ISO 9000 Certification

ISO 9001

and

ISO 9000.3

ISO 9000

• There are 5 Standards in the basic ISO 9000 series: conformance models or guides.

• A conformance model is a Standard to which your organisation must conform in order to be certified.

• A guide is a set of recommendations concerning the establishment of an effective quality system in order to be certified in one of the conformance models.

•

ISO 9000ISO 9000

GuidesISO 9000ISO 9004

GuidesISO 9000ISO 9004

Conformance ModelsISO 9001ISO 9002ISO 9003

Conformance ModelsISO 9001ISO 9002ISO 9003

Guides

ISO 9000– Guidelines for selection and use of the

standards on quality management, quality system elements, and quality assurance.

ISO 9004– Guidelines for quality management and quality

system elements.

Conformance models

ISO 9001– Quality assurance in design/development,

production, installation, and servicing.

ISO 9002– Quality assurance in production, installation,

and servicing.

ISO 9003– Quality assurance in final inspection and test.

Quality system

• A quality system is the organisational structure, responsibilities, procedures, processes, and resources needed to implement quality management. It should only be as comprehensive as needed to meet quality objectives.

What is certified?

• Your quality system must conform to the ISO 9000 Standard that your organisation selects.

• It is the quality system that becomes certified (registered) during the certification process.

Terms

• Product: The material or service provided. – Applies in the Standard to

Incoming material/service In-process product/service Finished product/service

• Supplier: Your organisation

• Subcontractor: Your supplier

• Customer: The organisation that receives your product/service.

Selecting a conformance model

If your organisation … Then consider …

Has significant product/service design activities, 9001

Manufactures products or services according toapproved design or customer specifications.(This may be the case of companies withoutsignificant new product/design activities.)

9002

Has a product/service where the quality of thisproduct/service is solely dependent on finalinspection and testing.(This may be the case of distributors of certainproducts.)

9003

Quality Audits

• An audit is an evaluation of your quality system and documentation.

• Your organisation may undergo several types of audits:

– First-party audits

– Second-party audits

– Third-party audits

Third-party audits

• The third-party audit is a quality system audit performed by an auditor on the supplier in order to achieve certification for one of the ISO 9000 Standards. The third-party auditor must be independent of both the customer and the supplier.

• Third-party audits cannot be performed by the customer or the supplier.

What is looked for?

• Do your documents conform to the requirements of the Standard?

• Do your operations conform to the documents?

• Do your records show past conformance to your documents?

9 stages to certification

• Strategic planning

• Gap analysis

• Corrective action

• Documentation and records

• Implementation

• Pre-certification audit

• Registrar documentation review

• Site preparation

• Certification audit

Strategic planning

• Management: Displays strong commitment to the certification effort Selects a registrar Selects a conformance model for which organisation

may seek certification Forms a project team Establishes a timeline Assesses training needs regarding ISO 9000 and

organisational background.

Gap analysis

• Corrective action teams: Evaluate the existing quality system against the

selected conformance model Evaluate the documentation against the quality

system and the selected conformance model.

Corrective action

• Corrective action teams institute changes in quality system as identified in stage 2.

Documentation and records

• Corrective action teams: Implement a document structure and control system Institute a control of quality records process Revise documents as necessary Provide training about changes, additions, and other

topics as identified in stage 1.

Implementation

• Management: Implements and monitors all changes in the quality

system Ensures all gaps identified in stage 2 are closed Maintains records of all changes.

Pre-certification audit

• Pre-assessment auditor ensures that all operations and documentation are according to the selected conformance model.

Registrar documentation review

• Registrar reviews quality manual (and any other requested documents) as advance organiser to the organisation and the supporting documentation.

Site preparation

• Management prepares organisation for the registrar and certification audit.

Certification audit

• Registrar reviews quality system and documentation to determine if quality system meets the selected conformance model and can be certified as such.

Time taken depends on:

The amount of existing documentation The complexity and size of the organisation The ISO 9000 conformance model chosen for

certification The commitment of management The documentation skills of the project teams The project management skills of the project teams The availability of certification auditors.

Typically 12 to 18 months

The 20 Sections of ISO 9001

• ISO 9001 Standard contains 20 sections (known as 4.1 – 4.20.)

– ISO 9002 Standard contains 19 of the 20.

• ISO 9003 Standard contains 16 of the 20.

Management responsibility

• “Your organisation’s management shall provide for

A quality policy Assignment of responsibility and authority to

personnel Resources for identification and verification Appointment of a management representative A management review for the suitability and

effectiveness of your quality system.”

Quality system

• “Your organisation shall Plan, establish, maintain, and document your quality

system to ensure that your product and/or service conforms to specified requirements

Provide an outline of the documentation structure and reference to immediate supporting documents in a quality manual

Provide quality plans.”

Contract review

• “Your organisation shall review each contract or accepted order with your customer to ensure that

Customer requirements are adequately defined Your organisation has the capability to meet these

needs.”

Design control

• “Your organisation shall control and verify the design of its product to ensure that it meets specified requirements.”– Not 9002– Not 9003

Document and data control

• “Your organisation shall control all your quality system documents and data to ensure availability of documented information to those requiring it.”

Purchasing

• “Your organisation shall ensure that purchased product conforms to specified requirements.”– Not 9003

Control of customer-supplied product

• “Your organisation shall provide for verification, storage, and maintenance of customer-supplied product provided for incorporation into your product.”

Product identification and traceability

• “Your organisation shall provide any necessary identification and traceability of incoming materials, in-process product, and finished product.”

Process control

• “Your production, installation, and servicing processes are operated under controlled conditions.”– Not 9003

Inspection and testing

• “Your organisation shall ensure that Incoming product is verified for conformance to

specified requirements In-process product is inspected and tested as

necessary Finished product is verified as conforming to

specified requirements prior to release.”

Control of inspection, measuring, and test equipment

• “Your organisation shall control, calibrate, and maintain inspection,

measuring, and test equipment and software used in your quality system to demonstrate the conformance of product to specified requirements

ensure that measurement uncertainty is known and consistent with the required measurement capability.”

Inspection and test status

• “Your organisation shall ensure identification of inspection and test status of product throughout production, installation, and servicing.”

Control of non-conforming product

• “Your organisation shall ensure that non-conforming product is prevented from unintended use or installation.”

Corrective and preventive action

• “Your organisation shall Investigate the cause of non-conforming product

and consider corrective action needed to prevent recurrence

Analyse your quality system to detect and eliminate potential causes of non-conforming product.”

Handling, storage, packaging, preservation, and delivery

• “Your organisation shall provide adequate handling, storage, preservation, packaging, and delivery of your product to ensure that it meets specified requirements.”

Control of quality records

• “Your organisation’s control of quality records process shall ensure that your quality records demonstrate that:

Your quality system operates effectively Required product quality is achieved.”

Internal quality audits

• Your organisation’s internal quality audit plan shall verify that your quality activities and related results meet requirements, and determine the effectiveness of your quality system.”

Training

• “Your organisation shall identify training needs and train personnel to meet these needs.”

Servicing

• “When servicing is a specified requirement in the contract, your organisation shall control that servicing and verify that it meets specified requirements.”– Not 9003

Statistical techniques

• “Your organisation shall identify and use appropriate statistical techniques as necessary to verify the acceptability of process capability, product characteristics, and service.”

The Certification Audit

• The registrar visits your site(s) to:• Meet with upper management to provide an

overview of what will occur while they are there and answer any of management’s questions

• Determine whether or not your quality system is implemented according to the selected conformance model and the quality system documentation. To assess your quality system, the registrar asks your employees questions and observes employees performing their jobs.

The outcome?You cannot fail certification.

The worst that can happen is that you quit!

If your organisation’s quality system … Then the registrar …

Conforms to the selected ISO 9000 Standard Grants certification of your quality system

Has a minimal amount of non-conformancesGrants certification of your quality system(may be contingent upon correction of non-conformances.)

Has many non-conformancesDoes not grant certification.The registrar may specify an allotted time that allnon-conformances must be corrected beforehe/she returns to re-audit.