reaction time - Fair price - Work completed by a professional team selected, trained and qualified for the job. - The various technological audits carried out by auditors with the appropriate professional background. - Ensure maintaining information confidentiality - Maintain strict professional and personal ethical rules.

5.4.2 We guarantee performance of the highest standard in accordance with the appropriate national and international standards such as ISO Guide 17021:2006, ISO Guide 65 (EN – 45011). The division is accredited by the international accreditation body RvA to ISO 9001, ISO 14001, ISO 13485. The division strives to maintain and increase its accreditation and recognition by internationally recognized standards.

5.4.3 We operate to provide certification services and mutual recognition world wide via the international certification network IQNET, and cooperation with network members with the aim of developing services and products with added value to its clients. The division's procedures are suited to the IQNET's procedures.

5.4.4 We participate in the advancement of quality in Israel by conducting operations such as: Initiation of national quality activities, National Quality week, Participation in national quality activities: Quality conference for the Israeli quality board National prize for quality in industry. 5.4.5 We grant the "Gold Mark" to manufacturers and service providers who have quality and excellence ingrained and who have at least 3 quality standards testifying to the suitability of the management systems , processes' and products to international and national standards , and "Platinum Mark" for manufacturers and service providers who have 5 quality standards.

5.4.6 We operate to update our clients with innovations/updates/changes in the standards, approval systems within the scope of the divisions activities. In addition we update our clients on general quality issues that are of interest to the general public . 5.4.7 We encourage all enquiries in order to improve and discuss all suggestions aimed at advancing the divisions objectives. We initiate continuous improvement of the employee's professional ability through relevant training and courses. 5.4.8 Management of Impartiality 5.4.8.1 We are committed to impartiality in our management system certification activities and ensure the objectivity of our management system certification activities. 5.4.8.2 We identify, analyze and document the possibilities for conflict of interests arising from provision of certification and resulting relationships. Detailed information hereto shall be made available to the QCC (impartiality safeguarding committee) for decision (see Form 101.06E). 5.4.8.3 We do not provide certification in cases of unacceptable threat to impartiality. 5.4.8.4 We do not certify another certification body's management systems certification activities 5.4.8.5 The quality and certification division does not deal with consulting and does not provide internal audits to its certified clients.







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5.4.8.6 We do not outsource audits and do not offer linked activities with organizations that provides management system consultancy. 5.4.8.7 We make sure, that personnel who have provided management system consultancy in previous two years, shall not be used to take part in certification activities, unless more than 3 years passed. 5.4.8.8 We take actions to respond to any threats to our impartiality arising from external actions. 5.4.8.9 We make sure that all our personnel act impartially and shall not allow commercial, financial or other pressures to compromise impartiality. The personnel of the division is instructed to report any situations that might result in threats to impartiality. 5.4.8.10 All the activities of the division’s staff are based on the Ethical Code – W.I 0.1. 5.4.8.11 Periodically the Quality and Certification Division shall review conformance with the impartiality requirements of ISO 17021. The results shall be recorded on form 101.06 and presented to the QCC of SII for approval. 5.4.9 Liability and Financing 5.4.9.1 We evaluate the risks arising from certification activities and posses appropriate insurance to cover liabilities. 5.4.9.2 We demonstrate to the committee for safeguarding impartiality (QCC) our finances and sources periodically. 5.5 Division's Goals - The detailed objectives will be determined within the framework of the annual management review 5.5.1 Customers – Increase customer satisfaction and improve customer loyalty. Increase the sales range to the customer

5.5.2 Excellence in the process – Improve operational efficiency and improve quality of work in particular service deadlines. Increase clarification, transparency and accuracy of documents dealing with customer communication . 5.5.3 Infrastructure – Increase employee's satisfaction by improving employee's abilities and development of knowledge and management information infrastructure.

5.5.4 Financial performance - Maintaining the overall revenues and profitability by providing for product development and infrastructure.

6. Division's Products

6.1 Operational service of the Standards Mark – Standard Mark granted by the approval committee assures that a certain product complies with the set requirements of quality as determined and defined by the various standards. The quality and certification division operates the Standards Mark System for the institute: 6.1.1 Standards Mark – An approval label signifying that a certain product adheres to the standards requirements. The standards mark system is voluntary. With that, in accordance with the Minister of Industry and trades decision there are a number of products for







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which the labeling of the Standards Mark is obligatory. This obligation deals mainly with products which have a safety risk. The activity is completed in accordance with the following procedures :

S.I.I procedure 005 – Requirements of quality systems operated at the manufacturers producing products labeled with the Standards Mark.

S.I.I procedure 006 – Policy determining the order, the importance and the degree of supervision of products produced bearing the Standards Mark.

S.I.I procedure 007 – Regulations for operating the Standards Mark system. 6.1.2 Safety Mark - An approval label signifying that a certain product adheres to the safety requirements. The Safety Mark ensures protection from dangers when using the product. The approval in this field is provided in accordance with the SII procedures as defined by the detailed SII procedures mentioned in the Standard Mark (clause 5.1.1) 6.2 Green Mark – An approval label signifying that a product meets the criteria proving that it's environmental impact is minimal. The label with this Mark prevents deception of the public and ensures appropriate use of the definition "environmental friendly". The activity is done in accordance with SII procedure 004 – regulations governing approval provision for the Green Mark to products with minimal environmental impact. 6.3 Process certification – Approval given in the framework of the Standards Mark, ensuring that the manufacturer maintains relevant means, appropriate organizational system work processes ensuring the continuation of the process and quality system meeting the demands of the relevant Standards Institute procedures. Processes such as: Imported cement manufacturing, swaying hydrant maintenance, vehicle reinforcement, fire detection system maintenance, roof sealing etc. The approval in this field is provided in accordance with the SII procedures as defined by the detailed SII procedures mentioned in the Standards Mark (clause 5.1.1) 6.4 Management systems certification - All the management systems that the division approves focuses on the operation of a methodical and controlled process of the management fields in the organization, in accordance with the requirements of the specific standard. Fulfilling the standards requirements ensures a clearly defined policy, defined aims and measures of the relevant management processes, process application control of the company's policy, organizational learning process and continuous lesson building, measurement of the processes affectivity and efficiency. The division's products in this field are:

I.S. ISO 9001:2008- quality management system certification. Focuses on the quality of the management process to manufacture products and or services, and to increase their effectivity. The activity is conducted in accordance with S.I.I procedure 002 – Approval of quality systems that operate according to the requirements of Israeli standard I.S. ISO 9001 – directives and regulations I.S. ISO 90003 : 2004 Quality management system approvals in the field of software – Approval according to the requirements of I.S. ISO 9001:2008 and guidelines to this standard serve as a manual for interpreting I.S ISO 9001:2008 for organizations in the field of software.







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I.S. ISO 14001 – environmental quality management system – Management of the parts of the organization with impact on the environment, by analyzing the risks to the environment and planning measures for them , prevention and/or reduction of environmental impact. The activity is conducted in accordance with S.I.I procedure 009 – Approval of environmental management systems that operate according to the requirements of Israeli standard ISO 14001 –regulations.

I.S. 18001 OHSAS – Procedure for hygiene and safety in the workplace – Controlled management of operational sections in the organization dealing with workers industrial safety, health and hygiene. The operation is done in accordance with S.I.I procedure 014 - approval of safety and hygiene systems operating in accordance with the requirements of Israeli standard S.I.I 18001 OHSAS – directives and regulations.

ISO/TSI 16949 – Quality management for materials, processes and products supplied to the worldwide automotive industry – approval focusing on the quality of the management processes of manufacturers in the industry, supplying parts, systems and products to the automotive industry. The process is done and certificates granted by NQA ( British C.B) . The activity is conducted in accordance with S.I.I 011- approval of systems operating in accordance with standard ISO/TSI16949.

I.S. 9301 – Safety management of the overland transportation system – the standard is based on the quality management Israeli standard ISO 9001:2008 with emphasis on issues relating to overland transportation system. The activity is conducted in accordance with S.I.I procedure 002 – approval of quality systems operating in accordance with the requirements of one of the Israeli standards from the I.S. 9000 series - directives and regulations.

TL 9000 – Quality management in the field of communications industry – Approval focusing on the quality of the management processes of manufacturers developing and providing services in the communication field. The approval is granted in conjunction with the NQA ( British organization ) . The activity is conducted in accordance with S.I.I procedure 002 – approval of quality systems operating in accordance with the requirements of one of the Israeli standards from the I.S. 9000 series - directives and regulations.

I.S. ISO/IEC 27001 – Information security management – Approval given to organisations focusing on providing comprehensive solutions to information security issues throughout all parts of the organization and an overall organizational view. The standards' requirements include establishing management and maintenance of the required controls, systematic monitoring and preparation of reaction ways for every possible event. The activity is conducted in accordance with S.I.I procedure 002 – approval of quality systems operating in accordance with the requirements of one of the Israeli standards from the I.S. 9000 series - directives and regulations.

I.S. AS 9100 - Quality management in the aerospace industry - approval focusing on the quality of the management processes of manufacturers in the industry, supplying parts, systems and products to the aviation industry. The approval is granted in conjunction with the NQA (British CB). The activity is conducted in accordance with S.I.I 016. approval of aerospace quality systems operating in accordance with AS9100 rev B.

CE – Approval of products in the medical devices – Approval of products in the field of medical equipment given by notified bodies authorized by the EEC. The approval is given in conjunction with MDC ( German organisation ) LNE/GMED ( French organization ). The activity is done according to European directive EEC 93/42 and appropriate certification bodies procedures'.







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I.S. ISO 13485:2003- production and development of medical devices – approval given for production of medical equipment in accordance with European directives and international standards. The activity is conducted in accordance with S.I.I procedure 002 – approval of quality systems operating in accordance with the requirements of one of the Israeli standards from the I.S. 9000 series - directives and regulations. I.S. ISO 22000 – management system for safety in food. Requirement for every organization in the food chain – Organisational approval especially for production and packaging. The standard includes HACCP requirements. HACCP- safety management for food manufacturers and service providers in the food field – the approval is given by the Standards Institution. The activity is conducted in accordance with S.I.I procedure 015 – approval of food safety systems HACCP – directives and regulations. BRC for food manufacturers – requirements of British Retailers Consortium for food manufacturers. The approval is given in cooperation with ISA (Dutch organization) The activity is conducted according to ISA's guidelines. BRC – IOP for food packaging manufacturers – requirements of British Retailers Consortium for food packaging manufacturers. The approval is given in cooperation with ISA (Dutch organization ) The activity is conducted according to ISA's guidelines. BRC for agricultural packing houses – requirements of British Retailers Consortium for agricultural packing houses. The approval is given in cooperation with ECAS (Dutch organization) the activity is conducted according to ECAS's guidelines. TNC – Approval for agricultural produce and packaging according to standards laid out by TESCO retail chain. The approval is given in cooperation with ECAS and approved by CMI (British organization). EUREPGAP - Approval for agricultural produce and packaging according to the EUREPGAP organization, an international European organization. The approval is given in cooperation with ECAS (Dutch organization) the activity is conducted according to ECAS's guidelines. IQNET 9004 standard for checking the organizations excellence – The approval is granted for meeting the requirements of this standard of organizations excellence by the IQNet. QWEB – assessment of the trading sites online internet suitability.

6.5 Conducting audits and additional services according to the customers' requirements: 6.5.1 Second party audits – Purchasing administration of the Israeli M.O.D – Conducting audits of the quality management system in organisations and transferring the audits' findings to M.O.D (Purchasing administration of the ministry of defense ) per customer's request, as a condition of registering as a supplier to the M.O.D. 6.5.2 Production approval for the American M.O.D –







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QPL/QML Qualified Product List /Qualified Manufacturers List according to MIL STD 790. 6.6 Appreciation certificates 6.6.1 Gold Mark – Certificate granted to organizations who have quality and excellence ingrained and who have at least 3 quality standards testifying to the suitability of the management systems, processes' and products to international and national standards. 6.6.2 Platinum Mark - Certificate granted to organizations who have quality and excellence ingrained and who have 5 or six quality standards testifying to the suitability of the management systems, processes' and products to international and national standards. 6.6.3 Diamond Mark - Certificate granted to organizations who have quality and excellence ingrained and who have 7 or more quality standards testifying to the suitability of the management systems, processes' and products to international and national standards.







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7. Organizational structure of the division

I – Professional coordination only

Division Director

Eli Cohen-Kagan

Head of Standard Mark

Operation Directorate

Joshua Miller

Training Center

Shai Hanoch

Head of Customer Service Directorate

A. Weinberg

Head of Systems Certification Directorate

Jacob Jarosinski

Director’s Assistant for Budget and Control

Ravit Shahar

Administration

Hen Goldberg

Quality & Information Management

Orit Shirian

Head of Green Label Directorate

Benny Braun







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8. Diagram of the job descriptions of the division

Standard Mark Operation Directorate

Customer Directorate System Certification Directorate

Management of existing customers

Sector manager

Customer managers

ProfessionalCoordinator

Routine Control

Customer liaison

Marketing

Communication with operational organizations

Preparation of product files

Control performance percentage

Professional management

Work schedule control in conjunction with customers

Management of existing customers

Correspondence + cost preparations

Training material and interpretation

Control sold hours

Auditor placement

Cost approval

Customer liaison

Contract Review *, Cost approval

Auditor training

Courses Professional review and control of customer files

Marketing with sector manager

Assist sector manager

Management of lead auditor in projects

Report inspection

Control salary reporting

Future human resources planning

Professional management

Work schedule control in conjunction with customers

Auditor assistance

Marketing with sector manager

Auditor welfare

Product development

Manage working relations with labs

Product development

Costing consultation per field

Product development

Certification Decisions –Approval of certifications

• Contract Review of ISO 22000 FSMS – see AC 02.04

Knowledge source

Income source







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9. Diagram of the divisions core processes, focusing on the customer

Auditors –Headquarter employees

Quality and Certification Division

Internal processes

Customer

Standard association

stamp operation

administration

Management system

approvaladministration

Customer administration

Training center

Routine report management – human resources

Human resourcemanagement

Continuous informationprovision

Initial certificationprocess

Inspection process

Customer documentation management

Payments and collection

Satisfaction survey

Customer complaints and handling enquiries

Marketing

Development : New products

Development : Infrastructure

Quality control –implementation

Quality management

Preparation for external audits

employee viewpoint survey

Welfare

Institu

tes lab

s

within

the fra

mework

of

stand

ard as

sociati

on sta

mp

External accreditation bodies

Development and professional advancement

Training and certification

Administration services

External certification bodies







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9.1 Flow diagram of work process – quality system approval

Corrective action

needed ?

Approved ?

Paid?

Corrective action

needed ?

Conducting audits and checks

Signing aSupervision agreement

Implementing corrective action


Preparation in the organisation –documentation and application Approval of price quote

Checking the corrective action


Certification approval


Customer reminder

Customer payment required ( proforma )

Documentation approval Providing price quote

Customer enquiry

Index :

Quality and certification divisionCustomer

Approved ?

Approved ?

No

No

No

No

No

Yes

Yes

Yes

Yes

Yes

Yes

No

Supervision

Preliminary ( Initial clarification )







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9.2. Flow diagram of work process – standards mark approval

Corrective action

needed ?

Approved ?

Defect Discovered ?

Minor/Major defect

Professional committee : Recommendation to grant permit/approval



Conducting quality auditsConducting process audits

Checking the products

Approval of price quote

Checking the corrective action Approval of supervision agreement



Documentation approval:Quality procedures

Product file

Providing price quote

Customer enquiry

Index :

Quality and certification division

Customer

Approved ?

Continuation of

process ?

No

No

No

No

No

Yes

Yes

Yes

Yes

Yes

Yes

No

Supervision

Initial clarification– Standard Association Stamp

Preliminary survey ( if required )

Informing the Customer

Permits committee :Provision of permit/approval

Fields checked :Quality system

Manufacturing processProduct characteristics

Lab

Lab/ Quality and certification division

Professional committee

Minor defect

Major defect

Permit revoked ?

Permits committee

Permit cancellationYes

No

Minor defect







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10. Mapping core processes

Procedure Output Input Customer Process Owner

Process N.o.

Management systems and processes AC 02.05 AC 02.04

Approved price quote

Customers details Customer Customer Service Directorate assistant

Providing price quote to customer

1.

AC 02.01 Report of procedure checked Report of certification audit Certification certificate

- Organisations procedures - Quality system of the organisation

Customer Auditor Conducting certification process especially checking and approving procedures , and practical audit at customers facility

2.

AC 03.03 AC 03.04

Approval continuation of suitability to the standards requirements

- Organisations procedures - Quality system of the organisation

Customer M.O.D (when relevant )

Auditor Conducting supervision process

3.

- Updating supervision schedule - Updating details in the system - Updating price quote - Updating certificate

Details changed at customer

Customer Auditor

Head of system certification directorate

Changes in customers details

4.

AC 02.02 AC 02.03

- Progress Reports Auditors - Auditor training - Auditor accreditation

- Reports of audit - Accompanying auditors - I.S. ISO 19011 - RVA audits

Customer


Quality control of auditors

5.

AC 02.03 - Auditor accompanying report - Reports control report - Auditor training - Auditor assessment

- Accompanying auditors - Reports control - Approval system - Checking Customers files

Customer


Service (product) control

6.

AC 02.02 AC 02.06

-Grading auditors - Customers satisfaction survey per auditor

Training schedule Accompanying auditors

Auditors Head of system certification directorate

Auditor training

7.







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Process N.o.

Management systems and processes AC 01.09 New services and

products - Sector analysis - International standards

Management of quality and certification division

Head of customer service directorate

Product development and services

8.

- Expanding the customer base - Expanding the activity of existing customers

- Market reports - Products reports - Events and conferences - New products



Marketing activity

9.

- Consultants professionalism - Organisations better prepared for audits

- Products interpretation guidelines - Courses for consultants



Relationship with consultants to organisations

10.

- Verification of attendance report in order to finalize orders - Employees motivation

- Activity reports control - Personal advancement

Auditors Head of system certification directorate

Administrative treatment of auditors

11.

AC 01.04 Complete and updated customer file

- Customers documents - Audit reports - Correspondence with the customer

Auditors Management of quality and certification division

Directorate assistants

Management of customers files ( including in the computer system)

12.

Standards mark system WI 03.00 Approved price

quote Customers details Customer Providing

price quote to customer

13.

WI 03.00 Standards mark certificate

- Organizations procedures - Quality system of the organization

Customer Conducting initial clarification

14.

WI 03.09 WI 03.01 WI 03.02 WI 03.03 WI 03.40 WI 03.42

Approval continuation of suitability to the standards mark requirements/process documentation

- Organizations procedures - Quality system of the organization

Customer Conducting supervision process :

15.

WI 03.06 Three way agreement

- Standards mark approval for manufacturer Manufacturer enquiry

Customer –Producer Customer -Marketing

Signing three angle" agreement

WI 03.07 Updated testing schedule for

- Standardizations committee decision

Customer Announcements of







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Process N.o.

Management systems and processes products affected by change

- Announcement to standards mark manufacturers

revision/change of standards

WI 03.02 - Updating supervision schedule - Updating price quote

Details changed at customer

Customer Auditor

Changes in customers details

16.

WI 03.05 monitoring and measuring points updated and according to control

Engineering ReportsInternational standards -

Manufacturers Institutes labs

Documenting/Changing monitoring and measuring points

17.

WI 3.20 Updated work schedule and pricing

Work schedule and pricing per previous year

Customer Preparation for the new year

WI 03.41 - Canceling deception in advertising - Publics confidence

- Information regarding misleading advertising - Standards and directives

User-citizen Dealing with misleading advertising

AC 02.06 Qualified auditors - Auditors - Certifying and training schedule

Divisions auditors Certifying auditors to conduct audits according to S.I.I 005

WI 03.10 - Certifying new processes - Standards mark for new products

Engineering ReportsInternational standards -

User-citizen Manufacturers

Development of new certifications

19.

Training Center ( See Quality Manual for Training Center )

11. Omissions

11.1 Clause 7.6 – Control of monitoring and measuring devices – The division does not deal with

measuring devices. Within the frame work of the standards mark the labs carry out measurements by

their instruments.

12. Detailed Divisions Response to the requirements of the ISO 9001:2008 Standard (details include only the issues that are not outlined in the divisions procedures)

Management responsibility (clause 5 in the standard)12.1 12.1.1 Obligation of senior management to develop and implement the quality management system and effectiveness which is defined by a relevant quality policy (See clause 5.4), defining measurable quality







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goals and aims (see clause 5.5 and details in management reviews), holding management reviews and initiating activities to advance improvements in work processes.

12.1.2 The management devotes specialized resources for the advancement of quality systems within the budgetary framework and annual work schedule.

12.1.3 Focusing on the client, defined in the manual as a central role in the division's activities (see clause 5.3) The focus is expressed in dedicating one person responsible for customer liaison, the responsible auditor, and defining a customer manager whose role is to provide back up to the auditor in connection with customer liaison. The customers are divided into sectors of activities in order to provide a service suitable for all the customers' characteristics. Sector managers are responsible for developing services suitable for the type of customers in the sector .

In addition each sector classified the division's customers into three groups according to the scope of their activities in order to adapt the level of service to their needs:

a. Strategic/Reputation customers – Large customers ( in terms of the scope of their activities in the division ) or with importance in the field. The responsibility is the LEAD AUDITOR. Every group of customers is managed by a sector manager according to the scope of their activities.

b. Complicated customers – Customers with combined quality systems, or a number of certifications or approval of standards mark. The responsibility is the LEAD AUDITOR. Every group of customers is managed by a sector manager according to the scope of their activities.

c. Remaining customers – The responsibility is the AUDITOR. d. Focusing includes the needs of all parties that rely upon certification services, such as the public,

legislation and conformance with mandatory standards and our customer’s customer needs. 12.1.4 The Quality Policy is defined within the framework of this manual (clause 5.4) The policy is distributed to the workers within the schedule of the annual training, and is assessed for its compatibility within the framework of the annual management review.

12.1.5 The Quality goals – These goals are detailed in this manual (clause 5.5).More detailed aims are defined in the management review, measured and updated accordingly.

12.1.6 Planning the Quality system is detailed in this guide for the various clauses. Changes conducted in the quality system are completed in a controlled manner with the responsibility on the division manager in coordination with the divisions management.

12.1.7 Management representative for quality – The Management representative for quality is the division manager. 12.1.8 Internal communication – The internal communication of the division is conducted through a intertwined number of activities :







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Every auditor has a mail box in which all the mail customer correspondence and internal mail is kept. This form of communication is insufficient as the auditor is away from the office, therefore most of the communication is done telephonically/by e-mail.

a. Communication of auditor with customer manager – Telephonic communication mainly e-mails .

This, in addition to face-to-face meetings when the auditor arrives at the institute.

b. Auditor meetings – The division manager and management members conduct meetings with groups of auditors at least quarterly , to sort out major issues and exchange ideas.

c. Personal meetings- Auditors – The division manager organizes personal meetings with the auditors

on his own initiative at least once a year. The administration head of the management operations system meets the auditors at least twice a year for personal meetings.

d. Personal meetings – administration workers – The division manager holds meetings with the

administration workers every two months to sort out personal issues and solving professional issues.

e. Training meetings – The product managers conduct training meetings at least once a year. In addition at least once a year personal training meetings are held with the auditors.

f. Sector managers – Regular quarterly meetings are held to coordinate their work with all the

customers. g. Open door policy - The division manager and administration heads keep an " open door policy " for

every worker and every auditor to sort out personal issues and solving professional issues.

h. Electronic mails – Messages are passed on to auditors also by way of the units electronic mail. i. Northern based auditors have a contact point at the Haifa branch, assisted by the branches employees to transfer information and data needed on a regular basis.

j. Customer service workers meet for regular meetings to receive information, responsibility of the customer service manager, at least once a month. The rest of the communication is done on a one to one basis with the customer service coordinator of the division.

k. Meetings with all the divisions workers – Every quarter meetings are held of all the divisions

workers, including transferring information on a social basis.

l. Divisional leaflet – The division advertises a divisional leaflet 6 times a year, including updates and information on various activities taking place in the division

Resource management (clause 6 in the standard)12.2

12.2.1 Human resources (clause 6.2)- a. Functions of the defined workers (See procedure AC 01.02),especially qualifications needed for the job. In correlation qualifications for workers and auditors are completed, as detailed in the relevant divisions procedures (See central table). The workers know the relevant quality goals needed for their job, and in the routine management structure appropriate relevant results are shown.







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b. At the beginning of each year, training needs are being identified and a training plan is being established in order to ensure competency of personnel.

12.2.2 Infrastructure (clause 6.3)- a. The working infrastructure of the headquarter includes centralized computing system ,telephonic system for communication with customers and with auditors, and an archive for management of customers files. b. Auditors work mainly at the customers sites, and receive communication instruments (cellular phone),car for mobility and some lap top to provide better service to the customer and to ease communications with headquarters. 12.2.3 Work environment-

a. The administrative workers of the division are concentrated on one floor. Auditors, have a specific area on a separate floor in order to complete office work. The auditors have cubicles, based on available space, in order to work with the computer system , conducting office work and compiling information. The cubicles are used for a number of auditors. In both areas the system is one of "open space". The coordinators have a separate work area , coordinators office, to advance their activities.

b. The division has boardrooms to conduct meetings with customers and for work meetings and small group training.

c. Customer reception – The division has a waiting room to receive audience waiting for meetings with auditors or functionaries in the division. 12.3 Product implementation (clause 7 in the standard) 12.3.1 Communication with the customer –

Official communication – Official communication with the customer includes official correspondence, especially signature on agreements, certification receipt, detailed in the operational procedures ( See table in clause 17)

Correlating and dealing with questions and various enquiries – the customer managers are available for the customers needs to clarify various issues by way of fax, telephone, electronic mail or face to face meetings. This, in addition to communication with the auditor, responsible for his service quality. The details of the customer are updated in the computer system and used by all bodies that have access to the system. In addition, the customer's details are updated in the customer's files, for the auditor's use. The contact people with the customer are defined as per clause 16.1.3 above.

12.3.2 Design and Development (Clause 7.3. of the standard) – The division follows the requirement of

clause 7.3 while developing and implementing new standards and services (see AC.01.09). 12.3.3 Validation of manufacturing processes and service provision (Special processes – clause 7.5.2 in the standard) – Audits of management system are special processes that can not be measured on an absolute basis at the end of the audit. Therefore the audits are conducted with emphasis on the auditors' qualifications, training and supervision of their work process, work by advanced methods, statistical evaluation over a period of time of the product of their work in relation to the organization meeting the quality processes demands.







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12.3.4 Identification and traceability (clause 7.5.3 in the standard)- Customers are identified by a customer number that is output from the computer system. Projects are

identified in accordance with the customer number. Status of service that customer receives is defined in the computer system.

12.3.5 Customers property-

The customers purchased information is kept by the auditors in accordance with the confidentiality agreement and ethical code of the division which obliges each and every worker.

The computer system is backed up according to the procedures of the information systems division and is its responsibility.

In accordance with the customers request auditors sign a confidentiality agreement ( NDA- non disclosure agreement).

12.4 Measuring ,analysis and improvement ( clause 8 in the standard )

12.4.1 Measuring and monitoring (clause 8.2)

Customer satisfaction is measured by customer satisfaction surveys conducted from time to time. The results of the survey are analyzed and used as a basis for discussions in the division and to improve the service.

In addition, Sector managers are in direct contact with strategic customers, at least once a year, as a basis to receive defined feedback from the customer regarding service provided to him. These results are also analyzed and used for the management review.

Deserting customers are dealt according to a methodical manner by the sector manager and customer manager ,in order to prevent their removal from the system. The feedback from the customer is recorded , analyzed and documented accordingly.

Measuring and monitoring processes is conducted by measuring the level of service defined in the framework of the standards mark administration. In addition a measurement of the customer level service is conducted by means of the Call Center, and by way of additional checking tables enabling further checks of the service level provided to the customer. 12.4.2 Improvement (clause 8.5)

As part of the management review the suitability of the activities is compared to the divisions policy and meeting goals and aims defined at least annually. According to results aims are set and goals renewed.(If needed)

In addition the functionaries are checked to see if they meet their defined aims and new / challenging aims are set according to the results, with responsibility being on the administration heads.

With regards to the process of internal audits, non conformance handling , corrective and preventative actions-see procedures as defined in the following table







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13. Cross-reference division procedures to standard requirements:

Companies procedure Standards requirements

Procedure/ Work instruction (IQNET Doc. Ref.)

Number Requirement Number

Quality Manual AC 00.00 General requirements 4.1

Quality Manual

(Reg 105-code of conduct)

AC 00.00 Quality Manual 4.2.1

Documentation and information control AC 01.11 Document control 4.2.3

Quality records management/Information

confidentiality

AC 01.14 Records control 4.2.4

Quality Manual AC 00.00 Managements obligation 5.1

Dealing with complaints and disagreements AC 01.07 Focusing on the customer 5.2

Quality Manual AC 00.00 Quality Policy 5.3

Quality Manual AC 00.00 Planning 5.4

Areas of responsibility and organizational structure

Job description

AC 01.01

AC 01.02

Authority and responsibility 5.5.1

Quality Manual AC 00.00 Management representative 5.5.2

Quality Manual AC 00.00 Internal communication 5.5.3

Management review AC 01.06 Management review 5.6

Certification of auditors (BD 312)

Certification of supervising auditor according to SII 005

AC 02.02

AC 02.06

Human Resources 6.2

Quality Manual AC 00.00 Infrastructure 6.3

Quality Manual AC 00.00 Working environment 6.4

Procedures to approve a management system AC 03.01 Product implementation

planning

7.1

Calculations preparation (BD 310)

Calculations environmental quality management

system (BD 311)

AC 02.04

AC 02.05

Setting requirements

concerning the product

7.2.1

Procedures to approve a management system AC 03.01 Survey of requirements

relating to the product

7.2.2

Quality Manual AC 00.00 Communication with

customer

7.2.3

Standards mark – initial enquiries AC 01.09 Development and design 7.3







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Companies procedure Standards requirements

Procedure/

Work instruction (IQNET Doc. Ref.)

Number Requirement Number

Operation of external auditors according to institutes

procedures.

Agreements with external certification organizations

according to institutes purchasing procedures.

Institutes

procedures

Purchasing 7.4

Performing system audit Processes to approve management system

Approval provision Annual follow up

Suspension and Withdrawing process and appeals

AC 02.01 AC 03.01 AC 03.02 AC 03.03 AC 03.04

Manufacturing and service

provision

7.5.1

Quality Manual AC 00.00 Validation of manufacturing

processes and service

provision

7.5.2

Quality Manual AC 00.00 Identification and traceability 7.5.3

Quality records /Information confidentiality AC 01.04 Customers property 7.5.4

Quality records /Information confidentiality AC 01.04 Preserving the product 7.5.5

Not applicable Control of monitoring and

measuring devices

7.6

Quality Manual AC 00.00 Customer satisfaction 8.2.1

Internal audit AC 01.05 Internal audit 8.2.2

Checking and testing AC 02.03 Measuring and monitoring

processes

8.2.3

Quality Manual AC 00.00 Measuring and monitoring

the product

8.2.4

Non conformances/Corrective actions/Preventative actions AC 01.08 Non conforming product control 8.3

Checking and testing AC 02.03 Data analysis 8.4

Quality Manual AC 00.00 Continuous improvement 8.5 Non conformances/Corrective actions/Preventative actions AC 01.08 Corrective actions 8.5.2 Non conformances/Corrective actions/Preventative actions AC 01.08 Preventative actions 8.5.3




Documents

Quality Manual-Quality & Certification Division · 1.1 This Quality Manual was prepared according to ISO 17021 requirements. 1.2 The Quality Manual refers to the Quality and Certification