Receiving Inspection Procedure ISO 9001 2015 | QP1210

ISO Receiving Inspection Procedure

The ISO Receiving Inspection Procedure describes the process of receiving materials, components, parts, finished goods, etc., inspecting them when required, and determining their disposition. in accordance with ISO 9001:2015.

This procedure applies to receipt of all incoming items. (12 pages, 1536 words)

ISO Receiving Inspection Responsibilities

Warehouse Personnel are responsible for receiving materials; inspecting for correct items, quantities, and possible damage/nonconformity; stocking items; and forwarding paperwork to the Procurement Manager.

Accounts Payable is responsible for paying invoices.

The Procurement Manager is responsible for reviewing receiving/inspection documentation, contacting vendors in case of damaged shipments or discrepancies, and forwarding documentation to Accounts Payable.

The Quality Assurance Manager is responsible for conducting detailed examinations of incoming materials when required; recommending acceptance or rejection of goods to the Procurement Manager; and review, analysis, and reporting of receiving/inspection data.

ISO Receiving Inspection Definitions

Certificate of Analysis (C of A) – Supplier’s written statement, authorized by contract or purchase order, certifying that supplies or services comply with contract requirements based on quantitative instrumented physical or chemical analysis of representative samples taken from the shipment accompanying the certificate.

Certificate of Conformance (C of C) – Supplier’s written statement, authorized by contract or purchase order, certifying that supplies or services comply with contract requirements, signed by a responsible individual, and displaying part number and version number, buyer’s purchase order (PO) number, PO date, and PO revision number. Also called “Certificate of Compliance”.

Direct-to-stock (DTS) – Parts/supplies placed directly into stock without inspection; done to reduce duplicate inspections and where a vendor has a history of providing satisfactory quality.

First article inspection (FAI) – Process monitoring of key characteristics to ensure that parts can be manufactured continually, inexpensively, in compliance with specifications, and with minimum variation.

Positive recall – Where incoming product is released for urgent production purposes prior to verification, it is positively identified and recorded in order to permit immediate recall and replacement in the event it is found not in conformance to specified requirements.

ISO Receiving Inspection Activities

  • Receiving and Stocking
  • Detailed Inspection
  • Items Received on Certificate of Conformance or Certificate of Analysis
  • Receiving/Inspection Review

ISO Receiving Inspection References

ISO Receiving Inspection Forms

 

 

Receiving Inspection Report ISO Template | QP1210-3

Receiving Inspection Report ISO Template

The Quality Assurance Manager should record found nonconformities (e.g., no FAI report for a new part) on the Receiving Inspection Report ISO Template, review the event/situation and place those products “on hold. QP1210-3 RECEIVING AND INSPECTION REPORT covers information regarding receiving, inspection, and rejected parts disposition. Regardless of that determination, the Quality Assurance Manager should submit a copy of the report to the Procurement Manager and the Procurement Manager should maintain this record for vendor evaluation.

The Quality Assurance Manager should tag acceptable items and notify Receiving to update inventory and place items into stock. Quality tags should indicate part number (and other identifiers, if needed) and date of acceptance. The Quality Assurance Manager should periodically review and analyze reports for nonconformities and trends. If found nonconformities, trends, or occurrences suggest a need for corrective action, the Quality Assurance Manager should ensure that any such action is taken.

Receiving Inspection Report ISO Template Details

Pages: 01
Words: 120
Format: Microsoft Word 2013 (.docx)
Language: English
Manual: ISO 9001
Procedure: ISO Receiving Inspection Procedure QP1210
Type: Report

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Receiving Log ISO Template | QP1210-1

Receiving Log ISO Template

Receiving should update the Receiving Log ISO Template with the appropriate information, move incoming items to their appropriate storage areas, and forward the packing slip to the Procurement Manager for reconciliation with the related purchase order. QP1210-1 RECEIVING LOG covers log number, date, sender, tracking number, and more. Receiving should visually inspect all incoming shipments for possible damage. If damage is apparent (e.g., packaging is dented or punctured, leakage is evident), Receiving should notify the Procurement Manager and move the suspect shipment to the appropriate holding area for determination of disposition.

If the shipment shows no signs of damage, information on the packing slip should be matched with the incoming shipment and Item inventory should be updated. For items that must undergo a detailed inspection to conform to contractual or other requirements, Receiving should notify the Quality Assurance Manager and move the shipment to the appropriate holding area. Receiving should not place parts, components, supplies, etc., into inventory unless they are found to conform to specified requirements, unless they are released under positive recall or are DTS items.

Receiving Log ISO Template Details

Pages: 01
Words: 13
Format: Microsoft Word 2013 (.docx)
Language: English
Manual: Quality Assurance Policy Statement and Procedures
Procedure: ISO Receiving Inspection Procedure QP1210
Type: Log

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Return Materials Authorization ISO Template | QP1030-3

Return Materials Authorization ISO Template

Upon being notified by the customer of its intent to return goods, Sales (or Customer Service) should prepare a Return Materials Authorization ISO Template. A Return Goods Authorization (RGA) number will be assigned or generated and this will be given to the customer, to identify the product upon its return. If the RGA is for a defective product, a customer complaint should also be logged. Return Goods Authorization gives a customer express permission to return product that does not satisfy that customer’s needs.

QP1030-3 RETURN GOODS AUTHORIZATION should be used as a receiving report for the return. All items received will be inspected, counted, and recorded on this form. The individual responsible for receiving the items should sign and date the form. Receiving should place the returned product in a designated “hold” area, with a copy of the RGA attached for identification, and notify Quality Assurance to analyze, verify, and report on the identified nonconformity.

Return Materials Authorization ISO Template Details

Pages: 01
Words: 57
Format: Microsoft Word 2013 (.docx)
Language: English
Manual: ISO 9001
Procedure: ISO Control of Nonconforming Product-Material Procedure QP1030
Type: Form

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Risk Opportunities Management ISO 9001 2015 | QP0600

ISO Risk Opportunities Management Procedure

The ISO Risk and Opportunities Management Procedure assesses threats related to the organizational context, interested parties, and the quality management system in order to prioritize the risks and manage them effectively and efficiently in conformance with the company’s QMS and ISO 9001:2015. (14 pages, 2131 words)

ISO Risk Opportunities Management Responsibilities

The Quality Manager is responsible for (1) directing the Organization’s risk assessment and management processes. (2) identify potential nonconformities, ensuring that preventive actions appropriate to the nature of the potential nonconformities are taken, and ensuring that preventive actions yield the desired results.

The Organization’s Top Management[1] is responsible for creating the Risk Management Committee[2], providing the resources needed to assess and manage risk, and initiating preventive actions and following up on there effectiveness at Management Review

[1] Top Management typically consists of the Organization’s chief executive (e.g., President) and finance official (e.g., Controller), at a minimum.

[2] Also referred to as RMC or “the Committee” in this document.

ISO Risk Opportunities Management Definition

Failure Modes and Effects Analysis (FMEA) – Stepwise approach to identification of possible field failures in a design, process, or product, and their consequences.

Preventive Action – Measure put in place to eliminate, or reduce the likelihood of, a potential nonconformity.

Hazard – Source of danger or specific situation that may influence the probability and/or extent of loss.

Risk – 1. Possibility that the quality management system may not achieve its intended result(s); Something that may enhance desirable effects; prevent, or reduce, undesired effects; or that may limit improvement.

Risk assessment – Identifying and ranking potential hazards (threats) in the work environment.

Risk management – Actions to address risk can include: avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

Threat – Indication or source of impending danger.

Vulnerability – Weakness; inability to withstand an attack or cope with a disaster.

ISO Risk Opportunities Management Activities

  • Risk Management Committee
  • Risk Assessment Guidelines
  • Risk Assessment
  • Risk Management Actions and Review

ISO Risk Opportunities Management References

  • ISO 9001:2015, “Quality Management Systems – Requirements”, International Organization for Standardization (ISO), Sept., 2015 http://www.iso.org.
  • Quality Procedures
  • Statutory and Regulatory Requirements
    • Laws & Regulations: Certain businesses (e.g., food processors, medical, chemical and pharmaceutical manufacturers) are required to identify, evaluate, and manage risks (a) to comply with laws and regulations and (b) because their products or processes have the potential to adversely affect worker or consumer health and safety. These organizations are strongly urged to seek the help of qualified and competent legal counsel, as well as certified and experienced health and safety experts.

ISO Risk Opportunities Management Forms

  • QP0600-1 Risk Assessment / Management Worksheet
  • QP0600-2 Risk Controls Cost-Benefit Worksheet
  • QP0600-3 Preventive Action Report

Situational Analysis ISO 9001 2015 | QP0500

ISO Situational Analysis Procedure

The ISO Situational Analysis Procedure identifies how the Company is situated in the marketplace and interacts with the business environment. It evaluate its current situation in order to develop a meaningful quality strategy that leverages the Company’s strengths and minimize its weaknesses in conformance with the company’s QMS and ISO 9001:2015. (14 pages, 2358 words)

ISO Situational Analysis Responsibilities

Top Management is responsible for ensuring the situational analysis is appropriate for developing quality strategies.

The Quality Manager is responsible for ensuring the QMS conforms to requirements, processes are delivering intended results, reporting on QMS performance and improvement, promoting the customer focus, and ensuring the integrity of the QMS throughout planned changes.

The Strategy Team is responsible for gathering information on the Company’s situation, analyzing the information, and preparing and presenting a situational analysis report.

ISO Situational Analysis Definition

Situational analysisAlso known as a “SWOT analysis.”An in-depth process for developing an understanding of the needs of the customer, which involves a combination of data gathering techniques conducted from a variety of internal and external perspectives; a methodology used to aid the organization’s strategic planning process; identifying, evaluating, and planning around the organization’s strengths, weaknesses, opportunities, and threats.

Strengths and Weaknesses are internal and may include topics related to values, culture and performance of the organization.

Opportunities and Threats are external and may include issues related to values, culture and performance of the organization.

ISO Situational Analysis Activities

  • Situational Analysis Introduction
  • Assessing the Company’s Situation
  • SWOT Scoring Attributes
  • Analyzing the Data
  • Situational Analysis Report
  • QMS Components

ISO Situational Analysis References

  • ISO 9001:2015, “Quality Management Systems – Requirements”, International Organization for Standardization (ISO), Sept., 2015 http://www.iso.org.
  • Statutory and Regulatory Requirements
    • Laws & Regulations: Certain businesses (e.g., food processors, medical, chemical and pharmaceutical manufacturers) are required to identify, evaluate, and manage risks (a) to comply with laws and regulations and (b) because their products or processes have the potential to adversely affect worker or consumer health and safety. These organizations are strongly urged to seek the help of qualified and competent legal counsel, as well as certified and experienced health and safety experts.
  • Quality Procedures

ISO Situational Analysis Forms

Vendor Audit Checklist ISO Template | QP1120-2

Vendor Audit Checklist ISO Template

If a vendor will be supplying critical products, materials, or services, the Procurement Manager should conduct an audit, using QP1120-2 VENDOR AUDIT CHECKLIST for guidance, and the vendor must pass that audit prior to placing an order with that vendor. The results of the vendor audit should be kept in the vendor’s file.

The Vendor Audit Checklist ISO Template covers general information, pre-audit records, pre-audit interview with principal(s), quality procedures, and more. To be an approved vendor, one should be able to provide the company reasonable assurances of its capabilities. The degree of assurance required will depend on the nature and severity of risk the vendor’s product/service poses to the quality, safety, and reliability of the company’s product.

When evaluating critical vendors, the Procurement Manager should give preference to those that are certified to ISO 9001, as this provides the company greater assurance of vendor product/process quality than if a vendor is not certified. If a vendor will be supplying noncritical products, materials, or services, the Procurement Manager may begin ordering without a vendor review.

Vendor Audit Checklist ISO Template Details

Pages: 03
Words: 139
Format: Microsoft Word 2013 (.docx)
Language: English
Manual: ISO 9001
Procedure: ISO Supplier Evaluation Procedure QP1120
Type: Checklist

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Vendor Performance Log ISO Template | QP1120-4

Vendor Performance Log ISO Template

Receiving should record critical vendors’ deliveries in the Vendor Performance Log ISO Template and inspect incoming material. If, during incoming inspection, Receiving identifies materials that do not conform to requirements, Receiving should handle such material and notify the Procurement Manager and the Quality Assurance Manager. The Procurement Manager should maintain a record of each vendor’s performance on QP1120-4 VENDOR PERFORMANCE LOG. The Vendor Performance Log ISO Template should include:

  • Vendor name and contact info;
  • Vendor class;
  • Vendor quality and performance ratings;
  • Certification(s), if any;
  • Last quality audit date and auditor (if applicable); and more.

Keep in mind the company should select vendors (suppliers) based on their ability to supply parts, components, etc., in accordance with company, customer, and regulatory requirements. This applies to all vendors of products, materials, and services that directly affect the quality of the company’s products/services.

Vendor Performance Log ISO Template Details

Pages: 01
Words: 69
Format: Microsoft Word 2013 (.docx)
Language: English
Manual: Quality Assurance Policy Statement and Procedures
Procedure: ISO Supplier Evaluation Procedure QP1120
Type: Log

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Verification Checklist ISO Template | QP1100-4

Verification Checklist ISO Template

The Team should maintain records of verification results, and necessary actions arising from the results, using QP1100-4 VERIFICATION CHECKLIST as a guide. The Verification Checklist ISO Template keeps track of the input requirement, who it was verified by, and the date.

The Team should, in accordance with the Project Plan, conduct design verifications to ensure that D&D outputs meet D&D input requirements. Keep in mind the design phase is the most important phase of the product life cycle, because inherent quality, effectiveness, and customer satisfaction of the product are established there. No matter how carefully a product may be manufactured or how perfect a quality control program, inherent qualities cannot be improved except through design enhancement.

It is crucial that adequate planning and controls be established, implemented, and maintained during the design phase to optimize quality, effectiveness, safety, and customer satisfaction prior to manufacturing. At the end of the project, the Product Development Team should review all records generated during the course of design and development, looking for opportunities for improvement.

Verification Checklist ISO Template Details

Pages: 01
Words: 08
Format: Microsoft Word 2013 (.docx)
Language: English
Manual: ISO 9001
Procedure: ISO Design Development Procedure QP1100
Type: Checklist

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ISO 9001 2015 Procedures | ABR211M

What’s Included in the ISO 9001 Procedures Manual?

You will receive 536 pages of content within seven sections:

1. ISO 9001 Quality Manual Template

First, two choices: a 20 page (long) or 4 page (lean) Quality Manual is used as a top level Quality document governing your company’s Quality Procedures.

2. ISO Manual Table of Contents

Next, 302 pages that include 24 prewritten ISO Quality Procedures, 57 ISO forms and corresponding activities–customize each Microsoft® Word document template to your needs.

3. ISO Job Descriptions

The ISO 9001 Manual also includes 80 pages with 25 ISO Job Descriptions covering the primary ISO Quality Functions.

 4. ISO 9001 Introduction Training Guide

A 60 page training guide explains the basic concepts of ISO Quality Management (QMS), its structure, standards and definitions, and more.

5. “How To” ISO Manual Preparation Guide

A 38 page Procedure writing guide provides guidance to develop and implement your own ISO Quality Procedures.

6. ISO 9001 Manual Keyword Index

Easily find what you are looking for inside the ISO 9001 Manual using the 26 page Keyword Index.

How to Create an SOP Standard Operating Procedure Template

“We are a small credit counseling business in the Midwest. Our industry requires ISO certification.  We decided to purchase the ISO [9001] Manual even though our industry does not require the same procedures as a manufacturer.  I was impressed with the details of their manual and was able to extract sufficient information to complete our ISO [9001] certification in nine months.  I would recommend the manual to any manufacturer seeking certification.  All the information contained in the manual may not be pertinent to your business but should at least guide you in the proper components required.”

Robert Kory
Falls Credit Management, Inc.

ISO 9001 Procedures Manual

Create an ISO 9001 Procedures Manual fast. Save time writing out quality procedures. Our Quality Management System (QMS) comes with the basic components to get your started. You will receive Quality Manual, 24 procedures, 57 forms, and 25 job descriptions pre-written in Microsoft Word for easy editing.

Are you implementing an ISO quality program at your organization? What will be your first step? How will you get started? Our ISO 9001:2015 Procedure Templates will answer many of these questions.

ISO 9001 Quality Procedures

We have heard from several customers about the need for implementing ISO 9001 quality procedures in their unique organizational settings. If you are asking ‘How do I get started?’ or ‘How do I roll out ISO 9001:2015 in my company?’ Then you have come to the right place.

Implementing the ISO 9001 Quality Management System can serve as a business improvement tool. Frequently the ISO 9001 2015 standard is perceived as a checklist item; Get ISO 9001 Certified-Done. The real goal of ISO 9001:2015, however, is continual improvement of the organization. Embracing the concepts of ISO 9001 can enhance an organization in several ways, which we will cover in upcoming articles.

Free Sample ISO 9001 2015 Quality Procedure

Collect your Free ISO 9001 2015 Procedures. This sample Word files provides an example of the look and feel form the ISO Manual. Your will see how the header block is structured, revisions section, the style of write, content and more.

Putting Together an ISO Quality Management System

We have put together what you will need to build a Quality Management System. It starts with a situational analysis to determine your interested parties, their wants, needs, opportunities and risks. What are Interested Parties?

Interested Parties

They are stakeholders in your organization. Customers, owners, suppliers, employees, the community and others that have a stake in the ongoing success of your organization. Top Management should use the results of the situational analysis in the development of the Company’s QMS Scope, Quality Policy, Quality Objectives, and QMS processes.

QMS Scope

QMS Scope, consists of defining the requirements of relevant interested parties, the types of products and services covered by the QMS, and provide justification for any exclusions to requirements of ISO 9001 that the organization determines is not applicable to the scope of its quality management system.

Note: Exclusions to ISO 9001 may only be claimed if they do not affect the organizations ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.

Quality Policy

Quality Policy, must be appropriate to the purpose and context of the company. It ties in with and provides a framework for the Quality Objectives, includes a commitment to satisfy requirements, and a commitment to continual improvement of the QMS.

Quality Objectives

Quality Objectives, are derived from the Quality Policy, are measurable, and communicate to interested parties the effectiveness of the QMS. As quality objectives, they provide a basis for planning that at a minimum includes: Who, will do What, by When, requiring What resources, and How will results be evaluated.

QMS processes

QMS processes are those necessary for the QMS. Each QMS process shall identify:
• the inputs and outputs expected,
• the sequence and interaction of these processes with each other,
• measurable process criteria (or control method),
• resources required by the process,
• responsibility for the process,
• process risks (and approach to controlling risk),
• how the process will be evaluated, and
• opportunities for improvement.

ISO Quality Manual

Next, you can can create a Quality Manual. A Quality Manual explains the “scope” of your system. It is not required anymore, but it helps to explain what the boundaries are (scope), your Quality Policy, Quality Objectives, and QMS Processes.

We provide two versions of the Quality Manual. A shorter “lean” version and a longer version. The short version of the Quality Manual reflects lean thinking most of all. Rather than borrow the text of the standard verbatim, we stripped the Quality Manual to the bare essentials. It’s not going to be for everyone – some will, no doubt, still insist that their ISO Quality Manuals parrot the text of the ISO 9001 standard, so that they’re sure their Quality Management System documentation covers every aspect of ISO 9001.

Putting in a lot of verbiage that’s not required by the standard, however, it can make your Quality Manual less user-friendly, less useful, and less likely to be improved. In fact, the new ISO 9001:2015 does not require a Quality Manual at all. But just in case this is your approach, we also provide a long version of the quality manual that covers all of the text of the ISO 9001 standard — all 123 shall statements.

There is a new term “Documented Information” that has replaced required procedures. There are 24 quality procedures in the new and improved ISO 9001:2015 QMS. Quality procedures that are included are ones that many organizations consider important or critical (e.g., Internal Auditing, Corrective Action). Those procedures are modeled on the Deming Cycle — they have a Plan, Do, Check, and Act phase. Some procedures that aren’t typically high priority and/or that didn’t amount to much more than simple work instructions (e.g., Serial Number Designation) have been omitted.

ISO 9001 Documented Information (clause 7.5.3)

Let’s address what we feel is a real misconception about ISO 9001; the documentation requirements. It’s gone! First; the ISO 9001 standard does not have complex or complicated documentation requirements. In fact, they are quite simple; ISO 9001 no longer requires specific procedures. What does this mean?

You specify what you need. If your need work instructions then create them. If you workforce is quite skilled and your product is does not vary a lot, then maybe you just need training material. It’s your decision.

While it may difficult for most organizations to get by with no procedures, the fact that there are no ISO required standard operating procedures should send a message that, despite the perception of the opposite, ISO 9001 is not about a lot of procedures. Your organization must decide what procedures are needed based on issues related to compliance, importance, and performance.

An important concept to understand is that procedures are only one way to document processes, and the ISO standard recognizes that. Processes can be documented by Work Instructions, Visuals Aids, or training materials. The real requirement by ISO is that key business processes are understood and consistently carried out.

Throughout the updated manual, we refer to ISO 9001 requirements. We’ve done something new with the “Forms and Records” section at the end of each procedure. We’re still providing sample forms for you to use, but now they’re categorized with the ISO 9001 clause that requires the record. For example, in the Internal Audits procedure, there’s a form for audit reports; the Forms/Records table tells you the report requirement is in clause 9.2.2.

We think this is a much improved product, one that will smooth the bumps in your organization’s road to ISO 9001:2015 compliance and certification. Download Free Sample ISO Procedures to see how easy it is to edit MS Word Templates to build your own policy and procedure quality management system.

Fast ISO 9001 Procedures Manual

The ISO 9001 Procedure Manual is written from a manufacturing perspective, yet the quality policies and procedures can be generalized for any business. An ISO 9001 Quality Procedures Manual simplifies the task of complying with the ISO 9001 standard. With the purchase of this ISO 9001 Procedure Manual, you get 24 ISO procedures, 57 quality forms/records, 25 job descriptions, background on ISO 9000, a two sample ISO Quality Manual, and guidelines to help you develop an effective quality management system (QMS).

Fast ISO 9001 2015 Quality Procedure Templates

The Bizmanualz ISO 9001 Procedures Manual comes with over 536 pages of quality procedures and work instructions documentation (download only). All policies and procedures contained in the ISO 9001 manual are modeled on “Plan-Do-Check-Act” or PDCA Cycle.

You also get an explanation of the ISO 9001 2015 standard and helpful guidance to help you produce your company’s ISO 9001 procedures manual.

Take advantage of this comprehensive ISO 9001 Procedures Manual. Get your ISO 9001 certification journey started the right way — use the ISO 9001 QMS manual to simplify the process of developing, implementing, and managing your quality management system effectively! Download Free ISO 9001 2015 procedures.