ISO9001：2022质量手册英文版(按标准条款).docx

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1、ISO9001：2022质量手册英文版(按标准条款) ISO 9001:2022 Quality Manual A quality manual is a document that states the companys intentions for operating the processes within the quality management system. It can include policies for all areas of the business that affect your ability to make high-quality products an

2、d meet your customers and ISOs requirements. These policies define how your department managers will implement procedures within the boundaries specified in the quality manual. The use of Quality Manual are as follows: 1.To communicate managements expectations to employees 2.To demonstrate the compa

3、nys plan to conform to the requirements of ISO 9001:2022 3.To demonstrate the fulfilment of Clause 5.3, that organizational roles, responsibilities and authorities are assigned, communicated and understood 4.To provide a starting point for auditors: 1.Internal 2.Customer 3.ISO Certification Body To

4、develop a quality manual, you might consider these steps: 1.List policies to be written (note any ISO requirements that do not apply). 2.Draft policies based on applicable ISO requirements. 3.List operating procedures or refer to them as appropriate. 4.Determine the format and structure of the manua

5、l and make the first draft. 5.Circulate the draft manual for input from all departments and address inadequacies identified. 6.Attain a formal approval and release. The contents of your quality manual are completely up to you. But, remember that everything you say you do, you must show evidence that

6、 you really do it! So be careful what you include and make sure the policies reflect actual practices. Here are some common topics included in quality manuals. the scope of QMS Quality policy Explanation of the companys documentation structure Organizational chart Policy statements for each applicab

7、le ISO requirement Reference to operating procedures 1) The scope of the Quality Management System. This is in place to identify the limit of the system and is based on the scope agreed with the registrar to be placed on the ISO9001 certificate. This is the explanation of what your company does, be

8、it “Design and Manufacture of the bevel Gear,” “Machining Services for Customers in the oil and service Industry,” or “Providing Fast Food for People in Kuwait city.” The second part of the scope requirement is to identify any exclusions from the standard. In many cases, the Quality Manual will iden

9、tify none, but the most common exclusion is the requirement of the ISO 9001 standard for “Design & Development” for companies such as a machining shop, which works exclusively from customer drawings and does not design any products itself. 2) The documented procedures established for the Quality Man

10、agement System (or references): Documentation means anything written down or captured in some form such as written procedures, policies, checklists, forms, or graphics, drawings, flowcharts, diagrams, IT systems. This is called documented information in the current version (2022) of ISO 9001. Confus

11、ingly, they have also decided to use the same term for what was formerly called records those things that showed what had been done, such as registers, logs, competed for forms, reports, meeting minutes and so on. Documented information in 9001 terms means both the written stuff that describe your q

12、uality system and say how it should operate (eg, flowcharts, procedures, policies, checklists) and the written stuff that shows what was done. A system must be documented to achieve ISO 9001 certification because having certain documented information is required by the Standard. All the documents t

13、needs to control how things are done, whether procedures, flowcharts, checklists, forms, IT systems or any other media or format that work in your business. But note that no mandatory procedures are prescribed. Nor a quality manual. What can confuse people is that actually, you can choose what your

14、documents look like, what format and structure you use, and what to put in them. Provided you meet these requirements. You can use one or many formats, from checklists and flowcharts to intranets, wikis or workflow embedded into IT systems. You can use any media, hardcopy or soft, including intranet

15、, online, internet or wiki. One often used way to do that was with a thing called a quality manual. And you can still do that if you choose. And it can be in hard copy (paper) or softcopy: online documents like web pages, help files or IT systems. And you can write your document in various ways, fro

16、m easy and user-friendly to bureaucratic, verbose and very hard to follow. And such a manual may be the only document you have for your system, or it may be one of a number of documents. Or something in between. 3) A description of the interaction of processes. This is most simply done with a flowch

17、art that identifies all the processes in the organization with arrows showing how they connect. While an in-depth flowchart may help you to better understand the interactions between processes in your organization, a simple top-level flowchart is all that is needed for most people to understand the

18、basics. Example of Quality Manual 1.0 Company Profile Include your company profile 1.1 The mission of the Firm Our mission is to enhance mobility through innovation, leadership and public service. Innovation by providing unparalleled value combined with flexibility and risk-taking ability, leadershi

19、p by delivering exceptional performance in every domain and corporate responsibility through service to society. 1.2 The vision of the Firm To strive relentlessly with an aim to achieve excellence in all businesses that we venture into, with the objective of becoming an organization that all its emp

20、loyees and associates are proud of. 2.0 Organization Scope Design, Development of Land, Construction Sales of Residential and Commercial Complexes 2.1 Exclusions: NIL 2.1 Quality Policy XXX is committed to delivering quality construction work with promised amenities, in time possession, which meets

21、and exceeds the needs & expectation of our customers. We promise our valued customers commitment to excellence in each activity by each employee in the organization by adopting innovative and best in class engineering and management practices with continual improvement in business and quality manage

22、ment system as a part of our efforts for enhancement in customer satisfaction while assuring 100% quality and quantity. 2.2 Key Objectives Timely completion of projects Increase Customer satisfaction Reduce Customer Complaint 3.0 Glossary & Abbreviations 4.0 Context of Organization 4.1 Understanding

23、 the organization and its context: Shah Promoters and Developers determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system through PEST and SWOT. The external and

24、internal issues identified through PEST and SWOT are continuously being monitored and reviewed by CEO. PEST SWOT 4.2- Understanding the needs and expectations of interested parties xxx has determined the interested parties who are relevant to the xxx Quality management system and the requirement of the interested parties in order to prevent the potential effect on the organizations ability to consistently provide products and services which meet the customer and applicable statutory and regulatory requirements.