ISO 9001 Quality Management Systems: Implementation and Integration

Sample ISO 9001 Quality Management Systems

Implementation and Integration

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ISO 9001 Quality Management Systems: Implementation and Integration

© STP

ISO 9001 Quality Management Systems: Implementation and Integration

A guide to assist organizations in successfully implementing, integrating and maintaining an effective ISO 9001 program

© STP

Users of This Guide Include

• Manufacturers • Service organizations • Companies whose supply

chains require certification • Hotels and resorts • Construction and

engineering firms • Software developers • QMS auditors • And many more…

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Features of This Guide

• Authored by an experienced auditor and expert in EHS and quality management systems • Presents the author’s unique

“Identify-Insure-Improve” approach • Summarizes the clauses and

requirements of ISO 9001 • Describes the steps to

develop and implement an initial internal audit

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Features of This Guide

• Explains how to review and improve processes, and implement corrective and preventive action • Presents sample documents,

forms and a manual adaptable to users’ own systems • Includes checklists and

recommended tasks • Explains how to integrate

ISO 9001, ISO 14001 and OHSAS 18001 programs

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Comprehensive Topic Areas

• Overview of the ISO 9001 Standard • Three-step Identify-Insure-

Improve process model for implementing a QMS • Recommended methods for

auditing a process system • Preventive and corrective

action • Managing for continual

improvement

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Comprehensive Topic Areas

• Registration and self-declaration of compliance • Automotive industry (TS

16949) • Medical device

manufactures (ISO 13485) • Project managers (ISO 1006) • Unifying ISO 9001 and

environmental and health and safety management systems

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Features – Explanatory Text

Summarizes the clauses and requirements in easy-to-understand terms

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Sample Explanatory Text

Chapter 6

Four Basic Questions to Ask About Every Process

When an organization audits its Quality Management System, the ISO 9000 Fundamentals and Vocabulary states that there are four basic questions that should be asked related to every process being evaluated by an organization:

1. Did the organization identify and define the process? (4.1)

2. Did the organization define and assign responsibilities for the process?

3. Have procedures been implemented and maintained?

4. Is the identified process effective in accomplishing and attaining the results required?

In addition, the following questions would be excellent for internal auditors to review when auditing their system.

• What are the inputs to this process? Are there supporting documents, procedures, and work instructions for it? What are the related customer requirements?

• What are the identified risks and legal requirements of this process?

• What objectives have been set for this process?

• Is there evidence that the process is being carried out as planned? 4.1

• Are personnel aware of the policy statement and its meaning to their job? 5.3

• Are adequate resources and infrastructure provided for the process? 6.1, 6.3 Any outsourcing of services, equipment? 4.1

• Are competency requirements defined for the process? 5.5.1, 6.2.2

• Are actions taken for continual improvement? 4.1f, 8.5.1 of process

See also Figure 6-3: Pilot’s 3 I’s Method for Process Audits in this chapter.

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Features – Checklists

Follow the Identify-Insure-Improve approach for implementing and maintaining a QMS to ISO 9001 requirements

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Sample Checklist

Checklist 5A

ISO9 4/09 ©STP Checklist 5A-3

7. Measurement, Analysis and Improvement (8)

7.a Monitoring and Measurement (8.2)

7.a.1. Customer Satisfaction (8.2.1)

7.a.2. Processes (8.2.3)

7.a.3. Product (8.2.4)

7.b Control of Nonconforming Product (8.3)

7.c. Analysis of Data (8.4; 8.2.1;7.2.1)

Areas to Monitor (Some Examples) Customer Satisfaction

Business Operations

Financial Control

Legislation—Compliance

Purchasing—Raw Materials Acquisition—Subcontractor Control

Best Available Technology

Industry Trends

Operational Control—Customer Complaints, Procedures—Manuals—Policies, Forms,

Analysis—Data

Personnel—Supplier Performance

Internal/Subcontractor—Identified, Competent, Trained, Performance

Quality—Objectives and Targets

Continual Improvement

Processes

Quality

Statistical Techniques

Design

Nonconformances

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Features – Recommended Tasks

Break down the requirements of ISO 9001 clauses into a series of practical steps

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Sample Recommended Task

5-80 ISO9 4/09 ©STP

Task 6 B cont’d. Purchasing (7.4) Information (7.4.2) • Purchasing information shall describe the product to be

purchased. • Insure adequacy of specified purchasing requirements

prior to communication with supplier. • Describe the product to be purchased and where

appropriate include requirements for: — approval of product, procedures, processes and

equipment, qualification of personnel, and quality management system.

7.4.2 Purchasing Information Your organization will insure that the purchasing information shall include the requirements for generating and issuing approval of products whether manually, non-automated, or automated. When an organization receives a request for a purchase order for purchasing a product or service, they will determine an appropriate supplier to fulfill the order and complete the necessary paperwork. All orders are reviewed to insure that the information describing the product or service to be ordered is completed, including requirements for the approval of the product, procedures, processes, equipment, and personnel and for QMS requirements.

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Features – Model Forms

Provide examples of procedures, documents and forms that demonstrate compliance

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Sample Model Form

Chapter 5

5-30f ISO9 11/12 ©STP

Figure 5-4 Record Control Log

Record Name (Alphabetical order)

Document Control #

Person Responsible Retention Record

Format Location Access Given To

Calibration records - lathing equipment #101

CR-101-xx Production or Quality Control

manager

5 years Hard copy

Production department

Production staff and quality

Corrective action reports for internal audit (year)

CCR-IAR-(year)-xx

Management representative

7 years Electronic Quality department All managers

Customer complaint reports (year)

CCR-(year)-xx

Customer service manager

7 years Electronic Customer files - Customer service

Quality staff auditors and all managers

Internal audit report (year)

IAR-(year) Management representative

7 years Electronic Quality department Quality staff, auditors and all managers

ISO 9001 orientation training checklist

Orient-train


Duration of employment + 1 year

Hard copy

Personnel file - human resources

All managers

Management system review minutes (year)

Mgmtrev-(year)


5 year Electronic Quality department Executive managers

Operation’s training matrix

Ops-train Department manager

Duration of employment + 1 year

Electronic Personnel file - human resources or

department managers

All managers

Supplier corrective action reports (year)

SCAR-(year)-xx

Purchasing manager

7 years Hard copy

Supplier files - purchasing

Purchasing staff

Note: All hard copy records are disposed of by shredding and electronic records are disposed of via deletion.

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Features – Model QMS Manual

Offers an example of a complete QMS manual containing all components required by ISO 9001

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Sample Model QMS Manual

ISO9 12/08 ©STP Intro-1

Introduction to ISO 9001:2008

Organizations today are exposed globally with regards to their business management systems for quality. Successful businesses focus on managing risks and building improved quality operating systems for business sustainability and to satisfy customer requirements. By managing, controlling and improving their management system(s), they operate more effectively and efficiently, improving “Performance, Productivity and Profits”© — Pilot’s Three P’s.

International standards have become an important framework for conducting and improving one’s business. An ISO 9001 quality management system is the base of any business, whether large or small.

Through its many associations, the business community has come forward to support these standards in over 170 countries. Over the years, government regulatory reform initiatives and industry responses to customer concerns and social issues have driven the standards to improve quality on a global front, to criteria that is accepted around the world.

This book is a resource for those who need to understand and/or implement a quality management system conforming to the International Standard – ISO 9001, which is based on customer satisfaction, leadership, a process approach and involvement of competent people.

Since 2002, this book has been used by Fortune 500 companies, government departments, small- and medium-sized industries in North America, utilizing Pilot’s simple Three Step process approach.

The “Three Step” process approach, (Identify, Insure, Improve), as well as tools, such as control plans, checklists, gap analysis and a sample manual are outlined to guide you in implementing your management system and integrating it with other management systems such as environmental, and health and safety management systems. (See Chapter 7 for more details on system integration.)

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Formats

• Online single-user • Online multi-user • Loose-leaf • CD • Loose-leaf & CD

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Up to 4 updates per year

Sample Release Notes

ISO 9001QualIty ManageMent SySteMS IMpleMentatIOn and IntegratIOn

Release # 134 NovembeR 2012

new and nOtewOrthy

• Has Your Organization Conducted a Survey on the Costs Associated with Document Management?

This update outlines some of the costs and reference tools associated with document management. Document management is an important function which helps to provide consistent information (internal and external communications), to conform to customer requirements and to improve the quality of your service or product. The costs associated with document management include time spent developing the document (research, drafting, approving, maintaining and updating content), as well as filing and retrieving documents, and disposing of the outdated printed copies. Each organization determines the extent of its documentation and the best format for producing and managing it. For details of ISO 9001’s document management requirements, see Chapter 5, Step Two: Insure.

hIghlIghtS Of thIS releaSe

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The following pages are a longer sample from ISO 9001 Quality Management Systems: Implementation and Integration


ISO9 12/08 ©STP 2-1

2

ISO 9001 Requirements

Eight Principles of Quality Management The Quality Management System for ISO 9001 is based on the Eight Management Principles outlined in this chapter. These are referenced from ISO 9000:2005, Quality Management Systems Fundamentals and Vocabulary,1 which outlines the fundamentals of quality management. Each principle is followed by an explanation of how adhering to the principles can provide value to your organization.

Top management can use these principles as a framework to guide them in improving performance and achieving organizational excellence. These principles are derived from the ISO technical committee responsible for developing and maintaining the ISO 9000 Standards—ISO/TC176, quality management and quality assurance.2

Space is provided after each principle for you to note how your own organization’s principles follow the ISO Standard.

1 “International Standard ISO 9000, Third edition September 2005, Quality Management

Systems—Fundamentals and Vocabulary,” International Organization for Standardization, Geneva.

2 See www.iso.org/iso/iso_technical_committee?commid=53882.

http://www.iso.org/iso/iso_technical_committee?commid=53882

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2-2 ISO9 12/08 ©STP

Principle 1—Customer Focus

“Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.”

Key benefits:

• identifies and understand customer’s needs,

• insures that customer’s needs and expectations are met,

• increases the effectiveness of your organization’s resources,

• improves operational management to meet customer needs,

• insures personnel have knowledge and skills to satisfy customer requirements, and

• improves customer loyalty for repeat business and increases revenue and market share.

Communication of customers’ needs throughout the organization, together with the monitoring and measurement of their requirements will insure a balanced approach to meeting customer expectations for products, delivery, price, and dependability,

Once customers’ needs and expectations are identified, objectives should be set that are in tune with those needs. These objectives need to be communicated throughout your organization and evaluated to insure that they are met. Meeting your objectives will insure that relevant goals and targets are linked to customer needs and expectations, providing customer satisfaction and continually improving your customer focus.

Notes: ______________________________________________________ ______________________________________________________

______________________________________________________

______________________________________________________

______________________________________________________


ISO9 4/02 ©STP 2-3

Principle 2—Leadership “Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.”

Key benefits: By considering the needs of interested parties including customers, employees, suppliers, shareholders and local communities, your organization establishes and communicates a clear vision, a quality policy, objectives and targets, with a strategy to attain them. Leadership will provide shared values, translate the vision into measurable goals and targets, and provide ethical role models at all levels of the organization, building trust and open communication. Top management will provide resources for human development and training, and provide employees with the freedom to act with defined responsibility and accountability. Interested parties will be recognized for their contributions, building and encouraging quality and continual improvement.

Notes: ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________

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2-4 ISO9 4/02 ©STP

Principle 3—Involvement of People

“People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.”

Key benefits: When personnel within your organization are em-powered, they are more willing to accept ownership of problems and will strive to find methods to resolve them. Given the responsibility, they will seek opportunities to enhance and share their competence, knowledge and experience, becoming a motivated, committed and involved group, accountable for their own performance. They will openly discuss problems and issues for resolution.

They are eager to participate in and contribute to furthering the organization’s objectives and continual improvement of customer’s satisfaction. The successful involvement of people will depend on the leadership of the organization.

Notes: ______________________________________________________ ______________________________________________________

______________________________________________________

______________________________________________________

______________________________________________________


ISO9 2/10 ©STP 2-5

Principle 4—Process Approach “A desired result is achieved more efficiently when activities and related resources are managed as a process.”

Key benefits: Systematically identifying the key activities within the functions of your organization, establishing the inputs and outputs of each process and focusing on the resources and methods required to achieve the desired results of the process, will assist in effective use of resources, lowering costs and shortening cycle times. The management of resources including personnel, materials, equipment, monitoring and control equipment, information, and infrastructure will provide improved, consistent and predictable outcomes. Notes: ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________

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2-6 ISO9 2/10 ©STP

Principle 5—System Approach to Management “Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.”

Key benefits: A system approach focuses on your processes to achieve defined objectives in the most effective and efficient way. A system approach proves to others that you have consistency. Organizations benefit as your employees have a better understanding of their roles and responsibilities necessary to achieve these objectives. With a system approach you identify your requirements and plan your actions, understanding your organizational capabilities. You understand what the capabilities and resource constraints are, prior to action, and define what activities are needed within the system to operate. You insure monitoring and measurement for continual improvement, providing confidence to customers and interested parties as to the consistency and effectiveness of your organization and its processes.

Notes: ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________


ISO9 4/02 ©STP 2-7

Principle 6—Continual Improvement “Continual improvement of the organization’s overall performance should be a permanent objective of the organization.”

Key benefits: By insuring that continual improvement is a consistent organization-wide approach, your organization will insure per-formance, and provide a vehicle for seizing opportunities. Continual improvement is an objective of strategic and business planning, for all employees to improve their organization’s products, processes and quality management system. Organizations can insure this principle, by setting realistic and challenging improvement goals, providing training on techniques for continual improvement of products, processes and systems. It is a good idea to establish and measure goals to track performance, encouraging and rewarding those individuals contributing to improvements within the organization. Notes: ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________

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2-8 ISO9 4/02 ©STP

Principle 7—Factual Approach to Decision Making “Effective decisions are based on the analysis of data and information.”

Key benefits: A factual approach to decision making gives you an increased ability to review, challenge or agree with information, enabling you to make the best decision possible at the time. There are two reasons for the mistakes we make in life: inexperience and lack of information. Effective decisions are based on insuring that data and information are sufficient, that they are accurate and reliable, and are provided easily to those who require it. Personnel can make informed decisions, and have the resources to assist in providing the correct evidence to support objectives and criteria needed to meet requirements, whether they are to customer, organizational or International Standard requirements. Notes: ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________


ISO9 12/08 ©STP 2-9

Principle 8—Mutually Beneficial Supplier Relationship: “An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.”

Key benefits: Creating relationships with your suppliers forms a partnership approach, where expertise and resources are pooled together to create value for both parties. This partnership provides your organization with optimization of both costs and resources. Your organization needs to identify and select who these suppliers will be. It is important to be selective when identifying these key suppliers and insure that they will assist your organization to meet your customer’s needs and expectations. Your relationship needs to be a partnership with open and clear communication. Information should be shared and changes made to improve activities in order to meet your end results. It is important to encourage and recognize achievements and improvements that support your quality management system. Notes: ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________

Chapter 2

2-10 ISO9 12/08 ©STP

Terminology

Key Words: Process, Product, Quality Table 2-1 outlines three key words: “process, product, and quality.” For a complete explanation of the terminology, purchase the ISO 9000:2005, Quality Management Systems Fundamentals and Vocabulary from your local standards body.


ISO9 12/08 ©STP 2-11

Table 2-1 Terminology: Process, Product, Quality1

Terms What are your Organization’s processes, products? These will be outlined in your QMS Manual.

Process 3.4.1 “set of interrelated or interrelating activities which transforms inputs into outputs Note 1: Inputs to a process are generally outputs of other processes. Note 2: Processes in an organization (3.3.1) are generally planned and carried out under controlled conditions to add value. Note 3: A process where the conformity (3.6.1) of the resulting product (3.4.2) cannot be readily or economically verified is frequently referred to as a “special process.”

Do you have a process map(s) for your organization’s operations? - Macro and Micro List document name(s) here.

Product - 3.4.2 “result of a process (3.4.1). Note 1: There are four generic product categories, as follows: – Services (e.g., transport); - Software (e.g., computer program, dictionary); - Hardware (e.g., engine mechanical part); - Processed materials (e.g., lubricant). Most products comprise elements belonging to different generic product categories. Whether the product is then called service, software hardware or processed material depends on the dominant element. For example, the product “automobile” consists of hardware (e.g., tires), processed materials (e.g., cooling liquid), software (e.g., engine control software, driver’s manual), and service (e.g., operating explanations given by the sales agent).”

What product(s) does your organization provide to customers?

1 “International Standard ISO 9000, Third edition 2005, Quality Management Systems—

Fundamentals and Vocabulary,” International Organization for Standardization, Geneva.


ISO9 12/08 ©STP 2-12

Note 2: Service is the result of at least one activity necessarily performed at the interface between the supplier (3.3.6) and customer (3.3.5) and is generally intangible. Provision of a service can involve, for example, the following: – an activity performed on a customer-supplied tangible product (e.g., automobile to be repaired); – an activity performed on a customer-supplied intangible product (e.g., the income statement needed to prepare a tax return); – the delivery of an intangible product (e.g., the delivery of information in the context of knowledge transmission); – the creation of ambience for the customer (e.g., in hotels and restaurants). Software consists of information and is generally intangible. It can be in the form of approaches, transactions or procedures (3.4.5). Hardware is generally tangible and is a countable characteristic (3.5.1). Processed materials are generally tangible and their amount is a continuous characteristic. Hardware and processed materials often are referred to as goods. Note 3: Quality assurance (3.2.11) is mainly focused on intended product.”

Quality-3.1.1 “degree of a set inherent characteristics (3.5.1) fulfils requirements (3.1.2). Note 1: The term “quality” can be used with adjectives such as poor, good or excellent.

How do you determine quality control within your organization? Do you outline these on your quality control plan, outlining the characteristics and requirements?


ISO9 12/08 ©STP 2-13

Note 2: “Inherent”, as opposed to “assigned”, means existing in something, especially as a permanent characteristic.” 3.5.1 Characteristic- “distinguishing feature. Note 1: A characteristic can be inherent or assigned. Note 2: A characteristic can be qualitative or quantitative. Note 3: There are various classes of characteristic, such as the following: - Physical (e.g., mechanical, electrical, chemical or biological characteristics); - Sensory (e.g., related to smell, touch, taste, sight, hearing); - Behavioral (e.g., courtesy, honesty, veracity); - Temporal (e.g., punctuality, reliability, availability); - Ergonomic (e.g., physiological characteristic, or related to human safety); Functional, e.g., maximum speed of an aircraft.” 3.1.2 Requirement- “need or expectation that is stated, generally implied or obligatory. Note 1: “Generally implied” means that it is custom or common practice for the organization (3.3.1), its customers (3.3.5) and other interested parties (3.3.7), that the need or expectation under consideration is implied. Note 2: A qualifier may be used to denote a specific type of requirement, e.g., product requirement, quality system requirement, customer requirement.

Note 3: A specified requirement is one which is stated, for example, in a document (3.7.2). Note 4: Requirements may be generated by different interested parties.”

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2-14 ISO9 12/08 ©STP

ISO 9001:2008 Requirements The ISO 9001 standard focuses on the development of an effective, efficient Quality Management System structure, and its continual improvement, so that it meets customer, statutory and regulatory requirements. The new standard added a note under Scope that “statutory and regulatory requirements may be expressed as legal requirements.” This has assisted in making the ISO 9001 more compatible with the ISO 14001 standard for environmental management systems, an important feature for those organizations working to integrate the two systems. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome is referred to as the “process approach.” The emphasis is on providing products or services using this process approach to insure customer satisfaction and meeting not only the customer requirements but legal requirements as well. The following is an overview of the ISO 9001 element clauses. The description of each element begins at Clause 4, as the first three clauses pertain to Scope, Application, Normative References, and Terms and Definitions. The only exclusion you may have would be to element/clause 7 under Product Realization. You may not perform any functions related to do 7.3—Design and Development. This exclusion needs to be outlined in your quality manual. The exclusion can not affect the organization’s ability or responsibility to meet customer requirements or statutory and regulatory requirements.

ISO 9001 Elements or Clauses 1 Scope

1.1 General 1.2 Application

2 Normative Reference 3 Terms and Definitions


ISO9 2/10 ©STP 2-15

4 Quality Management Systems 4.1 General Requirements 4.2 Documentation Requirements

4.2.1 General 4.2.2 Quality Manual 4.2.3 Control of Documents 4.2.4 Control of Records

5 Management Responsibility 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning

5.4.1 Quality Objectives 5.4.2 Quality Management System Planning

5.5 Responsibility, Authority and communication 5.5. 1 Responsibility and Authority 5.5. 2 Management Representative

5.5. 3 Internal Communication 5.6 Management Review

5.6.1 General 5.6.2 Review Input 5.6.3 Review Output

6 Resource Management 6.1 Provision of Resources 6.2 Human Resources

6.2.1 General 6.2.2 Competence, Training and Awareness

6.3 Infrastructure 6.4 Work Environment

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2-16 ISO9 2/10 ©STP

7 Product Realization 7.1 Planning of Product Realization 7.2 Customer-related Processes

7.2.1 Determination of Requirements Related to the Product 7.2.2 Review of Requirements Related to the Product 7.2.3 Customer Communication

7.3 Design and Development 7.3.1 Design and Development Planning 7.3.2 Design and Development Inputs 7.3.3 Design and Development Outputs 7.3.4 Design and Development Review 7.3.5 Design and Development Verification 7.3.6 Design and Development Validation 7.3.7 Control of Design and Development Changes

7.4 Purchasing 7.4.1 Purchasing Process 7.4.2 Purchasing Information 7.4.3 Verification of Purchased Product

7.5 Production and Service Operations 7.5.1 Control of Production and Service Provision 7.5.2 Validation of Processes for Production and Service

Provision 7.5.3 Identification and Traceability 7.5.4 Customer Property 7.5.5 Preservation of Product

7.6 Control of Monitoring and Measuring Equipment


ISO9 12/08 ©STP 2-17

8 Measurement, Analysis and Improvement

8.1 General

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

8.2.2 Internal Audit

8.2.3 Monitoring and Measurement of Processes

8.2.4 Monitoring and Measurement of Product

8.3 Control of Nonconforming Product

8.4 Analysis of Data

8.5 Improvement

8.5.1 Continual Improvement

8.5.1 Corrective Action

8.5.1 Preventive Action

Chapter 2

2-18 ISO9 12/08 ©STP

Figure 2-1: ISO 9001 Element Detail Model


ISO9 12/08 ©STP 2-19

What are the Element Requirements? Each element and sub-element of ISO 9001 is listed below with its general requirements. For full documentation, you may wish to purchase the ISO 9001 Standard from the standards body in your specific country.

4 QUALITY MANAGEMENT SYSTEM 4.1 General Requirements 4.2 General Documentation requirements 4.2.1 General 4.2.2 Quality Manual 4.2.3 Control of Documents

4.2.4 Control of Records

4 QUALITY MANAGEMENT SYSTEMS

Define Scope

4.1 General Requirements Your organization shall establish, implement, maintain, and continually improve a QMS in accordance with the ISO 9001 Standard. To implement your QMS, the organization shall: a. IDENTIFY the processes needed for the QMS and their

application. b. IDENTIFY sequence and interaction of these processes. c. IDENTIFY criteria and methods required to insure effective

operation and control of these processes. d. INSURE implementation of actions to achieve planned results,

ensuring availability of resources and information. e. INSURE measurement, monitoring, analysis of these processes to

achieve planned results. f. IMPROVE continually improve these processes. Processes shall be managed by the organization in accordance with ISO 9001 standard.

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2-20 ISO9 12/08 ©STP

Note: Outsourced processes (performed by external parties) that affect product conformity with requirements shall be identified and controlled. Control type may be influenced by factors such as the potential impact of the activities on the product requirements and the controls on it. Insure that controls are outlined in 7.4 purchasing, as well as under legal and customer requirements. The processes needed for your QMS should include processes for management activities, provision of resources, product realization, and measurement.

4.2 Documentation Requirements

4.2.1 General Your organization must document and maintain its QMS. The QMS documentation shall include: a. a quality policy and objectives; b. a quality manual; c. documented procedures and records as required by the standard; and d. documents and records required by the organization to insure

effective planning, operation and control of its processes. Where the term “Documented Procedure” is indicated in the standard, the procedure must be established, documented, implemented, and maintained. Documentation can differ from one organization to another due to size and types of activities, complexity of processes and their interactions, and competence of personnel. Documentation can be in any form or type of medium. Note: A single document may include requirements for one or more procedures, or the requirement may be covered in a number of documents.

4.2.2 Quality Manual Your organization will establish a quality manual that will describe the scope of the system, including details of and justification for any exclusions, and the core elements of your QMS and how they interrelate. Documented procedures need to be referenced and include a description of how the processes of the QMS interact.


ISO9 12/08 ©STP 2-21

4.2.3 Control of Documents The documents required for your QMS need to be controlled. You need to develop a procedure to describe how you manage the following: a. Approve documents for adequacy, prior to issue. b. Review, update as necessary, and re-approve documents. c. Identify the current revision status of documents and insure

changes are identified. d. Insure relevant versions of applicable documents are available at

points of use. e. Insure documents remain legible, readily identifiable, and

retrievable. f. Insure that documents of external origin determined by

organization to be necessary for planning and operation are identified and their distribution controlled.

g. Prevent the unintended use of obsolete documents, and apply suitable identification to them if they are retained for any purpose.

4.2.4 Control of Records Documents defined as quality records shall be controlled. Records shall be established, and controlled to provide evidence of conformance to requirements and effective operation of the QMS. A procedure shall be established to describe the control of quality records, including: a. how records are identified, b. where they are stored and protected so as not to be lost or damaged, c. retrieval of records, d. what are their retention times, e. who is responsible for maintaining them, f. the maintenance of records, and g. record disposal. Records are kept to provide the proof (evidence) that activities have taken place, tests have been conducted, and monitoring has been completed. They should be legible, readily identifiable, and retrievable.

Chapter 2

2-22 ISO9 12/08 ©STP

5 MANAGEMENT RESPONSIBILITY 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.4.1 Quality Objectives 5.4.2 Quality Management System Planning 5.5 Responsibility, Authority, and Communication 5.5.1 Responsibility and Authority 5.5.2 Management Representative 5.5.3 Internal Communication 5.6 Management Review 5.6.1 General 5.6.2 Review Input

5.6.3 Review Output

5 MANAGEMENT RESPONSIBILITY

5.1 Management Commitment Top management is responsible for developing and improving the QMS. The commitment to meet customer requirements and expectations needs to be communicated to the organization. Top management shall provide evidence of its commitment to the development, implementation and improvement of the quality system by: • insuring that the importance of meeting customer, as well as

statutory and regulatory/legal requirements is communicated to the organization;

• establishing a quality policy and quality objectives; • insuring that everyone in the organization understands the quality policy

and objectives and how they relate to their own individual positions; • conducting management reviews to assess how the system is

working and identify ways to improve it; and • insuring the availability of necessary resources to assist the running

of the quality system.


ISO9 12/08 ©STP 2-23

5.2 Customer Focus Top management shall insure that customer needs and expectations are determined, converted into requirements, and fulfilled with the aim of achieving customer satisfaction.

5.3 Quality Policy Top management shall take the responsibility to define, implement, maintain, and communicate their quality policy: The policy needs to: • be appropriate to the purpose of the organization; • include a commitment to comply with requirements—meeting

customer and statutory and regulatory requirements, as well as to continually improve the effectiveness of the quality management system;

• provide a framework for establishing and reviewing quality objectives;

• be communicated and understood at appropriate levels in the organization; and

• be reviewed for continual suitability.

5.4 Planning

5.4.1 Quality Objectives Top management shall insure that quality objectives are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy including the commitment to continual improvement. Quality objectives shall include those needed to meet product requirements (see 7.1).

5.4.2 Quality Planning Top management shall insure that the planning of the QMS is carried out to achieve the requirements given in 4.1—General Requirements and Quality Objectives. The integrity of the QMS needs to be maintained when changes are planned and implemented.

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5.5 Responsibility, Authority, and Communication

5.5.1 Responsibility and Authority Top management shall insure that responsibilities and authorities are defined and communicated.

5.5.2 Management Representative Top management will appoint a member of the organization’s management who, irrespective of other responsibilities, will have the responsibility and authority to: • insure that the QMS is established, implemented and maintained in

accordance with the ISO 9001 and the organization’s requirements; • report to top management on the performance of the system,

including needs for improvement; and • insure promotion of awareness of customer requirements

throughout the organization. The responsibility of a management representative may include liaison with external parties on matters relating to the quality management system.

5.5.3 Internal Communication Top management shall insure communication processes are established to insure that communication takes place at various levels and functions within the organization regarding its QMS and its effectiveness. Such information can include the organization’s quality policy, its objectives and targets, customer and other requirements, process monitoring and measurement statistics, and audit results. A communication plan will assist your organization to identify its requirements and plan how it will achieve internal communications. There are many tools that can be used for internal communication such as emails, notice boards or bulletin boards, in-house newspapers, suggestion boxes, or team meetings.


ISO9 12/08 ©STP 2-25

5.6 Management Review

5.6.1 General Top management shall review the QMS at planned intervals to insure its: • continuing suitability, • adequacy; and • effectiveness. The review shall include assessing opportunities for improvement and changes to the organization’s QMS, to guarantee the quality policy is adhered to and quality objectives met.

5.6.2 Review Input Inputs to management reviews shall include current performance and improvement opportunities. This input can come in the form of: • internal and third-party audit results, • customer feedback, • process performance and product conformance reports, • the corrective and preventive action system, • follow-ups on nonconformances from earlier management reviews, • improvement recommendations, and • what changes could affect the QMS.

5.6.3 Review Output The output from the management review shall include decisions and actions related to improvement and effectiveness of the QMS, its processes, and the product related to customer requirements and resource needs.

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6 RESOURCE MANAGEMENT 6.1 Provision of Resources 6.2 Human Resources 6.2.1 General 6.2.2 Competence, Awareness, and Training 6.3 Infrastructure

6.4 Work Environment

6 RESOURCE MANAGEMENT

6.1 Provision of Resources The organization needs to determine and provide the resources needed to implement, maintain, and improve the effectiveness of the QMS, and enhance customer satisfaction by meeting their requirements.

6.2 Human Resources

6.2.1 General Personnel performing work affecting conformity to product requirements (directly or indirectly) need to be competent. Competency is based on: • applicable education, • training, • skills, and • experience.

6.2.2 Competence, Training and Awareness Your organization shall identify competency for personnel performing activities affecting conformity to product requirements (including legal requirements), provide the training where applicable or other actions to satisfy these needs, and insure necessary competency has been achieved. You must insure that your employees are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. Records must be maintained on employees’ education, training, skills, and experience.


ISO9 2/10 ©STP 2-27

6.3 Infrastructure Your organization shall identify, provide, and maintain the infra-structure needed to achieve conformity to product requirements. The infrastructure includes, as applicable, resources such as workspace, buildings and associated utilities, process equipment (both hardware and software), and supporting services such as communication, information systems or transportation.

6.4 Work Environment Your organization shall identify and manage the work environment to achieve conformity to product requirements. Work environment relates to the conditions under which work is being performed. These conditions can include physical, environmental and other factors, such as: lighting, noise, temperature, humidity or weather. Note: Examples are not all-inclusive.

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7 PRODUCT REALIZATION 7.1 Planning of Realization Processes 7.2 Customer-Related Processes 7.2.1 Determination of Requirements Related to the Product 7.2.2 Review of Requirements Related to the Product 7.2.3 Customer Communication 7.3 Design and Development 7.3.1 Design and Development Planning 7.3.2 Design and Development Inputs 7.3.3 Design and Development Outputs 7.3.4 Design and Development Review 7.3.5 Design and Development Verification 7.3.6 Design and Development Validation 7.3.7 Control of Design and Development Changes 7.4 Purchasing 7.4.1 Purchasing Information 7.4.2 Purchasing Information 7.4.3 Verification of Purchased Product 7.5 Production and Service Provision 7.5.1 Control of Production and Service Provision 7.5.2 Validation of Processes for Production and Service

Provision 7.5.3 Identification and Traceability 7.5.4 Customer Property 7.5.5 Preservation of Product

7.6 Control of Monitoring and Measuring Equipment


ISO9 12/08 ©STP 2-29

7 PRODUCT REALIZATION

7.1 Planning of Product Realization The organization shall plan and develop the processes they need for product realization. The planning of product realization should be consistent with the requirements of the other processes of the organization’s QMS (see 4.1). In planning product realization, your organization shall identify and determine the following, as appropriate: • quality objectives and requirements for your product(s); • establish processes and insure documentation; • provide resources specific to the product; • verification and validation activities to meet the requirements; • monitoring, measurement, inspection and test activities specific to

the product and the criteria for product acceptability; and • records needed to provide evidence of the processes and product

meeting the requirements (4.2.4).

Note: A quality plan – a document specifying the processes of the QMS (including the product realization processes) and the resources to be applied to a specific product, project or contract.

You may also apply the requirements given in Design (7.3) to the development of the product realization process.

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7.2 Customer-related Process

7.2.1 Determination of requirements related to the product. Your organization shall determine: • requirements specified by the customer; requirements for delivery,

and post-delivery activities; • requirements not stated by the customer but necessary for intended

or specified use; • regulatory and statutory product requirements; and • any other requirements that are determined by the organization. Note: Post delivery activity examples: include: warranty provisions, contractual obligations, maintenance services, and recycling or final disposal.

7.2.2 Review of Requirements related to the Product Your organization shall review the product requirements prior to a commitment to supply the product to the customer (i.e., submission of tender, acceptance of contracts or orders, acceptance of changes to contracts or orders). Your organization must insure that they: • Define product requirements. • Resolve contract or order requirements differing from those

previously expressed. • Have the ability to meet defined requirements. • Where the customer provides no documented statement of

requirements, insure clear understanding of what is required. The customer requirements shall be confirmed before acceptance.

• Maintain records of the results of review and subsequent follow-up actions (4.2.4).

• Amend documentation when product requirements are changed. Inform relevant personnel of changed requirements.

7.2.3 Customer Communication Your organization must identify and implement effective communication with customers relating to: • product information; • inquiries, contracts, or order handling (including amendments); and • customer feedback, including customer complaints.


ISO9 12/08 ©STP 2-31

7.3 Design and Development

7.3.1 Design and Development Planning Your organization shall plan and control the design and development of your product(s). Design and development planning shall include: • stages of design and/or development; • review, verification, and validation activities appropriate to each

design and/or development stage; (Note: may be conducted and recorded separately or in combination.) and

• responsibilities and authorities for design and development activities.

Insure that your organization shall manage the interfaces between all groups involved in design and development (from customers to contractors to your own employees) to insure effective communication and clarity of responsibilities. Planning output shall be updated, as appropriate, as your design and development progresses.

7.3.2 Design and Development Inputs Your organization shall identify inputs relating to product requirements and maintain records (4.2.4) including: • functional and performance requirements, • applicable regulatory and statutory requirements, • applicable information derived from previous similar designs, and • any other requirements essential for design and development. These inputs shall be reviewed for adequacy and completeness and to insure that these requirements are not ambiguous or in conflict with each other.

7.3.3 Design and Development Outputs Outputs of design and development shall be provided in a form that enables verification against the design and development input. Design outputs shall be approved prior to release. Design and development outputs should: • meet the input requirements; • provide the necessary information for purchasing, production,

service;

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• contain or reference product acceptance criteria; and • specify characteristics of product that are essential for safe and

proper use. Note: Preservation of product details can be outlined in production and

service provision

7.3.4 Design and Development Review Systematic reviews should be performed at suitable stages in the design and development process, in accordance with your planned arrangements (7.3.1). These reviews conducted by those representatives of functions concerned with design and development stages should evaluate the ability of the results of design and development to meet the set requirements and identify any problems and propose necessary actions. Records of these reviews should be maintained along with the action items required.

7.3.5 Design and Development Verification Verify that the design and development outputs meet input requirements needs to be documented (4.2.4) and any action items arising also need to be recorded and maintained. Verification shall be performed in accordance with planned arrangements (7.3.1).

7.3.6 Design and Development Validation Validation of design and development shall be performed in accordance with planned arrangements (7.3.1) to insure that the resulting product is capable of meeting the requirements for the intended use or specified application. Validation shall be completed and recorded wherever possible, prior to the delivery or implementation of the product. Records of results and any necessary actions shall be maintained.

7.3.7 Control of Design and Development Changes Identify, document, and control design and development changes and necessary actions and maintain records. Review, verify, and validate as appropriate and approve the changes before implementation. This review of design and development changes shall be documented and includes evaluation of the effect of the changes on constituent parts and products already delivered.


ISO9 2/10 ©STP 2-33

7.4 Purchasing

7.4.1 Purchasing Process Your organization shall control its purchasing processes to insure purchased product conforms to specified requirements. The type and extent of control applied to suppliers and product shall be dependent upon the effect they have on product realization or the final product. Suppliers should be evaluated and selected, based on their ability to supply product in accordance with the organization’s requirements. Your organization needs to establish the criteria for selection, evaluation, and re-evaluation. Records shall be maintained of the results of evaluations and any necessary actions.

7.4.2 Purchasing Information Your organization shall inform your suppliers on purchasing information describing the product(s) to be purchased, including, where appropriate, the requirements for approval of: • product, • procedures, • processes, • equipment, • qualification of personnel, and • quality management system requirements. Insure adequacy of specified requirements prior to their communication to the supplier.

7.4.3 Verification of purchased product Your organization shall establish and implement inspection or other activities for insuring that the purchased product meets specified purchase requirements. Intended verification arrangements and methods of product release should be stated within the purchasing information.

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7.5 Production and Service Provision

7.5.1 Control of Production and service provision Your organization shall plan and carry out your production and service provision under controlled conditions. These conditions shall include: • insuring availability of information that describes the product

characteristics, • insuring availability of work instructions as necessary, • use of suitable equipment, • availability and use of equipment for monitoring and measurement, • implementation of monitoring and measurement, and • implementation of release, delivery, and post-delivery activities.

7.5.2 Validation of processes for production and service provision Your organization shall validate any process for production and service provision where the resulting output cannot be verified by monitoring and measurement. This includes processes where deficiencies only become apparent after the product is in use or service has been delivered. Your organization shall establish arrangements for these processes, as applicable: • defining criteria for review and approval of processes, • approval of equipment and qualified personnel, • using specific methods and procedure, • record requirements—validation, and • re-validating the production and service processes.

7.5.3 Identification and traceability The product, where appropriate, should be identified by suitable means throughout product realization. Your organization shall identify the product status related to monitoring and measurement requirements. Identify where traceability is a requirement and control and maintain records of the unique identification of the product. Note: In some industry sectors, configuration management is a means for identification and traceability.


ISO9 2/10 ©STP 2-35

7.5.4 Customer Property Your organization shall exercise care with customer property that is under your control or being used by your organization. Customer property should be identified, verified, protected, and safeguarded. Lost, damaged or unsuitable property shall be reported to the customer and records maintained. Customer property can include intellectual property and personal data.

7.5.5 Preservation of Product Your organization shall preserve conformity of product(s) and constituent parts during internal processing and delivery to intended destination to maintain conformity to requirements. This preservation shall include identification, handling, packaging, storage, delivery, and protection.

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7.6 Control of Monitoring and Measuring Equipment Your organization shall identify the monitoring and measurement requirements and equipment needed to provide evidence of conformity of the product to determined requirements (see 7.2.1) and insure that they are carried out in accordance with these requirements. Measuring equipment shall insure valid results and must meet the following criteria. Equipment must be: • calibrated or verified at specified intervals, or prior to use.

Measurement standards traceable to international or national measurement standards must be used. Where no such standards exists, you must record the basis used for your calibration or verification;

• adjusted or re-adjusted as necessary; • identification of calibration status; • safeguarded from adjustments that would invalidate the

measurement result; and • protected from damage and deterioration during handling,

maintenance and storage. In addition, your organization shall assess and record the validity of previous measuring results, when equipment is found not to conform to requirements. Your organization needs to take appropriate action on the equipment and any product that was affected by the nonconformance. You are required to record and maintain the results of calibration and verification. The ability of computer software to satisfy the intended application shall be confirmed prior to initial use and reconfirmed as necessary when used in the monitoring and measurement of specified requirements (verification and configuration management – maintaining suitability for use).


ISO9 5/12 ©STP 2-37

8 MEASUREMENT, ANALYSIS, AND IMPROVEMENT 8.1 General 8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction 8.2.2 Internal Audit 8.2.3 Monitoring and Measurement of Processes 8.2.4 Monitoring and Measurement of Product 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5 Improvement 8.5.1 Continual Improvement 8.5.2 Corrective Action

8.5.3 Preventive Action

8 MEASUREMENT, ANALYSIS, AND IMPROVEMENT

8.1 General Your organization shall plan and implement the monitoring, measurement, analysis, and improvement processes needed to confirm conformity of the: • product requirements, • QMS, and • continual improvement of the effectiveness of the QMS. You need to identify the applicable methods, including statistical techniques, and the extent of their use.

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2-38 ISO9 5/12 ©STP

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction As one method of measuring the performance of the QMS, your organization shall monitor information relating to customer perception (input from sources such as customer satisfaction surveys, opinion surveys, lost business reports, warranty claims, dealer reports) as to whether the organization has met customer requirements. Identify the methods for obtaining and using this information for meeting and improving customer requirements.

8.2.2 Internal Audit Internal audits shall be conducted at your organization, at planned intervals, to determine whether the QMS conforms to specified criteria (i.e., ISO Standard) and is effectively implemented and maintained meeting the following: • planned arrangements (see 7.1), • requirements of this International Standard, and • QMS requirements established by the organization. An audit program shall be planned and documented in a procedure. The audit criteria, scope, frequency, and methods need to be defined, as well as the roles and responsibilities and requirements for planning, conducting, reporting, and maintaining records for the audits and their results. Selection of auditors and conduct of audits shall insure objectivity and impartiality of the audit process. Auditors shall not audit their own work. When planning the audit, take into consideration the risks, the status and importance of the processes and areas to be audited, as well as the results of previous audits. Management responsible for the area being audited will insure that actions are taken without undue delay to eliminate the detected nonconformances addressed from the audit and their causes. Follow-up activities shall include verification of actions taken and reporting of verification results (see 8.5.2 Corrective Action). Note: Refer to the International Standard’s guideline for auditing ISO 19011:2011—“Guidelines for Auditing Management Systems.”


ISO9 12/08 ©STP 2-39

8.2.3 Monitoring and Measurement of Processes Your organization shall apply suitable methods for monitoring and where applicable, measurement of the QMS processes in relation to impact on its product requirements and effectiveness of QMS (quantifying risks – take into consideration the status of the importance of the process), to demonstrate the ability of the processes to achieve planned results. Corrections and corrective action(s) will need to be taken, as appropriate when planned results are not achieved.

8.2.4 Monitoring and Measurement of Product Your organization shall monitor and measure the characteristics of the product to verify that product requirements have been met according to planned arrangements. This shall be carried out at appropriate stages of the product realization process. Evidence of conformity with the acceptance criteria needs to be maintained. Records will indicate the person(s) authorizing release of the product for delivery to the customer (see 4.2.4 Control of Records). You must insure that product release and service delivery does not proceed until all the planned arrangements (see 7.1 Planning of Product Realization) have been completed satisfactorily, unless approved by a relevant authority, and where applicable, the customer.

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8.3 Control of Nonconforming Product Your organization shall identify and control product(s) that do not conform to product requirements to prevent unintended use or delivery. Establish a documented procedure to define the controls and related responsibilities and authorities for dealing with nonconforming product. The standard outlines that organizations shall deal with nonconforming product, where applicable, by one or more of the following ways, taking action to: • Eliminate the detected nonconformity. • Preclude its original intended use or application. • Authorize its use, release or acceptance under concession by a

relevant authority and, where applicable, by the customer. • Take action appropriate to the effects, or potential effects, of the

nonconformity when the nonconforming product is detected after delivery or use has started.

Insure that records of the nonconformities and actions taken, including concessions obtained, are documented and maintained (see 4.2.4). Nonconforming product that has been corrected needs to be re-verified to demonstrate conformity to the requirements.


ISO9 12/08 ©STP 2-41

8.4 Analysis of Data Your organization shall determine the suitability and effectiveness of your QMS and evaluate where continual improvement can be made. To accomplish this you will need to determine, collect and analyze appropriate data generated as a result of monitoring and measurement and from other relevant sources. Analysis of data will provide information on the following: • customer satisfaction (see 8.2.1); • conformance to product requirements (see 7.2.1); • characteristics and trends of products and processes, including

opportunities for preventive action; and • suppliers.

8.5 Improvement

8.5.1 Continual Improvement Your organization shall continually improve the effectiveness of its QMS through the following clauses (sometimes referred to as elements): • quality policy (5.3), • quality objectives (5.4.1), • internal audit (8.2.2), • analysis of data (8.4), • corrective action (8.5.2), • preventive action (8.5.3), and • management review (5.6).

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8.5.2 Corrective Action Your organization shall document a procedure on dealing with nonconformities. The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions need to be appropriate to the effects of the nonconformities encountered. In your documented procedure define how you handle the following requirements: • Review nonconformities (including customer complaints). • Identify causes of nonconformities. • Evaluate the need for action to insure that nonconformities do not

recur. • Determine and implement the corrective action needed. • Record results of action taken (see 4.2.4). • Review of corrective actions taken.

8.5.3 Preventive Action A documented procedure shall be written to define how you manage preventive actions, to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions need to be appropriate to the effects of the potential problems. In your documented procedure, describe how you deal with the following: • Identify potential nonconformities and their causes. • Evaluate the need for action to prevent occurrence of

nonconformities. • Determine and implement action(s) needed. • Record results of action(s) taken (see 4.2.4). • Review of preventive action taken.

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ISO 9001 Quality Management Systems:

Implementation and Integration



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