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ISO Terms Explained

by ISOUpdate.com - Apr 11, 2022

To the novice quality manager, ISO jargon can be extremely overwhelming. What is an NCR? What do you mean by OFI? Are we certified or accredited? But before you go and pull out your hair, let’s take a moment to go over some of the most frequently used terms and their definitions with regards to ISO and Management System Certification.

Are you Accredited, Certified or Registered to an ISO Standard?

First things first. You are not certified to an ISO Standard, your company’s management system is certified. Individuals cannot be certified to an ISO Standard. However, individuals can receive training to become auditors to audit companies against an ISO Standard. For example, you may seek training and personnel certification to become an ISO 27001 Lead Auditor. You cannot be certified to ISO 27001.

The terms ‘’accreditation’’ “registration” and ‘’certification’’ are sometimes used interchangeably, but they don’t share the same meanings, technically.

CERTIFICATION:

An organization is considered certified to an ISO Standard if they have developed and maintained a compliant management system that has been audited by a third-party auditor from an accredited Certification Body (CB). To maintain certification, the organization will undergo annual audits from the CB to verify continuing compliance to the specific standard. A certification document or a certificate will be issued as an attestation of conformity of an organization’s management system to a specific management system standard or other normative requirements. Certification can be revoked if regular audits are not conducted, or if your management system persistently or seriously fails to meet certification requirements.

ACCREDITATION:

Accreditation is how an authoritative body provides formal recognition that an organization is competent to carry out specific tasks. Accreditation Bodies (AB) accredit Certification Bodies (CB) that demonstrate competence to audit and certify organizations conforming with management system standards. The accreditation process ensures impartiality and competence and fosters confidence and acceptance of the CB’s certifications by public and private sector end users. Accreditation provides assurance to customers that CB’s operate according to internationally accepted criteria.

REGISTRATION:

Registration is another term for Certification. The terms Registration and Registrar are not used much anymore in this industry and Certification is now the preferred term.

Audits, Auditing & Auditors

Auditing:

Auditing is the systematic process of collecting and evaluating information about an organization’s management system to determine their level of compliance with the standard they are being audited against.

Types of Auditors

Consultants:

Management system consultants provide organizations with specific advice, instructions or solutions towards the development, implementation, and maintenance of a management system. They may also prepare or produce manuals or procedures for the management system.

Internal Auditors:

An internal auditor is a company employee who independently and objectively evaluates the operations of an organization’s management system. Internal auditors perform internal assessments of the organization and prepare reports for management.

Note: Internal audits are required by ISO management system standards but cannot be used to grant certification to an organization.

Third-Party or External Auditors:

Individual(s) who conducts the audit(s) on behalf of the certification body. Unlike a consultant or internal auditor, third-party auditors are impartial. Their job is to collect and evaluate objective evidence to determine if the management system complies with the ISO Standard. Based on these findings, the CB will make a recommendation for certification.

Certification Body:

A Certification Body (CB) is an accredited third-party organization that audits and issues certificates to companies seeking certification to various ISO Standards. CB’s obtain accreditation to be able to certify to a specific ISO Standard(s). CB’s are audited by Accreditation Bodies (AB) to ensure impartiality and conformity of their work and processes.

Accreditation Body:

An Accreditation Body (AB) is an organization that provides accreditation services. AB’s provide formal, third party recognition that a Certification Body is competent to issue certification to specific ISO Standards.

The ISO Lingo – Commonly Used Term & Definitions:

The following Terms & Definitions are from ISO/IEC 17021-1

Certified Client

organization whose management system has been certified

Impartiality

presence of objectivity ; freedom from conflict of interest / bias

Note 1 to entry: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the certification body.

Client

organization whose management system is being audited for certification purposes

Auditor

person who conducts an audit

Competence

ability to apply knowledge and skills to achieve intended results

Guide

person appointed by the client to assist the audit team

Observer

person who accompanies the audit team but does not audit

Technical Area

area characterized by commonalities of processes relevant to a specific type of management system and

its intended results.

Note: The term “technical area” is applied differently depending on the management system standard being considered. For any management system, the term is related to products, processes and services in the context of the scope of the management system standard. The technical area can be defined by a specific certification scheme or can be determined by the certification body. It is used to cover a number of other terms such as “scopes”, “categories”, “sectors”, etc., which are traditionally used in different management system disciplines.

Nonconformity (NCR)

non-fulfilment of a requirement

Major Nonconformity (Major NCR)

a nonconformity that affects the capability of the management system to achieve the intended results.

Note: Nonconformities could be classified as major in the following circumstances:

if there is a significant doubt that effective process control is in place, or that products or services will meet specified requirements;
a number of minor nonconformities associated with the same requirement or issue could demonstrate a systemic failure and thus constitute a major nonconformity.

Minor Nonconformity (Minor NCR)

a nonconformity that does not affect the capability of the management system to achieve the intended results.

Technical Expert

person who provides specific knowledge or expertise to the audit team. Specific knowledge or expertise is that which relates to the organization, the process or activity to be audited.

Certification Scheme

conformity assessment system related to management systems to which the same specified requirements, specific rules and procedures apply

Audit Time

time needed to plan and accomplish a complete and effective audit of the client organization’s management system

Duration of management system certification audits (Audit Duration)

part of audit time spent conducting audit activities from the opening meeting to the closing meeting, inclusive.

Audit activities normally include:

conducting the opening meeting;
performing document review while conducting the audit;
communicating during the audit;
assigning roles and responsibilities of guides and observers;
collecting and verifying information;
generating audit findings;
preparing audit conclusions;
conducting the closing meeting.

Opportunity for Improvement (OFI)

Situations where the evidence presented indicates a requirement has been effectively implemented, but based on auditor experience and knowledge, additional effectiveness or robustness might be possible with a modified approach.

Are ISO Standards Right for My Business?

by ISOUpdate.com - Aug 11, 2020

Product, Place, Price, Promotion. AKA, The Marketing Mix. This tool developed by J. McCarthy is a business basic model “used to pursue its marketing objectives in the target market”.

The Marketing Mix is one tool that can help you as an organization understand how to promote yourself and your product in a way that makes sense for your customer and their needs.

One thing you may learn during your analysis is your customers’ need for quality for example, or perhaps they care deeply about the environment and spending their dollars with environmentally conscious companies.

Researching your customer and their purchasing decisions can lead you to a new growth avenue – but can you achieve these?

In this article, you will learn how the adoption of standards, like ISO 9001, ISO 14001 or ISO 45001 can not only help your organization and its longevity, but it can also show your commitment to your customers through certification.

Why ISO Standards?

Part of ISO Guidelines is a framework for success – guiding requirements that have been created by industry professionals and evaluated by a committee. They have been approved as an internationally adopted and recognized framework to build a business upon.

For example, if you work in the Aerospace industry, you have a different framework than those in the Automotive industry because you have different unique challenges.

The generic quality framework, ISO 9001:2015, was designed as a foundation for success with generic business principles and frameworks to allow organizations to create or improve an organization at its most basic roots to ensure efficiency and quality of work.

Implementing ISO 9001 into your business allows you to take time to look deep into the organization, and evaluate what you do great, what you do well, and what needs improvement.

Standards are not only a great foundation to grow a business upon though. These guiding requirements allow you to look within your organization, find your strength and allow them to shine and identify possible areas for improvement, places that need help to grow to their full potential.

The nature of ISO Standards audit processes allows unbiased reviews to truly see the organization without judgement. This is a great marketing opportunity to showcase your strengths.

Promote your certificate, your congratulatory statements from auditors, and what you are proud of.

Part of ISO 9001 is also measuring and monitoring. If you are interested in learning about how much productivity has gone up each quarter, or the number of sales per year, you are encouraged to do so in ISO 9001.

This is a great opportunity to learn real facts about your organization, in an effective manner, that you can then share with your customers. These are real, tangible numbers than can really impress prospective clients.

If you are looking to attract new people to your organization, you might want to look into obtaining ISO 14001:2015 certification. “Of those born between 1981 and 1996, 62% want to work for a company that makes a positive impact”.

Companies with an active interest in sustainable practices, and the certification to prove that, can gain a lot of edge in the competitive hiring market place. Not only that but showcasing your commitment to sustainability and quality of goods and workplace safety with certification to ISO 45001, the standard for occupation health & safety, can prove to prospective hires how committed to their wellbeing you are.

Standards help you as an organization navigate best practises while allowing you to thrive as a unique organization and culture.

ISO Certification does not ask you to subscribe to a one size fits all approach to business. But it does show you how to eliminate inefficiencies and set you on a path for growth and longevity with a base set of tools for success.

What is Quality

by ISOUpdate.com - Sep 23, 2019

The Concept of Quality in ISO 9001

Quality can be defined as “fitness for use,” “customer satisfaction,” “doing things right the first time,” or “zero defects.” Webster’s dictionary defines quality as “a degree of excellence” and “superiority in kind”.

Within an organization, quality is controlled and measured using a quality system – a mechanism that coordinates and maintains the activities of the organization needed to ensure that the characteristics of products, processes or services are within certain bounds. A proper quality system considers all interested parties – everyone directly or indirectly affected by these activities and is typically documented in a quality manual. The quality manual dictates the associated processes and documents that specify procedures and standards to achieve and maintain quality of goods, services and outputs of the company.

Basic Elements in a Quality System

There are three basic elements in a quality system: Quality Management, Quality Control, and Quality Assurance.

Quality Management being the means of implementing and carrying out the quality policy.
Quality Control being all the techniques and activities of an organization that continuously monitor and improve the conformance of products, processes or services to specifications.
Quality Assurance being all the planned and systematic actions necessary to assure that a product or service will satisfy the specified requirements.

As stated in an ANSI/ASQ standard: “Quality control has to do with making quality what it should be, and quality assurance has to do with making sure quality is what it should be.”

Quality Audits

How can an organization determine if their Quality System is effective? This is done through a quality audit – an independent assessment comparing the various management and quality activities to a specific standard.

An independent assessment implies that the person performing the audit is not associated with the activity being audited. In the past, the specific standard to which a quality system was compared was up to the business owners themselves. Be it customer satisfaction, internal approval or whatever was deemed acceptable to leave the factory. It wasn’t until 1987 that an ISO technical committee developed and published the ISO 9000 family of standards – quality standards that set the benchmark for the minimum requirements for an adequate quality system. – Source

What are Quality Standards?

Quality Standards can be defined as “documents that provide requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and services are fit for their purpose”. – Source

Using standards, an organization can effectively share their goals, processes, procedures, and vocabulary needed to meet the expectations of their stakeholders. Standards provide organizations with an effective road map for the understanding, procedures, and vocabulary needed to meet the expectations of their stakeholders. Because standards provide descriptions and terminology, they allow for ease in international communication and help increase trust between international consumers, suppliers and trade.

One specific standard that is most well known and attributed to Quality is ISO 9001.

ISO 9001 is the internationally recognized QMS standard that was designed as a business improvement tool to help organizations of any size continually improve and streamline operations, reduce operating costs, satisfy more customers and win more business.

When Quality Fails

by ISOUpdate.com - Sep 9, 2019

Standards function to provide the end-user with quality products and services, but they also protect the vitality and reputation of a business. Your system should be built in such a way that it is constantly putting measures and checkpoints in place that does not allow product to leave your hands until it is safe, and up to yours and your customers’ standards. So, how does a product of subpar quality leave your plant? Who is responsible? How did your management system allow this failure to happen? When your product fails, or worse, you must issue a recall and you want to assign blame. Who is to blame? Why did your system fail you?

Case Study – Toyota Unintended Acceleration Recall, 2009

If an auto manufacturer finds flaws in their cars and lists a product recall, the public’s perception of this company will suffer. No greater example of this exists than the 2009 recall of Toyota sedans.

Toyota issued a recall of 8.5 million of their sedans in 2009 due to unintended acceleration caused by floor mat issues, brake problems and “sticky” gas pedals. The recall was issued in response to accidental deaths and provides an example of the grave consequences that may arise from poor execution of a QMS. In this case study, findings suggest that Toyota ignored quality warnings when failures began to happen. This is not a problem that is exclusive to Toyota, but rather an industry, and worldwide, problem. Read the full case study here.

InfoTrend dives into the deteriorated public opinion of Toyota immediately following the recall from the period of 2009-2011 in the United States. They deeply investigated the effects the media had on the public’s opinion, and how the recall shaped their opinion of the brand, being pro-, con- or neutral about the brand.

In 2014, Simply Communicate discussed the strategy Toyota took to rebuild their company image, and their internal culture and morale after the damage took its toll on the company. The shift in the culture at Toyota was substantial, losing talent, working hard to keep talent, and striving to keep employees, even if it meant shifting their jobs, all without losing more profits.

The NHTSA has a handy recall check for those in North America to verify their VIN number against any product recall it may be involved in.

It’s not easy to bounce back from catastrophic product failure, and that is especially true for organizations without multi-millions of profits and bail-out opportunities. It is the goal of a properly implemented ISO 9001 QMS to prevent these failures from happening in the first place. How did my system allow this failure to happen?

How does Failure Occur, and who is to Blame for a Product Failure?

If, or when, a product failure occurs, your organization shouldn’t point fingers. The first question you need to ask is “how did my quality management system allow this failure to occur?”. A simple investigation tactic you may want to implement is “Root-Cause Analysis – 5 Whys”. This method prompts you to ask yourself and your organization “why” until you have a root-cause (this could take fewer or more than 5 “why’s”). The basic framework allows you to develop pathways for why a failure happened in the first place, and where you can identify areas for improvement.

Failures should not be a cause for removal of your certification or attempted to be hidden from your auditor. Failures, especially those caught by your system, should be celebrated. Consider them an indication that your system is working if the problem is caught, and an area for improvement is identified. Feedback is essential for growth, and even negative feedback should be viewed in a positive light and mentality.

Why is Quality Important for My Business?

The aim of any business is to maintain quality to an acceptable standard and failure to do so can result in any number of serious consequences. Quality control is important to guarantee customer satisfaction and more importantly retention. Customers are only likely to be retained and return for another experience if previous services have lived up to their expectations of a certain quality. More importantly, quality also has an effect on company reputation which is paramount to attracting new customers and profits.

Perhaps to customers, the quality of goods or services is the most important aspect of your company, this role proves to be vitally important for the survival and growth of an organization. Maintaining consistent quality without incurring massive costs should then be a primary goal for any organization.

Using ISO 9001:2015 Standard as Strategic Planning Model

by ISOUpdate.com - Aug 7, 2019

ISO 9001 as a Strategic Planning Model - ISO Update

Written by Kashif Mumtaz

Regardless of the other terms used in ISO 9001:2015, the term, Strategic Direction has not been defined in ISO 9000:2015 Quality Management Systems – Fundamentals and Vocabulary. However, ISO 9001:2015 contains the following strong linkages to the strategic direction of the organization:

Clause 4.1 – External and internal issues must be relevant to the Strategic Direction of the organization.
Clause 5.1 – The Quality Policy and Quality Objectives must be compatible with the Strategic Direction of the organization.
Clause 5.2 – The Quality Policy must support the Strategic Direction of the organization.
Clause 9.3 – Management Review Process must ensure the suitability, adequacy effectiveness and alignment of the Quality Management System with the Strategic Direction of the organization.

Strategic Direction as we believe is the organization vision of where the organization wants to be in the future and the development of an overall Strategic Plan is affected by various internal and external factors. Refer to the clause 4.0 of ISO 9001:2015 Context of the Organization which states that the organization shall determine external and internal issues relevant to its purpose and its strategic direction and those affect its ability to achieve the intended results of its Quality Management System. ISO 9001:2015 further elaborates in Notes (1 – 3) of the clause 4.1 that issues can include positive and negative factors or conditions for consideration – Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and international, national or regional economic environments. Understanding of the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.

The strategic planning process is a continual process and if we look at the traditional strategic planning process, it very much resembles with the Plan-Do-Check-Act (PDCA) Cycle of which ISO 9001:2015 is a big promoter to apply this cycle to all organizational processes and the Quality Management System as a whole to implement plans to achieve objectives including strategic. In addition, various functions within the organization having their own strategies can closely be aligned and integrated within the Context of the Organization which is basically overall strategic plan of the organization highlighting all internal and external factors with their resulting impact on the organization along with the approaches to managing risk(s) at the functional and company-wide levels for the achievement of larger mission of the organization.

Having said that, we can say that framework provided by ISO 9001:2015 can be used by the organizations for strategic planning but when the management rejects QMS as strategic planning model and make intuitive decisions then ISO 9001:2015 cannot address or contribute in the overall strategic planning process.

About the Author

Kashif Mumtaz is serving as QA Manager at Omrania in Riyadh, Saudi Arabia and has more than 17 years’ experience in quality assurance & management systems. He is Chartered Quality Professional (CQP) and holds a master’s degree in Quality Management from UK

How Can Total Quality Management Improve Organizational Effectiveness?

by ISOUpdate.com - Jan 22, 2019

Today’s organizational environment is filled with constant and rapid change; technology changes with the blink of an eye, competition is increasing, and customers are demanding greater quality and lower costs. To adapt to these changes and still meet their goals, organizations need to be efficient. Efficiency requires an overall approach and cannot be reached by focusing on a particular process, or on a specific area within an organization. But, how can total quality management improve an organization’s effectiveness?

What is Total Quality Management?

Total Quality Management: a business philosophy which focuses on customer satisfaction and relies on an understanding that a strong focus on employees is necessary to achieve efficiency within an organization.

Total Quality Management is oriented to create quality awareness across an organization, and it considers both the organization’s processes and the employees as integral aspect in an organization quality improvement capacity.

Total Quality Management promotes commitment, participation, cooperation and continuous improvement within organizations. Because every employee and every process is important in achieving organizational effectiveness, Total Quality Management can assist in this matter by empowering all employees and making everyone responsible for meeting internal and external customers expectation.

Every employee, regardless of their role within the organization, can improve quality within their processes.

Total Quality Management can also help organizations achieve effectiveness is by encouraging a dynamic approach to quality improvement. Variations can occur within processes that can negatively alter the desired results.

These variations need to be detected, communicated and addressed promptly to prevent deviations from proposed goals. Therefore Total Quality Management, by encouraging teamwork and empowering employees to make decisions, can facilitate good communication and an effective response within and across different functional units within an organization.

Organizational effectiveness is reached by achieving common goals. Since internal and external customers expectations drive organization’s processes, by meeting and exceeding these expectations, organizations can reach their goals and also obtain a competitive advantage.

Many organizations can utilize Total Quality Management to increase their efficiency. Total Quality Management has been implemented in manufacturing, education, government administration and services. Any type of organization can benefit from Total Quality Management and use it to adapt to constant changes, improve their effectiveness and thus increase competitiveness.

Typical Performance Indicators for an ISO 14001 Management System

Resources

by ISOUpdate.com - Mar 12, 2018

Key Performance Indicators for an ISO 14001 Management System

Why Do You Need Performance Indicators for Your Environmental Management System?

Performance Indicators are the measures that you put in place on your processes and business that provide you with the information that you need to see how well your ISO 14001 management system is performing. Each process could have a whole series of measures that will let you know how well it is performing financially, with regards to quality, H&S compliance and of course environmentally. After all, as the saying goes, “what gets measured gets done.”

Each process could potentially have many different measures that are important to it. Many of these measures will be monitored, and action taken at a local level. While others that are more important could be elevated to being Key Performance Indicators (KPIs) for the business. This ensures that those measures that are vital to your business or have a potential risk associated to them are highlighted.

What Performance Indicators Do You Need for Your ISO 14001 Management System?

Many businesses are used to implementing performance measures as part of their quality management system, however they are equally as important as part of your ISO 14001 management system. Your measures need to be selected with great care for each process within your business and only those that are truly important should be elevated as KPIs for management monitoring.

Each business is of course different as are each of your processes. Therefore, your indicators and measures will always be different to those employed by other businesses. However, some typical measures are detailed below to give you some idea as to what you should implement within your own business:

Use of Natural Resources:

Water, electricity, and gas usage by the business
The amount of paper used within the business

Discharges to Air, Land, and Water:

Pollutant parts per million measures
Weight to landfill

Incidents and Potential Incidents:

Number of actual and potential incidents
Time lost due to incidents

Proactive Measures:

Risk reduction measures implemented
Environmental audit scores

Learn about ISO 45001 and how Performance Indicators have changed since OHSAS 18001

Why is Quality so Important in Business today?

Resources

by ISOUpdate.com - Mar 6, 2018

Have you ever stood staring at a range of products in a supermarket trying to make up your mind which one to buy? They all look quite similar, but one stands out and you buy it. Why? It’s got a sign on the shelf and a logo on the product to tell you that it’s won an award for quality.

So you’ve just based your purchase on Quality – Your customers are making the same decision every day!

Quality is more than just finished product, it’s the processes, systems and people that are behind the product. Quality is everybody’s responsibility.

Quality is the pursuit of excellence, striving to be the best we can and getting ahead of our competitors. It is meeting the needs and expectations of all stakeholders – our customers, our suppliers, our staff and the community at large.

How can we ensure that we are exploiting all avenues to be the very best? A recognized standard such as ISO 9001 certification promotes the use of quality tools in business. The ASQ (American society for quality) estimates that for every €1 spent on a quality management system, such as ISO 9001, returns €6 in revenue, €16 in cost reduction and €3 in profit – that’s €25 for every €1 spent!

93% of organisations agree that the implementation of a quality management system such as ISO9001 was a significant driver of success and most would agree that without it they could not justify their pricing to customers.

If you are looking at ways to improve your ROI by improving your quality then consider ISO certification. Using an expert to help you implement a quality management system will ensure ISO 9001:2015 accreditation which will in turn help you make significant improvements and lead to significant growth.

This post has been a guest posting from Joann O’Brian over at our friends at CG Business Consulting Ireland .

What are Ten Simple Ways to Improve Your QMS

Resources

by ISOUpdate.com - Feb 16, 2018

Improving your Quality Management System is simpler than you think. By learning about ways to improve, you are already well on your way to achieving success with your organization or auditor training. Follow these 10 simple suggestions and you will see changes.

10 Simple Ways to Improve your Quality Management System

1. Commit to improvement

For any QMS to improve, it is essential that everyone is committed to seeking problems, evaluating efficiency and effectiveness of processes and implementing better and improved ideas. Management should be the first to make this commitment and if management “walks the talk” then everyone will follow.

2. Analyse and assess current QMS

Organizations need to take a closer look at their current practices in order to identify any gaps between what is being done and what should be done. This can be achieved by interviewing workers in critical control points, reviewing procedures and records and observing how processes are occurring. Any steps that are not adding value to the process, the system or the organization must be identified, removed or improved.

3. Include everyone in training programs

A QMS is not the responsibility of one person or one department. Everyone must be involved in improving the quality of products, services and processes.

Organizations should establish a training program for new employees and existing ones. These programs should promote knowledge, produce skills and capacities and reduce resistance when implementing new ideas for improvement.

4. Define clear goals and objectives

QMS should aim at achieving specific goals. If a clear path is not drawn, there’s a risk that people will be working real hard but in different directions. Time should be spent in assuring everyone knows these goals, how they’ll be achieved, how they’re measured and periodically they should be informed of where the organization is standing in relation to these goals.

5. Use the correct key performance indicators

Organizations need to carefully select and review their KPI’s (Key Performance Indicators). KPI’s let an organization know how efficient and effective processes are, and indicate where possible problems could be. If they are not giving a real overall picture of where the organization is at regarding quality, then another look should be taken to change or improve what and how performance is being measured.

6. Listen to the suggestion

Create a system that will promote workers and customers to share improvement ideas. Many great improvement ideas come directly from the people processing a product or the people that actually use it.

7. Give credit

Giving credit to those who deserve it encourage participation throughout the organization and motivates workers by recognizing their work and their ideas. Compensation or recognition should not necessarily be monetary, a simple public recognition in working meetings to can have great effects in lifting workers morale.

8. Make the system simple

A QMS that is extremely complex and overloaded with documents is not necessarily the best one. If documents and procedures are long and complicated, it is very likely that people will never use them.

Evaluate the system and make sure that it makes sense and that it’s as simple as possible.

9. Create quality groups

Some organizations face difficulty with workers from different departments or areas that are reluctant with sharing information. By bringing together people from different areas to evaluate processes and recommend improvements, an open and more effective communication can be achieved between areas that operationally seem to be apart.

10. Have a quality attitude

In order to reach the goals that have been set, organizations need to identify and detect problems and weaknesses but they must focus on improvements. If managers are constantly focusing on failures and defects and not on how to remove or improve them, the right attitude and mindset for quality will never be achieved.

Learn how to prepare your company for the ISO Implementation Process.

Documentation Changes around ISO 9001:2015

by ISOUpdate.com - Feb 7, 2018

ISO 9001:2015 represents a major change to the 9001:2008 version. One of these changes regards the Quality Management Systems (QMS) documentation.

The 2008 version of the standard, uses two separate terms “documents” and “records” to identify its documentation, whereas, in the recently published Draft International Standard of the new revision, both these terms are combined as “documented information”.

For those familiar with the 2008 version, it can be said that where it refers to “documented procedures” in the new revision it is expressed as a requirement to maintain documented information. Also, where the 2008 version refers to as “records” it is now expressed as a requirement to retain documented information. Below, there’s a list of the documented information that the new standard requires to be maintained and retained.

Documented information that is required to be maintained with ISO 9001:2015

The scope of the QMS, including the products and services it covers and the justification of those requirements that the QMS will not be able to apply.
Information that supports the operations of processes.
The quality policy.
Information that defines characteristics of products and services, activities to be performed, and the results to be achieved.

Documented information that is required to be retained with ISO 9001:2015

Information necessary to have confidence that processes are being performed as planned and conform to requirements.
Information on the quality objectives.
Information as evidence of fitness for purpose of monitoring and measurement resources.
Information as evidence of competence.
Information describing the results of the review of requirements related to products and services.
Information resulting from the design and development process.
Information on review of design and development changes.
Information of the results of the evaluation, monitoring of performance and re-evaluation of the external providers.
Information necessary to maintain traceability when required.
Information describing the results of the review of changes, personnel authorizing the change, and any necessary actions
Information providing traceability to the person(s) authorizing release of products and services for delivery to the customer.
Information on actions taken on nonconforming process outputs, products and services.
Results of monitoring and measurement activities.
Information as evidence of the implementation of the audit programme and the audit results
Information as evidence of the results of management reviews.
Information as evidence of the nature of the nonconformities, actions taken, and the results of any corrective action.

As it can be seen from the above list, in the new version of the standard, it will not be required to create and maintain a Quality Manual, which has been around since the creation of ISO 9001 in 1987.

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