Experience Sharing of Process of Product Certification

Fugro Certification Services LimitedJoseph PoonOctober 2010

Summary of Presentation

• Certification Process

• Certification Requirements

• Preparation for Certification

Types of Construction Product Certification Available

No. Description Scheme

1 Production and Supply of Concrete QSPSC

2 Passive Fire Protection Products HKISC PCCS-PFPP

3 Heat Soaked Tempered Glass HKISC PCCS-TG

4 Tile Adhesives HKCI PCCS-TA

5 Cement HKCI PCCS-CP

6 Repair Mortars HKCI PCCS-RM

7 Ceramic Tiles HKCI PCCS-CT

What is a Type 5 (System 5)Product Certification Scheme

According to ISO/IEC Guide 67

• initial assessment of quality and production systems

• initial inspection / testing

• reassessment of quality and production systems

• regular audit testing

Certification Process

Information to be provided by Manufacturer

• Application form• Quality manual• Quality procedures and work instructions related to all activities

stated in product certification scheme• Product models to be certified• Organization chart showing key personnel• Related CVs of competent personnel (if necessary) • Drawings and technical information related to Products• Certificates of origin for raw materials

Document Review

• Adequacy of Quality System documents

• Availability and adequacy of the technical documentation to meet scheme requirements

1st Stage Audit

• Review of the major elements of ISO9001 implemented by manufacturer

• Understanding of the inspection process of raw materials.

• Understanding of the production process.

• Understanding of the packaging and storing process.

• Understanding of the transportation process.

• Discussion of the sampling procedures of audit testing

• Review of quality control laboratory

• Review of 3 months quality control records

2nd Stage Audit

ItemProcess Verification

Records Verification In

SchemeIn

procedure

ISO9001 Management System

Yes Yes Management review, internal audit

Raw materials Yes Yes Checking records, acceptance criteria, testing certificates, personnel training records

Production Yes Yes Calibration and maintenance records for equipment, records of NC products, personnel training records

Packaging and Storage Yes Yes Calibration and maintenance records for equipment, personnel training records

Transportation Yes Yes Calibration and maintenance records for equipment, personnel training records

Quality Control Laboratory Yes Yes Calibration certificate and maintenance records for equipment, personnel training records

Initial Type Testing / Audit Testing

• Samples selected by the audit team• Chain of custody• Laboratory appointed by CB• Testing witnessed by the audit team• Results to be reviewed by the audit team

Failure of Audit Testing

• Case of failure must be investigated and appropriate actions to be taken

• Re-test on additional samples

• If result of re-test is unacceptable, certification cannot be proceeded / certification is suspended

Outcome of Certification Audit

No NC – Certification recommended

Minor NC – Certification is recommended after receipt ofcorrection and corrective action plan follow up visit s required

Major NC or – a follow up visit is required systematic Minor NC

Critical NC – system failure, certification to be re-applied

Actions to be Taken after Certification Audit

No NC -

Minor NCs Corrective Action Plan within 2 weeks Actions to be completed within 4 weeks

Major NC or Systematic minor NCs

Corrective Action Plan within 2 weeks Actions to be completed within 1-3 months A follow up assessment is required

Critical NC Certification to be re-applied after at least 6 months following date of Certification Assessment

Certificate Example

Obligations of Manufacturers

• Implement a QMS • Comply with Regulations and Scheme Requirement• Pay to the Certification Body fees for Certification Audit• Afford assessment team full assistance and cooperation during

the Certification audit• Keep Certification Body inform in writing of changes:

Ownership or name Management Representative or company directors Quality Manual or significant items in its plant Location of the plant and/or Quality System Management

Office Close of a manufacturing plant

Surveillance & Re-Certification Audit

Intervals Fire product Glass QSPSC Tile

AdhesiveRepair Mortar Cement

Surveillance Audit

6 – 9 months

6 months 3 months– 1st year

4 months - 2nd year

6 months – 3rd year

1 year 1 year 6 months

Re-certification Audit

(2nd Cycle)

3rd Year 3rd Year 3rd Year 3rd Year 3rd year 3rd year

2nd Cycle (SV) 6 – 9 months

6 months 6 months 1 year 1 year 9 months

Use of Certification Mark

• Product

• Packaging materials

• Quotations

• Delivery notes

• Stationery

• Brochures and other advertising media PCCS-TABSEN 12004:2007

Product Model : XXXXX

Certificate No. XXXX

Use of HKCAS Accreditation Symbol

• Stationery

• Literature

• Advertisements

• Not product

• Not packaging materials

Certification Regulations

• Procedure for application and certification• Obligation of manufacturers

• Obligation of certification body

• Certification rights

• Surveillance visit / renewal audit

• Use of certification mark

• Complaints

• Appeal

Preparation for Certification

To make the Certification Process smoother

• Approach / Engage a CB at an early stage

• Provide all relevant documentation to the CB for review at theearliest possible stage

Certification Requirements

• Establish & maintain a documented QMS to ISO 9001:2008 standard

• Demonstrate compliance with the Administration Procedure and Technical Requirements of the specific scheme

• Maintain a QMS office for the overall management, manufacturing and supply of the products

• Establish product related procedures and maintain quality records for a period of time (3 months)

• Obtain all relevant statuary regulatory licences for the operation / production of the plant

Preparation for Certification

• Identify the criteria for competent persons• Ensure responsible person are competent • Provide regular training to the competent persons who affect product

quality • Control incoming materials (procedures and criteria)• Control suppliers / sub-contractors (procedures and criteria)• Monitor the implementation of the production plans regularly• Review quality system every year• Maintain quality records

Preparation for Certification (Documentation)

• Quality System Manual

• Plant Production Control (PPC) Plan to include

Incoming raw materials

Production process

QC control

Statistical techniques

Product traceability

Preparation for Certification (Documentation)

Production Process to

• Define plant and production process

• Verify the processes by means of inspection and testing

• Document in a plan

• Include frequency, value and criteria on equipment and operation

• Define actions to be taken if control values not obtained

Preparation for Certification (Documentation)

Finished Products Testing Plan to include

• Number and size of samples

• Frequency of sampling

• tests to be performed

Preparation for Certification (Documentation)

Schedules

• Calibration and maintenance of production equipment

• Calibration and maintenance of QC equipment

• Staff training

• Inspection and testing of raw materials

Preparation for Certification (Records)

• Quality system records

• Records of inspection and testing of raw materials• Calibration and maintenance records of production / testing

equipment

• Staff training records

• Production records

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