ISO 9000 complaint definition iso

ISO 9000 Share DEFINITION of 'ISO 9000'

A series of international guidelines for quality control. ISO 9000 pertains specifically to the criteria that needs to be met during the manufacturing process. These guidelines do not guarantee product quality, but merely the standards used in the production of goods.

BREAKING DOWN 'ISO 9000'

ISO rules and guidelines were established by the International Organization for Standardization. These rules first gained popularity in Europe, then spread to America in the 1990s. The certification process for this standard takes over a year and requires substantial documentation and demonstration.

Trading Center ISO 14001 ISO Currency Code ISO 14000 American National Standards Institute ... Intermodal Freight Standardization Qualifying Disposition Quality Control Non-Qualified Stock Option - NSO Next Up Dictionary: # a b c d e f g h i j k l m n o p q r s t u v w x y z Content Library Articles Terms Videos Guides Slideshows FAQs Calculators Chart Advisor Stock Analysis Stock Simulator FXtrader Exam Prep Quizzer Net Worth Calculator Connect With Investopedia Work With Investopedia About Us Advertise With Us Write For Us Contact Us Careers Get Free Newsletters Newsletters Work With Investopedia About Us Advertise With Us Write For Us Contac laxtzdkz. outlet moncler online italiat Us Careers © 2017, Investopedia, LLC. All Rights Reserved Terms Of Use Privacy Policy
complaint definition iso

latest mens moncler t shirts at flannels liverpool
moncler vest
complaint letter to apartment manager
moncler man
men's moncler t shirt long sleeve The procedures and thoughts behind the way the contributions have been measured or estimated should be documented. Combine separate contributions in order to give an overall value. For example, where individual sources of uncertainty are independent, the overall uncertainty can be calculated as a multiple of the sum of squared contributing uncertainty components, all expressed as standard deviations. Computer software or spreadsheet programs can help automate this calculation.

The whole procedure should be documented in such a way that sufficient information is available for the result to be reevaluated if new information or data become available. A complete set of documentation should include:

A description of the methods used to calculate the measurement result and its uncertainty from the experimental measurements The values and sources of all corrections A list of all components of uncertainty with full documentation about how each of these was evaluated.

Reference 4 includes many practical examples with data from different analyses, as well as formulas for evaluating, calculating and reporting standard and expanded uncertainty. Sample analysis reports should include an uncertainty number, which is typically expressed as:

Result = x ± u (units) or Result = x (units) Uncertainty = u (units)

Implementing Difficult Requirements

The Labcompliance ISO 17025 Accreditation Package comes with procedures and forms to easily implement and document difficult requirements. They include measurement uncertainty, traceability, validation of spreadsheets and training. To learn more about the package, click here

6. Steps Towards ISO/IEC 17025 Accreditation

ISO/IEC 17025 accreditation should be carefully thought out and properly prepared. It can be quite expensive but can also have big benefits. The balance between costs and benefits should be calculated and documented. Implementing ISO/IEC 17025 will impact the entire laboratory and also supporting services such as human resources, documentation and finance departments. Therefore, while the decision to initiate and fund the project will be made by management, all affected departments should be involved in the process. The entire process is divided into two phases: investigation phase and implementation phase. Figure 6 illustrates the steps for both phases.

Figure 5. Steps Towards ISO/IEC 17025 Accreditation

Investigation

In the investigation phase, information is collected to decide if becoming accredited makes good business sense and typically follows these steps:

Management initiates, funds, and otherwise supports the investigation. Management nominates a project owner. Ideally the person should have experience in laboratory operations, good business sense, an understanding of quality systems and excellent communication skills. The project manager with support from management recruits a project team. Members should come from laboratory management, QA, finance, human resources, training, and documentation groups. The project team defines the scope of the intended accreditation. This could include all calibrations and/or tests performed in a lab, or just part of them. The project team studies the accreditation requirements in detail. The main source is the standard ISO/IEC 17025, with additional support from official guidelines, other literature, and external expert advice. The project team develops a requirements list. The list should include all documents as required by the standard, for example, policies, a quality plan, and procedures for most of the requirements. The project team prepares a gap analysis by comparing ISO requirements as listed above with what is already available and implemented. A gap exists where existing policies, processes or procedures do not fully meet the stated requirements. This analysis should include all processes and procedures for management controls and technical controls, such as for sampling, method validation, equipment calibration, qualification and maintenance, employee qualifications, and others. Using the outcome of the gap analysis, the project team develops a task list. The list is completed with additional tasks such as selecting and dealing with an accreditation body. The project team, together with the help of an external consultant, makes an estimation of the overall ISO/IEC implementation costs, which should include costs for initial set-up and also for maintaining the quality system. The costs are compared with the direct and tangible estimated additional returns that come from getting accreditation status. Tangible returns are, for example, savings through more efficient operation. The team makes a rough estimation of the return on investment for both the short and long term views, and makes a recommendation to management. Management decides to accept or reject the proposal and whether to proceed with accreditation. Implementation

Once the decision for ISO/IEC 17025 accreditation is made, the laboratory develops and implements documentation in preparation for the accreditation assessment. Typically implementation follows these steps:

The project owner forms implementation teams for different areas. It is critical that all affected departments at all management levels are represented in the teams. The project owner with the help of QA searches for an accreditation body and selects the one that best fits the laboratory’s needs. There are several ways to find accreditation bodies. Probably the best way is to ask other accredited laboratories about their experiences. The teams develop documentation such as procedures under the supervision of the project owner. The project owner arranges for staff training. Quality assurance performs an internal audit and initiates corrective actions, if necessary. The selected accreditation company performs a pre-assessment. The project owner initiates corrective actions. The accreditation company performs an accreditation audit.

ISO 17025 Implementation: Step-by-Step

The Labcompliance ISO 17025 Accreditation Package comes with a best practice guide for effective step-by-step implementation of ISO 17025 - from beginning to the end!. To learn more about the package, click here

7. Documentation ISO/IEC 17025 requires different types of documentation, as illustrated in the documentation pyramid in Figure 7.

Figure 7: Documentation Pyramid

A policy documents the laboratory’s intent to implement ISO/IEC 17025. The Quality Manual is the top tier of the document hierarchy. It describes the approaches to achieve quality data. It also includes policy statements describing the laboratory’s intention to conform to ISO/IEC 17025 requirements. For example, a policy statement could be: All personnel involved in calibration and testing should be competent for the assigned task.

A process or generic procedure describes how various quality requirements can be achieved. For example, it describes how the requirement ‘Personnel should be competent for the assigned task’ can be implemented.

Standard operating procedures (SOPs) or Working Procedures are step-by-step instructions for how to exactly perform a specific task, such as calibrating a specific instrument.

Records are generated on a day-by-day basis, such as analytical results from product tests or calibration records of a balance.

All documents should be properly controlled. For example, each change should be authorized and logged, and the updated document should get a new revision number or code.

Policies and Quality Manual

Policies including the quality policy statement should be documented in the Quality Manual. Senior management should write the quality policy statement, which should outline the laboratory’s commitment to quality. The quality manual describes the quality system and documents the laboratory’s goal and overall concept for how to conform to ISO/IEC 17025. It should also describe how the remainder of the quality system documentation is organized. It should be developed by working groups representing different departments.

Processes

Processes or standard procedures describe how various ISO/IEC 17025 requirements can be achieved. For example, it describes how the requirement ‘All personnel involved in calibration and testing should be competent for the assigned task’ can be implemented. Another example is the laboratory’s approach to calibrating and checking different types of equipment. For a better understanding, process flowcharts should be included in a process description.

Standard Operating Procedures (SOPs) and Work Instructions

Routine activities follow documented procedures. These are typically defined as standard operating procedures (SOPs) or work instructions. While quality manuals and processes describe tasks and approaches, procedures and work instructions give step-by-step instructions on performing tasks. Examples of SOPs are procedures for checking and calibration of equipment. All laboratory SOPs should use the same format, to make writing and reading easier. A good practice is to have an SOP for how to author, review, approve, distribute, and update SOPs. Preferably senior members of anticipated user groups should write SOPs. This helps ensure that SOPs have the right level of information and are used and followed.

Records

Records to demonstrate conformity with ISO/IEC 17025 and as required by customers should be retained for a specific amount of time. Examples are original laboratory observations, test results, supporting documents such as chromatograms, and training certificates and equipment calibration protocols.

Checklists, forms, templates, and examples help implement quality work effectively and consistently. Examples of these include checklists and worksheets for vendor assessment, handling nonconforming test results, and for internal audits. These items help document specific tasks consistently and effectively.

Document Control

Development and maintenance of documentation should be controlled through document control and management procedures that are part of the management system. Documents include both internal, such as SOPs, quality manuals, and training plans and external documents, such as regulations, standards, test methods, and instrument operating manuals.

The procedure for document control should ensure that:

Official documents are created or acquired, reviewed, and approved prior to use. Documents are uniquely identified with document and revision number, date of revision, and issuing authority. A quality list with all controlled documents is maintained by QA. The list includes document and revision number, title, date of issue, date of last review, and locations. Internal documents include page numbers and total number of pages on each page. Users of the documents are adequately trained before the documents are released. Current authorized versions of documents are readily available at the user’s workspace. 8. Internal and External Audits

Quality managers manage internal audits. They verify conformance to the ISO/IEC 17025 requirements and also to company policies, processes and procedures. Internal audits are also quite useful in preparation for external audits. External auditors can come from clients or from accreditation bodies. They verify that the laboratory is operating in compliance with ISO/IEC 17025.

There should be procedures for staff responsibilities before, during, and after internal and external audits. Overall owners should be defined, and all employees who may be affected by the audit should be trained. This chapter summarizes recommendations for audits. To make best use of internal audits, they should be designed, executed, and followed up very much in the same way as expected external audits. The recommendations for audit preparation, performance, documentation, and follow-up are written for the audited departments, not for the auditors.

Internal Audit Schedule

Internal auditing should follow a predetermined schedule covering all activities over a reasonable period of time. It is inconvenient to audit all activities in a single audit, so it should be spread over several quarterly or monthly audits. The schedule for such audits is conveniently drawn as a matrix covering, for example, a year in which dates are set for each part of the quality system. Audit schedules can be organized as horizontal or vertical. A vertical audit checks compliance of, for example, a single test through all steps from sampling to archiving of records. A horizontal audit examines every aspect of a single requirement, for example, equipment. Figure 8 shows an example of a horizontal audit..

Figure 8: Example for Horizontal Audit Schedule

Audit Phases

Internal audit activities are spread over different phases which included preparation, conduct, close and follow-up. Typical steps for each phase are listed below:

Preparation Assign an overall owner and host for the audit Assign a technical contact to get access to and review the completeness of records and other documentation for items to be audited. The assigned technical contact should be present all the time. Set up a work area for the inspectors. Review the schedule. Prepare and train staff. An audit may be a tough experience for all people involved, so everyone needs to be informed about what will happen and what questions may be asked. Conduct Maintain a continuous log of the audit. Provide copies (do not give originals away). Keep duplicates of all information supplied to auditors. Take immediate corrective action, when appropriate. Hold a daily debriefing meeting to assess the progress. Keep all documents in the work area. Accompany the auditor at all times. Be courteous and cooperative. Answer only questions that are asked.  If you are unable to answer, tell the auditor openly. Protect proprietary information. Close Clarify any open questions or causes for dissatisfaction in the exit meeting Follow-up Develop a corrective action plan (owners, tasks, deliverables, and schedule). Develop a preventive action plan (owners, tasks, deliverables, and schedule). Monitor the plan

SOP and Checklists for Internal Audits

The Labcompliance ISO 17025 Accreditation Package comes with a  procedure and checklists for internal audits. They are optimized to serve as learning esperienience for external assessments.  To learn more about the package, click here

9. Dealing with Multiple Regulations and Quality Standards

Laboratories are frequently faced with situations where they have to comply with both regulations and quality standards at the same time. Examples are:

A clinical laboratory performs contract analyses from pre-clinical and clinical studies for pharmaceutical companies. The laboratory also performs special tests for hospitals. The laboratory has to operate in compliance with U.S. FDA and EU GLP and GCP regulations for clinical and pre-clinical study tests. Some customers also require laboratory accreditation according to ISO/IEC 17025, others according to ISO 15189, a standard for medical laboratories. A chemical company is certified for ISO 9001. The scope of the certification also covers the analytical service laboratory. In addition, the laboratory performs contract analyses for other companies and has received laboratory accreditation in compliance with ISO/IEC 17025. The laboratory has to work in compliance with ISO 9001 and with ISO/IEC 17025. An independent test laboratory performs GLP studies as a subcontractor for a pharmaceutical company. Occasionally, the laboratory also performs analyses for pharmaceutical manufacturing control departments. The laboratory has also received laboratory accreditation for specific food analyses according to ISO/IEC 17025. The laboratory has to comply with ISO/IEC 17025 and with GLP and cGMP regulations.

International companies frequently face this kind of problem. Their laboratories have to comply with regulations from different countries simultaneously with quality and accreditation standards. The solution to this problem is to combine all regulations and quality standards in a single quality manual and a single set of operating procedures. The recommended documents and how they relate to each other are shown in Figure 7.

The quality manual should place the company’s own quality system first and foremost.  This may be based on a well-known laboratory quality standard, such as ISO/IEC 17025. The quality manual and operating procedures should include aspects of various regulations and quality standards applied within the company. For specific requirements of single regulations, the quality manual and procedures should include sections that only apply to those particular regulations. For example, the ‘responsibility’ section would mention that for GLP studies, the function of a study director is required. The tasks and responsibilities should be described in an SOP.

 

Specific and/or Generic Procedures

Labcompliance procedures are designed to be specific for ISO 17025 when it makes sense. Others are generic enough such that they can be used for all quality system. To learn more about procedures included the ISO 17025 accreditation package, click here

 

References ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories, 2005. Labcompliance, ISO/IEC17025 Accreditation Package, 2009. http://www./books/iso17025 EURACHEM/CITAC Guide, Use of Uncertainty Information in Compliance Assessment, 2007. EURACHEM/CITAC Guide CG4, Quantifying Uncertainty in Analytical Measurement, ISBN 0-948926-15-5, 2000. EUROLAB, Measurement Uncertainty Revisited: Alternative Approaches to Uncertainty Evaluation, 2007. ILAC, Introducing the Concept of Uncertainty in Association with the Application of the Standard ISO/IEC 17025, 2002. ILAC Policy on Traceability of Measurement Results, 2002. EURACHEM/CITAC Guide, Traceability in Chemical Measurement: A Guide to Achieving Comparable Results in Chemical Measurement, 2003. EUROLAB, Guide to the Evaluation of Measurement Uncertainty for Quantitative Test Results, 2006. ISO Guide 98-3, Uncertainty of measurement -- Part 3: Guide to the Expression of Uncertainty in Measurement (GUM:1995), Geneve, Switzerland, 2008. P. Bedson and M. Sargent, The Development and Application of Guidance on Equipment Qualification of Analytical Instruments, Accreditation and Quality Assurance, 1 (6), 265-274 (1996). EUROLAB Technical Report 2/2006, Management of Computers and Software in Laboratories with Reference to ISO/IEC 17025:2005. L. Huber, Validation and Qualification in Analytical Laboratories, Interpharm, Informa Healthcare, New York, USA, 1998. Second revision 2007. M. Thompson, S. Ellison and R. Wood, International Harmonized Protocol for Proficiency Testing of Chemical Analytical Laboratories, Pure Appl. Chem., Vol. 78, No. 1, pp. 145–196, 2006, www.iupac.org/publications/pac/2006/pdf/7801x0145.pdf. American Association for Laboratory Accreditation, A2LA Policy on Measurement Traceability, 2005. ISO/IEC Guide 2, Standardization and Related Activities: General Vocabulary, 2005. X. R. Pan, Hierarchy of Reference Materials Certified for Chemical Composition, Metrologia 34 (1997) 35-39. Links to Other Websites 

To be updated on an ongoing basis

 

ISO Organization For ordering ISO Standards and Other Documents EURACHEM Has useful downloads that help to implement ISO 17025 Labcompliance Tutorial: Computer System Validation Useful information how to validate computer systems in laboratories Laboratory Compliance Package Comes with laboratory compliance master plan, 30+ SOPs and Checklists ISO 17025 Accreditation Package Frequently Asked Questions 

This chapter will be updated based on questions and contributions from visitors

 

Q: Is ISO 17025 Accreditation required and sufficient to comply with FDA Regulations, such as GLP and GMP?

Most requirements are the same or very similar, but ISO 17025 is neither required nor sufficient. However, many FDA laboratories have ISO 17025 implemented.

Rev 2: 2005

Q: When has ISO/IEC 17025 been introduced ?

Rev 1: 1999

Rev 2: 2005

Q: Is there any website where you can view or download the ISO 17025 Standard?

ISO Standards are copyright protected. I am not aware of a website with free download.

Q: Which organizations can award ISO 17025?

There are many in each country. To find them in your area, use Google Search.

Q: What to do in case there is no proficiency testing scheme for my application?

Do everything you can to proof accuracy of your analytical data. Mechanisms include: extensive use of certified reference material, verification of accuracy with an independent analysis method and cross check of results within other departments in you organization. Document the steps you took. 

Q: Is an ISO/IEC 17025 accredited laboratory also automatically ISO 9001 Certified?

ISO 17025 has a statement that testing and calibration laboratories that comply with the International Standard will also operate in accordance with ISO 9001.

On  the other hand it states that  demonstrated conformity to this International Standard does not imply conformity of the quality management system within which the laboratory operates to all the requirements of ISO 9001. This means, ISO 17025 conforms to related requirements of ISO 9001, but it does not contain all the requirements as specified in ISO 90001. So the answer to question above is 'no'.

Expert Advice on Selected Topics

This chapter will be updated on an on-going basis

 

 

Part11 Step-by-Step Labcompliance.com ISO 17025 Quality Plan plus 40 SOPs Labcompliance.com Quality by Design for Method Validation Labcompliance.com

 



Easy 9001 | the easiest way from zero to ISO 9001 certification Questions & Answers Contact About Us Home Easy Steps to ISO 9001 Our Solution ISO 9001:2015 Upgrade Why easy9001.com? How to Buy? Testimonials Easy Steps to ISO 9001 Our Solution ISO 9001:2015 Upgrade Why easy9001.com? How to Buy? Testimonials About Us Contact Questions & Answers Home Our Product: All-In-One Easy 9001 Toolkit™

Price: US$ 995

Download and start using now

The All-In-One Easy 9001 Toolkit ™ is an award-winning ISO 9001 package that enables beginners to easily implement ISO 9001:2015 in-house and quickly achieve ISO 9001 certification. It only takes 5 Easy Steps with this comprehensive ISO 9001 solution that's complete with everything you need.

“All-In-One” - Comprehensive Solution

The search is over: we give you the tools you need for ISO 9001! The All-In-One Easy 9001 Toolkit ™ is a complete and integrated ISO 9001 package that includes:

easy-to-customize, pre-written templates for the entire ISO 9001 documentation with step-by-step customization instructions,

ISO 9001 quality manual with step-by-step customization instructions,

a complete set of ISO 9001 forms and checklists with customization instructions,

training materials and PowerPoint presentation,

all internal audit materials,

insider secrets for a successful certification audit,

a marketing strategy to convert your new ISO 9001 certification into higher revenue,

all implementation tools, and

a project guide that makes the use of the All-In-One Easy 9001 Toolkit ™ clear and easy.

You don't need to buy anything else!

“Easy”

Every single component of the All-In-One Easy 9001 Toolkit ™ is designed for ease of use so that you don't need any prior ISO 9001 knowledge to implement an ISO 9001 quality management system by yourself in-house. The detailed guides and instructions are easy to understand, easy to use and free of unnecessary steps and requirements; the documentation templates are straight-forward, pre-written and only need to be customized following the included customization instructions; the forms and checklists not only make it easy to set up your ISO 9001 quality management system but also to meet all ISO 9001:2015 requirements. In addition, our All-In-One Easy 9001 Toolkit ™ contains all you need to implement your ISO 9001 quality management system so you won't spend time and efforts finding the necessary tools.

You won't be alone with your ISO 9001 project : the All-In-One Easy 9001 Toolkit ™ comes with unlimited free access to our senior ISO 9001 experts to help you. With our All-In-One Easy 9001 Toolkit ™ even beginners can implement ISO 9001.

You'll Benefit

The All-In-One Easy 9001 Toolkit ™ will benefit you and your entire company:

Quality Managers : You'll easily get your ISO 9001 project done!

Marketing : You'll quickly be able to increase sales using the powerful ISO 9001 certificate!

Owners : Your company will save significant costs while achieving competitive advantage quickly!

Why not start ISO 9001 today so that you can reap the benefits sooner rather than later?

What is included?

All of the 26 components and over 65 individual tools below are included in the All-In-One Easy 9001 Toolkit ™ to achieve ISO 9001 certification in only 5 easy steps.

Step 1: Getting Started

1.

Easy 9001 Implementation Guidebook “Your Step-By-Step Guide from Zero to Certification”

2.

Executive Summary of ISO 9001 and its Benefits

3.

Position Description for the ISO 9001 Management Representative

4.

Training Plan for the ISO 9001 Management Representative

5.

Employee Memo on ISO 9001

6.

ISO 9001:2015 Compliance and Gap Analysis

7.

Registrar Interview Checklist

Step 2: ISO 9001 Documentation Development

8.

ISO 9001 Quality Policy (Template & Instructions)

9.

Process Flowchart (Template & Instructions)

10.

Scope Statement (Template & Instructions)

11.

ISO 9001 Quality Manual

12.

Customization Instructions - ISO 9001 Quality Manual

13.

ISO 9001 Procedures Manual

14.

Customization Instructions - ISO 9001 Procedures Manual

Step 3: ISO 9001 Implementation & Training

15.

Work Instructions

16.

Set of 32 ISO 9001 Forms & Checklists

17.

Customization Instructions - ISO 9001 Forms & Checklists

18.

Set of 10 Employee Newsletters

19.

PowerPoint Presentation “ISO 9001 for Everybody”

Step 4: Internal ISO 9001 Audits

20.

Internal Auditor Position Description

21.

Instructions for Internal ISO 9001 Audits

22.

Checklist for Internal ISO 9001 Audits

23.

Audit Report Form

Step 5: ISO 9001 Certification

24.

Insider Secrets for a Successful ISO 9001 Certification Audit

25.

Powerful Marketing of your ISO 9001 Certification

Getting Help & Support

26.

24/7 Expert Customer Support

Product Description

The All-In-One Easy 9001 Toolkit ™ is a complete and integrated ISO 9001 package that includes everything you need. The following is a detailed description each of the 26 included components:

1. Easy 9001 Implementation Guidebook - Your Step-By-Step Guide from Zero to Certification

The “Easy 9001 Implementation Guidebook” is your step-by-step guide for the entire ISO 9001 implementation project, starting from the very beginning until you reach ISO 9001 certification. This guide keeps the ISO implementation process simple: it focuses on getting things done to quickly reach your goal of ISO certification without unnecessary paperwork, layers of “task teams” and other hurdles. The guidebook is very easy to follow, and there is no prior knowledge of ISO 9001 required. The following chapters are included:

Getting Started

Planning the ISO 9001 Project

Training

ISO 9001 Documentation Development

ISO 9001 Implementation and Training

Writing Work Instructions

Internal ISO 9001 Audits

ISO 9001 Certification

Marketing

Maintaining ISO 9001 Certification

49 Pages – PDF File (use the free Acrobat Reader to view)

2. Executive Summary of ISO 9001 and its Benefits

The “Executive Summary of ISO 9001 and its Benefits” is a concise introduction to ISO 9001 that gives executive management the necessary understanding of ISO 9001 and its benefits to the company. The summary focuses on what executive management need to know without wasting valuable time. The following topics are covered:

The Foundation of ISO 9001

ISO 9001 Summary

ISO 9001 Facts

ISO 9001 Benefits

Management Involvement

15 Pages – MS Word Document

3. Position Description for the ISO 9001 Management Representative

The “Position Description for the ISO 9001 Management Representative” includes a comprehensive description of job requirements, work environment and qualifications of your company's ISO 9001 Management Representative (that's how the the person in charge of ISO 9001 has traditionally been called). The purpose of this document is to provide you with an overview of the requirements of the ISO 9001 Management Rep position, potentially advertise the position, select the ideal candidate, and document the position requirements for this crucial ISO 9001 position.

2 Pages – MS Word Document

4. Training Plan for the ISO 9001 Management Representative

The proper planning for training is a crucial ISO 9001 requirement, and this training plan makes it easy to meet the requirements. The “Training Plan for the ISO 9001 Management Representative” ensures that the important training for the ISO 9001 Management Rep is properly planned, conducted and documented (ISO 9001 auditors routinely ask about this document).

1 Page – MS Word Document

5. Employee Memo on ISO 9001

Use this memo to introduce your employees to the upcoming ISO 9001 implementation at your company. This memo will give your employees a basic understanding of ISO 9001, tell them what is expected of them, and – most importantly – alleviate your employees of any fear regarding ISO 9001 they may have. In short, the “Employee Memo on ISO 9001” will make the ISO 9001 implementation smoother for you. In addition, you may use this memo to demonstrate to your ISO 9001 auditor that you provided basic ISO 9001 training to your employees.

1 Page – MS Word Document

6. ISO 9001:2015 Compliance and Gap Analysis

This comprehensive checklist is used to determine the level of ISO 9001 compliance at your company prior to the start of the ISO 9001 implementation. The purpose of this gap analysis is to identify the functional areas in your company that require attention in order to become ISO 9001 compliant. Another use of the “ISO 9001:2015 Compliance and Gap Analysis” is to demonstrate to your company's management where ISO 9001 will lead to tangible improvements. The “ISO 9001:2015 Compliance and Gap Analysis” evaluates your company against 285 criteria.

57 Pages – MS Word Document

7. Registrar Interview Checklist

This checklist is an invaluable tool to help you choose the ideal ISO 9001 registrar (the organization that issues your ISO 9001 certificate) for your company's individual circumstances. The “Registrar Interview Checklist” contains 24 important selection criteria that will have a significant impact on the success and on the cost of your ISO 9001 certification.

2 Pages – MS Word Document

[back to top]

8. ISO 9001 Quality Policy (Template & Instructions)

The ISO 9001 quality policy is the most top level document of all the ISO 9001 required documents; it sets the corporate policy on quality for the company. The ISO 9001 standard includes specific requirements for the quality policy. To make it easy for you to establish your company's quality policy in accordance with all ISO 9001 requirements, we are providing you with a prewritten template that you can easily modify to fit your company's circumstances. Detailed customization instructions are included.

4 Pages – MS Word Document

9. Process Flowchart (Template & Instructions)

The “Process Flowchart” is designed to describe the key processes and the overall process flows of most companies. The result: an easy way to meet the ISO 9001:2015 requirements for “a description of corporate processes and their interaction” as you may not even need to customize our “Process Flowchart”. If however, you chose to customize it, simply follow the included step-by-step instructions.

2 Pages – MS Word Document

10. Scope Statement (Template & Instructions)

The “Scope Statement” describes the scope, boundaries and exclusions of your ISO 9001 quality management system according to several specific ISO 9001:2015 requirements. This template applies all pertinent requirements; detailed, word-by-word customization instructions are included.

4 Pages – MS Word Document

11. ISO 9001 Quality Manual

The “ISO 9001 Quality Manual” summarizes your company's ISO 9001 quality management system and contains the overall requirements. With the newest revision of the ISO 9001 standard (ISO 9001:2015), the ISO 9001 Quality Manual is no longer an explicitly required document (though some auditors argue that one only gained the flexibility to call it by another name). We include the ISO 9001 Quality Manual in this toolkit because it can be a very useful marketing tool, and customizing it is extremely easy and fast.

28 Pages – MS Word Document

12. Customization Instructions - ISO 9001 Quality Manual

The “Customization Instructions - ISO 9001 Quality Manual” make it very easy and fast to adapt the ISO 9001 Quality Manual to your company's circumstances - just follow the instructions step-by-step and you might be done in less than one hour!

11 Pages – PDF File (use the free Acrobat Reader to view)

13. ISO 9001 Procedures Manual

The “ISO 9001 Procedures Manual” is the very core of your ISO 9001 documentation. It contains all the procedures required for your ISO 9001 quality management system. The structure and numbering system reflects that of ISO 9001:2015 (and Annex A) in general though a few requirements have been combined and a few divided up for the sake of simplicity and easy usage. This complete manual contains 44 procedures - addressing each ISO 9001:2015 clause - including a procedure that makes it easy to establish your company's quality objectives. All procedures have been designed from scratch to be true templates that - together with detailed customization instructions - allow you to create your own, individual ISO 9001 documentation, error-free and fully ISO 9001:2015 compliant. The two key features are:

Easy Implementation of ISO 9001: This pre-written template has been developed for easy ISO 9001 setup. The customization is very easy and fast if you follow the included detailed, step-by-step customization instructions.

Easy Compliance with ISO 9001: Your ISO 9001 documentation, which you will create using this template, will make it easy for your company to actually follow the requirements of ISO 9001 without unnecessary bureaucracy and paperwork.

195 Pages – MS Word Document

14. Customization Instructions - ISO 9001 Procedures Manual

The “Customization Instructions - ISO 9001 Procedures Manual” are easy-to-understand and easy-to-follow, step-by-step instructions on how to edit the procedures templates to make them fit your company. Customization instructions have a major impact on the ease of customization and the quality of the final, customized documentation. We placed particular emphasis on the quality of our customization instructions to ensure that you will be able to develop excellent and individualized ISO 9001 documentation in the shortest amount of time.

75 Pages – PDF File (use the free Acrobat Reader to view)

[back to top]

15. Work Instructions

Work instructions are the detailed, step-by-step instructions that are specific to your company's individual work processes. Our All-In-One Easy 9001 Toolkit ™ includes an easy to fill-in work instructions template, plus sample work instructions for the planning of new projects, products and services. Work instructions are typically written by the people performing the work; these two tools are designed to make it easy for them.

5 Pages – MS Word Document

16. Set of 32 ISO 9001 Forms & Checklists

Our “Set of 32 ISO 9001 Forms & Checklists” make the ISO 9001 implementation and the compliance with ISO 9001:2015 requirements so much easier as each form or checklist allows you to meet one, two or several ISO 9001 requirements in one easy step. These forms and checklists compliment the ISO 9001 Procedures Manual and make it easy to meet its requirements. All forms and checklists are professionally designed for ease of use: they are self-explanatory and they “walk” the user through an entire process (for example, the corrective action process). Due to this special feature, our forms replace many work instructions. All forms are ready for use either as paper form or electronic form. Though our ISO 9001 forms and checklists can be customized if needed, all that's really necessary is to enter your company name and logo.

Form 1: Archive Label The “Archive Label” is used to identify file storage boxes and to easily meet the ISO 9001 requirements for record retention and record destruction. You will find this easy-to-use label to be a real time-saver. Designed to meet ISO 9001:2015, clause 7.5.3 requirements.

1 Page – MS Word Document

Form 2: Calibration Form The “Calibration Form” is an important part of any calibration program. It includes calibration instructions and calibration records. The form can be easily used for a wide range of devices that require calibration. Designed to meet ISO 9001:2015, clause 7.1.3 and 7.1.5 requirements.

1 Page – MS Word Document

Form 3: Corporate Environment Form The “Corporate Environment Form” is an important strategic planning tool that is used to define the internal and external environment in which the company operates. This form addresses several ISO 9001:2015 requirements related to the 'context of the organization' (ISO 9001:2015, clause 4.1 and 4.2).

3 Pages – MS Word Document

Form 4: Corrective and Preventive Action Plan Our “Corrective and Preventive Action Plan” form (short, “CAP”) walks the user through the entire corrective action process (or the entire preventive action process) – it is not necessary to refer to separate instructions. The corrective action process is a key ISO 9001 requirement; using our self-explanatory form makes meeting requirements of ISO 9001:2015, clauses 4.4, 6.1, 6.3, 8.5.6, 9.1.1, 10.1, 10.2 and 10.3 particularly easy.

1 Page – MS Word Document

Form 5: Customer Complaint Resolution Resolving a customer complaint in a professional way can turn a disgruntled customer into a satisfied and loyal customer. Our “Customer Complaint Resolution” form ensures that no opportunity is missed to properly resolve every customer complaint. The form includes brief work instructions to ensure that all aspects of this important ISO 9001 requirement (ISO 9001:2015, clause 9.1.2) are met.

1 Page – MS Word Document

Form 6: Customer Survey Finding out what your customers really think of your business is not only crucial if you want to stay ahead of your competition but it is also a central ISO 9001 requirement. Use our innovative “Customer Survey” form as a template for your company-specific survey that allows you to gain valuable customer feedback without taking much of your customers' time. Designed to meet the requirements of ISO 9001:2015, clause 9.1.2.

1 Page – MS Word Document

Form 7: Employee Evaluation The “Employee Evaluation” form is used for the periodic employee performance evaluation – but it is more than just a regular employee review: we included several sections to cover a spectrum of ISO 9001 requirements in one easy step. Our innovative “Employee Evaluation” form saves you much time and efforts during the ISO 9001 implementation and while meeting ISO 9001:2015, clause 7.2 and 7.3 requirements.

4 Pages – MS Word Document

Form 8: Employment Checklist Hiring a new employee usually requires various documents, related to government regulations, company policy etc. Use the “Employment Checklist” to make the employment process easy for the hiring manager, to ensure that consistently all required documents are in place for each new employee, and to meet ISO 9001:2015, clause 7.1.2, 7.2 and 7.3 requirements.

1 Page – MS Word Document

Form 9: Employment Termination Checklist Many companies are increasingly afraid of firing employees due to the risk of lawsuits. Our “Employment Termination Checklist” is designed to minimize this risk as it includes a 15-point checklist that requires the firing manager to meet important requirements before terminating an employee. In addition, our “Employment Termination Checklist” includes a checklist used after an employee is terminated. Designed to meet requirements of ISO 9001:2015, clause 7.1.2, 7.2 and 7.3.

2 Pages – MS Word Document

Form 10: Engineering Change Request The “Engineering Change Request” (ECR) form is used to have engineering evaluate a concern or improvement suggestion. The “Engineering Change Request” form is comprehensive yet easy-to-use; it includes a section to describe the requested changes (including sketches), a section on effects on products and assemblies, a section for the evaluation and follow-up action. Using this form will save you time and prevent mistakes.

3 Pages – MS Word Document

Form 11: Interested Parties Worksheet The “Interested Parties Worksheet” is used to gather required information for the definition of the corporate environment during strategic planning. This user-friendly worksheet includes instructions for an easy way to meet the requirements of ISO 9001:2015, clause 4.2.

3 Pages – MS Word Document

Form 12: ISO 9001 Management Review Form The “ISO 9001 Management Review Form” is a particularly valuable form: it is used to keep a record of the ISO 9001 required Management Review Meetings, it includes the agenda points of the ISO 9001 Management Review Meetings, and it includes action plans that allow for easy follow-up. Using our “ISO 9001 Management Review Form” will allow you to meet several ISO 9001 requirements (ISO 9001:2015, clauses 9.1.3, 9.3.1, 9.3.2, 9.3.3, and 10.1); in addition, you will be able to avoid a typical ISO 9001 audit non-compliance.

3 Pages – MS Word Document

Form 13: Job Description Our comprehensive “Job Description” form allows you to easily meet various ISO 9001 requirements in one easy step. The form includes instructions that help filling out the form. Designed to meet ISO 9001:2015, clauses 5.3, 7.2 and 7.3 requirements.

2 Pages – MS Word Document

Form 14: Maintenance Form The “Maintenance Form” is an easy way to establish any kind of maintenance program (for example, equipment maintenance, maintaining work environment etc.). The form combines maintenance plan and maintenance records; instructions are included. This efficient form is designed to meet ISO 9001:2015, clauses 7.1.3 and 7.1.4 requirements.

2 Pages – MS Word Document

Form 15: Meeting Notes Template The “Meeting Notes Template” is designed to help you gain more benefits from any meetings. Use this simple form to not only keep meeting minutes but to end your meeting with a specific action plan.

2 Pages – MS Word Document

Form 16: New Employee Training Plan New employees typically require company-specific training and introduction to the company. The “New Employee Training Plan” is designed to consistently provide the needed training to new employees and keep a record of the training.