The Procurement Manager should maintain a QP1120-1 APPROVED VENDOR LIST, to contain information on vendors that have demonstrated they are capable of meeting the company’s quality and other requirements. The Approved Vendor List ISO Template should include, at a minimum:
Vendor item ID/part number
Vendor contact information
Scope of registration, and more.
The Approved Vendor List ISO Template may be organized by vendor, product name, order number, or by any other item of key information. When a vendor has proved during its probationary period that it is capable of meeting requirements, the Procurement Manager should add it to the list.
Disqualified vendors should be removed from the QP1120-1 APPROVED VENDOR LIST (or may be changed to “removed” status) and the date of disqualification/removal noted only when a suitable replacement is identified, from which the company begins receiving material. The Procurement Manager shoud notify a removed/disqualified vendor of its status in writing; a copy of the disqualification notice should be placed in that vendor’s file.
The Lead Auditor should prepare an audit plan, using QP1020-2 AUDIT PLAN for guidance, at least two (2) weeks in advance of the scheduled audit. The actual lead time will vary according to the area being audited, the scope of the audit, and other factors.
The Audit Plan should include the purpose, scope, criteria, and objectives for the audit, as well as identify audit date(s) and Audit Team members.
A schedule (agenda) for the opening and closing meetings – and, if possible, interviewing department personnel – should be provided.
When developing the Audit Plan, the Lead Auditor should be sure to allow time for auditors to review and clarify notes and meet with other team members for discussion during the audit.
Areas to be visited/observed should be identified.
In preparing the plan, the Lead Auditor should review previous audit reports, Corrective Action Requests (CAR), production histories, complaint files, satisfaction surveys, and any other documents deemed relevant to the audit.
The Lead Auditor should begin the audit with an opening meeting, to be attended by all personnel identified in the Audit Plan ISO Template. Other department personnel may attend the Meeting, at the direction of Department Management.
The Lead Auditor should prepare an annual Internal Audit program before the start of the calendar year, using the Audit Program ISO Template for guidance, and submit it to Top Management for approval. QP1020-1 SAMPLE AUDIT PROGRAM organizes audit scopes such as document control and procurement based on type and time period. The Lead Auditor should review the findings of the current year’s Audits (internal and external) and should draw up the Audit Program based on such factors as:
Status and importance of the processes and areas to be audited; and
Frequency of audits.
Not every part of the company’s QMS requires an annual Internal Audit, according to ISO 9001. However, best practices dictate that every part of the company’s QMS should be audited at least once a year. In other words, a full System Audit should be performed annually, either through a series of Internal Audits or a single Full System Audit.
A Audit Report ISO Template should be prepared, documenting in detail the conclusion, findings, and observations presented during the closing meeting. Note that findings not presented in the closing meeting may not be included in QP1020-4 AUDIT REPORT. When the final Audit Report ISO Template is complete, it should be distributed as directed by Top Management.
At a time agreed to by the Lead Auditor and the manager of the audited department/area/process, an Auditor should be assigned to conduct a follow-up visit, to verify corrective actions taken as a result of the audit. At the time of the follow-up, the manager of the audited area should demonstrate that corrective actions required by the audit have been implemented and are having the desired effect. A summary of Internal Audit activity, including audit results, should be reported at the next Management Review Meeting.
The Quality Assurance Manager is responsible for maintaining the monitoring and measuring equipment Calibration Log ISO Template. The purpose of QP1170-2 CALIBRATION DATABASE is to identify equipment location, calibration status, calibration frequency, range of accuracy, and calibration history.
The calibration database should also identify those instruments that may be used as working or reference standards to calibrate other instruments. The Quality Assurance Manager should ensure that maintenance and calibration of monitoring and measuring equipment is performed in accordance with the manufacturer’s specifications and that environmental conditions are suitable for the calibrations, inspections, measurements, and tests as they are being carried out.
Frequency of calibration for each piece of monitoring and measuring equipment is established by the Quality Assurance Manager and is based on the type of measurements made, the frequency of use, manufacturer specifications, and the calibration history of the device. A default frequency of once every six months should be used, unless otherwise indicated by the Quality Assurance Manager.
The ISO Competence and Awareness Procedure outlines the methods and responsibilities for ensuring the competence of personnel performing work that affects the quality of your company’s products and/or services based on their education, training, skills, and experience.
This procedure applies to all company personnel. (24 pages, 3926 words)
ISO Competence and Awareness Responsibilities:
Department Managers are responsible for ensuring the competence of department employees (e.g., periodically reviewing training/ competence records with them) and working with the Human Resources Manager to develop individual training plans and competency requirements.
The Human Resources is responsible for ensuring that appropriate training opportunities are available to each employee, maintaining a training/competence record for every employee, and working with Department Managers to develop individual training plans and competency requirements.
Managers are responsible for defining the minimum competency requirements for positions under their supervision and for assuring that employees meet those competency requirements.
ISO Competence and Awareness Definition:
Probationary – Subject to testing/trial to determine fitness for a job or task for a limited time period. Probationary employees are typically new to a company; occasionally, an underperforming employee may be put on probation.
ISO Competence and Awareness Procedure Activities
New Employee Section
New Employee Orientation
Employee Development Planning
Competence Documented Information
ISO Competence and Awareness Procedure References
ISO 9001:2015, “Quality Management Systems – Requirements”, International Organization for Standardization (ISO), Sept., 2015 http://www.iso.org.
Quality Management should enter the corrective action request in the Corrective Action Log ISO Template. QP1040-2 CORRECTIVE ACTION LOG covers CAR number, date opened, source, problem description, and more. The Department Manager should assign an employee or employees to investigate the cause and/or take the necessary action(s) to correct and eliminate the recurrence of the problem, assign a target completion date, and notify QM of the assignment.
QM should update the Corrective Action Log ISO Template accordingly. If the corrective action takes more than one business day to complete, the person assigned responsibility for the corrective action should give a periodic (e.g., daily) status report to the Department Manager.
The QM should periodically (e.g., weekly) review the status of open corrective actions with Department Managers to help ensure actions are appropriate and are completed in a timely manner. If QM determines that the corrective action has been effective, they will inform the affected Department Manager of the “closed” status of the request and update the QP1040-2 CORRECTIVE ACTION LOG accordingly.
When it is determined that a corrective action is required, such action should begin with a Corrective Action Report ISO Template. Every QP1040-1 CORRECTIVE ACTION REPORT should include a description of the problem, observation, or nonconformance and indicate when and where it was observed. Department Management, QM, or Top Management may initiate such a request. The completed Corrective Action Report ISO Template should be submitted to QM, which should assign a CAR number.
Upon reviewing the report, QM should forward it to the manager of the department where the nonconformance exists. The investigator should record any observations, measurements, and the results of the investigation on QP1040-1 CORRECTIVE ACTION REPORT. Additional sheets (for root cause analysis, other comments, notes, etc.) should be attached to the report, as needed.
Upon completing the corrective action, the person responsible for taking such action (or when more than one person takes action, a designated individual) should sign the Corrective Action Report and forward it to QM for review. If QM determines that the corrective action has been effective, they will sign and date the Request form, inform the affected Department Manager of the “closed” status of the request. If it is determined that the corrective actions taken were ineffective, a new QP1040-1 CORRECTIVE ACTION REPORT should be generated.
Critical Vendor-Contractor Evaluation ISO Template
The Procurement Manager should periodically (or as needed) evaluate critical vendors, using QP1120-3 CRITICAL VENDOR-CONTRACTOR EVALUATIONS. Categories on the Critical Vendor-Contractor Evaluation ISO Template should be based on such factors as:
The vendor’s performance history;
Number/percent of defects found – history of supplying quality products or services;
Ability to deliver on time, consistency of on-time delivery;
Record of delivering quantities ordered (back orders, etc.);
Vendor audit results; and more.
New vendors should be subject to a “probationary period”, the length of this period to be determined by the Procurement Manager and based on such factors as the criticality of the vendor’s services/materials. The Procurement Manager may put a vendor “on notice” (on probation) on the basis of the degree of nonconformity in a single incident, a series of nonconformities, or a detected trend toward nonconformity.
Critical Vendor-Contractor Evaluation ISO Template Details
The company’s Sales Representative (or “Sales”) should present information regarding the company’s products or services, answer questions, solicit orders, and enter sales information on the appropriate order document(s), QP1080-1 CUSTOMER ORDER is one example. The Customer Order ISO Template covers purchase order number, date of order, model number, description, and more. The Sales Manager should enter accurate and complete information on the customer order form, including terms, conditions, requirements, customer information, and order configuration.
The Sales Manager should identify the customer’s specified requirements (including those for delivery and post-delivery activity), requirements not stated by the customer but necessary for the product’s specified or intended use, applicable regulatory (statutory) product requirements, and requirements the company from its unique vantage point considers necessary. The Sales Manager should submit a copy of the Customer Order ISO Template to Accounts Receivable to obtain credit pre-approval, if needed, and facilitate processing of applicable paperwork. Payment terms for the customer should be in accordance with the company’s credit policies.
The ISO Customer Satisfaction Procedure identifies steps (delineate a process) for obtaining information about customer perceptions regarding your company’s products/services meeting stated and unstated requirements in conformance with ISO 9001:2015.
This procedure applies to the post-sales service and retention of all customers. (12 pages, 1679 words)
The company should use information gathered by Customer Service Representatives to make improvements in its products, services, internal operations, and other aspects of the business.
ISO Customer Satisfaction Responsibilities
Customer Service Representatives are responsible for interfacing with the customer after the sale and for monitoring and relating information regarding customer perceptions of the company and its ability to satisfy their requirements.
The Customer Service Manager is responsible for managing a group of Customer Service Representatives (CSRs), resolving issues that cannot be resolved by CSRs, escalating issues to upper management where necessary, and reporting to Top Management on customer service tasks and issues.
The Senior Onsite Manager is responsible for ensuring that their site’s products and services meet or exceed customer requirements.
ISO Customer Satisfaction Definitions
Customer perceptions – Customer perceptions represent the feelings and attitudes for the organizations products and services. Monitoring examples can include customer surveys, customer feedback on delivered products and services, customer meetings, market-share analysis, compliments, complaints, dealer reports, warranty claims or provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.
ISO Customer Satisfaction Procedure Activities
Customer Satisfaction General
Customer Satisfaction Survey
Customer Satisfaction Review
ISO Customer Satisfaction Procedure References
ISO 9001:2015, “Quality Management Systems-Requirements”, International Organization for Standardization (ISO), Sep., 2015
On a monthly basis, the Customer Service Manager should print a sales order report, listing sales orders completed between 90 and 120 days ago. A Customer Satisfaction Survey ISO Template and business reply envelope, addressed to the company’s Quality Assurance department, should be prepared and addressed to each customer listed on the sales order report. If a contact person is not listed, the survey should be sent to the person in charge of the customer department that is using the product. QP1190-2 CUSTOMER SATISFACTION SURVEY covers the model type, hours used per week, questions regarding the service/products, and more.
When a customer returns a Customer Satisfaction Survey ISO Template, the Mail department should promptly route the form to Quality for review. Quality should retain a copy of the survey in a master file for statistical analysis and review, forwarding the original survey to Customer Service Representatives for any immediate action required. The CSR should record conversations, exchanges, and their results on the QP1190-2 CUSTOMER SATISFACTION SURVEY, attaching additional sheets if needed. The completed form should be filed in the customer file or logged in the customer database. A copy of the form may be routed to internal Department managers for their review (e.g., to determine if improvements to products or operational or design areas are required).
Customer Service Representatives should maintain a Customer Service Log ISO Template, recording pertinent information on all customer contacts after the sale. QP1190-3 CUSTOMER SERVICE LOG should be reviewed and analyzed and results of analyses reported to Top Management on a periodic basis. The Customer Service Log ISO Template covers customer name, product description, problem/reason for contact, and more.
The company should use information gathered by Customer Service Representatives to make improvements in its products, services, internal operations, and other aspects of the business. Customer Service Representatives should report on customer feedback and analysis on an as-needed basis or, at the very least, at the next Management Review meeting. Customer Service Representatives should receive appropriate training in telephone etiquette, negotiating, problem resolution, and other interpersonal skills. Keep in mind it’s important to identify steps (delineate a process) for obtaining information about customer perceptions regarding the company’s products/services meeting stated and unstated requirements.
The ISO Data Analysis-Continual Improvement Procedure continually improves the effectiveness of the company’s QMS, determining where improvements can be made by using the Quality Policy, quality objectives, audit results, and data analysis in conformance with ISO 9001:2015.
This procedure applies to the company’s QMS. (4 pages, 744 words)
ISO Data Analysis-Continual Improvement Responsibilities
The Quality Assurance Manager is responsible for analyzing measurement data.
Quality Management is responsible for reporting measurement data at periodic Management Reviews.
Department Managers are responsible for producing and using process monitoring and measuring data for the purpose of continually improving the company’s Quality Management System.
ISO Data Analysis-Continual Improvement Definitions
Special cause variation – Product/process variation, caused by an unusual or unexpected event.
Pareto diagrams – Histogram chart method that ranks data high to low to separate the vital few from the trivial many. Also know as the 80/20 rule.
Trend or run charts – chart method that plots process output over time.
Control charts– Output of Statistical Process Control (SPC) calculations that derive the process variability from the mean to detect special cause variation.
ISO Data Analysis-Continual Improvement Activities
ISO Data Analysis-Continual Improvement References
ISO 9001:2015, “Quality Management Systems-Requirements”, International Organization for Standardization (ISO), Sept., 2015 http://www.iso.org.
The ISO Design Change Procedure outlines the procedure for requesting changes to your company products or processes and implementing those changes, to assure orderly, controlled, and effective changes to every aspect of the design of your company products in conformance with ISO 9001:2015.
This procedure applies to all of your company’s design processes and to all products designed by your company; specifically, to change control. (8 pages, 1156 words)
Design change requests often come from existing customers as a result of complaints, new capabilities, or requirements. Such requests may also originate within the company (e.g., responding to news of a competitive product, production issues, supply issues, preventive actions).
ISO Design Change Responsibilities
Design Engineers are responsible for ensuring that all product design changes are recorded, communicated, and implemented; the department is also responsible for evaluating change requests and determining appropriate responses.
Document Control or an individual designated by Management is responsible for assuring that obsolete/superseded documents are removed from the work environment and only current revisions of necessary documents are available at point of use.
ISO Design Change Procedure Activities
Requesting Design Changes
Engineering Change Notice
Change Design and Development, Review, Verification, Validation and Testing
Preproduction Planning and Manufacturing
ISO Design Change Procedure References
ISO 9001:2015, “Quality Management Systems – Requirements”, International Organization for Standardization (ISO), Sept., 2015 http://www.iso.org.
Design Completion Checklist-Electromechanical Devices ISO Template
For electromechanical products, a Design Completion Checklist-Electromechanical Devices ISO Template should be completed and evaluated. QP1100-2 DESIGN COMPLETION CHECKLIST FOR ELECTROMECHANICAL DEVICES covers items inside the device, hardware, labeling, software, and more. At the completion of each design/development activity, a review of the results should be performed.
Reviews should be objective, unbiased examinations by appropriately trained employees who were not directly involved in that design activity. The design team should keep a record of all such reviews and necessary actions that arise from them. Review results and actions arising from them should be documented in report form and signed by Management employees as complete and accurate.
All changes made as a result of review findings should likewise be documented. Reports should include conclusions and recommended follow-up and should be disseminated in a timely manner to appropriate organizational functions, including management. The Product Development Team should keep all such reports in the Design & Development file.
Design Completion Checklist-Electromechanical Devices ISO Template Details