Certification Method ISO 9001-2008

8/8/2019 Certification Method ISO 9001-2008

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Introduction:

ISO 9001:2008 is an internationally recognized standard for the certificationof Quality Management System for various businesses / systems. Theseapply to the businesses and processes that create value and provide controlto the products / services in an organization. This standard prescribessystematic control of activities to ensure that needs and expectations ofcustomers are met and a healthy and safe environment is maintained for thebenefit of the customers, workers who produce these products and servicesas well as people at large in the adjoining vicinity. These are designed andintended to apply to virtually any product or services, made by any process,anywhere in the world.

Euro Cert has established certain minimum expectations for companies whowish to register their Quality Management Systems (QMS) to ISO 9001:2008.These expectations are based upon our understanding of the requirementsof the standard and the requirements for third party registration/certificationto the standard gained through our collective experience in auditing qualitymanagement systems of many varied applications.

In order to claim conformity with ISO 9001:2008, the organization has to beable to provide objective evidence of the effectiveness of its processes andits quality management system. Objective evidence does not necessarilydepend on the existence of documented, it is up to the organization todetermine what records are necessary in order to provide objectiveevidence.

Background to the ISO 9001:2008 revision process

In order to assist organizations to have a full understanding of the new ISO9001:2008, it may be useful to have an insight on the revision process, howthis revision reflects the inputs received from users of the standard, and theconsideration given to benefits and impacts during its development.

Prior to the commencement of a revision (or amendment) to a managementsystem standard, ISO/Guide 72:2001, Guidelines for the justification anddevelopment of management system standards recommends that aJustification Study is prepared to present a case for the proposed projectand that it outlines details of the data and inputs used to support its


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arguments. In relation to the development of ISO 9001:2008 user needs

were identified from the following:

the results of a formal Systematic Review on ISO 9001:2000 that wasperformed by the members of ISO/TC 176/SC2 during 2003-2004

feedback from the ISO/TC 176/Working Group on Interpretations the results of an extensive worldwide User Feedback Survey on ISO

9001 and ISO 9004 by ISO/TC 176/SC 2/WG 18 and similar nationalsurveys.

The Justification Study identified the need for an amendment, provided thatthe impact on users would be limited and that changes would only be

introduced when there were clear benefits to users.

The key focuses of the ISO 9001:2008 amendment were to enhance theclarity of ISO 9001:2000 and to enhance its compatibility with ISO14001:2004.

A tool for assessing the impacts versus benefits for proposed changes wascreated to assist the drafters of the amendment in deciding which changesshould be included, and to assist in the verification of drafts against theidentified user needs. The following decision making principles were applied:

1. No changes with high impact would be incorporated into the standard;

2. Changes with medium impact would only be incorporated when theyprovided a correspondingly medium or high benefit to users of thestandard;

3. Even where a change was low impact, it had to be justified by thebenefits it delivered to users, before being incorporated.

The changes incorporated in this ISO 9001:2008 edition were classified interms of impact into the following categories:

No changes or minimum changes on user documents, includingrecords

No changes or minimum changes to existing processes of theorganization

No additional training required or minimal training required No effects on current certifications


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The benefits identified for the ISO 9001:2008 edition fall into the following

categories:

Provides clarity Increases compatibility with ISO 14001. Maintains consistency with ISO 9000 family of standards. Improves translatability.

Benefits

Most organizations want ISO 9001 certification to qualify for a tender or toachieve preferred supplier status: typically for a Local Authority or for a

supply chain requirement. However, whoever you decide to choose as yourCertification Body, make sure they are UKAS accredited. It could prove acostly mistake if you dont. There are many benefits to achieving ISO 9001certification, including:

Preferred status for tenders

Improved internal working

Winning more business

Less costly errors and re-work

Enhanced status

Better communications and motivated staff Improved customer satisfaction and loyalty

Preferential insurance premiums

Increased profitability

Competitive advantage

The audit process is an independent check of your systems and proceduresto show if you are doing what you say that you should do and if it meets therequirements of ISO 9001, failure to this could potentially cause defectiveservices and products to reach your customers or for internal processes tobe inefficient costing you money. In addition to just auditing conformancethe certifications auditor will also highlight opportunities for improvementand suggest where there may be better ways to do things.

If you are the quality representative (often the Quality manager) then it isalso an ideal opportunity for you to influence the workings of the companyfor the better, most auditors will be happy to raise non-conformities and


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suggestions for improvement in areas that you identify need to be improved.

Most management teams place a lot of weight on correcting the independentauditors findings, so initiatives that would have otherwise encountered hugeresistance can be pushed through with greater ease by using the auditorsfindings!

ISO 9001 Certification Audit Process

The audit process is itself quite simple; if this is your first audit then you willhave what they call a document review audit. During this audit the auditorwill review all of the documentation that forms your quality managementsystem to ensure that you have covered all aspects of the ISO 9001

requirements within the documentation. The auditor will also discuss withyou the best way to conduct the audit of your actual process for your initialaudit.

The initial audit will cover all aspects of your quality management systemcovered by ISO 9001; the auditor will plan a series of visits to each processto follow your processes through the company. He will ask questions andobserve what you actually do, gathering evidence from records and otherdocuments to support his findings. This audit can take just 1 or 2 days toseveral days with more than one auditor depending on the size of yourorganization.

The findings of this initial audit will be fed back to your management team ata closing meeting and if no major non-conformances have been found theauditor will recommend you for certification. The report will be sent back tothe head office where it will be reviewed and within a few days you shouldreceive your certificate to ISO 9001.

If the auditor finds issues with your system then he may issue a non-conformance, if these non-conformances are of a serious nature or they aremultiple then it could delay your certification. The auditor will wish to seeevidence of the closure of these problems before recommending you forcertification, either by a follow up audit or through you sending the evidenceif that is possible.

Once you are certified the certification body will audit you thereafter on a sixmonthly or annual basis, reviewing your entire system over a period of


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usually 3 years. They will expect to see evidence of continual improvement

over this period as well as to find that you are following your system.

Audit ProcessISO 9001 is easy even for absolute beginners simply follow our 5 Easy Stepsto implement ISO 9001 and achieve ISO 9001 certification:

STEP 1: PreparationRealistically, if you are new to the ISO 9001 standard you are probably goingto need some guidance and where appropriate, we can provide access togood-practice examples and guides. When you're ready, well discuss yourrequirements with you and provide you with a Fixed Price quotation so you

can budget accurately. Your quotation will be based on factors like what youdo, how many locations you operate from and how many people you employ(if any).

STEP 2: ApplicationOnce you decide to go-ahead, we'll assign a Lead Assessor to you. He or shewill be your principal contact throughout the registration process andbeyond. They will build up detailed knowledge of your organisation and willbe able to answer any questions you may have.

STEP 3: Pre-Audit Assessment (known as Stage 1)Your Lead Assessor will visit you to explain the standard and undertake aconformity evaluation of your current arrangements for quality management. You will then receive a detailed report including all required actions.Together, you will then determine the appropriate timetable for your AuditAssessment.

STEP 4: Audit Assessment (known as Stage 2)Once you are ready for your formal Audit Assessment, your Lead Assessorwill make the required arrangements for you. On completion, you will beinformed of the Auditor's recommendation before he or she leaves yourpremises.

STEP 5: Registration & CertificateFollowing the Auditor's recommendation, your registration will be reviewedand if approved your certification will be confirmed. Soon after, yourcertificate of conformity to the ISO 9001 standard will be issued and sent toyou.


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STEP 6: Continual AssessmentHaving achieved certification, you will want to maintain your registration andyour Lead Assessor will remain on hand to undertake the required annualreviews to ensure you continue to meet the requirements of ISO 9001.ISO 9001: 2008 Required DocumentationQuality Documents

Quality policy (clause 4.2.1.a)

Quality objectives (clause 4.2.1.a)

Quality manual (clause 4.2.1.b)

Documented Procedures: 4.2.3 Control of documents

4.2.4 Control of records

8.2.2 Internal audit

8.3 Control of nonconforming product

8.5.2 Corrective action

8.5.3 Preventive actionThese documented procedures have to be controlled in accordance with therequirements ofclause 4.2.3Records required by ISO 9001:2008

Clause Record required5.6.1 Management reviews6.2.2 (e) Education, training, skills and

experience.

Must maintain records of education,training, skills, and experience; thereis a procedure

7.1 (d) Evidence that the realizationprocesses and resulting product fulfillrequirements.

Records needed to provide evidencethat the realization (existing)processes and resulting product(service) meet requirements.

7.2.2 Results of the review of requirements


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related to the product and actions

arising from the review.

The organization shall review thecustomer requirements of theservice. This review must beconducted prior to commitment tocustomer. Need records of the resultsof the review.

7.3.2 Design and development inputsrelating to product requirements

7.3.4 Results of design and developmentreviews and any necessary actions

7.3.5 Results of design and developmentverification and any necessaryactions

7.3.6 Results of design and developmentvalidation and any necessary actions

7.3.7 Results of the review of design anddevelopment changes and anynecessary actions

7.4.1 Results of supplier evaluations and

any necessary actions arising fromthe evaluations.

Records of evaluating suppliers mustbe maintained

7.5.2 (d) As required by the organization todemonstrate the validation ofprocesses where the resulting outputcannot be verified by subsequentmonitoring or measurement

Need records to validate a processwhere you cannot monitor ormeasure easily

7.5.3 The unique identification of theproduct, where traceability is arequirement

7.5.4 Customer property that is lost


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damaged or otherwise found to be

unsuitable for use

Must maintain records re: customerproperty issues

7.6(a) Basis used for calibration orverification of measuring equipmentwhere no international or nationalmeasurement standards exist

7.6 Validity of the previous measuringresults when the measuringequipment is found not to conform torequirements

7.6 Results of calibration and verificationof measuring equipment

8.2.2 Internal audit results and follow-upactions

8.2.4 Indication of the person(s)authorizing release of product.

Need a record of how service getsreleased (approved). This could

include daily inspection records, etc.8.3 Nature of the productnonconformities and any subsequentactions taken, including concessionsobtained

8.5.2 Results of corrective action8.5.3 Results of preventive action

Documents which are not necessarily requiredbut can be offered assupporting the organizations processes. This documentation shouldbe minimized.

Process maps, process flow charts and/or process descriptions Organization charts

Specifications

Work and/or test instructions

Documents containing internal communications

Production schedules


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Approved supplier lists

Test and inspection plans

Quality plans

REQUIRED DOCUMENTS

Certification process requires the certification request to the CertificationBody. At the Audit all the below are checked:License of the Company and the accompanying documentsOther permits requiredOrganizational Structure / ChartObjectivesProcedures andInstructions for External Documents (e.g. Legislation)Files

TIME ISSUE AND VALIDITY OF CERTIFICATEIf the Audit of assessment of Food Safety Management System is successfuland there is a positive recommendation by the inspection team, then theCertificate is been issued in a short time. The certificate is valid for threeyears and this period is supported by two annual surveillance audits.

Certification Method ISO 9001-2008

Documents

Transcript of Certification Method ISO 9001-2008