运行三个月以上的时间

Run for more than three months


If we want to do a good job in the application, then we should definitely operate in accordance with the requirements of documentation, at least to ensure that more than three months, at least a management review and other work, but also to gradually improve ourselves, do a good job in the reform of the corresponding mechanism, etc., these aspects are to be handled in accordance with the requirements.

Make a corresponding application

We need to apply for ISO9001 certification to a nationally recognized institution, and then sign the corresponding certification contract, but also need to determine the scope of certification. And a month before the audit, you need to do a good job in the submission of information.

There is a need for applications, quality manuals, business licenses, relevant documents, etc., because there are more materials, we should still do the corresponding confirmation, so as not to solve the subsequent problems.

ISO9001 system implementation steps
For companies that are implementing or preparing to implement ISO9001 certification, this may be a "complex" project. From the formulation of the implementation plan to the final certification, what are the processes in the middle, and what should be paid attention to in each process? The implementation of ISO9001 22 steps, let's take a look.



Step 1 Develop an implementation plan

Implementation programmes generally include the following elements: System diagnosis (current situation investigation and identification), the establishment of ISO implementation team and organization of related training, system document structure planning, program document preparation, quality manual preparation, third-level document preparation, system document review and release, system document publicity and training, system trial operation, internal audit training, the first internal audit meeting, management review meeting, supplementary audit (about internal audit and management evaluation) Audit), quality system improvement and improvement, certification application, on-site audit, external audit nonconformity correction, get the certificate.



Step 2 Set up an ISO implementation team

Determine the division of functions of team members and members. In particular, identify the "Management representative" and the "ISO Implementation Team Leader". The management representative is generally held by the actual operator of ISO9001 quality management system, and the position is only ranked below the general manager in the organizational structure chart, and the management agent can be part-time.



Step 3 Organize training

Training of ISO team members by management agent or ISO implementation team leader (in some cases external training by consulting company). Through training and publicity, let the whole company feel that the implementation of ISO has now begun, forming a kind of atmosphere. At the same time, let members know what work is done in the process of ISO implementation, everyone's work content, how to cooperate with the overall progress, and what ways to solve the problems encountered.



Step 4 System file structure planning

The planning content includes: one is to determine the preparation plan and progress of the entire system document, and the other is to determine the content of the quality management system document (what procedures to compile, what specifications, what forms, etc.). In general, companies that have been established for a period of time have various forms and processes that have been perfected and can be collected. However, if the newly established company needs to write the entire set of documents, so the task is very heavy, the best way is to refer to the system documents of other enterprises in the same industry.



Step 5 Determine the deletion of terms

The principle of deletion is that it must not affect the responsibility to meet customer requirements and ensure product quality. Compliance with this Standard cannot be claimed unless the exclusions are limited to those requirements in Chapter 7 of this Standard that do not affect the organization's ability or responsibility to provide products that meet customer and applicable legal and regulatory requirements.



Step 6 Determine the format of the document

There are several aspects of the system document to be determined: 1. Quality manual, program document cover; 2. Inside page format of quality manual, program file, specification (three levels) < including header style, document level (purpose, scope of application, definition, responsibility, procedure, quality record, related documents, appendix), font format (including font size, font type, line spacing, first line indent, etc.); 3. Program document revision page format; 4. The best way is to prepare a "Guidelines for the preparation of system documents" to specify the relevant content.



Step 7 Establish the flow of each process

Gather the "flow charts" mentioned in the procedure documents and specification documents identified earlier: and meet to discuss the processes. Because some processes are related to several departments, if they are not discussed clearly, there may be contradictions between various departments and they are not connected to each other. Each process is drawn by the relevant departments according to their actual operation.



Step 8 Start writing program files

The preparation of program documents can be written by more professional personnel or provided by the ISO team template Each relevant department is responsible for the preparation of program documents in their own departments. The advantage of choosing the latter is that the documents made by the departments themselves are easy to implement in the subsequent operation process and are more practical. All departments to compile together, of course, the speed can be faster.



Step 9 Write a quality manual

The timing of the quality manual is different in different enterprises. The general practice is to compile the program document first, and then write the quality manual after the difference is not too much. Because the procedure document is not finalized, there are many things in the manual that are difficult to determine.



Step 10 Write a level 3 document

The three level documents include specification documents, standards, machine operation guidelines, procedures, etc.



Step 11 Writing and modifying Level 4 documents (forms)

For forms related to other departments, it is best to discuss with each other before finalizing.



Step 12 Review and release of quality system documents

Note the following: Check whether the format of each file meets the requirements; Check whether the contents of each document meet the requirements of the standard; Check whether there is any conflict between the documents and whether the related content is connected; Whether the corresponding forms and related supporting documents are reasonable; The quality manual shall be the focus of the review. When the document is released, it is managed in strict accordance with the Document Management Procedure.



Step 13 Publicity, training and trial operation of system documents

This training is mainly for the content of system documents. Let each department have a clear understanding of the specification of the quality management system for each activity, how the various processes operate, especially the general procedures, such as: Corrective and Preventive Action procedures.



Step 14 ISO9001 quality management system trial run

Problems arising in the operation process of each department should be recorded, summarized and discussed at regular meetings to decide whether to modify the file or optimize the process. Note: The modification of the system during trial operation may be relatively common. Therefore, there may be many different formats of quality records in the external audit, which is allowed, because it is only a trial run!



Step 15 Internal audit training

It is generally required that internal auditors must have internal audit certificates. At least two or more people in the company have internal audit certificates. Otherwise, the whole system will be considered as "seriously inconsistent" and will not be passed. When the company does not have more than 2 people with internal certification, it should be dealt with in time, and teachers can be invited to train outside the factory. If there are more than 2 people with internal audit certificates, the internal audit training can be conducted by their own company, which can reduce company expenses.



Step 16 First internal audit

Internal audit shall strictly follow the Internal Audit Procedure. Specific contents and steps are as follows: 1. Prepare annual internal audit plan; 2. Prepare the current internal audit plan; 3. Distribute the internal audit plan to relevant departments (generally one week in advance); 4. Prepare internal audit checklist; 5, the implementation of internal audit (first meeting, on-site audit, the last meeting); 6. Fill in the internal audit non-compliance report and internal audit distribution table (including terms and departments); 7. Internal audit closing report.



Step 17 Implementation of management review activities

Management review activities mainly include the following activities: Annual management review plan (similar to the annual internal audit plan, but the cycle is once a year, the interval can not be more than 12 months), the current management review plan, management review meeting notice (delivered to the relevant departments one week before the management review, To facilitate the preparation of relevant information), management review input report, operation report of each department, statistics on the achievement of relevant quality objectives (including sub-objectives) of each department, and management review output report


The 18th step internal quality system review

Review: Audit of internal quality system audit and management review.



Step 19 Certification application

After the improvement and improvement of the quality system, the certification application can be made for three months, different certification companies have different application formats, as long as you choose a good certification company, and then the following things, they will be reasonably arranged.



Step 20 Accept external audit (including document review and on-site audit)

The document audit is generally ahead of the on-site audit, that is, the company's quality management system documents to the certification company, submitted to its audit. Before the on-site audit, the certification company will send the relevant audit plan to the trial company, and the trial company will do the external audit preparation work, including reception.



Step 21 Correction of non-conformance items audited on site

Correction must include: cause analysis, correction, corrective measures, etc. If there are no serious nonconformities, the correction date is generally one week to 30 days, that is, the shortest is 7 days after no problems can be obtained.



Step 22 Get your card

In 4-6 weeks after the certification, the enterprise can obtain the certification certificate issued by the certification body