Auditor Workshop Expected Outcomes July 19th, 2013 · ANAB Accreditation Rule (AR) 44 – ISO 50001...

Company Confidential

Registration Management Committee

Auditor Workshop Expected Outcomes July 19th, 2013 Reg Blake – VP Corporate Development and Regulatory Affairs BSI Group America Inc.

RMC Workshop Indianapolis, IN 18 – 19 July 2013


Contribution Thanks

• Sidney Vianna – DNV

• Robert (Bob) Parsons – NQA USA

• Steve Holladay - ANAB

2



Agenda

• Why are we addressing this issue?

• ISO 9001

• ISO 14001

• Aviation Space and Defense (ASD) Standards

– AS5553

• Other standards:

– ISO 50001

– SN 9001

• Closing Comments



Definition

• The Penguin English Dictionary defines it as:

– Result, effect

• Oxford Dictionary - Definition of outcome – (noun):

– the way a thing turns out; a consequence:

“it is the outcome of the vote that counts”

• Merriam Webster - Definition:

– something that follows as a result or consequence; “a surprising outcome”; “patient outcomes of bypass surgery”



Why are we addressing this issue?

• IAF and ISO expectations

• Industry expectations

• Stakeholder expectations

• More awareness needed



Reference/Source Documents

• Joint Communiqués issued by IAF and ISO:

• Original Document for ISO 9001 can be located at:

http://www.anab.org/media/17250/expectedoutcomesiso9001.pdf

• Original Document for ISO 14001 can be located at:









Reference/Source Documents – ANAB Accreditation Rules

• ANAB Accreditation Rule (AR) 42 (ISO 9001)

• ANAB AR 43 (ISO 14001)

• ANAB AR 47 (AS5553)

• ANAB AR 44 (ISO 50001)

• ANAB AR 49 (SN 9001)

• ISO 9001 Auditing Practices Group Guidance on: “Output matters!”



Expected Outcomes for Accredited Certification to ISO 9001 (from the perspective of the organization’s customers)

• “For the defined certification scope, an organization with a certified quality management system consistently provides products that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction.”

– Notes:

a. “Products” also include “services.”

b. Customer requirements for the product may either be stated (for example in a contract or an agreed specification) or generally implied (for example in the organization’s promotional material, or by common practice for that economic/industry sector).

c. Requirements for the product may include requirements for delivery and post-delivery activities.



What accredited certification to ISO 9001 means

• To achieve conforming products, the accredited certification process is expected to provide confidence that the organization has a quality management system that conforms to the applicable requirements of ISO 9001. In particular, it is to be expected that the organization:

A. has established a quality management system that is suitable for its products and processes, and appropriate for its certification scope;

B. analyzes and understands customer needs and expectations, as well as the relevant statutory and regulatory requirements related to its products;

C. ensures that product characteristics have been specified in order to meet customer and statutory/regulatory requirements;



What accredited certification to ISO 9001 means (Cont’d)


D. has determined and is managing the processes needed to achieve the expected outcomes (conforming products and enhanced customer satisfaction);

E. has ensured the availability of resources necessary to support the operation and monitoring of these processes;

F. monitors and controls the defined product characteristics;



What accredited certification to ISO 9001 means (Cont’d) • To achieve conforming products, the accredited certification

process is expected to provide confidence that the organization has a quality management system that conforms to the applicable requirements of ISO 9001. In particular, it is to be expected that the organization:

G. aims to prevent nonconformities, and has systematic improvement processes in place to:

1. Correct any nonconformities that do occur (including product nonconformities that are detected after delivery)

2. Analyze the cause of nonconformities and take corrective action to avoid their recurrence

3. Address customer complaints;



What accredited certification to ISO 9001 means (Cont’d)


H. has implemented an effective internal audit and management review process, and

I. is monitoring, measuring and continually improving the effectiveness of its quality management system.



What accredited certification to ISO 9001 does not mean

1. It is important to recognize that ISO 9001 defines the requirements for an organization’s quality management system, not for its products. Accredited certification to ISO 9001 should provide confidence in the organization’s ability to “consistently provide product that meets customer and applicable statutory and regulatory requirements”. It does not necessarily ensure that the organization will always achieve 100% product conformity, though this should of course be a permanent goal.




2. ISO 9001 accredited certification does not imply that the organization is providing a superior product, or that the product itself is certified as meeting the requirements of an ISO (or any other) standard or specification.



ANAB Accreditation Rule (AR) 42

• Expected Outcomes for Accredited Certification to ISO 9001:

– The expected outcomes for an organization with accredited certification to ISO 9001 are documented in a Joint Communiqué issued by IAF and ISO (http://www.anab.org/media/17250/expectedoutcomesiso9001.pdf ).

– The CB shall have processes to ensure that its auditors and other certification personnel are knowledgeable of the expected outcomes and consistently reinforce them with the CB’s clients.



ANAB Accreditation Rule (AR) 47 – Accreditation Program for Avoidance of Counterfeit Electronic Parts Management Systems (ACEPMS) - AS5553

• End User Expected Outcomes of Accredited Certification to ACEPMS:

» End users can expect an organization with a certified ACEP management system shall have a process that eliminates or significantly reduces the risk of counterfeits in its products.

» The CB shall have processes to ensure that its auditors and other personnel for certification are knowledgeable of the expected outcomes and are consistently reinforcing this with the CB’s clients.



Expected Outcome of the International Aerospace Quality Group (IAQG)

• ASD Industry and Regulators can expect that the IAQG focuses on the goal of achieving significant improvements in quality and reductions in cost throughout the aviation, space and defense supply chain and its value streams using harmonized standards (i.e. AS9100 / 9110 / 9120).

Design Manufacture Maintenance

Value Stream



Expected Outcome of the IAQG Industry Controlled Other Party (ICOP) Scheme

• Users of the IAQG ICOP scheme shall have the utmost confidence that all parties involved in the ICOP process, and its oversight, operate to the highest standards of performance, ethics, integrity and competence such that an ASD Certification Body certification is recognized by the customer as having value.

SMS

AB

CB

Auditors

AAB

TPAB

OPMT

Cert. Org



Customers Expected Outcome of Suppliers Using AS9100, AS9110 and AS9120

• The expected outcome of using any of these standards is to receive a product or service that meets or exceeds expectations for quality, price and delivery performance based on measurable and achievable objectives.

Quality Price Delivery

Customers Expected Outcomes



Expected Outcome of AS9101D

• Although it is important to make sure that AS9101D documentation is correctly completed, it is even more important that AS9101D ensures the recorded information supports the certification decision.

Getting the paper work correct

Sufficient evidence to support the certification

Stakeholder perspective

Expected Outcome



General Outcomes of ASD Sector • Another outcome of using the AS9100 series

standards is to have a supplier as a partner for the long term.

Continued viability of

organization Collaboration

Long term partner

Effective and Efficient Supply Chain



General Outcomes of ASD Sector • Another key outcome of using the AS9100 series

standards is to deliver customer satisfaction.

Adequately evaluated

Appropriate actions taken

Data accuracy and integrity

Customer Satisfaction



General Outcomes of ASD Sector • Effective and timely use of the OASIS Feedback

Process and other customer feedback processes.

Awareness, knowledge and understanding

Evaluation method

Provision of meaningful

data

Continual Improvement of AQMS



ANAB Accreditation Rule (AR) 43

•Expected Outcomes for Accredited Certification to ISO 14001:

– The expected outcomes for an organization with accredited certification to ISO 14001 are documented in a Joint Communiqué issued by IAF and ISO (http://www.anab.org/media/17253/expectedoutcomesiso14001.pdf).

– The CB shall have processes to ensure that its auditors and other certification personnel are knowledgeable of the expected outcomes and consistently reinforce them with the CB’s clients.



ANAB Accreditation Rule (AR) 44 – ISO 50001

• Expected Outcomes for Accredited Certification to ISO 50001:

» An organization with a certified ISO 50001 EnMS is expected to demonstrate improved energy performance through the use of its EnMS.

» The CB shall have processes to ensure that its auditors and other certification personnel are knowledgeable of the expected outcomes and consistently reinforce them with the CB’s clients.



ANAB Accreditation Rule (AR) 49 – Accreditation Program for SN 9001 Quality Management Systems

• End User Expected Outcomes of Accredited Certification to SN 9001:

» End users can expect an organization with a certified SN 9001 management system to provide safer and more effective snow and ice management.

» The CB shall have processes to ensure that its auditors and other personnel for certification are knowledgeable of the expected outcomes and are consistently reinforcing this with the CB’s clients.



Closing Comments

• It is a flawed mythical assertion that an organization can be in conformance to an AS9100 series standard, yet produce and supply products or services that do not meet customer needs and expectations.

• Certified organizations and certification body auditors often miss the point that the basic requirements such as quality, price and on time delivery are much more important than just focusing on conformance to the detailed requirements in the AS9100 series standards.

• The product or service should always remain on our radar screens. Consistency in producing a product or service that meets or exceeds a customer’s needs and expectations is the outcome we continually need to strive for.



Closing Comments

• Certified organizations processes, throughout the value stream, need to produce and deliver conforming products and services. The AS9100 series standards require it and the integrity of an accredited AQMS certification demands it.

• The output of the AQMS is what matters most to the Members of the IAQG.



Expected Outcomes for Accredited Certification to ISO 14001 (from the perspective of interested parties)

• “For the defined certification scope, an organization with a certified environmental management system is managing its interactions with the environment and is demonstrating its commitment to:

A. Preventing pollution.

B. Meeting applicable legal and other requirements.

C. Continually enhancing its environmental management system in order to achieve improvements in its overall environmental performance.”



What accredited certification to ISO 14001 means • The accredited certification process is expected to ensure that the

organization has an environmental management system, suitable for the nature of its activities, products and services, that conforms to the requirements of ISO 14001, and in particular can demonstrate for the defined scope that the organization:

A. has defined an environmental policy appropriate to the nature, scale and environmental impacts of its activities, products and services;

B. has identified the environmental aspects of its activities, products and services that it can control and /or influence and determined those that can have a significant environmental impact (including those related to suppliers / contractors);

C. has procedures in place to identify applicable environmental legislation and other relevant requirements, to determine how these apply to its environmental aspects and to keep this information up to date;




• The accredited certification process is expected to ensure that the organization has an environmental management system, suitable for the nature of its activities, products and services, that conforms to the requirements of ISO 14001, and in particular can demonstrate for the defined scope that the organization:

D. has implemented effective controls in order to meet its commitment to comply with applicable legal and other requirements;

E. has defined environmental objectives and targets that are measurable, where practicable, taking into account legal requirements and significant environmental aspects, and has programmes in place to achieve these objectives and targets;

F. ensures that people working for or on behalf of the organization are aware of the requirements of its environmental management system and are competent to perform tasks that have the potential to cause significant environmental impacts;



What accredited certification to ISO 14001 means • The accredited certification process is expected to ensure that the

organization has an environmental management system, suitable for the nature of its activities, products and services, that conforms to the requirements of ISO 14001, and in particular can demonstrate for the defined scope that the organization:

G. has implemented procedures for communicating internally, as well as responding to and communicating (as necessary) with interested external parties;

H. ensures that those operations associated with significant environmental aspects are carried out under specified conditions and monitors and controls the key characteristics of its operations that can have a significant environmental impact;

I. has established and (where practicable) tested procedures to address and respond to emergencies that can have an effect on the environment;




• The accredited certification process is expected to ensure that the organization has an environmental management system, suitable for the nature of its activities, products and services, that conforms to the requirements of ISO 14001, and in particular can demonstrate for the defined scope that the organization:

J. periodically evaluates its compliance with applicable legal and other requirements;

K. aims to prevent nonconformities, and has procedures in place to:

1. correct any nonconformities that do occur

2. analyze the cause of any such nonconformities and take corrective action to avoid their recurrence, and

L. has implemented effective internal audit and management review procedures;




1. ISO 14001 defines the requirements for an organization’s environmental management system, but does not define specific environmental performance criteria.

2. Accredited certification to ISO 14001 provides confidence in the organization’s ability to meet its own environmental policy, including the commitment to comply with applicable legislation, to prevent pollution, and to continually improve its performance. It does not ensure that the organization is currently achieving optimal environmental performance.




3. The ISO 14001 accredited certification process does not include a full regulatory compliance audit and cannot ensure that violations of legal requirements will never occur, though full legal compliance should always be the organization’s goal.

4. Accredited certification to ISO 14001 does not necessarily indicate that the organization will be able to prevent environmental accidents from occurring

Auditor Workshop Expected Outcomes July 19th, 2013 · ANAB Accreditation Rule (AR) 44 – ISO 50001...

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