ISO9001 System Implementation Steps
For companies that are implementing or preparing to implement ISO9001 certification, this may be a "complex" project. What exactly are the processes from formulating the implementation plan to finally obtaining the certificate, and what should be noted in each process? Let's take a look at the 22 steps to implement ISO9001.
Step 1: Formulate the Implementation Plan
Implementation The plan generally includes the following content: System diagnosis (current status survey, identification), establishment of ISO implementation team and organization of related training, system document structure planning, procedure document writing, quality manual writing, third-level document writing, system document review and release, system document promotion and training, system trial operation, internal audit training, first internal audit meeting, management review meeting, supplementary audit (regarding internal audit and management review), quality system improvement and enhancement, certification application, on-site audit, correction of external audit nonconformities, obtaining the certificate.
Step 2: Establish the ISO Implementation Team
Determine team members and the functional division of each member. Especially determine the "Management Representative" and the "ISO Implementation Team Leader." The management representative is generally the actual operator of the ISO9001 quality management system, positioned just below the general manager in the organizational chart; the representative can hold concurrent positions.
Step 3: Organize Training
For the ISO team members, training is conducted by the management representative or the ISO implementation team leader (sometimes external training is provided by consulting companies). Through training and promotion, the entire company feels that the ISO implementation has already started, creating an atmosphere. At the same time, members clearly understand what work is done during the ISO implementation process, each person's responsibilities, how to coordinate with the overall progress, and how to resolve issues through proper channels.
Step 4: Plan the System Document Structure
The planning content includes: First, determine the writing plan and schedule for the entire system document; second, determine the content of the quality management system documents (which procedures to write, which specifications, what forms, etc.). Generally, companies that have been established for some time already have various forms and processes perfected and can just collect them. However, newly established companies need to write the entire set of documents, which is a heavy task; the best approach is to refer to system documents from other companies in the same industry.
Step 5: Determine Clause Reductions
The principle of reduction is: it must not affect meeting customer requirements and ensuring product quality responsibility. According to the standard: unless the reduction is 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 requirements, compliance with this standard cannot be claimed.
Step 6: Determine Document Writing Format
Several aspects of system documents need to be determined: 1. Cover pages of the quality manual and procedure documents; 2. Inner page formats of the quality manual, procedure documents, and specifications (third-level) including header styles, document hierarchy (purpose, scope, definitions, responsibilities, procedures, quality records, related documents, appendices), font formats (including font size, font type, line spacing, first-line indent, etc.); 3. Revision page format for procedure documents; 4. The best way is to write a "System Document Writing Guide" to specify related content.
Step 7: Establish Processes for Each Procedure
Collect the "flowcharts" involved in the previously determined procedure and specification documents: and hold meetings to discuss each process. Because some processes involve several departments, if not clearly discussed, contradictions and disconnections may occur between departments later. Each process is drawn by the relevant department according to its actual operation.
Step 8: Start Writing Procedure Documents
Procedure documents can be uniformly written by more professional personnel or the ISO team can provide templates and each relevant department is responsible for writing its own procedure documents. The advantage of the latter is that documents created by each department themselves are easier to implement in subsequent operations and are more practical. If people from each department write together, the speed can also be faster.
Step 9: Write the Quality Manual
The timing of writing the quality manual varies among different companies. The usual practice is to write procedure documents first and then write the quality manual when they are nearly finalized. Because if the procedure documents are not finalized, many contents in the manual are difficult to determine.
Step 10: Write Third-Level Documents
Third-level documents include specification documents, standards, machine operation instructions, procedures, etc.
Step 11: Write and Modify Fourth-Level Documents (Forms)
For forms related to other departments, it is best to discuss mutually before finalizing.
Step 12: Review and Release Quality System Documents
Pay attention to the following: Check whether the format of each document meets requirements; Check whether the content of each document meets standard requirements; Check whether there are conflicts between documents and whether related content connects properly; Check whether corresponding forms and related supporting documents are reasonable; The quality manual is the focus of the review. Document release must be strictly managed according to the "Document Management Procedure."
Step 13: Promote, Train on, and Trial Run System Documents
This training mainly targets the content of the system documents. Make each department clearly understand the standardization of various activities by the quality management system, and how various processes specifically operate, especially the general procedures, such as: "Corrective and Preventive Action Procedure", etc.
Step 14 ISO9001 Quality Management System Trial Operation
Problems encountered by each department during operation should be recorded, summarized, and regularly discussed in meetings to decide whether to revise documents or optimize processes. Note: Modifications during the system trial operation may be quite common. Therefore, during external audits, there may be many different formats of quality records, which is allowed because it is only a trial operation!
Step 15 Internal Audit Training
Generally, internal auditors must have an internal audit certificate. The company should have at least two people with internal audit certificates. Otherwise, the entire system will be considered a "major nonconformity" during external audits and will not be approved. If the company does not have more than two people with internal audit certificates, it should be addressed promptly, such as inviting instructors for external training. If there are more than two people with internal audit certificates, the internal audit training can be hosted by the company's own personnel, which can reduce company expenses.
Step 16 First Internal Audit
Internal audits must strictly follow the "Internal Audit Procedure." The specific content and steps are as follows: 1. Prepare the annual internal audit plan; 2. Prepare the current internal audit plan; 3. Distribute the current internal audit plan to relevant departments (usually one week in advance); 4. Prepare the internal audit checklist; 5. Conduct the internal audit (opening meeting, on-site audit, closing meeting); 6. Fill out the internal audit nonconformity report and internal audit distribution table (including clauses and departments); 7. Internal audit closure report.
Step 17 Management Review Activity Implementation
Management review activities mainly include the following: Annual management review plan (similar to the annual internal audit plan, but the cycle is once a year, interval not exceeding 12 months), current management review plan, management review meeting notice (delivered to relevant departments one week before the review to prepare related materials), management review input report, operation reports from each department, statistics on achievement of quality objectives (including sub-objectives) of each department, management review output report.
Step 18 Internal Quality System Re-audit
Re-audit: Audit of internal quality system audits and management reviews.
Step 19 Certification Application
After the quality system is improved and refined, certification application can be submitted after three months of operation. Different certification bodies have different application formats. Once you choose the certification body, they will reasonably arrange the subsequent matters.
Step 20 Accept External Audit (including document review and on-site audit)
Document review usually precedes the on-site audit, which means submitting your company's quality management system documents to the certification body for review. Before the on-site audit, the certification body will send the relevant audit plan to the audited company, which should prepare for the external audit, including reception arrangements.
Step 21 Correction of Nonconformities Found in On-site Audit
Corrections must include: Cause analysis, correction, corrective actions, etc. If there are no major nonconformities, generally the correction period is from one week to 30 days, meaning the shortest is 7 days after which, if no issues remain, the certificate (electronic version) can be obtained.
Step 22 Obtain Certificate
The company can receive the certification certificate (paper version) issued by the certification body 4-6 days after certification.
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