I S O  9 0 0 1 : 2 0 0 8
Q u a l i t y   M a n a g e m e n t   S y s t e m  ( Q M S )

 

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It is an international organization, the participation of this organization is voluntary. Up to the present, more than 120 countries worldwide are member countries. Its nature is quite similar to that of the UN, of course UN is about global politics, economics and culture, ISO is only focus on international product safety, endeavour to break the international trade barriers.

ISO 9000 series major standards:

 

ISO 9000 -	QMS fundamental knowledge and definitions and terms;
ISO 9001 -	QMS requirements, used for certification, as an evidence to the customers that the organization products/services meet customer requirements and satisfaction;
ISO 9004 -	QMS effectiveness and efficiency guidelines. used of continue improvement of an organization;
ISO 10011 -	QMS and EMS audit guidelines.

What is ISO 9000 ?

ISO 9000 is International Organization of Standardization Technical Committee (ISO/TC176) achievement after many years of hard work, the series condense more than a hundred years of industrial experiences of developed countries, it is scientific, formal, and process oriented quality management standards, it provides the users (including organizations of all industries, all sizes, all types and all products) with a baseline for an integrated quality system, defined the requirements and the common language of quality management. Up to the present more than 120 countries and places all over the world adopted these ISO 9000 standards, over 50 countries providing third party assessment and certification, more than 500,000 organizations of various types are certified. An international standard series meet with such international recognition and acceptance within such a short period of time is un-precedential.

Benefits of ISO 9000 :

Implementing ISO 9000 standards, established and maintaining a QMS, is introducing a new concept, accepting and adopting a system which is equal to developed country customer focus, quality as core value and process approach model, this ensures product quality is controlled under any set of conditions, it is an economical and sustainable customer satisfaction approach, its benefits are much more than the traditional management approaches:

• Closing the gap between developed countries, international economy and trading community;
• Stabilize quality management, and quality assurance;
• Reduce quality cost, reduce quality lost, improve economic effectiveness;
• Enhance competitiveness, improve market share;
• Standardize internal management, enhance employee quality awareness, improve operation effectiveness and overall performance;
• Monitor organizational management approaches. Improve enterprise overall level of performance.

For products exporting to Western countries,
ISO 9000 is a passport.

ISO 9000:2008 and its Applicability:

All the requirements are universal, applicable to organizations of all types, sizes and products.

For any elements of the standard not applicable to an organisation, considerations can be made for omission, but only limited to Section 7 elements that do not affect the ability of the organization to provide customer satisfaction and compliance with applicable laws and regulations.

ISO 9000:2008 key elements:

is ISO 9001:1994 new version, requires top management to make major planning and decisions, prepare “plans”, and then “implement” and “monitor”, finally collect data from records of implementation “processes” in order to “compile” and “analyse”, according to “PDCA cycle”, to achieve “continual improvement” requirements.

ISO 9001:2008 key points:

• Satisfy customer needs and expectations, attempt to excel
• consider profit, cost and risk
• not to forget social needs
• used for certification and contract purposes

Four component parts:

• Management responsibility
• Resource management
• Process management
• Measurement, analyse and improvement

ISO 9001:2008 four key components classified:

 

(1) Management Responisbility	(2) Resource Management	(3) Process and/or Service Realization	(4) Measurement, Analysis and Improvement
Management commitment Customer focus Quality policy Quality planning Responsibility and authority and communication	Resource provision Manpower resources Infrastructure Working environment	Produce realization planning Customer related process Design and development Purchasing Production and service operation Measurement, inspection and equipment control	General Measurement and control Non-conforming products and control Data analysis Improvement.

ISO 9001:2008 Consulting and certification process:

 

Management Decision ↓	Management made strategic decision and sourcing consulting companies, FormalWin is your preferred choice.
Enquiry ↓	FormalWin will do our best to assist you in certification process, we provide consulting and supporting your choice of certification body.
Quotation ↓	Submit a《Certification data information》to the selected audit bodies, receive quotation from them, if necessary, ask for an interview.
Sign contract ↓	Upon mutual understanding and agreement, sign certification contract, define certification activities, receive《Certification acceptance letter》and《Auditee guidelines》from audit body. Related fees are payable about ten days prior to certification.
Initial visit ↓	When the audit body received your《Certification acceptance letter》, a lead auditor will inspect your business license, product introduction or manufacturing processes, also assess your QMS documents to see if they cover all the elements of the Standard, he will provide a written report to you.
Document assessment ↓	when necessary, the appointed lead auditor will pay a prelimary-visit to your company, so as to collect information, eliminate misunderstanding, and well prepared.
Pre-audit ↓	This step is not mandatory. But if you want to make sure to pass at the first audit with minimum non-conformity, your selected audit body is happy to provide you with a pre-audit with written reports for your corrective action.
Site-audit ↓	Before site audit, lead audit will provide an audit plan, after your consent, the audit team will carryout audit according to the agreed plan on-site, the audit will be objective and random to assess your QMS conformance with the Standard requirements. Any non-conformity will be reported in a standard format, you will have to accept and agree to take corrective actions.
Corrective Action ↓	For any non-conformity raised and reported, you must provide corrective action plans and ensure implementation.  Evidence of completion will have to be provided to the lead auditor. if a partial re-audit deemed necessary, a seperate arrangement will have to be made with the audit body at a later date.
Registration and issue of certificate ↓	Upon confirmation of passing the ISO 9000 certification, will will receive the official certification within a month or so from the audit body.
Follow-up audit ↓	Within the 3 year validity period, audit body will take a follow-up audit every year, this is to ensure continual compliance to the ISO 9000 requirements.
Re-certification ↓	A seperate quotation will be necessary with the audit body
FormalWin consulting service process:
Initial meeting ↓	One of our dedicated project managers will meet with potential customer management, try to understand the organisation's present status and actual requirements.
Planning ↓	Prepare a Master Plan according to the unique situation of the customer, agreed and signed by both parties.
Training ↓	Conduct company-wide awareness meeting, provide basic concepts to all employees.
Develop structure Define relationship ↓	set-up ISO 9001 Steering committee, promotion team, document team, internal audit team, appoint management representative, define management structure.
Training ↓	Training all middle managers and above on ISO 9001 foundation knowledge. Train document team.
Documentation ↓	Develop quality policy, objectives. Document team to draft procedures, work instructions, quality manual, improve record keeping.
Co-ordination ↓	Consultant to review, amend and improve drafted documents and co-ordinate various functions for proper release.
Trial run ↓	Trial run according to the documents.
Training ↓	Departments familiar with the documented requirements, consultants provide supports and assistance.
Corrective action ↓	Corrective action on-site and improve as necessary.
Training ↓	Train selected staff to become internal auditors.
Implementation ↓	Implement according to document.
Seminar ↓	A pre-audit seminar to provide management staff with adequate knowledge on how to prepare the formal audit.
Audit ↓	Conduct internal audit and management review, enable internal auditors to familiar with auditing techniques, identify non-conformities and improve as needed.
Seminar ↓	A company-wide seminar to prepare everyone for the important certification 3 party audit event.
Simulation audit ↓	FormalWin consultants will conduct a full simulation audit just prior to the certification audit, make last minute adjustments to ensure pass at the firt attempt.
Certification audit ↓	Certification audit by the selected audit body
Post-audit ↓	FormalWin is able to provide annual maintenance and continuous improvement services upon request

FormalWin suggested audit bodies for your reference

• BSI
• SGS
• TUV
• DNV
• LRQA
• HKQAA
• UCS and many others are also very good, welcome your enquiry

FormalWin experience sharing:

FormalWin service features:

1.  Focus on training, tailored to different grades at different stages of the project, courses are meeting specific needs of staff. Customer will fully understand ISO 9001:2008 essences, improve quality awareness, build up foundation for a company-wide quality culture.

2.  Emphasis team spirit, assist in ISO 9000 Steering Committee, promotion team, document team, internal audit team and management representative, emphasis on mutual understanding. Develop ISO 9000 QMS operation group, enable smooth running of QMS, start-off improvement cycle, enhance corporate effectiveness.

3.  Experience and well qualified consulting team, our professional knowledge are refreshed every year to ensure competancy, we are working in teams to make sure dis-continuity risks can be minimized and high level quality service can be sustained.

Client references:

We have more than 12 years on international management system consulting. Our happy customers exceed 2000 and the number is increasing every month. Our services cover most of the industry sectors, including manufacturing, services, utilities, governments, IT and and others. We shall post commendation letters from time to time on this website, and you are most welcome to contact us for any specific references to help you make the right decision on choosing your preferred consulting provider

System maintenance service:

We are most happy to provide post ISO 9001:2008 service, this is a long term service to ensure your system is maintained and sustained to be effective, we shall assist you by periodic checking, monitoring and training (including senior staff management know hows, employee attitude, and many other courses tailored to your needs);  system monitoring (including site inspection, problem-solving, document review); internal audit supervision, conduct internal audits, management review support and so on..

You shall have the most flexible and quality consulting from us, always catered to your needs and expectations.